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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Version / remarks:
Ames (1975)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Paraffin waxes and Hydrocarbon waxes, chloro
EC Number:
264-150-0
EC Name:
Paraffin waxes and Hydrocarbon waxes, chloro
Cas Number:
63449-39-8
Molecular formula:
C18H33Cl5 C18H30Cl8 C20H36Cl6 C20H33Cl9 C25H45Cl7 C25H42Cl10 C25H29C23 C30H53Cl9 C30H49Cl13 C30H35Cl27
IUPAC Name:
Paraffin waxes and Hydrocarbon waxes, chloro
Details on test material:
C22-26; 42% Cl (liquid). Cereclor 42.

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
Arochlor-induced rat liver postmitochondrial supernatant (S-9 mix).
Test concentrations with justification for top dose:
0.25 - 2500 µg/ml
Controls
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
yes
Remarks:
DMSO
Positive controls:
yes
Positive control substance:
other: 1,3-propanesultone for TA1535 and TA100; 2-acetylaminofluorene was for TA1538 and TA98.
Evaluation criteria:
The criteria for a positive response was taken to be a two-fold or greater increase in the mean number of revertant colonies appearing in the text plates over and above the background spontaneous reversion rate observed with the solvent, DMSO, together with evidence of a dose-response relationship.

Results and discussion

Test results
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Remarks on result:
other: strain/cell type: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with and without activation

Negative with and without activation.
Executive summary:

Negative with and without activation.