Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
toxicity to reproduction: other studies
Type of information:
experimental study
Adequacy of study:
supporting study
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:
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
Type of method:
in vivo

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

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
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
5 consecutive days
Frequency of treatment:
daily
Duration of test:
5 days (with exposure) + 5 weeks (without exposure)
Doses / concentrations
Dose / conc.:
1 000 mg/kg bw/day (nominal)
No. of animals per sex per dose:
10
Control animals:
yes, concurrent vehicle
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

Effect levels

Key result
Dose descriptor:
NOAEL
Effect level:
< 1 000 mg/kg bw/day (nominal)
Sex:
male
Basis for effect level:
other: sperm morphology

Applicant's summary and conclusion

Conclusions:
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).