Reaction mass of Sodiumbis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) and Sodium [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) and Sodiumbis[1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-)

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: gene mutation

Type of information:

experimental study planned

Study period:

not yet defined

Justification for type of information:

- Name of the substance on which testing is proposed to be carried out: substance under registration EC: 915-756-5

CONSIDERATIONS:
- Available GLP studies:
The test substance is mutagenic in bacteria, as determined in an OECD 471 study (BASF SE, 2016).
The test substance is not mutagenic in mammalian cells, as determined in an OECD 476 study (BASF SE, 2016).
The test substance is not chromosome damaging, as determined in an OECD 487 study (BASF SE, 2016).
- Available non-GLP studies: Not Available
- Grouping and read-across: the direct-acting mutagenic activity of nitroreductase was confirmed on one component (CAS 57206-81-2) and played a significant role in the mutagenic properties of the substance.
- Historical human data: Not Available
- (Q)SAR: Not Available
- in vitro methods:
The test substance is mutagenic in bacteria, as determined in an OECD 471 study (BASF SE, 2016).
The test substance is not mutagenic in mammalian cells, as determined in an OECD 476 study (BASF SE, 2016).
The test substance is not chromosome damaging, as determined in an OECD 487 study (BASF SE, 2016).
- Weight of evidence: Not Available
For more details, please see the attached justification

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2021

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 489 (In vivo Mammalian Alkaline Comet Assay)

GLP compliance:

yes

Type of assay:

mammalian comet assay

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of Sodiumbis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) and Sodium [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) and Sodiumbis[1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-)

EC Number:

915-756-5

Molecular formula:

C32H18NaCrN6O8

IUPAC Name:

Reaction mass of Sodiumbis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) and Sodium [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) and Sodiumbis[1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-)

Details on test material:

- Name of test material (as cited in study report): Eukesolar Black ER Liquid - dried
- Physical state: powder
- Analytical purity: 99.11 area-% (HPLC, 260 nm) 99.71 area-% (HPLC, 375 nm) (For details see analytical report-No.: 15L00121)
- Lot/batch No.: Dye powder sample 14/103 from Material no. 52629782; batch no. M-R/G
- Expiration date of the lot/batch: June 09, 2016
- Stability under test conditions: The stability of the test item under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
- Storage condition of test material: Room temperature

Administration / exposure

Route of administration:

oral: gavage

Results and discussion

Test results

Sex:

not specified

Genotoxicity:

other: to be performed