Registration Dossier
Registration Dossier
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EC number: 500-099-5 | CAS number: 37625-56-2
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study planned
- Justification for type of information:
- TESTING PROPOSAL ON VERTEBRATE ANIMALS
NON-CONFIDENTIAL NAME OF SUBSTANCE:
CAPA 3050
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION [please address all points below]:
- Available GLP studies: no studies are available
- Available non-GLP studies: no studies are available
- Historical human data: no data are available
- (Q)SAR: (Q)SAR predicitions will not be accepted in isolation
- In vitro methods: not applicable - the testing proposal is based on the results of an equivocal result in a study in vitro
- Weight of evidence: not applicable - the testing proposal is based on the results of an equivocal result in a study in vitro
- Grouping and read-across: not applicable. a previous proposal for read-across has been rejected by ECHA
- Substance-tailored exposure driven testing: not applicable
- Approaches in addition to above: not applicable
CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- The generation of genotoxicity data in vivo to clarify the results of a postive or equivocal result in vitro is a standard requirement under REACH and cannot be adapted for this substance based on any Column 2 or Annex XI adaptations.
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Based on the equivocal response seen in the in vitro clastogenicity study, a mouse bone marrow micronucleus assay is proposed for CAPA 3050.
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Test material
- Reference substance name:
- CAPA 3050
- IUPAC Name:
- CAPA 3050
- Reference substance name:
- ε-Caprolactone, oligomeric reaction products with propylidynetrimethanol
- EC Number:
- 500-099-5
- EC Name:
- ε-Caprolactone, oligomeric reaction products with propylidynetrimethanol
- Cas Number:
- 37625-56-2
- Molecular formula:
- (C6H14O3)x.C6H10O2 (x=0-6)
- IUPAC Name:
- 2-Oxepanone, polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol
- Reference substance name:
- 2-Oxepanone, polymer with 2-ethyl-2-(hydroxymethyl)-1, 3-propanediol
- IUPAC Name:
- 2-Oxepanone, polymer with 2-ethyl-2-(hydroxymethyl)-1, 3-propanediol
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): CAPA 3050
- Substance type: Oligomer
- Physical state: Liquid
- Analytical purity: 100%
- Lot/batch No.: WCB000999
- Expiration date of the lot/batch: 23th August 2015
- Stability under test conditions: Stable for the duration of the study
- Storage condition of test material: Ambient
Constituent 1
Constituent 2
Constituent 3
Results and discussion
Applicant's summary and conclusion
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.
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