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Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
fertility, other
Remarks:
based on test type (migrated information)
Type of information:
other: Experimental study with methanol, a metabolite of methyl formate.
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test procedures based on scientific principles and standards, limited documentation, acceptable for assessment.

Data source

Reference
Reference Type:
publication
Title:
Sperm count, morphology, and fluorescent body frequency in autopsy service workers exposed to formaldehyde.
Author:
Ward, J. B. et al.
Year:
1984
Bibliographic source:
Mutat Res 130: 417-424

Materials and methods

Principles of method if other than guideline:
Male mice were treated orally with methanol and maintained without exposure for 5 weeks. Sperm morphology was examined.
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:
Methyl alcohol
Details on test material:
- Name of test material (as cited in study report): methanol
- Analytical purity: no data

Test animals

Species:
mouse
Strain:
B6C3F1
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratory, Portage, MI
- Age at study initiation: 4-month old

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on exposure:
no data
Details on mating procedure:
not applicable
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
no data
Duration of treatment / exposure:
5 consecutive days
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:
1000 mg/kg bw
Basis:
nominal conc.
No. of animals per sex per dose:
10
Control animals:
yes, concurrent vehicle

Examinations

Statistics:
The effects of exposure and non-exposure for each factor were compared by Student´s t-test.
Statistical analyses were performed using the Statistical Package for the Social Sciences (SPSS) [Nie et al., 1975].

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
< 1 000 other: mg/kg
Sex:
male
Basis for effect level:
other: sperm morphology

Overall reproductive toxicity

Reproductive effects observed:
not specified

Any other information on results incl. tables

In the methanol-treated animals, a slight, but statistically insignificant increase in sperms abnormalities (1.86 +-0.91% vs. 1.12 +-0.39% in the water control) was observed, while the treatment with cyclophoshamide (100 mg/kg) resulted in an about 5-fold increase (5.84 +-1.94).

Applicant's summary and conclusion

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