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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Constituent 1
Chemical structure
Reference substance name:
Di-''isodecyl'' phthalate
EC Number:
247-977-1
EC Name:
Di-''isodecyl'' phthalate
Cas Number:
26761-40-0
Molecular formula:
C28H46O4
IUPAC Name:
1,2-benzenedicarboxylic acid, di-isodecyl ester
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: other: Salmonella strains TA98, TA100, TA1535, TA1537
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.