Registration Dossier

Diss Factsheets

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
[Please provide information for all of the points below. The information should be specific to the endpoint for which testing is proposed. Note that for testing proposals addressing testing on vertebrate animals under the REACH Regulation this document will be published on the ECHA website along with the third party consultation on the testing proposal(s).]

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: 2-(2-2-pentamethylene-1,3-oxazolidyl-3)ethyl methacrylate
- Name of the substance for which the testing proposal will be used [if different from tested substance]: same as above

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 GLP study is available for this endpoint
- Available non-GLP studies: No non-GLP study is available for this endpoint
- Historical human data: Not available
- (Q)SAR: Not suitable for this endpoint
- In vitro methods: No in vitro test to address this endpoint is available, in vitro results require the proposal of this in vivo study
- Weight of evidence: No relevant structural analogs
- Grouping and read-across: No relevant structural analogs
- Substance-tailored exposure driven testing [if applicable]: Not applicable
- Approaches in addition to above [if applicable]: None
- Other reasons [if applicable]: The results of the in vitro micronucleus study were positive, thus requiring an in vivo proposal as per the guidance documents

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:
- Specific adaptations described in column 2 are not applicable

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed [if relevant]:

Data source

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(1-oxa-4-azaspiro[4.5]dec-4-yl)ethyl methacrylate
EC Number:
224-116-8
EC Name:
2-(1-oxa-4-azaspiro[4.5]dec-4-yl)ethyl methacrylate
Cas Number:
4203-89-8
Molecular formula:
C14H23NO3
IUPAC Name:
2-(1-oxa-4-azaspiro[4.5]dec-4-yl)ethyl methacrylate
Test material form:
liquid: viscous

Test animals

Species:
mouse

Administration / exposure

Route of administration:
oral: gavage

Results and discussion

Applicant's summary and conclusion

Executive summary:

In vivo micronuleus test is proposed.