Registration Dossier

Administrative data

Endpoint:
in vivo mammalian germ cell study: gene mutation
Type of information:
experimental study planned
Study period:
After final decision is issued.
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).]

- Name of the substance on which testing is proposed to be carried out: 4,6-dichloro-N-(1,1,3,3-tetramethylbutyl)-1,3,5-triazin-2-amine
EC Number: 276-309-1
CAS Number: 72058-41-4

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
A literature search was conducted and no GLP studies were found for the in vivo genotoxicity (gene mutation; Comet assay) endpoint.

- Available non-GLP studies
A literature search was conducted and no non-GLP studies were found for the in vivo genotoxicity (gene mutation; Comet assay) endpoint.

- Historical human data
A literature search was conducted and no historical human data was found for the in vivo genotoxicity (gene mutation; Comet assay) endpoint.

- (Q)SAR
In the Danish QSAR database, the result of the 3 battery of software programs was “inconclusive” and “outside applicability domain”. There are no other applicable models available. In summary, QSAR could not be applied for the in vivo genotoxicity (gene mutation; Comet assay) endpoint for this substance.

- In vitro methods
Not applicable.

- Weight of evidence
A literature search was conducted and no data was found that could be used in a Weight of evidence approach for the in vivo genotoxicity (gene mutation; Comet assay) endpoint.

- Grouping and read-across
Read-across using the analogue approach was considered to fill the in vivo genotoxicity (gene mutation; Comet assay) data gap. However, no substances with relevant available studies were found.

- Substance-tailored exposure driven testing [if applicable]
Not applicable

- Approaches in addition to above [if applicable]
Not applicable

- Other reasons [if applicable]
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:
- [free text]
Adaptation options as defined in Annexes VI to X were not applicable for in vivo genotoxicity (gene mutation; Comet assay) endpoint of this substance.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed [if relevant]
Not relevant.

Data source

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 489 (In vivo Mammalian Alkaline Comet Assay)
Qualifier:
according to
Guideline:
OECD Guideline 488 (Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays)
Principles of method if other than guideline:
It has not been decided which one is the first option.
GLP compliance:
yes
Type of assay:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
Colour: light yellow

Test animals

Species:
rat

Results and discussion

Applicant's summary and conclusion