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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:
1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Referenceopen allclose all

Reference Type:
review article or handbook
Title:
SIDS DOCOSANOIC ACID
Author:
METI (former MITI)
Year:
1998
Bibliographic source:
OECD SIDS ; METI (former MITI), Japan (1998)
Reference Type:
study report
Title:
Unnamed
Year:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
Deviations:
not applicable
Qualifier:
according to guideline
Guideline:
JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
Principles of method if other than guideline:
/
GLP compliance:
yes
Type of assay:
other: not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Docosanoic acid
EC Number:
204-010-8
EC Name:
Docosanoic acid
Cas Number:
112-85-6
Molecular formula:
C22H44O2
IUPAC Name:
docosanoic acid
Test material form:
other: solid
Details on test material:
- Name of test material (as cited in study report): Docosanoic acid
- Molecular formula (if other than submission substance): C22H44O2
- Molecular weight: 340,58g/mol
- Substance type:Not applicable
- Physical state:solid
- Analytical purity:85.9%
- Impurities (identity and concentrations):c14-C20 fatty acids: ca. 11%; C24 fatty acid: ca. 2%

Method

Target gene:
/
Species / strain
Species / strain / cell type:
Chinese hamster lung (CHL/IU)
Metabolic activation:
with and without
Metabolic activation system:
S9, rat, induced with phenobarbital and 5,6-benzoflavone
Test concentrations with justification for top dose:
350-2800 µg/ml (-S9, 24hr continuous treatment)
288-2300 µg/ml (-S9, 48hr continuous treatment)
875-3500 µg/ml (+/-S9, short term treatment)
Vehicle / solvent:
1 % Carboxymethylcellulose sodium
Controls
Positive controls:
yes
Positive control substance:
cyclophosphamide
mitomycin C
Details on test system and experimental conditions:
For continuous treatment, cells were treated for 24 or 48 hrs without S9. For short-term treatment, cells were treated for 6 hrs with and without S9 and cultivated with fresh media for 18 hrs.
Evaluation criteria:
/
Statistics:
/

Results and discussion

Test results
Species / strain:
Chinese hamster lung (CHL/IU)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: with metabolic activation: no; without metabolic activation: >= 2703 µg/ml (24hr), 2242 g/mL (48hr)
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
True negative controls validity:
not specified
Positive controls validity:
valid
Additional information on results:
Fifty percent inhibition of cell proliferation was observed at 2,703 ug/mL for 24hr continuous treatment and at 2,242 ug/mL for 48hr continuous treatment, respectively. Cell proliferation inhibition was not observed in short-term treatment with or without S9 mix.
Structural chromosomal aberrations and polyploidy were not induced up to a maximum concentration of test substance under conditions of continuous treatment, and short-term treatment with and without an exogenous metabolic activa tion system.

Applicant's summary and conclusion

Conclusions:
Chromosomal aberration test in CHL/IU cells was negative with and without metabolic activation.