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SAFETY REPORT OF Nail Drops
For Camilla of Sweden AB
2017-02-20
2
Table of content Table of content ..................................................................................................................................... 2
Part A: Cosmetic product safety information ...................................................................................... 3
1. Quantitative and qualitative composition of the cosmetic product .............................................. 3
2. Physical/chemical characteristics and stability of the cosmetic product ..................................... 4
3. Microbiological quality ................................................................................................................. 4
4. Impurities, traces, information about the packaging material ..................................................... 4
5. Normal and reasonably foreseeable use .................................................................................... 5
6. Exposure to the cosmetic product .............................................................................................. 5
7. Exposure to the substances ....................................................................................................... 5
8. Toxicological profile of the substances ....................................................................................... 6
9. Undesirable effects and serious undesirable effects .................................................................. 7
10. Information on the cosmetic product......................................................................................... 7
Part B: Cosmetic product safety assessment ..................................................................................... 7
1. Assessment conclusion .............................................................................................................. 7
2. Labelled warnings and instructions of use .................................................................................. 7
3. Reasoning ................................................................................................................................... 7
Appendix 1 .................................................................................................................................... 11
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Part A: Cosmetic product safety information Product: Nail Drops Responsible person: Camilla of Sweden AB, Kristineholmsvägen 10F, 441 39 Alingsås, Sweden Manufacturer: Camilla of Sweden AB, Kristineholmsvägen 10F, 441 39 Alingsås, Sweden
1. Quantitative and qualitative composition of the cosmetic product
All raw materials are purchased from Naturkosmetikkompaniet.
Råvara INCI name CAS noConc %
(w/w)
Function in the
product
Jojoba-olja Simmondsia
Chinensis
Seed Oil
90045-98-0 97,32 EMOLLIENT
SKIN
CONDITIONING
Apelsin Citrus
sinensis peel
oil expressed
97766-30-8
/ 8028-48-6
0,96 PERFUMING
Lavendel Lavandula
angustifolia
flower oil
8000-28-0 0,31 PERFUMING
Myrra Commiphora
Myrrha Oil
84929-26-0 0,34 SKIN
CONDITIONING
E-vitamin Tocopherol 10191-41-0 1,08 ANTIOXIDANT
SKIN
CONDITIONING
4
2. Physical/chemical characteristics and stability of the cosmetic product
Finished product: Product type: Nail care Physical form: Oil Allergens: Limonene and Linalool is present in the product at concentrations >0.001%. Stability According to the manufacturer the shelf-life of the unopened product is 24 months. After opening the shelf-life of the product is 6 months.
3. Microbiological quality
The product does not contain water and is therefore classified as a low risk product according to ISO 29621. According to the rapport “Hudkrämer och liknande produkter” Tillsynsrapport från enheten för kosmetika och hygienprodukter 2011-04-13 (Reviderad 2011-05-17) from the Swedish medical Agency it is not relevant to perform challenge testing on water free products.
4. Impurities, traces, information about the packaging material
For ingredients see table 2.
INCI name CAS noConc %
(w/w)
Purity/
Conc in
raw
material
Certificate Allergens Classification
Simmondsia
Chinensis
Seed Oil
90045-98-0 97,32 100% eko
Citrus sinensis
peel oil
expressed
97766-30-8 /
8028-48-6
0,96 100% eko Limonene
& Linalool
present in
concentra
tons
>0.001%
H304, H315,
H317
Lavandula
angustifolia
flower oil
8000-28-0 0,31 100% Limonene
& Linalool
present in
concentra
tons
>0.001%
H304, H315,
H317
Commiphora
Myrrha Oil
84929-26-0 0,34 100% Limonene
present in
>0.001%
R22
R 36/38
Tocopherol 10191-41-0 1,08 >97% H317
5
The raw material is mainly certified organic, i.e. the content of impurities has been check by certification bodies. Considering the concentrations of impurities that are expected in certified organic raw materials, the concentrations of impurities in the cosmetic product are negligible. Primary packaging material: Glass bottles.
5. Normal and reasonably foreseeable use
Oil for daily nail care.
6. Exposure to the cosmetic product
a) The site of application: Nails
b) The surface area of application: 11 cm2
c) The amount of product applied: 0.2 g/application
d) The duration and frequency of use: 1 times/day
e) The normal and reasonably foreseeable exposure route(s): inhalation and
dermal
f) Retension factor: 0.1
g) The targeted (or exposed) population(s): Adults
Exposure Adult: 0.2 x 0.1/60 kg =0.3 mg/kg/day
Impact due to particle size (nano): No raw materials in nano form.
