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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:
other information
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Principles of method if other than guideline:
Annex V to Council Directive 67/548/EEC on the approximation
of laws, regulations and administrative provisions relating
to the classification, packaging and labelling of dangerous
substances, published in the Seventeenth Adaptation,
Commission Directive 92/69/EEC, OJEC L383A, 121-123, 1992.
(B.3 : Acute Toxicity (Dermal)).
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: N/A
Duration of exposure:
24 h
Doses:
2000 mg/kg
No. of animals per sex per dose:
Male: 2000 mg/kg bw; Number of animals: 5
Female: 2000 mg/kg bw; Number of animals: 5

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:
None
Gross pathology:
Effects on organs:
No treatment-related abnormalities.
Other findings:
Signs of toxicity (local):
Signs of skin irritation were seen in all animals but, with
the exception of desquamation in one female, had completely
resolved by the end of the study.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU