Perfluamine

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian cell study: DNA damage and/or repair

Type of information:

experimental study planned

Study period:

2019

Justification for type of information:

TESTING PROPOSAL ON VERTEBRATE ANIMALS

An Ames assay, chromosome aberration study and mouse lymphoma study were attempted with CASRN 338-83-0. Due to solubility and physical-chemical property issues the assays could not be conducted as suitable vehicles were not identified and the substance is not soluble in culture media alone. As a result, in vivo studies have been proposed.

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: Perfluamine (EC number: 206-420-2, CAS number: 338-83-0)


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: GLP genetic toxicity studies are not available on the test article.
- Available non-GLP studies: Non-GLP genetic toxicity studies are not available on the test article.
- Historical human data: No historical human data pertaining to genetic toxicity are available for the test article.
- (Q)SAR: The chemical class to which the test article belongs is not well represented in current (Q)SAR models and due to the large number of data points required to build a robust model, one can not be created for this endpoint that would be appropriate for this chemical class.
- In vitro methods: The test article is not soluble in any of the vehicles compatible with current in vitro genetic toxicity studies.
- Weight of evidence: This substance is part of the Perfluorinated Organic Chemicals, C5-C18 category. All available genetic toxicity data on category members suggests that they are not mutagenic.
- Grouping and read-across: This substance is part of the Perfluorinated Organic Chemicals, C5-C18 category. As the category genetic toxicity data points were not accepted for the test article in its current dossier, it is proposed that experimental in vivo data be generated via a mammalian erythrocyte micronucleus test with the test article.

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 test article is not soluble in any of the vehicles compatible with current in vitro genetic toxicity studies so we propose that in vivo genetic toxicity methods be utilized for this endpoint.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed: OECD 489 - in vivo Mammalian Alkaline Comet Assay

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 489 (In vivo Mammalian Alkaline Comet Assay)

Version / remarks:

29 July, 2016

Deviations:

no

Test material

Test material information

Constituent 1

Reference substance name:

PTPA

IUPAC Name:

PTPA

Details on test material:

- Name of test material (as cited in study report): (CF3CF2CF2)3N, PTPA, 338-83-0