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FINAL REPORT"ACUTE ORAL TOXICITY IN RATS - FIXED DOSE"

F111 - 008180.R.1

Sponsor of Study:

Address:

Ecolyzer Protocol:Receipt of Subst. Test:Start of Trial:End of Trial:Emission Report:Test Substance:Declared ChemicalComposition:Quantity (mL ou g):LotIVal./Fab. Declared:Chemical Name of Subst. Test:Purity:Uniformity:Study InitiationStudy Termination:

Operational unit:

Study Director:

GREENSUN IND. COM. DE PROD. LlMP. LTOAR. DA FONTE, 1028 - NOVA CIDADE 28890-000 RIO DASOSTRAS - RJ008180.R10/05/201117/05/201103/06/201109/06/2011DESENGORDURANTE INDUSTRIAL GSF 200

Unreported

200,00200-0904 26/04/2012 26/04/2011UNREPORTEDUNREPORTEDLiquid16/05/201103/06/2011

Laboratórios Ecolyzer Ltda.Rua Romão Puiggari, 898 - Vila das MercêsPhone/Fax: (Oxx11) 2969-5020E-mail: [email protected]: 04164-001 - São Paulo - SP

André Luiz Figueiredo JúniorBiologistRua Romão Puiggari, 898 - Vila das MercêsSão Paulo - SP CEP: 04164-001

LABORATÓRIOS ECOLYZER LTDA.Rua Romão Puiggari, 898· Vila das Mercês- São Paulo- SP· Brasil- CEP04164 001 •Tel. (55 11) 29695020· [email protected]. www.ecolyzer.com.br

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RESUME

The test was conducted Acute Oral Toxicity - Fixed Dose for rats to study the possible toxic effectsof the test. The test substance used was pure and administered orally to rats from 8 to 12 weeks ofage, at a dose of 2000 mg / kg body weight on the pretest. The animais were observed at the timethat they had died behavioral changes, clinical signs and gross pathological findings. The definitivetest was conducted with a dose of 2000 mg / kg P. V., in which the animais showed clinical signs oftoxicity, which classifies the test substance in the toxicological class V.

INTRODUCTION

Average Oral Lethal Dose (DL500ral) is defined as the amount of a substance expressed inmg of product per kg of body weight required to kill 50% of a population of animais after a singleoral administration within a short period of time.

Acute oral toxicity constitutes the sum of adverse effects occurring in a short time afterapplication of an oral single dose of the test substance.

Dose is the amount of substance administered. The dose is expressed as weight ofsubstance per unit weight of test animal (ex mg / kg).

OBJECTIVE

The trial of acute oral toxicity to rats - a fixed dose is as purpose to evaluate thetoxicological characteristics of a substance, providing information about the health risks of an acuteoral exposure.

MATERIALS E METHODS

Materiais and Equipment

Digital ScaleGlass of common laboratoryRigid ProbeDisposable Syringe

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Rua Romão Puiggari, 898· Vila das Mercês- São Paulo- SP• Brasil- CEP04164 001 •Tel. (55 11) 2969 5020· ecolyzeneecolyzer.corn.br- www.ecolyzer.com.br

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Teste substance and dose levels.

The test substance in liquid form was originally used pure.

Pre test: concentration of 1000 mg / mL (2000 mg / kg).Definitive test: concentration of 1000 mg / mL (2000 mg / kg)

Test System.

Have been used albino rats (Rattus norvegicus) nulliparous and not pregnant Wistar, adultwith aged 8 to 12 weeks at the beginning of the experiment, having 172 to 272 9 of body weight.

Condições de teste

Test Conditions

The animais were acclimated to laboratory conditions for at least five days before the startof the experiment. Ventilation were maintained with 10 to 15 air changes per room per hour,temperature between 19 and 23 o C, relative humidity between 30 and 70% and photoperiod of 12hours light and 12 hours in the dark.

The diet was constituted of commercial feed, supplemented with filtered water, bothprovided ad libitum. The animais were randomized into polypropylene boxes, covered by a metalgrid and covered with wood shavings, with a maximum of five animais per cage.

Methodology

The animais were fasted nutritional approximately 12 hours (at night). After this stage wereweighed individually, and then after the calculations to determine the doses used, the testsubstance was administered orally to animais in a single dose.

The animais were observed daily for 14 days after application of the substance testedclinically, and we noted the onset, degree and duration of symptoms. These findings were basedmainly on examinations of skin, hair, eyes, mucous membranes, system circulatory, respiratoryand nervous, somatomotor activity and behavior. The animais were weighed at the beginning andend of the experiment. Survivors were euthanized and necropsied at 14 days of testing.

The autopsy of ali animais in the test .was performed, with special attention to themacroscopic examination of organs heart, lung, liver, stomach, intestines, kidneys, spleen andadrenal glands.

Pretest

Firstly it held a pre-analysis, using an animal for each dose. The test is started in one of thefollowing doses: 5, 50, 300 and 2000mg/kg of PV (body weight). From the result of the observedparameters during the test, such as mortality and clinical signs of toxicity, new dose is applied orwill already be set to initial dose of the ultimate test

Definitive Test

For this second step are used five animais per dose. The test will start in one of thefollowing doses; 5, 50, 300 and 2000mg/kg; from the results of the pretest. The parameters areobserved in animal mortality and clinical signs of toxicity. From these observations the test item isclassified according to the table of the GHS. (Annex 1)

of 7LABORATÓRIOS ECOLYZER LTOA.

