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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
repeated dose toxicity: oral
Remarks:
other: repeated dose (eight daily doses)
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: abstract available, no information about purity of the test substance

Data source

Reference
Reference Type:
publication
Title:
Toxicity of methoxyacetic acid in male rats
Author:
Miller RR, Carreon RE, Young JT, McKenna MJ
Year:
1982
Bibliographic source:
Fundam Appl Toxicol, 2: 158-160.

Materials and methods

GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
No data given.

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male
Details on test animals and environmental conditions:
No data given.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
No data given.
Analytical verification of doses or concentrations:
not specified
Frequency of treatment:
eight daily doses.
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 30, 100 or 300 mg/kg bw
Basis:
no data
No. of animals per sex per dose:
Five animals.

Results and discussion

Results of examinations

Details on results:
At 100 and 300 mg/kg bw/d, there was a significant dose-dependent reduction in the absolute and relative thymus weight, the erythrocyte count, and the haemoglobin and haematocrit level (p < 0.05 in each case). In the high dose group from the 5th day of administration there were significant reductions in body weight, absolute and relative spieen and testes weights, and leucocyte count (p < 0.05 in each case). The following effects were seen at 100 and 300 mg/kg bw/d, on histological examination: loss of thymocytes in the thymic cortex and atrophy of the germ cells in the seminiferous tubules („degeneration of testicular germinal epithelium"). The high dose led to reduced cell density in the bone marrow and giant cell formation in the testes. Granulopoiesis, erythropoiesis and thrombopoiesis were not affected. The spieen was not examined in this study.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Executive summary:

Male F344 rats received 8 daily gavage administrations of 0, 30, 100 or 300 mg Methoxyacetic acid/kg bw over a 2-week period. At the two highest dose levels, absolute and relative thymus weights, RBC, Hb and Hct values were significantly decreased. In the 300 mg/kg bw group, there was a decrease of body weight, absolute and relative spleen and testicular weights, and leukopenia. Cellularity of thymus core and germinal epithelium were affected at 100 mg/kg bw and above. Testicular giant cells and reduced cellularity in bone marrow were observed at 300 mg/kg bw, whereas doses of 30 mg/kg bw produced no effects within the observation period (Miller et al., 1982).