Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-313-2 | CAS number: 105-60-2
Specific investigations: other studies
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:
- 1 989
- 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:
- 1 992
- 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
- 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
Constituent 1
- 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
