Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003-03-07 - 2003-08-28
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
French Republic, Prime Minister, Interministerial Group on Chemicals (GIPC)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid - liquid: suspension
Details on test material:
- Physical state: colourless liquid
- Content: 83.4% MEATG in water
- Lot/batch No.: 4677
- Storage condition of test material: at room temperature and under nitrogen gas

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: approximately 9 weeks
- Weight at study initiation: 331 ± 7 g for the males and 236 ± 8 g for the females
- Housing: single
- Food and water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 30 to 70
- Air changes (per hr): approximately 12
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
The test item was placed directly on the clipped area of the skin. A hydrophilic gauze pad was then applied to the skin.
The test item and the gauze pad were held in contact with the skin for 24 hours by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage. This dressing prevented ingestion of the test item by the animals.
No residual test item was observed on removal of the dressing.
Duration of exposure:
24 h
Doses:
The test item was applied undiluted at the dose-level of 2000 mg/kg, taking into consideration that its specific gravity was 1.25 g/mL. The volume of administration was therefore 1.6 mL/kg. The dose applied to each animal was adjusted according to body weight determined on the day of treatment.

No. of animals per sex per dose:
5
Control animals:
yes, concurrent no treatment

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No clinical signs and no deaths were observed during the study.
Clinical signs:
No cutaneous reactions were observed.
Body weight:
A reduced body weight gain was seen in all males and in 1/5 females between day 1 and day 8. The body weight gain of the other animals was similar to that of CIT historical control animals.
Gross pathology:
No apparent abnormalities were observed at necropsy in any animal.

Any other information on results incl. tables

No clinical signs and no deaths were observed during the study. A reduced body weight gain was seen in all males and in 1/5 females between day 1 and day 8.

The body weight gain of the other animals was similar to that of historical control animals.

No cutaneous reactions were observed.

No apparent abnormalities were observed at necropsy in any animal.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the experimental conditions, the dermal LD50 of MeaTG 83% is higher than 2000 mg/kg in rats.