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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:
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: This study is rated a "1" because it applied GLP and used appropriate testing procedures.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Phthalate Ester Testing in the National Toxicology Program's Environmental Mutagenesis Test Development Program
Author:
Zeiger E, et al
Year:
1982
Bibliographic source:
Environ Health Perspect 45:99-101
Reference Type:
publication
Title:
Mutagenicity Testing of di(2-ethylhexyl) Phthalate and Related Chemicals in Salmonella
Author:
Zeiger E, et al
Year:
1985
Bibliographic source:
Environ Mutagen 7(2):213-232

Materials and methods

Principles of method if other than guideline:
Method: other: Ames BN et al. Mutat Res. 31:347-364.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUCLID4 Test substance: other TS: DIDP with different CAS#

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:
homogenates of Aroclor 1254-induced Sprague-Dawley rat and Syrian hamster liver S9
Test concentrations with justification for top dose:
from 100 up to 10,000 ug/plate
Vehicle / solvent:
95% ethanol
Details on test system and experimental conditions:
IUCLID4 Type: Ames test
Evaluation criteria:
A positive mutagenic response was defined as a reproducible, dose-related increase in his+ revertants over 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:
no cytotoxicity
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
The test substance was not mutagenic in the preincubation modification of the Salmonella microsome test.