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Toxicological information

Genetic toxicity: in vitro

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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

Constituent 1
Chemical structure
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