Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
After an acclimatisation period of at least five days the animals were selected at random and given a number unique within the study. At the start, the animals weighed at least 200g, and were wight to twelve weeks of age. The animals were housed in susplended solid-floor polypropylene cages furnished with woodflakes. The animals were housed individually during the 24-hour exposure period and in groups of five, by sex, for the remainder of the study.Free access to drinking water and food, which was routinely analyzed was allosed throughout the study. The temp. and relative humidity were set to achieve limits of 19 to 25deg.C adn 30 to 70% respectively.The rate of air exchange was at least 15 changes per hour and the lighing was controlled.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The calculated vo,ume of test material was applied evenly to an aread of sjprm skin (app. 10% of the total body surface) using a graduated syringe.A piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of slef-adhesive bandage. The animals were caged individually for the 24-hour exposure period.
Duration of exposure:
24- hour contact period.
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 animals
Control animals:
not required

Results and discussion

Preliminary study:
The acute dermal demida lethal dose (LD50) was found to be greater than 2000 mg/kg.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
There were no deaths.
Clinical signs:
There were no signs of systemic toxicity.
Body weight:
All animals showed expected gains in bodyweght over the study period except for one famale whcih sowned an expceted gain over the first week and bodyweight loss over the second week.
Gross pathology:
No abnormalities were noted at cecropsy.

Applicant's summary and conclusion

Conclusions:
The test material does not meet the creiteria for classification and will not require labelling for dermal toxicity in accordance wtih EU regulations.
Executive summary:

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


-OECD Guidelines for the Testing of Chemicals No. 402 “Acute Dermal Toxicity” (adopted 24 February 1987)
-Commission Directive 92/69/EEC Method B3 Acute Toxicity (Dermal)

Method. A group of ten animals (five males and five females) was given a single, 24-hour, semi-occluded dermal application of undiluted test material to intact skin at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

Mortality. There were no deaths.

Clinical Observations. There were no signs of systemic toxicity.

Skin Irritation. Very slight or well-defined erythema was noted at the treatment sites of all males and four females one to six days after treatment. Crust formation was noted at three treated skin sites one day after dosing and at nine treated skin sites two to seven days after treatment. One treated skin site appeared normal throughout the study.

Bodyweight. All animals showed expected gains in bodyweight over the study period except for one female which showed an expected gain in bodyweight over the first week and a bodyweight loss over the second week.

Necropsy. No abnormalities were noted at necropsy.