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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: other: procedure described in paper by Ames
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Summary study report
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
review article or handbook
Title:
I U C L I D D a t a s e t Substance ID: 74869– 22–0
Author:
EUROPEAN COMMISSI – European Chemicals Bureau
Year:
2000
Bibliographic source:
I U C L I D D a t a s e t Substance ID: 74869–22–0 pag 77

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
not specified
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Five substances were tested:
one sample (API 78–9) of solvent–dewaxed light paraffinic distillate, CAS No. 64742–56–9,
four samples (API 78–10, 79–3, 79–4 and 79–5) of solvent–dewaxed heavy paraffinic distillate, CAS No. 64742–65–0

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
rat liver microsomal
Test concentrations with justification for top dose:
40,000 to 240,000 ug/plate
Controls
Untreated negative controls:
not specified
Positive controls:
not specified

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified

Any other information on results incl. tables

Plate assays were performed on all samples with and without rat liver microsomal metabolic activation. Suspension assays for paraffinic basestocks were also performed with a 20–minute pre–incubation with bacteria. Positive controls were also evaluated. No mutagenicity was demonstrated at any dose level. However, results are not conclusive for mutagenic potential because of the test materials insolubility, and the inability to demonstrate toxicity for the bacterial strains.

Applicant's summary and conclusion