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Acute Toxicity: dermal

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Administrative data

acute toxicity: dermal
Adequacy of study:
other information

Data source

Reference Type:
other: Body responsible for the test

Materials and methods

Test guideline
according to guideline
Principles of method if other than guideline:
Organisation for Economic Co-operation and Development
(OECD), OECD Guidelines for Testing of Chemicals, Section 4,
Health Effects, No. 402, "Acute Dermal Toxicity", Paris
Cedex, 1987.

European Community (EC), Council Directive 67/548/EEC, Annex
V, Part B, Methods for the determination of Toxicity, as
last amended by Commission Directive 92/69/EEC, B.3: "Acute
Toxicity (Dermal)". Official Journal of the European
Communities No. L 383, 1992.

United States Environmental Protection Agency (EPA). Health
Effects Test Guidelines, OPPTS 870.1200, Acute Dermal
Toxicity. Office of Prevention, Pesticides and Toxic
Substances (7101), EPA 712-C-96-192, August 1998.

Japanese Ministry of Agriculture, Forestry and Fisheries
(JMAFF), 12 Nousan, Notification No 8147, November 2000;
including the most recent partial revisions.
GLP compliance:
Limit test:

Test animals

other: Rat, Wistar strain, Crl:WI (Han)

Administration / exposure

Type of coverage:
propylene glycol
Duration of exposure:
24 h

Results and discussion

Effect levels
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
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:
other: Signs of toxicity related to dose levels: Piloerection and/or chromodacryorrhoea (snout) were noted among the animals on Day 1. No mortality occurred. Body weight loss was seen in all males and in 3/5 females during the first week of the stud
Gross pathology:
Effects on organs:
No abnormalities were found at macroscopic post mortem
examination of the animals.
Other findings:
Signs of toxicity (local):
Scales and/or scabs were seen in the treated skin-area of
the majority of animals during the observation period.

Applicant's summary and conclusion

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