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Acute Toxicity: oral

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Administrative data

acute toxicity: oral
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.423, "Acute Oral Toxicity - Acute Toxic
Class Method", 2001

European Community (EC), Council Directive 67/548/EEC, Annex
V, Part B, Methods for the Determination of Toxicity, as
last amended by Commission Directive 2004/73/EC, B.1 tris:
"Acute Toxicity (Oral) - Acute Toxic Class Method", 2004.

United States Environmental Protection Agency (EPA). Health
Effects Test Guidelines, OPPTS 870.1100, Acute Oral
Toxicity. Office of Prevention, Pesticides and Toxic
Substances (7101), EPA 712-C-98-190, 2002.

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

Test animals

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

Administration / exposure

propylene glycol

Results and discussion

Effect levels
Dose descriptor:
Effect level:
> 300 mg/kg bw
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 2
Female: 300 mg/kg bw; Number of animals: 3; Number of deaths: 0
Clinical signs:
other: Signs of toxicity related to dose levels: Two females treated at 2000 mg/kg were found dead on Day 1. No further mortality occurred at 2000 and 300 mg/kg. 2000 mg/kg: Hunched posture, uncoordinated movements, quick breathing, piloerection.
Gross pathology:
Effects on organs:
At macroscopic post mortem examination, dark red
discolouration of glandular mucosa of the stomach was found
in the animals that died during the study. Macroscopic post
mortem examination of the surviving animals at termination
did not reveal any abnormalities.

Applicant's summary and conclusion

Interpretation of results:
Migrated information Criteria used for interpretation of results: EU