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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:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data is from peer reviewed publication

Data source

Reference
Reference Type:
publication
Title:
Mutagenicity screening of twenty‐five cosmetic ingredients with the salmonella/microsome test
Author:
R. D. Blevins & D. E. Taylor
Year:
1982
Bibliographic source:
J. Environ. Sci. Health, A 17 (2), 217-239 (1982)

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Spot test was performed to determine the mutagenic potential of the test compound D & C yellow no 10
GLP compliance:
not specified
Type of assay:
bacterial gene mutation assay

Test material

Constituent 1
Reference substance name:
8004-92-0
Cas Number:
8004-92-0
IUPAC Name:
8004-92-0
Constituent 2
Reference substance name:
C.I. Food Yellow 13
IUPAC Name:
C.I. Food Yellow 13
Constituent 3
Reference substance name:
616-849-0
EC Number:
616-849-0
IUPAC Name:
616-849-0
Details on test material:
- Name of test material (as cited in study report): D & C yellow no 10
- Molecular formula (if other than submission substance): C18-H9-N-O8-S2.2Na
- Molecular weight (if other than submission substance): 477.3801 g/mol
- Substance type: Organic
- Physical state: No data available
- Purity No data available
- Impurities (identity and concentrations): No data available

Method

Species / strain
Species / strain / cell type:
S. typhimurium, other: LT2 - hisTA98, hisTA100, hisTA1535, hisTA1537, and hisTA1538
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
S9 was prepared from livers of male Sprague-Dawley rats (150- 200g) from Charles River Laboratories
Test concentrations with justification for top dose:
50 µg
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: sterile, double distilled water
- Justification for choice of solvent/vehicle: No data available
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
9-aminoacridine
sodium azide
other: 2-Aminoanthracene,
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (spot test)

DURATION
- Preincubation period: No data available
- Exposure duration: 48 hrs
- Expression time (cells in growth medium): 48 hrs
- Selection time (if incubation with a selection agent): No data available
- Fixation time (start of exposure up to fixation or harvest of cells): No data available

SELECTION AGENT (mutation assays): No data available
SPINDLE INHIBITOR (cytogenetic assays): No data available
STAIN (for cytogenetic assays): No data available

NUMBER OF REPLICATIONS: No data available

NUMBER OF CELLS EVALUATED: No data available

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data available

OTHER EXAMINATIONS:
- Determination of polyploidy: No data available
- Determination of endoreplication: No data available
- Other: No data available

OTHER: prior to and following chemical cosmetic ingredient exposure, plate counts were done to determine precentage survival of colony-forming units per complete growth medium plates.
Evaluation criteria:
The cosmetic ingredient was considered mutagenic if there was a significant increase (a reproducible dose related increase in the number of revertant colonies) in the number of colonies on the plate compared with both the nontreated and cosmetic ingredient treated plates. Colonies with a diameter of more than 0.2 mm were counted.

Results and discussion

Test results
Species / strain:
S. typhimurium, other: LT2 - hisTA98, hisTA100, hisTA1535, hisTA1537, and hisTA1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with and without

The test compound D & C yellow no 10 did not induce mutation in the Salmonella typhimurium LT2 - hisTA98, hisTA100, hisTA1535, hisTA1537, and hisTA1538 in the spot test performed and hence is negative for mutation in vitro.
Executive summary:

Spot test was performed to determine the mutagenic potential of the test compound D & C yellow no 10.

 

Following cosmetic ingredient treatment of the individualSalmonellastrains, the strains were plated on Vogel Bonner Medium E minimal agar plates and incubated for 48 hr at 37°C. The toxicity of the cosmetic ingredient was evidenced by either a clearing of the bacterial lawns (the reduction of colony counts below the range of spontaneous revertants) or the appearance of pinpoint his colonies.Prior to and following chemical cosmetic ingredient exposure, plate counts were done to determine percentage survival of colony-forming units per complete growth medium plates.The cosmetic ingredient was considered mutagenic if there was a significant increase (a reproducible dose related increase in the number of revertant colonies) in the number of colonies on the plate compared with both the nontreated and cosmetic ingredient treated plates. Colonies with a diameter of more than 0.2 mm were counted.

 

The test compoundD & C yellow no 10 did not induce mutation in theSalmonella typhimuriumLT2 - hisTA98, hisTA100, hisTA1535, hisTA1537, and hisTA1538 in the spot test performed and hence is negative for mutation in vitro.