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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in mammalian cells
Remarks:
Type of genotoxicity: gene mutation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to OECD guidelines and to GLP, so therefore meets the criteria of Klimisch code 1.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
Deviations:
no
GLP compliance:
yes
Type of assay:
mammalian cell gene mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
The test material (CAS 68783-96-0) is an alkyl aryl sulphonate described as a petroleum derived, calcium salt, overbased.

Method

Target gene:
TK +/-
Species / strain
Species / strain / cell type:
mouse lymphoma L5178Y cells
Metabolic activation:
with and without
Metabolic activation system:
Aroclor induced rat liver S9 cells
Test concentrations with justification for top dose:
500, 1000, 1500, 2000, 4000, and 5000 µg/ml
Vehicle / solvent:
DMSO
Controlsopen allclose all
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
7,12-dimethylbenzanthracene
Remarks:
with activation
Positive controls:
yes
Positive control substance:
ethylmethanesulphonate
Remarks:
without activation
Details on test system and experimental conditions:
The test material was suspended in culture and palced on a restricted media containing trifluorothymidine.

METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation; in suspension; as impregnation on paper disk


DURATION
- Preincubation period: 4 hours
- Exposure duration: 10-12 days


NUMBER OF REPLICATIONS: 2


DETERMINATION OF CYTOTOXICITY
- Method: relative total growth
Evaluation criteria:
Number of colonies/plate.
Statistics:
Mean and standard deviation.

Results and discussion

Test results
Species / strain:
mouse lymphoma L5178Y cells
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:

RANGE-FINDING/SCREENING STUDIES: Significant toxicity (<90% total growth) at 500 µg/ml occurred both with and without metabolic activation.

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

The test material was not genotoxic under the conditions of test.
Executive summary:

In a mammalian cell gene mutation assay, mouse lymphoma L5178Y cells cultured in vitro were exposed to a petroleum derived calcium salt, at concentrations of  500, 1000, 1500, 2000, 4000 and 5000 µg/ml in the presence and absence of mammalian metabolic activation. 

 

The positive controls induced the appropriate response.  There was no evidence of induced mutant colonies over background.

 

This study is classified as acceptable.  This study satisfies the requirement for Test Guideline OECD 476 for in vitro mutagenicity (mammalian forward gene mutation) data