Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Study test phase 2006-01-09 to 2006-01-23. Report completed & signed off 2006-02-21
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Meets the criteria for classification as Reliable without restriction according to Klimisch et al (1997)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name: FSM-003B
(FSM-003B is a synonym of S196439)
Nature of substance: powder
Batch number: CE-501-2
Date received: 23 August 2005

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Five male and five female Sprague- Dawley CD (Crl: CD (SD) IGS BR) strain rats were supplied by Charles River (UK) Ltd, Margate, Kent, UK. On receipt the animals were randomly allocated to cages. The females were nulliparous and non-pregenant. After an acclimitisation period of at least five days the animals were selected at random and given a number unique within the study by indelible ink marking on the tail and a number written on a cage card. At the start of the study the animals weighed at least 200g and were eight to twelve weeks of age. The weight variation did not exceed +/-20% of the mean weight for each sex.
The animals were housed in suspended solid floor cages. The animals were housed individually during the 24 hour exposure period and in groups of 5, by sex, for the remainder of the study. Free access to mains drinking water and food (Certified Rat and Mouse Diet) was allowed throughout the study. The diet, drinking water and bedding were routinely analysed and were considered not to contain any contaminants that could reasonably be expected to affect the study.
The temperature and relative humidity were set to achieve limits of 19 to 25 degrees centigrade and 30 to 70% respectively. Any occasional deviation from these targets were considered not to have affected the study. The rate of air exchange was at least 15 changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light (06:00 to 18:00) and twelve hours darkness.
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: Dried Arachis oil
Details on dermal exposure:
TEST SITE
- Area of exposure: Shorn back and flanks
- % coverage: 10%
- Type of wrap if used: A piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: After the bandage was carefully removed the treated skin and surrounding hair was wiped with cotton wool moistened with dried arachis oil to remove any residual material
- Time after start of exposure: 24h

TEST MATERIAL
- Amount applied : Dose level equivalent to 2337 mg/kg or 2000 mg active ingredient/kg bodyweight. The appropriate amount of test substance was moistened with dried arachis oil BP and applied as evenly as possible to the area of shorn skin.

VEHICLE
- Arachis oil BP
Duration of exposure:
24h
Doses:
2000 mg active ingredient/kg bodyweight (equivalent to 2337 mg/kg)
No. of animals per sex per dose:
5 male
5 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity 0.5, 1, 2 and 5 hours after dosing and subsequently once daily for fourteen days. After removal of the dressings and once daily for 14 days the test sites were examined for evidence of primary irritation. Individual bodyweights were recorded prior to application of the test substance on day 0 and on days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Clinical Observations: There were no signs of systemic toxicity
Body weight:
All animals showed expected gains in bodyweight over the study period
Gross pathology:
Necropsy: No abnormalities were noted.
Other findings:
Dermal Irritation: There were no signs of dermal irritation

Grey coloured staining was noted at all treatment sites one to three days after dosing and at the treatment sites of one male and one female four days after treatment. This did not affect evaluation of dermal reactions.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal median lethal dose (LD50) of the test substance in the Sprague-Dawley CD strain rat was found to be greater than 2337 mg/kg body weight (equivalent to 2000mg active ingredient/kg bodyweight).

The test substance does not meet the criteria for classification and will not require labelling for dermal toxicity in accordance with EU labelling regulations Commision Directive 93/21/EEC and Regulation (EC) No. 1272/2008.
Executive summary:

Introduction

The study was performed to assess the acute dermal toxicity of the test material in the Sprague-Dawley CD strain rat. The method was designed to meet the requiremnets of the following guidelines:

OECD Guidelines for the Testing of Chemicals No. 402 'Acute Dermal Toxicity' (adopted 24 February 1987)

Method B3 Acute Toxicity (Dermal) of Commission Directive 92/69/EEC.

Result & Conclusion

After a single application of the test substance there were no deaths, no signs of systemic toxicity, no signs of dermal irritation, all animals showed expected gains in bodyweight over the study period and no abnormalities were noted at necropsy. The acute dermal median lethal dose (LD50) of the test substance in the Sprague-Dawley CD strain rat was found to be greater than 2337 mg/kg body weight (equivalent to 2000mg active ingredient/kg bodyweight).

The test substance does not meet the criteria for classification and will not require labelling for dermal toxicity in accordance with EU labelling regulations Commision Directive 93/21/EEC and Regulation (EC) No. 1272/2008.