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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:
2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: HanBrl:WIST (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
Age at study initiation: Males, 9 weeks; Females, 12 weeks.
Weight at study initiationMales: 229.3 to 248.9 g. Females: 197.5 to 216.5 g.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Area covered: Approximately 10% of body surface.
Duration of exposure:
Duration of exposure 24 hours.
Postexposure period: 14 days. Skin flushed with lukewarm tap water and dried with disposable paper towels.
Doses:
2.0 mL/kg bw.
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
Clinical signs and mortality
Mortality: Animals were observed twice daily from Day 1 (pre-administration) through Day 15.
Clinical Signs: Animals were observed at least four times on Day 1 after administration, and once daily on Days 2 through 15.

Irritation: Animals were observed at least four times on Day 1 after administration, and once daily on Days 2 through 15.
Bodyweight: Day 1 (pre-administration), 8, and 15.
Necropsy: After sacrifice, all animals were examined macroscopically.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 mL/kg bw
Based on:
test mat.
Mortality:
No animals died.
Clinical signs:
None observed.
Body weight:
The body weights of all animals were within the range commonly recorded for this strain and age.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
Slight, moderate, and marked erythema maculata, slight and moderate scales, slight and marked crusts, yellow skin on the back and test item residuals were evident in males and females between Day 2 and Day 15. Refer to Table 1 below.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The acute dermal median lethal dose (LD50) of the test material in rats was found to be greater than 2000 mg/kg bodyweight.
Executive summary:

A GLP-compliant acute dermal toxicity (limit) study was conducted according to OECD Guideline 402 and Directive 92/69/EC, B.3 without deviation. Five male and five female HanBrl: Wist (SPF) strain rats were dosed at 2.0 mL/kg bw with undiluted test material that contained 95% active substance. Clinical signs and bodyweight development were unafffected during the study. The acute dermal median lethal dose (LD50) of the test material in rats was found to be greater than 2000 mg/kg bodyweight.