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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Nov. 26, 1996 - Jan. 10, 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guidance test with GLP compliance

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Code number: FAT45'176/A
Batch No.: WP2/96
Purity: ca. 60 %
Appearance: orange-brown solid
Storage: room temperature
Expiration date: 11/2004

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Test System: Rat, HanIbm:WIST (SPF)
Number of animals per group: 5 males and 5 females
Age at treatment: 8 weeks (males) and 11 weeks (females)
Initial Body Weight at Start of Treatment: males: 233.5 -258.7 g and females: 201.8-224.9 g.

Conditions
Standard Laboratory Conditions.
Air-conditioned with ranges for room temperature of 22 ± 3 °C and relative humidity 40-70 % and approximately 10-15 air changes per hour. 12 hours artificial fluorescent light /12 hours dark, music during the light period.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Remarks:
bi-distilled water
Details on dermal exposure:
One day before treatment, the backs of the animals were clipped with an electric clipper, exposing an area of approximately 10 % of the total body surface. Only those animals without injury or irritation on the skin were used in the test.
On test day 1, the test item was applied at a dose of 2000 mg/kg body weight evenly on the intact skin with a syringe and covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.
Application volume/kg body weight: 4 mL/kg
Twenty-four hours after the application the dressing was removed and the skin was flushed with lukewarm tap water and dried with disposable paper towels.
Duration of exposure:
24 h
Doses:
2000 mg/kg body weight (4 mL/kg)
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
no data
Statistics:
no data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths
Clinical signs:
No systemic signs of toxicity were observed.
Body weight:
no significant change
Gross pathology:
No macroscopic findings were observed at necropsy.
Other findings:
no data

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The median lethal dose of test item after single dermal administration to rats of both sexes was observed over a period of 14 days.
The LD50 (rat, dermal) is above 2000 mg/kg body weight.
Executive summary:

The test item was administrated to a group of 5 male and 5 female rats by dermal application, at the single dose of 2000 mg/kg body weight.

No death occurred during the study period. No clinical signs of systemic toxicity were observed during the observation period. There were no test item-related effects on body weight of the male and females animals during the observation period. No organ abnormalities were observed at necropsy.

The LD50 of test item was estimated to be greater than 2000 mg/kg.bw and the test substance is consequently not classified according to the CLP regulation (Regulation EC No. 1272/2008) for acute dermal toxicity.