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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:
27 June 2001 to 11 July 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted under GLP Guidelines

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: EC Directive 92/69, B.3
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Clear, colorless liquid; Density 1.60

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Dermal application for 24 hours to approximately 10% of total body surface (925 cm2 for males, 18 cm2 for females).
The test substance was held in place by surgical dressing.
Duration of exposure:
24 h
Doses:
A single dose of 2000 mg/kg (1.25 ml/kg) was administered.
No. of animals per sex per dose:
5 rats / sex / dose

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
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:
Signs of toxicity related to dose levels:
Lethargy, hunched posture, piloerection, chromodacryorrhea and/or diarrhea were noted in the majority of animals. The animals had recovered from these symptoms by day 4, with the exception of one female, which showed chromodacryorrhea between days 13 and 15.
Body weight:
The changes in body weight gain in males and females were within expected ranges.
Gross pathology:
Effects on organs:
No abnormalities were found at macroscopic post mortem
examination of the animals.
Other findings:
Signs of toxicity (local):
Erythema and/or scales were seen in the treated skin-area
and/or the right flank of the animals during the observation
period.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The dermal LD50 of the test substance was found to exceed 2000 mg/kg.