7. Exposure to the substances
See table 3. The systematic exposure dose (SED) of each ingredient per kg bw (tot body weight = 60 kg) and day has been calculated. The SED was low for all ingredients. For ingredients with available NOAEL values a margin of safety (MOS) have been calculated. As a worst case scenario 100% absorption has been used for all ingredients. The MOS for the ingredient with available NOAEL-value was > 100.
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Table 3. SED and MOS-values for the ingredients
8. Toxicological profile of the substances
Gathered information is presented in Appendix 1.
The following data bases and sources have been consulted for compiling toxicity data for the ingredients: CosIng, http://ec.europa.eu/consumers/cosmetics/cosing/ CIR (Cosmetic Ingredients Review) opinions Bibra, http://www.bibra-information.co.uk/ SCCS (Scientific Committee of Consumer Safety) opinions IUCLID (International Uniformed Chemical Information Database) datasets ECHA (European Chemicals Agency) EFSA (European Food Safety Authority HERA (Human and Environmental Risk Assessment on ingredients of household cleaning products) HSDB (Hazardous Substances Databank) Toxline, database SIDS (Screening Information Dataset) EPA (United States Environmental Protection Agency) FDA (United States Food and Drug Administration) INCHEM (International Program on Chemical safety) NICNAS (National Industrial Chemicals Notification and Assessment Scheme, Australian Government Department of Health and Ageing) C&L (Classification and Labeling) inventory CosmeticsINFO http://www.cosmeticsinfo.org/ PubMed http://www.ncbi.nlm.nih.gov/pubmed
INCI name CAS noConc %
(w/w)
SED mg/kg
bw/day at
100%
absorption
Total: 0.3
mg/kg/day
lowest
reported
NOAEL
mg/kg
bw
Margin of Safety
(MOS)/
comments
Simmondsia
Chinensis Seed Oil
90045-98-0 97,32 0,29 Safe according to
CIRTocopherol 10191-41-0 1,08 0,003 Safe according to
CIRCitrus sinensis peel
oil expressed
97766-30-8 /
8028-48-6
0,96 0,003 1000 333333
Commiphora Myrrha
Oil
84929-26-0 0,34 0,001 Safe according to
EMALavandula
angustifolia flower oil
8000-28-0 0,31 0,001
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9. Undesirable effects and serious undesirable effects
No undesired effects have been reported. Responsible person has set up a system to collect document, establish causality and manage the undesirable effects caused by the product.
10. Information on the cosmetic product
No additional information
Part B: Cosmetic product safety assessment
1. Assessment conclusion
Based on the information provided by the manufacturer and the toxicity data compiled for the ingredients, it can be concluded that the Nail Drops is unlikely to produce abnormally high number of adverse effects if used under normal or reasonably foreseeable conditions of use. The product will give users the level of safety that can reasonably be expected.
2. Labelled warnings and instructions of use
No warnings are needed. Limonene and Linalool should be included in the ingredient list of the product since the concentrations are >0.001%.
3. Reasoning
The Nail Drops contains well-known ingredients extensively used in different cosmetic products. None of the products indicate any specific worries (Tab 1, Part B). The Citrus sinensis peel oil expressed, Lavandula angustifolia flower oil and Commiphora Myrrha Oil are classified H315 (Causes skin irritation) and H317 (May cause an allergic skin reaction). The concentrations of these etheric oils are low and the risk for an adverse skin effect when using the product is very low. The finished product contains Limonene and Linalool at concentrations >0.001% which should be listed on the product. The product does not contain water and is therefore classified as low risk products according to ISO 29621, i.e. challenge testing is not needed. Information on packaging material is given from the manufacturer and interaction between the primary packaging material and the product is not expected. The raw material is mainly certified organic, i.e. the content of impurities has been check by certification bodies. Considering the concentrations of impurities that are expected in certified organic raw materials, the concentrations of impurities in the cosmetic product are negligible. The manufacturing of the product should follow a quality controlled standardised procedure.
