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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: scientifically acceptable and suffcient documented

Data source

Reference
Reference Type:
publication
Title:
Mutagenicity testing of di(2-ethylhexyl)phthalate and related chemicals in Salmonella
Author:
Zeiger E, Haworth S, Mortelmans K, Speck W
Year:
1985
Bibliographic source:
Environ Mutagen 7, 213-232

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
Tetrachlorophthatic anhydride (and related chemicals) were tested for mutagenieity in Salmonella typhimurium strains TA98, TA 100, TA 1535, and TA 1537 without metabolic activation and in the presence of rat and hamster liver S-9 metabolic activation systems.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

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:
S-9 mix
Test concentrations with justification for top dose:
Test 1 - 0, 33.3, 100, 333.3, 1000, 3333.3 and 6666.7 ug/plate;
Test 2 - 0, 1, 3.3, 10, 33, 100, 333, 1000 ug/plate
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: Positive control chemicals used were: TA 1535 and TA 100: sodium azide: TA 98: 4-nitro-o-phenyJenediamine: and TA 1537, 9-aminoacridine. 2-Aminoanthracene was used as the positive control for metabolic activation in all strains

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:
cytotoxicity
Remarks:
Test 1 -3333.3 ug/plate; Test 2-> 1000 ug/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: other: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

No mutagenic activity was seen with tetrachlorophthalic anhydride with and without metabolic activation

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative
Executive summary:

Tetrachlorophthatic anhydride (and related chemicals) were tested for mutagenieity in Salmonella typhimurium strains TA98, TA 100, TA 1535, and TA 1537 without metabolic activation and in the presence of rat and hamster liver S-9 metabolic activation systems.

No mutagenic activity was seen with tetrachlorophthalic anhydride with and without metabolic activation