Rua Romão Puiggari, 898· Vila das Mercês- São Paulo- SP· Brasil- CEP04164 001 •Tel. (55 11) 2969 5020· ecolyzeneecolyzer.corn.br- www.ecolyzer.com.br

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F111 - 008180.R.1

RESULT

Classification of the test substance.

The test substance was classified according to the table in Annex 1. This classification wasperformed according to the doses applied to animais and observed in these parameters.

Number of Deaths

Dose 1 - Pre test (2000 mg I kg): ODose 1 - Final (2000 mg I kg): O

Median lethal dose ( (DL~

- Female: > 2000 mg/Kg (PV.).

Confidence Interval to 95%.

- Not calculated.

Clinical signs.

Dose 1 - Pre test: The animal not showed clinical signs of toxicity.Dose 1 - Definitive: The animal not showed clinical signs of toxicity.

Pathological (macroscopic).

Animais that eventually died:

- Any animais died after administration of the test substance.

Survivors:

- Respiratory system: NN until the dose of 2000 mg/Kg of PV.- Cardio vascular system: NN until the dose of 2000 mg/Kg of PV.- Central Nervous System: not investigated _- Digestive system: NN until the dose of 2000 mg/Kg of PV.- Genitourinary system: NN until the dose of 2000 mg/Kg of PV.- Other (liver and splee): NN until the dose of 2000 mg/Kg of PV.

Note: NN = Nothing noteworthy

of7LABORATÓRIOS ECOLYZER LTOA.

Rua Romão Puiggari, 898· Vila das Mercês- São Paulo- SP· Brasil- CEP04164 001 •Tel. (55 11) 29695020· [email protected]. www.ecolyzer.com.br

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F111 - 008180.R.1

CONCLUSION

The test substance showed median lethal dose (DLso) to white rats, greater than 2000 mg I kgbody weight when administered orally pure, which classifies the test substance in the toxicologicalclass V. The animais showed clinical signs of toxicity after exposure to the substance test.

FILE ANO STORAGE

This test report was issued in two copies, one being sent to the Sponsor and one saved. The RawData, Study Plan, Final Report, comments relating to this study sample and the test substance arearchived and available at Ecolyzer Laboratories Ltda.

The records will be maintained during the period of five years and substance test within sixmonths, both frem the date of entry of the test substance in the laboratory.

OECLARATION

I, the undersigned, declare that this study represents a true and accurate record of resultsand meets the requirements of standard Nit-Dicla 035 - Rev. 01 - Princípio das Boas Práticas deLaboratório BPL. INMETRO, 2009.

Paqe 5 of 7LABORATÓRIOS ECOLYZER LTDA.

Rua Romão Puiggari, 898· Vila das Mercês- São Paulo- SP• Brasil- CEP04164001 •Tel. (55 11) 2969 5020 • [email protected]· www.ecolyzer.com.br

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F111-008180.R.1

DECLARATION

I, the undersigned, declare that this Final Report has been evaluated by the Unit for QualityAssurance and truthfully reflects the Raw Data and Study Plan.

I declare that audits and inspections were performed, as described below

Process Audit Date ofcompletion

Critical phases of the study 06/10/09-23/10/09 23/10/09 I 23/10/09 IReporting date the I Reporting date to IStudy Director Manage Operational

11/11/09 I 11/11/09 I06/06/2011 I 06/06/2011 I

Inspections I Audit,t

i Date of. completion

Operational Unit (Laboratory) I 26/10/09-:30/10/0'9 I

Raw Data, Study Plans, Final iReport I 06/06/2011

~~:.1(j)u~lanMion

U it Manager Quality Assuran eEcolyzer

DECLARATION

I, the undersigned, declare that this study was conducted under our supervision, accordingto the procedures described herein.

The results presented refer only to test the substance tested. Sampling is the responsibilityof Sponsor.

This document must not be reproduced.

of 7LABORATORIOS ECOLYZER LTDA.

Rua Romão Puiggari, 898· Vila das Mercês- São Paulo- SP· Brasil- CEP04164 001 •Tel. (55 11) 29695020· [email protected]. www.ecolyzer.com.br

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F111-008180.R.1

METHOD USED

OECO, Guídelíne For Testíng Of Chemícals, Acute Oral Toxicity - Fixed Dose Procedure,Sectíon 4: Health Effects, 420,17/12/2001. Pág. 1-14.

Annex 1: Classífícatíon table of the second acute toxícologícal GHS (GloballyHarmonisedClassificationSystem- OECD).

(> O - 5 mg/Kg )

(> 5 - 50 mg/Kg )

111 (> 50-300 mg/Kg )

IV (> 300 - 2000 mg/Kg )

V (> 2000 mg/Kg )

of7LABORATÓRIOS ECOLYZER LTDA.

Rua Romão Puiggari, 898 • Vila das Mercês- São Paulo- SP • Brasil- CEP 04164 001 • Tel. (55 11) 2969 5020· [email protected]· www.ecolyzer.com.br

i yzer c · and meets the requirements of standard nit-dicla 035 - rev. 01 - princípio das boas...

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