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Toxicological information

Specific investigations: other studies

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Administrative data

Endpoint:
biochemical or cellular interactions
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable publication which meets basic scientific principles

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Biochemical Studies of Promoters of Carcinogenesis in Rat Liver.
Author:
Kitchin, K.T. & Brown, J.L.
Year:
1989
Bibliographic source:
Teratogen. Carcinogen. Mutagen. 9, 273-285
Reference Type:
publication
Title:
Predictive assay for rodent carcinogenicity using in vivo biochemical parameters: operational characteristics and complementarity.
Author:
Kitchin K. et al.
Year:
1992
Bibliographic source:
Mut. Res. 266, 253-272

Materials and methods

Principles of method if other than guideline:
Adult female rats were orally dosed with 425 mg/kg bw (3/5 of LD50) of Caprolactam at 21 and 4 h before sacrifice. Five hepatic biochemical parameters (DNA damage, ODC, SGPT, cytochrome P-450 content, and glutathione content) were subsequently determined.
Type of method:
in vivo
Endpoint addressed:
carcinogenicity

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Caprolactam
- Analytical purity: > 99%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories
- Housing: 3 per cage

Administration / exposure

Route of administration:
oral: gavage
Duration of treatment / exposure:
single
Doses / concentrations
Remarks:
Doses / Concentrations:
425 mg/kg bw
Basis:
actual ingested
No. of animals per sex per dose:
6

Results and discussion

Any other information on results incl. tables

Caprolactam increased SGPT. There was no increase in ODC activity indicating lack of carcinogenicity potential.

Applicant's summary and conclusion