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The SED was calculated for all ingredients and MOS was calculated for the ingredient with available NOAEL value. The SEDs were low for all ingredients. The calculated MOS value was over 100, i.e. no reason for concern. The ingredients without NOAEL values were considered safe by CIR or EMA. Table 1, Part B
Danderyd 2017-02-20
Cecilia Clemedson, Ph.D., ERT AdvocoTox AB Danderyds Campus, Mörby Centrum, plan 7 SE-182 31 Danderyd, Sweden www.advocotox.se cecilia.clemedson@advocotox.se Mobile +46(0)70 601 91 89
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CURRICULUM VITAE of
Cecilia Clemedson
Title Ph. D. in Toxicology, ERT Birthplace Danderyd, Sweden Date of birth November 30, 1960 Business address: AdvocoTox AB, Danderyds Campus Mörby Centrum, plan 7 SE-182 31 Danderyd, Sweden Mobile +46-70-601 91 89 E-mail cecilia.clemedson@advocotox.se ACADEMIC EXAMINATIONS 1985 Bachelor of Science, microbiology, molecular biology, and chemistry, University of Uppsala. 1989 Licentiate of Philosophy, Department of Neurochemistry and Neurotoxicology, University of Stockholm. 1992 Doctoral Thesis at Department of Neurochemistry and Neurotoxicology, University of Stockholm. 2015 European Registered Toxicologist EDUCATION 1980 Course in ecology and environmental technology, 7 weeks, Royal
Technical High School (KTH), Stockholm. 1985 Course in Toxicology, 20 weeks, Karolinska Institutet, Stockholm. 1987 Course in ”Ion channels: structure, function and the methodology to study them”, 5 weeks, University of Stockholm. 1989 Course in ”The structure and function of the nervous system”, 7 weeks,
Karolinska Institutet, Stockholm. 1989 Course in Scientific Writing, University of Stockholm. 1990 Course in ”Reproductive toxicology”, Karolinska Institutet, Stockholm. 1991 Course in ”Neurotoxicology”, Karolinska Institutet, Stockholm. 1999 Course in ”Toxicokinetics”, Karolinska Institutet, Stockholm. 1999 Course in Principles, practices and problems in preparing The
Toxicological Expert Report, Pre-clinical and regulatory perspectives, Management Forum, London, UK.
2000 Course in ”Drug toxicology”, Karolinska Institutet, Stockholm.
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POSITIONS IN THE PROFESSION 1980-1982 Trainee at the Dept. of Neurochemistry & Neurotoxicology, University of
Stockholm. 1986-1992 Ph.D. student at the Dept. of Neurochemistry & Neurotoxicology,
University of Stockholm. 1992-1995 Programme Secretary of the MEIC programme, Department of
Pharmaceutical Biosciences, Division of Toxicology 1995-1997 Maternal leave 1997-2000 Managing director of NICA-Nordic Information Centre for Alternative
Methods, Stocksund, Sweden 1997- Managing director of CCTox Consulting, Stocksund, Sweden 2001-2010 Part owner of Expertrådet ECB Miljökompetens AB, Sollentuna, Sweden 2001- 2009 Board member of Expertrådet ECB Miljökompetens AB, Sollentuna,
Sweden 2001-2005 Coordinator of the EDIT programme 2005- 2010 Scientific Coordinator of ACuteTox, an Integrated Project under the
EU6FP. 2007-2009 Coordinator of Forinvitox, a project under the EU6FP 2009- Managing director and part owner of AdvocoTox AB, Danderyd, Sweden
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Appendix 1
Citrus sinensis peel oil expressed CAS NO 97766-30-8 / 8028-48-6
1. Acute toxicity
The oral LD50 value of orange oil in rats was established as exceeding 5000 mg/kg body
weight. Also dermal rabbit LD50 was >5000 mg/kg (ECHA 2015).
2. Skin irritation and corrosivity
Cold Pressed Orange Oil was considered irritating to skin and must be classified R38
"Irritating to skin" (ECHA 2015).
3. Eye irritation
The orange oil did not induce significant or irreversible damage to the rabbit eye (ECHA
2015).
4. Skin sensitisation
d-limonene is classified as ‘R43 May cause sensitisation by skin contact’. Based on data from
a human study the substance was not considered to be sensitising (ECHA 2015).
5. Dermal/percutaneous absorption
No data available
6. Repeated dose toxicity
The NOAEL and LOAEL for beagle dogs were considered to be 100 and 1000 mg/kg bw/day,
respectively, based on the increased absolute and relative female kidney weight and relative
male kidney weight (ECHA 2015).
