Sodium 2-(2,3-dihydro-1,3-dioxo-1H-inden-2-yl)quinoline-6-sulphonate

Genetic toxicity: in vitro

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

Test material information

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.