Registration Dossier

Administrative data

Endpoint:
toxicity to reproduction: other studies
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference
Reference Type:
publication
Title:
Experimental studies on toxicity of ethylene glycol ethers in Japan
Author:
Nagano, K. et al.
Year:
1984
Bibliographic source:
Environ Health Perspect 57:75-84

Materials and methods

Principles of method if other than guideline:
Evaluation of the toxicity of ethylene glycol alkyl ethers to the testis of mice.
GLP compliance:
not specified
Type of method:
in vivo

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Name of test material (as cited in study report): Ethylene glycol monophenyl ether
- Analytical purity: no data
- Other: Source: Wako Chemical Co.

Test animals

Species:
mouse
Strain:
ICL-ICR
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: The authors mention water and olive oil as vehicles, without specifying which vehicle was actually used for the test substance.
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
5 weeks
Frequency of treatment:
5 days per week
Duration of test:
5 weeks
Doses / concentrationsopen allclose all
Dose / conc.:
500 mg/kg bw/day (nominal)
Dose / conc.:
1 000 mg/kg bw/day (nominal)
No. of animals per sex per dose:
5
Control animals:
yes

Results and discussion

Effect levels

Dose descriptor:
NOEL
Effect level:
1 000 mg/kg bw/day (nominal)
Sex:
male
Basis for effect level:
organ weights and organ / body weight ratios

Observed effects

There was no effect of treatment on weights of testes or combined weights of the seminal vesicles and coagulating gland. Whether the test material had any effects on the morphology of blood or the testes was not stated.

Any other information on results incl. tables

Ethylene glycol monomethyl and ethyl ethers and acetates and ethylene glycol dimethyl ether were tested in this study and were found to produce decreased testicular weights and leukocyte counts and dose-related atrophy of the seminiferous tubule epithelium.

Applicant's summary and conclusion