Registration Dossier

Toxicological information

Specific investigations: other studies

Currently viewing:

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

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Adult female rats were orally dosed with 425 mg/kg bw (3/5 of LD50) of the test substance 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

Constituent 1
Chemical structure
Reference substance name:
ε-caprolactam
EC Number:
203-313-2
EC Name:
ε-caprolactam
Cas Number:
105-60-2
Molecular formula:
C6H11NO
IUPAC Name:
azepan-2-one
Specific details on test material used for the study:
- 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 or test system 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
Dose / conc.:
425 mg/kg bw/day
No. of animals per sex per dose:
6

Results and discussion

Any other information on results incl. tables

The test substance increased SGPT. There was no increase in ODC activity indicating lack of carcinogenicity potential.

Applicant's summary and conclusion

Conclusions:
The test substance increased SGPT. There was no increase in ODC activity indicating lack of carcinogenicity potential.
Executive summary:

Adult female rats were orally dosed with 425 mg/kg bw (3/5 of LD50) of the test substance 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. The test substance increased SGPT. There was no increase in ODC activity indicating lack of carcinogenicity potential.