5-amino-2-nitrobenzoic acid

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic and germ cell study: gene mutation

Type of information:

experimental study planned

Study period:

2021-2022 // The study will be conducted after a decision on the requirement to carry out the proposed test has been taken according to the procedure laid down in Regulation (EC) 1907/2006, and a deadline to submit the information required has been set.

Justification for type of information:

TESTING PROPOSAL ON VERTEBRATE ANIMALS
A testing proposal for an in vivo Transgenic Rodent Somatic and Germ Cell Gene Mutation Assay according to OECD TG 488 has been submitted by the registrant in order to meet the information required of Section 8.4 of Annex IX of the REACH Regulation.

An Ames test in accordance with OECD Guideline 471 was performed using Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537 and Escherichia coli strain WP2 uvrA with and with metabolic activation. The study showed positive results in Salmonella typhimurium strain TA98 without metabolic activation. Therefore, the Ames test was concluded to be positive and further in vivo testing is deemed required in accordance with column 2 of Annex IX of the REACH Regulation. On this basis, the registrant considers the testing proposal for an in vivo Transgenic Rodent Somatic and Germ Cell Gene Mutation Assay justified.

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: 5-Amino-2-Nitrobenzoic Acid

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: no GLP studies available to cover this endpoint
- Available non-GLP studies: no non-GLP studies available to cover this endpoint
- Historical human/control data: no historical human data available to cover this endpoint
- (Q)SAR: (Q)SAR methods are not appropriate to cover this endpoint
- In vitro methods: The in vitro testing gave positive results, therefore further in vivo testing is required
- Weight of evidence: no appropriate weight of evidence information is available to cover this endpoint
- Grouping and read-across: read-across was considered; however it has been concluded that no appropriate information from related or appropriate source substances is available to cover this endpoint
- 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:
- There are no adequate specific adaptation possibilities that allow to generate the necessary information.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed: the proposed testing will be run according to OECD Guideline 488 (Transgenic Rodent Somatic and Germ Cell Gene Mutation Assay)

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 488 (Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays)

GLP compliance:

yes (incl. QA statement)

Type of assay:

transgenic rodent mutagenicity assay

Test material

Test material information

Constituent 1

Reference substance name:

5-amino-2-nitrobenzoic acid

EC Number:

236-283-4

EC Name:

5-amino-2-nitrobenzoic acid

Cas Number:

13280-60-9

Molecular formula:

C7H6N2O4

IUPAC Name:

5-amino-2-nitrobenzoic acid

Test animals

Species:

rat

Administration / exposure

Route of administration:

oral: gavage