Registration Dossier

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

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
mouse
Strain:
B6C3F1
Sex:
male
Details on test animals 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
Remarks:
Doses / Concentrations:
1000 mg/kg
Basis:
nominal conc.
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

Observed effects

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