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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

- negative: Ames test (Ames et al. 1975) with Salmonella typhimurium TA1535, TA1537, TA1538, TA98 and TA100 in the presence and absence of rat liver S9 mix. (pre-GLP); cytotoxicity: unknown

- negative: Ames test (Ames et al. 1975) with Salmonella typhimurium TA1535, TA100, TA1537, TA153, TA1538, TA98 and TA100FR50 in the presence and absence of mammalian metabolic activation (cell-free- rat cecal bacterial enzymic extract and/or rat liver S9 mix) (pre-GLP); cytotoxicity: unknown

Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
unknown
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Principles of method if other than guideline:
Study conducted according to principles of AMES test as described in Ames, B. N., Mccann, J. & Yamasaki, E. (1975) Mutat, Res. 31, 347-364.
Manipulation of cultures, preparation of crude microsomal fraction (S9) from Aroclor 1254-induced rats and criteria used in scoring results were was conducted according to Brown, J.P. & Brown, R. J. (1976) Murat, Res. 40, 203-224.
GLP compliance:
no
Remarks:
Study conducted prior to implementation of GLP
Type of assay:
bacterial reverse mutation assay
Target gene:
Histidine locus
Species / strain / cell type:
S. typhimurium, other: TA1535, TA1537, TA1538, TA98, TA100
Metabolic activation:
with and without
Metabolic activation system:
liver microsomal S9 from Aroclor 1254-induced rats
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Key result
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Conclusions:
5,8-Dichlorchinizarin was evaluated in the bacterial reverse mutation assay (Ames test) using Salmonella typhimurium tester strains TA1535, TA1537, TA1538, TA98 and TA100 in the presence and absence of rat liver S9 mix. Under the conditions of the study, the test substance was negative for mutagenic potential.
Executive summary:

In a reverse gene mutation assay in bacteria according to Ames et al. (adopted 1975), Salmonella typhimurium strains TA1535, TA1537, TA1538, TA98 and TA100 were exposed to 5,8-Dichlorchinizarin in concentrations of 10, 50, 100 and 500µg/plate in the presence and absence of mammalian metabolic activation (rat liver S9 mix).

 

Revertants/nmol, i.e. the increase in numbers of revertants/plate per nmol increase in the quantity of test agent over the linear portion of the dose-response curve was <0.01 in the test groups with and without metabolic activation. 

Accordingly, no substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with 5,8-Dichlorchinizarin at any concentration level, neither in the presence nor absence of metabolic activation (S9).

 

There was no evidence of induced mutant colonies over background.

 

Under the conditions of the study, the test substance was negative for mutagenic potential.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Justification for classification or non-classification

Based on reliable, relevant and adequate data on the test substance is considered to be not mutagenic. According to Regulation EC No. 1272/2008, no classification and labelling for mutagenicity is required.