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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Study period:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Secondary literature source with limited documentation, but used in the CIR report for the assessment of 12-hydrosystearic acid and meets generally accepted scientific principles, acceptable for assessment.
Justification for data waiving:
other:
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
review article or handbook
Title:
Amended final report on the safety assessessment of hydroxystearic acid (Reviewed by the Cosmetic Ingredient Review Expert Panel)
Author:
Cosmetic Ingredient Review (CIR) Panel
Year:
1999
Bibliographic source:
Int. J. of Toxicol., 18 (Suppl. 1): 1-10

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
Principles of method if other than guideline:
Not applicable.
GLP compliance:
not specified
Type of assay:
in vitro mammalian chromosome aberration test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 12-hydroxystearic acid
-Composition:
Hydroxystearic Acid, 94.9%;
Stearic Acid, 8%;
Palmitic Acid, 1%;
Triglyceride (castor oil), 5%; and
Tolyvinyl stearate <1%

Method

Target gene:
Not applicable
Species / strain
Species / strain / cell type:
Chinese hamster Ovary (CHO)
Details on mammalian cell type (if applicable):
No data
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254-induced rat liver S-9
Test concentrations with justification for top dose:
In both initial and repeat tests doses ranged from 4 to 213 µg/mL in DMSO (vehicle) for 6, 18 and 42 h in the absence of S9 reaction mixture and for only 6 h in the presence of S9 mixture
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: Dimethyl sulfoxide (DMSO)
Controlsopen allclose all
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
yes
Positive controls:
yes
Positive control substance:
other: N-methyl-NP-nitro-N-nitrosoguanidine (MNNG)
Remarks:
2 microgram/mL N-methyl-N'-nitro-N-nitrosoguanidine (MNNG), was used as the positive control for nonactivated cultures
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
yes
Positive controls:
yes
Positive control substance:
benzo(a)pyrene
Remarks:
30 microgram/mL Benzo(a)pyrene was used as positive control for activated cultures
Evaluation criteria:
No data
Statistics:
No data

Results and discussion

Test results
Species / strain:
Chinese hamster Ovary (CHO)
Metabolic activation:
with and without
Genotoxicity:
not determined
Cytotoxicity / choice of top concentrations:
no cytotoxicity
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

Under the conditions of the study, the test substance did not induce a significant increase in chromosomal aberrations and was therefore considered to be negative in the CHO cytogenetic study.
Executive summary:

An in vitro cytogenetic study was conducted using Chinese hamster ovary (CHO) cells to determine the mutagenicity of the test substance.

In both initial and repeat tests doses ranged from 4 to 213 µg/mL in DMSO (vehicle) for 6, 18 and 42 h in the absence of S9 reaction mixture and for only 6 h in the presence of S9 mixture.

In the definitive assay, survival at the highest dose level scored was 52% in the non-activated 6 h treatment study; 48% in the non-activated 18 h treatment study; 44% in the non-activated 42 h treatment study and 82% in the S9 activated study.

The three highest doses with 200 scorable metaphase cells in the 6, 18 and 42 h treatment studies were selected for analysis. The test substance did not induce a statistically significant increase in structural or numerical chromosome aberrations in either the absence or presence of S9 activation, regardless of the treatment condition or harvest time.

Under the conditions of the study, the test substance did not induce a significant increase in chromosomal aberrations and was therefore considered to be negative in the CHO cytogenetic study.