Aluminium tristearate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

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:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Principles of method if other than guideline:

Salmonella/microsome test (Spot test) was performed to determine the mutagenic nature of Stearic acid

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Stearic acid

EC Number:

200-313-4

EC Name:

Stearic acid

Cas Number:

57-11-4

Molecular formula:

C18H36O2

IUPAC Name:

stearic acid

Specific details on test material used for the study:

- Name of test material: Stearic acid- IUPAC name: Octadecanoic acid- Molecular formula: C18H36O2- Molecular weight: 284.4804 g/mol- Substance type: Organic- Physical state: No data - Purity: No data- Impurities (identity and concentrations): No data

Method

Target gene:

Histidine

Species / strain

Species / strain / cell type:

S. typhimurium, other: LT2 - hisTA98, hisTA100, hlsTA1535, hisTA1537, and hisTA1538

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not specified

Cytokinesis block (if used):

No data

Metabolic activation:

with and without

Metabolic activation system:

Postmitochondrial preparations (S9) from livers of male Sprague-Dawley rats induced with Aroclor 1254

Test concentrations with justification for top dose:

50 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: Sterile double distilled water- Justification for choice of solvent/vehicle: The chemical was soluble in Sterile double distilled water

Controls

Untreated negative controls:

yes

Remarks:

Spontaneous revertants

Negative solvent / vehicle controls:

yes

Remarks:

Sterile double distilled water

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

9-aminoacridine

sodium azide

other: 2- aminoanthracene (all strains), 4-nitro-o-phenylene diamine (TA1538 and TA98)

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (spot test)DURATION- Preincubation period: No data- Exposure duration: 2 days (48 hrs)- Expression time (cells in growth medium): 2 days (48 hrs)- Selection time (if incubation with a selection agent): No data- Fixation time (start of exposure up to fixation or harvest of cells): No dataSELECTION AGENT (mutation assays): No dataSPINDLE INHIBITOR (cytogenetic assays): No dataSTAIN (for cytogenetic assays): No dataNUMBER OF REPLICATIONS: No dataNUMBER OF CELLS EVALUATED: No dataDETERMINATION OF CYTOTOXICITY- Method: mitotic index; cloning efficiency; relative total growth; other: No dataOTHER EXAMINATIONS:- Determination of polyploidy: No data- Determination of endoreplication: No data- Other: No dataOTHER: No data

Rationale for test conditions:

No data

Evaluation criteria:

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. 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 non-treated and cosmetic ingredient treated plates.

Statistics:

Mean ± SD

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

Remarks:

Results showed no significant difference in the reversion rates of the solvent control plates

Untreated negative controls validity:

valid

Remarks:

Results showed no significant difference in the reversion rates of the spontaneous reversion plates

Positive controls validity:

valid

Remarks:

Known mutagens were tested as positive controls and confirmed that each strain was responding properly to mutation

Additional information on results:

No data

Applicant's summary and conclusion

Conclusions:

Stearic acid failed to induce mutation in Salmonella typhimurium LT2 - hisTA98, hisTA100, hisTA1535, hisTA1537, and hisTA1538 both in the presence and absence of S9 metabolic activation system and hence is not likely to classify as a gene mutant in vitro.

Executive summary:

Salmonella/microsome test (Spot test) was performed to determine the mutagenic nature of Stearic acid. The study was performed usinginSalmonella typhimurium LT2 - hisTA98, hisTA100, hisTA1535, hisTA1537, and hisTA1538 with and without S9 metabolic activation system. The chemical as used at dose levels of 50µg/plate and the plates were incubated for 2 days. The plates were observed for a dose dependent increase in the number of revertants/plate. Negative and positive control plates were also made with the test plates. The negative controls were used to determine the spontaneous reversion rate to prototrophy for each strain, and to determine the effect of the solvents on the reversion rates.Stearic acid failed to induce mutation inSalmonella typhimurium LT2 - hisTA98, hisTA100, hisTA1535, hisTA1537, and hisTA1538 both in the presence and absence of S9 metabolic activation system and hence is not likely to classify as a gene mutant in vitro