7. Mutagenicity/genotoxicity
Orange Oil Cold Pressed was not mutagenic in in vitro tests with and without S9-mix (ECHA
2015).
8. Carcinogenicity
There was clear evidence of carcinogenic activity of d-limonene for male rats, as shown by
increased incidences of tubular cell hyperplasia, adenomas, and adenocarcinomas of the
kidney. There was no evidence of carcinogenic activity of d-limonene for female rats. This
mechanism of nephrocarcinogenicity has been proven as being male-rat specific and not
relevant for humans. There was no evidence of carcinogenic activity of d-limonene for male
and female mice (ECHA 2015).
9. Reproductive toxicity
The NOAEL for maternal toxicity was considered to be 591 mg/kg bw/day based on the
deaths and decreased bodyweight gain. The NOAEL for fetal toxicity was considered to be
591 mg/kg bw/day based on the delayed skeletal formation and decreased bodyweight gain
(ECHA 2015).
10. Endocrine disruptors
No data available
11. Other
The FDA includes the essential oil, oleoresin and extracts of sweet oranges on the list of
substances considered Generally Recognized as Safe (GRAS) for use in human food.
12
Oranges are also on FDA's list of the 20 most frequently consumed raw fruits in the United
States.
12. Conclusions
Botanical and botanically derived ingredients used in the formulation of cosmetics are
generally mild and safe.
13. NOAEL
1000
14. References
ECHA (2015) http://apps.echa.europa.eu/registered/data/dossiers/DISS-9ea84366-27a5-
40ae-e044-00144f67d031/AGGR-ca955460-e76e-4013-bdf0-f36576ec3c78_DISS-
9ea84366-27a5-40ae-e044-00144f67d031.html#section_1.1
13
Commiphora myrrha oil CAS NO 84929-26-08016-37-3
1. Acute toxicity
In rats, the acute oral LD50 value of myrrh oil is reported as 1.65 g/kg bw. In mice, no visible
signs of toxicity and no mortality were observed at oral doses of resin ≤ 3 g/kg bw (EMA
2010).
2. Skin irritation and corrosivity
No irritation or phototoxicity was found for myrrh oil (EMA 2010).
3. Eye irritation
No data available
4. Skin sensitisation
No sensitization (in 21 volunteers) was found for myrrh oil (EMA 2010).
5. Dermal/percutaneous absorption
No data available
6. Repeated dose toxicity
No data available
7. Mutagenicity/genotoxicity
Limited genotoxicity tests (micronucleus test in mice) have been performed, which indicated
no genotoxic potential. Protective effect against liver oxidative damage and genotoxicity
(EMA 2010).
8. Carcinogenicity
No data available
9. Reproductive toxicity
No data available
10. Endocrine disruptors
No data available
11. Other
No data available
12. Conclusions
The risks involved in oromucosal and cutaneous use of myrrh tincture are generally
estimated to be low. A few clinical case reports in the literature and results from tests in mice
point to a possibility of allergic skin reactions. Myrrh is, however, acceptable for use in both
food and cosmetic products according to evaluations made by the Council of Europe (EMA
2010).
13. NOAEL
No data available
14. References
EMA (2010) http://www.ema.europa.eu/docs/en_GB/document_library/Herbal_-
_HMPC_assessment_report/2010/11/WC500098927.pdf
14
Lavandula angustifolia flower oil CAS NO 8000-28-0
1. Acute toxicity
No data available
2. Skin irritation and corrosivity
No data available
3. Eye irritation
No data available
4. Skin sensitisation
No data available
5. Dermal/percutaneous absorption
No data available
6. Repeated dose toxicity
No data available
7. Mutagenicity/genotoxicity
No data available
8. Carcinogenicity
No data available
9. Reproductive toxicity
No data available
10. Endocrine disruptors
No data available
11. Other
No data available
12. Conclusions
Is thought to be non-toxic (Shenet 2014)
13. NOAEL
No data available
14. References
Shenet (2014) http://www.shenet.se/ravaror/eolavandin.html
15. Notes
No data available
15
Simmondsia Chinensis Seed Oil CAS NO 90045-98-0
1. Acute toxicity
Oral mouse and rat LD50 was greater than 5.0 g/kg (CIR 2008, 1992).
