5-sulphosalicylic acid

Genetic toxicity: in vivo

Administrative data

Endpoint:

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

Type of information:

experimental study planned

Justification for type of information:

TESTING PROPOSAL ON VERTEBRATE ANIMALS

In accordance with REACH Regulation (1907/2006) Annex VIII column 2 point 8.4 "appropriate in vivo mutagenicity studies shall be considered in case of a positive result in any of the genotoxicity studies in Annex VII or VIII". 5-Sulfosalicylic acid was negative in an in vitro gene mutation test in bacteria (OECD 471, GLP). However, 5-Sulfosalicylic acid revealed ambiguous results in a gene mutation study in mammalian cells (OECD 476, GLP). It was positive in an in vitro mammalian cytogenicity assay (OECD 473, GLP). Based on these positive results an in vivo Comet assay conducted according to OECD 489 is considered appropriate to fulfil data requirements of Annex VIII of the REACH Regulation.

NON-CONFIDENTIAL NAME OF SUBSTANCE:
5-Sulfosalicylic 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:
In-vitro Gene Mutation Study in Bacteria (OECD 471), In-vitro Gene Mutation Study in Mammalian Cells (OECD 476), in-vitro Chromosome Aberration Study (OECD 473)

- Available non-GLP studies: None available

- Historical human data: No data

- (Q)SAR:
Profiling with OECD QSAR Toolbox v4.3 revealed positive alerts for genetic toxicity. However, to date there is no QSAR model available which could replace in vivo genetic toxicity testing
- In vitro methods: In-vitro Gene Mutation Study in Bacteria (OECD 471), In-vitro Gene Mutation Study in Mammalian Cells (OECD 476), in-vitro Chromosome Aberration Study (OECD 473)
- Weight of evidence: No adequate data for this endpoint to be used in a weight of evidence approach could be identified
- Grouping and read-across: No adequate structural analogues with data fulfilling the ECHA requirements for read-across could be identified for this endpoint

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 following adaptations are possible according to REACH Regulation (1907/2006) Annex VIII column 2
8.4.2. The study does not usually need to be conducted
– if adequate data from an in vivo cytogenicity test are available or
– the substance is known to be carcinogenic category 1 or 2 or mutagenic category 1, 2 or 3.
8.4.3. The study does not usually need to be conducted if adequate data from a reliable in vivo mammalian gene mutation test are available.
The above mentioned adaptations are not applicable, hence an in vivo Comet assay conducted according to OECD 489 is considered appropriate to fulfil data requirements of Annex VIII of the REACH Regulation.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 489 (In vivo Mammalian Alkaline Comet Assay)

GLP compliance:

yes (incl. QA statement)

Type of assay:

mammalian comet assay

Test material

Test material information

Constituent 1

Reference substance name:

5-sulphosalicylic acid

EC Number:

202-555-6

EC Name:

5-sulphosalicylic acid

Cas Number:

97-05-2

Molecular formula:

C7H6O6S

IUPAC Name:

2-hydroxy-5-sulfobenzoic acid

Test material form:

solid: crystalline