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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:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The complete read across justification is detailed in section 13. Test substance is an isomer of the substance under registration; structural difference is not expected to significantly impact the genotoxic potential. Source study has reliability 2: only limited information available from a migrated NONS file, as per Article 25(3) request.

Data source

Reference
Reference Type:
other: information from migrated NONS file, as per Article 25(3) request; permission to refer granted by ECHA
Title:
Unnamed
Year:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Principles of method if other than guideline:
The method used was that of Prival and Mitchell (Mutat Res 97; 103-116:1982), using a metabolising system favourable to azo reduction (uninduced hamster liver S9, a modified list of co-factors, and a pre-incubation period of 30 minutes).
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
Similar Substance 01
IUPAC Name:
Similar Substance 01
Test material form:
solid

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
uninduced hamster liver S9
Test concentrations with justification for top dose:
10-5000 µg per plate
Vehicle / solvent:
Distilled water.
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: Congo Red
Remarks:
the positive control substance used in the presence of metabolic activation gave a satisfactory positive response

Results and discussion

Test resultsopen allclose all
Species / strain:
other: TA 1537, TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
possible effects starting at 1000 µg/plate (details reported below)
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Species / strain:
other: TA 1535, TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
valid

Any other information on results incl. tables

Toxic concentrations

Weak toxic effects were seen in TA 98 at 1000 µg/plate with S9 in one of two experiments and in TA 1537 at 1000 µg/plate without S9 in one of three experiments. The substance was also toxic to TA 1537 in one out of three experiments at 5000 µg/plate with and without S9.

Observations

In one experiment a slight increase in revertants in strain TA 1537 was observed after 100 µg/plate without S9 and at 10, 100, 1000 and 5000 µg/plate with S9. These increases were not observed in two subsequent repeat experiments. No other increases in revertants were observed.

Applicant's summary and conclusion

Conclusions:
Non mutagenic with and without the metabolic activation.
Executive summary:

Method

The test has been conducted according to the Prival and Mitchell method (Mutat Res 97; 103-116:1982). Information derived from migrated NONS file, as per Article 25(3) request with permission to refer granted by ECHA.

Strains S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 were used with and without S9 metabolic activation.

Results

In one experiment a slight increase in revertants in strain TA 1537 was observed at 100 µg/plate without S9 and at 10, 100, 1000 and 5000 µg/plate with S9. Such increases were not confirmed by two subsequent experiments. No other increases in revertants were observed.

Overall, test substance was considered as non mutagenic to bacteria.