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Toxicological information

Repeated dose toxicity: inhalation

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Administrative data

Endpoint:
short-term repeated dose toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Test procedure in accordance with accepted standard methods, insufficiently documented, limitations in tissue examination.

Data source

Reference
Reference Type:
publication
Title:
Subchronic inhalation toxicity of methanol.
Author:
Andrews, L.S., Clary, J.J., Terrill, J.B., Bolte, H.F.
Year:
1987
Bibliographic source:
J. Toxicol. Envir. Health 20, 117-124

Materials and methods

Principles of method if other than guideline:
Investigation of the effects of subacute exposure to methanol vapours in monkeys with histopathological examinations lacking brain and neural tissue.
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Methanol
EC Number:
200-659-6
EC Name:
Methanol
Cas Number:
67-56-1
Molecular formula:
CH4O
IUPAC Name:
methanol
Details on test material:
- Name of test material (as cited in study report): methanol
- Analytical purity: 99.85 %
- Other: Source: Celanese Corp., N.Y., no further data

Test animals

Species:
monkey
Strain:
Macaca fascicularis
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
not specified
Vehicle:
other: unchanged (no vehicle)
Remarks on MMAD:
MMAD / GSD: not applicable
Analytical verification of doses or concentrations:
yes
Details on analytical verification of doses or concentrations:
Chamber methanol concentration measured regularly by IR.
Duration of treatment / exposure:
4 weeks
Frequency of treatment:
6 h/d, 5 d/wk
Doses / concentrations
Remarks:
Doses / Concentrations:
0.66, 2.65, 6.63 mg/L (corresponding to 500, 2000, 5000 ppm)
Basis:
analytical conc.
No. of animals per sex per dose:
3
Control animals:
yes, concurrent no treatment
Positive control:
not applicable

Examinations

Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: no data

OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: at the end of exposure
- Dose groups that were examined: no data
Sacrifice and pathology:
GROSS PATHOLOGY: No data
HISTOPATHOLOGY: Yes (ophthalmoscopy)

Results and discussion

Results of examinations

Details on results:
CLINICAL SIGNS AND MORTALITY
No clinical signs of intoxication.

OPHTHALMOSCOPIC EXAMINATION
No methanol-related abnormalities.

HISTOPATHOLOGY: NON-NEOPLASTIC
No methanol-related abnormalities.

Effect levels

Dose descriptor:
NOAEC
Effect level:
6.63 mg/L air
Sex:
male/female
Basis for effect level:
other: clinical signs, histopathology, ophthalmoscopy

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion