Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
in vivo mammalian somatic cell study: gene mutation
Type of information:
other: read across from analogue substance
Adequacy of study:
key study
Study period:
not yet defined
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
see 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

Constituent 1
Reference substance name:
Reaction mass of sodium [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) and sodium bis[1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) and sodium bis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-)
IUPAC Name:
Reaction mass of sodium [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) and sodium bis[1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) and sodium bis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-)

Test animals

Species:
rat

Administration / exposure

Route of administration:
oral: gavage

Results and discussion

Test results
Sex:
not specified
Genotoxicity:
other: to be performed
Remarks on result:
other: the test is in read across from a submitted testing proposal still under evaluation

Applicant's summary and conclusion

Executive summary:

A read across approach is proposed for assessing the in vivo gene mutation properties of Solvent Black 7 EC 257-804-1, by using the results of a Comet Assay OECD 489 submitted as testing proposal on substance Acid Black 63:3 EC 915-756-5.

The Comet Assay requirement is the results of the application of Column 2 Annex VII of the REACH Regulation which requires that substances with positive results for in vitro gene mutation study in bacteria are further investigated for their mutagenic properties in vivo.