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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:
experimental study
Adequacy of study:
key study
Study period:
1992
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Purity > 99%

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
Hamster S9-mix
Test concentrations with justification for top dose:
7 different doses from 100 microgram/plate to 7 500 microgram/plate

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: strain/cell type: TA 1537
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with metabolic activation

Summarizing, it can be stated that C.I Pigment Red 3 is not mutagenic in the standard plate test (Ames Test) but in the preincubation method to Prival.
Executive summary:

C.I Pigment Red 3 was tested for mutagenicity with the strains TA 100, TA 1535, TA 1537 and TA 98 of Salmonella typhimurium.

The mutagenicity studies were conducted in the standard plate test (Ames Test) and in a modified preincubation test (Prival Test). The studies were performed in the absence and in the presence of a metabolizing system derived from hamster liver homogenate. A dose range of 6 different doses from 4 microgram/plate to 5 000 microgram/plate was used for the mutagenicity study. In a third independent experiment a dose range of 7 different doses from 100 microgram/plate to 7 500 microgram/plate was used.

 

Control plates without mutagen showed that the number of spontaneous revertant colonies was similar to that described in the 1iterature. All the positive control compounds gave the expected increase in the number of revertant colonies.

 

Toxicity: The test compound proved to be not toxic to the bacterial strains. 5 000 microgram/plate was chosen as top dose level for the mutagenicity study.

 

a) Ames Test: Mutagenicity: In the absence of the metabolic activation system the test com- pound did not show a dose dependent increase in the number of revertants in any of the bacterial strains.

 

b) Prival Test: In the presence of hamster liver S-9 using the preincubation method according to Prival C.I Pigment Red 3 induce a dose dependent increase in the number of revertant colonies, with the tester strain TA 1537.

 

Summarizing, it can be stated that C.I Pigment Red 3 is not mutagenic in the standard plate test (Ames Test) but in the preincubation method to Prival.