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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
No confirmation in an independent experiment
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
other: S.typhimurium TA1535, TA 1537, TA98, TA100, TA1538
Metabolic activation:
with and without
Metabolic activation system:
S9 mix from male Sprague-Dawley rats
Test concentrations with justification for top dose:
100, 500, 2500, 5000 and 10000 μg/plate
Vehicle / solvent:
Water
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2- Aminoanthracene (CAS 90-45-9), 2-Nitrofluorene, (CAS 607-57-8) 1,3 Propane Sultone, (CAS 1120-71-4), 9-Aminoacridine (CAS 90-45-9)
Details on test system and experimental conditions:
The experimental materials, methods and procedures are based on those described by Ames, B.N., et al (1975) Mutation Research 31: 347-364 and Yahagi et al (1977) Mutation Research 48- 121-130
The Salmonella/Mammalian-Microsome Assay was divided into two phases. The first phase, a preliminary toxicity determination was used to establish the dose range over which the test article will be assayed. The maximum dose established was 10000 μg/plate. The second phase was the pre incubation mutagenicity assay of the test article.

Results and discussion

Test results
Species / strain:
other: S.typhimurium TA1535, TA 1537, TA98, TA100, TA1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Remarks:
No toxicity was observed up to 10000μg /plate
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

DMH is not mutagenic in this assay