2. Skin irritation and corrosivity
Simmondsia Chinensis (Jojoba) Seed Oil was non- to slightly irritating when instilled into the
eyes of white rabbits (CIR 2008, 1992).
3. Eye irritation
Undiluted Simmondsia Chinensis (Jojoba) Seed Oil was not a skin irritant. Tests of topical
products containing Simmondsia Chinensis (Jojoba) Seed Oil found them to be nonirritants to
humans. (CIR 2008, 1992).
4. Skin sensitisation
In a maximization test, no sensitization reactions were observed with Jojoba Alcohol. Tests of
topical products containing Simmondsia Chinensis (Jojoba) Seed Oil found them to be
nonsensitizers to humans. Sensitization to undiluted Jojoba Oil was not observed (CIR 2008,
1992).
5. Dermal/percutaneous absorption
Based on the large molecular weight of the components of the Jojoba Oil ingredients, the CIR
Expert Panel concluded that they would not penetrate the skin (CIR 2008, 1992).
6. Repeated dose toxicity
No data available
7. Mutagenicity/genotoxicity
Jojoba Alcohol and mixture of Jojoba Oil and Hydrogenated Jojoba Oil were not mutagenic in
bacterial assays (CIR 2008, 1992).
8. Carcinogenicity
No data available
9. Reproductive toxicity
No data available
10. Endocrine disruptors
No data available
11. Other
No data available
12. Conclusions
The CIR Expert Panel evaluated the scientific data and based on the available information
concluded that Jojoba Oil and the related ingredients were safe for use as cosmetic
ingredients (CIR 2008, 1992).
13. NOAEL
No data available
14. References
CIR (2008, 1992) http://online.personalcarecouncil.org/jsp/CIRList.jsp?id=3116
1
Tocopherol CAS NO 54-28-4 / 16698-35-4 / 10191-41-0 / 119-13-1 / 1406-18-4 / 1406-66-2 / 2074-53-5 / 59-02-9 / 7616-22-0
1. Acute toxicity
In rats, the dermal LD50 is >3 g/kg for tocopherol. The oral LD50 of tocopherol greater
than 4 g/kg. In mice, the oral LD50 of tocopherol is >25 ml/kg (CIR 2014).
2. Skin irritation and corrosivity
Tocopherol was not an irritant (CIR 2014).
3. Eye irritation
No data available
4. Skin sensitisation
Tocopherol was not a sensitizer (CIR 2014).
5. Dermal/percutaneous absorption
Dermally applied tocopherols do penetrate the skin (CIR 2014).
6. Repeated dose toxicity
In rats, tocopherol was not toxic in a 60-day study. In a 90-day study, rats dosed orally
with 2000 mg/kg d-α-tocopherol died in 9 to 11 wks because of internal hemorrhage;
other signs of toxicity were observed in a dose-dependent manner. High doses of
tocopherol has a hemorrhagic activity (CIR 2014).
7. Mutagenicity/genotoxicity
Anti-mutagenic activity attributed to these compounds was consistent with their
antioxidant properties (CIR 2014).
8. Carcinogenicity
Carcingenicity studies were negative (CIR 2014).
9. Reproductive toxicity
Reproductive toxicity studies were negative
10. Endocrine disruptors
No data available
11. Other
The FDA includes Tocopherol on its list of nutrients considered Generally Recognized
As Safe (GRAS). Tocopherol is also on FDA's list of GRAS food preservatives
(CosmeticsINFO 2015).
12. Conclusions
The safety of Tocopherol and related ingredients (Dioleyl Tocopheryl Methylsilanol,
Potassium Ascorbyl Tocopheryl Phosphate, Tocophersolan, Tocopheryl Acetate,
Tocopheryl Linoleate, Tocopheryl Linoleate/Oleate, Tocopheryl Nicotinate, Tocopheryl
Succinate) has been assessed by the CIR Expert Panel. The CIR Expert Panel
evaluated the scientific data and concluded that Tocopherol and the related ingredients
were safe as used in cosmetics and personal care products (CIR 2014).
13. NOAEL
No data available
2
14. References
CosmeticsINFO (2015) http://www.cosmeticsinfo.org/ingredient/tocopherol-and-related-
ingredients
CIR (2014) http://online.personalcarecouncil.org/ctfa-static/online/lists/cir-
pdfs/FR667.pdf
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