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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted as part of the US National Toxicology Program. Article published in established peer-reviewed journal; standard protocol followed.

Data source

Reference
Reference Type:
review article or handbook
Title:
Phthalate ester testing in the National Toxicology Program’s Environmental Mutagenesis Test Development Program
Author:
Zeiger, E., Haworth, S., Speck, W., and Mortelmans, K.
Year:
1982
Bibliographic source:
Environmental Health Perspectives, 45, 99-101, 1982

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Reagent grade

Method

Target gene:
Histidine prototrophy assay in Salmonella typhimurium (Ames test)
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:
S9/cofactors (exogenous metabolic activation
Test concentrations with justification for top dose:
100-10,000 µg/plate (recommended maximum for OECD 471 is 5,000 µg/plate)
Vehicle / solvent:
DIBP dissolved in DMSO.
Details on test system and experimental conditions:
Slight deficiency in number/type of bacterial strains with respect to OECD 471.
Doses/concentration: 100-10,000 µg/plate (recommended maximum for OECD 471 is 5,000 µg/plate).
Pre-incubation modification of the method of Ames et al.
Bacteria were tested for reversion to histidine prototrophy, both in the absence and presence of S9/cofactors (exogenous metabolic activation system). Concurrent positive and solvents controls were included to demonstrate the effective performance of the assays.
Evaluation criteria:
Testing conducted in a blind manner. Decoding of samples performed by NTP after data evaluation.
Concurrent positive and solvents controls were included to demonstrate the effective performance of the assays.
Treatment of data: A positive mutagenic response was defined as a reproducible, dose-related increase in his+ revertants over the spontaneous level.

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:
valid
Remarks on result:
other: strain/cell type:
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

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

DIBP was not mutagenic in this assay, neither in the absence nor presence of an exogenous metabolic activation system.
Executive summary:

Bacteria were tested for reversion to histidine prototrophy, both in the absence and presence of S9/cofactors (exogenous metabolic activation system). Doses/concentration:100-10,000 µg/plate. Pre-incubation modification of the method of Ames et al. Concurrent positive and solvents controls were included to demonstrate the effective performance of the assays. DIBP was not mutagenic in this assay, with and without metabolic activation.