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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Biochemical changes in brain in methanol poisoning--an experimental study.
Author:
Rao, K.R. et al.
Year:
1977
Bibliographic source:
Indian J Med Res 65(2): 285-292

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: not specified
Principles of method if other than guideline:
Daily application of a single dose of methanol to monkeys by gavage over a period of 3 days.
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
monkey
Strain:
not specified
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 30 % solution
- Amount of vehicle (if gavage): no data
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
3 days
Frequency of treatment:
daily
Doses / concentrations
Dose / conc.:
2 340 mg/kg bw/day (nominal)
Remarks:
Basis: actual ingested
No. of animals per sex per dose:
7 males
Control animals:
not specified

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
mortality observed, treatment-related
Description (incidence):
2340 mg/kg bw was the lethal dose for all 7 animals after 3 days.
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
not examined
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not examined
Haematological findings:
not examined
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
no effects observed
Behaviour (functional findings):
not examined
Immunological findings:
no effects observed
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Neuropathological findings:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
not examined

Effect levels

Key result
Dose descriptor:
LOAEL
Effect level:
2 340 mg/kg bw/day (actual dose received)
Sex:
male
Basis for effect level:
mortality

Target system / organ toxicity

Key result
Critical effects observed:
no

Any other information on results incl. tables

2340 mg/kg bw was the lethal dose for all 7 animals under test after 3 days.

Applicant's summary and conclusion