safety report of nail drops for camilla of sweden ab€¦ · certificate allergens classification...

SAFETY REPORT OF Nail Drops

For Camilla of Sweden AB

2017-02-20

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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

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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

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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

http://www.ncbi.nlm.nih.gov/pubmed

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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 [email protected] Mobile +46(0)70 601 91 89

mailto:[email protected]

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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 [email protected] 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.

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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).


No irritation or phototoxicity was found for myrrh oil (EMA 2010).

3. Eye irritation

No data available


No sensitization (in 21 volunteers) was found for myrrh oil (EMA 2010).


No data available


No data available


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


No data available


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

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Lavandula angustifolia flower oil CAS NO 8000-28-0

1. Acute toxicity

No data available


No data available

3. Eye irritation

No data available


No data available


No data available


No data available


No data available

8. Carcinogenicity

No data available


No data available


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).


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).


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).


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).


No data available


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


No data available


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).


Tocopherol was not an irritant (CIR 2014).

3. Eye irritation

No data available


Tocopherol was not a sensitizer (CIR 2014).


Dermally applied tocopherols do penetrate the skin (CIR 2014).


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).


Anti-mutagenic activity attributed to these compounds was consistent with their

antioxidant properties (CIR 2014).

8. Carcinogenicity

Carcingenicity studies were negative (CIR 2014).


Reproductive toxicity studies were negative


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

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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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