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Toxicological information

Carcinogenicity

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Administrative data

Endpoint:
carcinogenicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable publication

Data source

Reference
Reference Type:
publication
Title:
Toxicities of ethylene glycol and ethylene glycol monoethyl ether in Fischer 344/N rats and B6C3F1 mice
Author:
Melnick RL: .
Year:
1984
Bibliographic source:
Environ. Health Perspect. 57: 147-155

Materials and methods

Principles of method if other than guideline:
Chronic and subacute studies
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of the test substance as stated in the publication: Ethylene glycol monoethyl ether;
purchased from: Union Carbide Corporation;
purity: > 99 %

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals and environmental conditions:
additional test animals: male/female B6C3F1 mice

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Duration of treatment / exposure:
103 weeks (chronic)
2 weeks (subacute)
Frequency of treatment:
5 days/week
Post exposure period:
1 week
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 500, 1000 or 2000 mg/kg bw/day
Basis:
nominal in water
No. of animals per sex per dose:
50
Control animals:
yes

Results and discussion

Any other information on results incl. tables

Subacute study results:

The most obvious effect was the marked reduction in survival of the high dose groups (2000 mg/kg). Survival of the medium-dose group of male rats (1000 mg/kg) was significantly reduced compared to the survival of the control group. Survival of the low-dose group was not significantly different to the control group.

Dose-related depressions in mean body weight were apparent in both male and female rat studies. The mean body weights of the male and female mouse groups treated with 2 -ethoxyethanol did not appear to differ markedly from the control.

Testis of the high-dose male rats and mice were generally decreased in size and testicular atrophy was seen. Additionally stomach ulcers were observed in many of the high-dose male and female rats and the high-dose male mice.

Chronic study result:

Gross observations indicated that chronic treatment with 2 -ethoxyethanol at the medium und low dose levels caused an apparent enlargement of the adrenal gland in male rats and interfered with the development of spontaneous gross lesions of the spleen, pituitary, and testis. In female rats the treatment caused a decrease in the incidences of enlarged spleens and pituitaries and of subcutaneous masses in the mammary gland region.

Applicant's summary and conclusion

Conclusions:
The test substance 2-ethoxyethanol was administered orally in a chronic and subacute study to mice and rats. The main observations during the subacute study were, apart from the marked reduction in survival (2000 mg/kg), testicular atrophy and stomach ulcers in the high dose groups. In the chronic study there were different observations like enlargement of adrenal gland, gross lesions of the spleen, pituitary, and testis. In the opinion of the author of this IUCLID dossier these observations can be a hint for a possible cancerogenic potential of the test substance.