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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study report does not state whether testing was performed under Good Laboratory Practices (GLP).

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, Haworth S, Speck W and Mortelmans K
Year:
1982
Bibliographic source:
Environmental Health Perspectives, Volume 45, Pages 99-101
Reference Type:
publication
Title:
Mutagenicity testing of di(2-ethylhexyl) phthalate and related chemicals in salmonella
Author:
Zeiger E, Haworth S, Mortelmans K and Speck W
Year:
1985
Bibliographic source:
Environmental Mutagenesis, Volume 7, Pages 213-232

Materials and methods

Test guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
A mutagenic response was defined as a reproducible, dose-related increase in the number of histidine-independent colonies over the spontaneous incidence. There was no requirement for a specific magnitude of increase.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
Di(tridecyl) phthalate
EC Number:
204-294-3
EC Name:
Di(tridecyl) phthalate
Cas Number:
119-06-2
IUPAC Name:
ditridecyl phthalate
Details on test material:
All testing was done using a preincubation modification of the method of Ames, Salmonella typhimurium TA98, TA100, TA1535 and TA1537 were used with S-9 liver homogenate preparations from Arochlor 1254-induced male Sprague-Dawley rats and Syrian hamsters. An overnight culture of Salmonella, S-9 fraction and DTDP were plated onto minimal agar at 37 Celsius for two days, after which the histidine revertant colonies were machine counted. DTDP was tested at 5 different concentrations.

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:
S9 fraction of Aroclor 1254 induced rat and hamster liver
Test concentrations with justification for top dose:
5 dose levels up to 10 mg/plate
Details on test system and experimental conditions:
Approximately 10E8 bacteria were mixed with 0.5 ml of either 0.1M sodium phosphate buffer or S-9 mix, and test substance. The reaction was carried out in triplicate. The mixture was incubated at 37°C for 48 hours, after which time histidine-revertant colonies were counted. The doses selected were separated by half-log intervals. The high dose was 10 mg/plate unless limited by solubility. Positive control chemicals were sodium azide, nitro-o-phenylenediamine, 9-aminoacridine and 2-aminoanthracene. Concurrent solvent and positive controls were included in all experiments. A toxicity pretest with TA 100 was conducted to determine the high dose 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:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
No mutagenic activity was observed at doses up to 10 mg/plate in Salmonella strains TA 98, TA 100, TA 1535 and TA 1537 with or without metabolic activation.
Executive summary:

The mutagenic capacity of DTDP was assessed using the Ames method. Salmonella typhimurium TA98, TA100, TA1535 and TA1537 were used with S-9 liver homogenate preparations from Arochlor 1254-induced male Sprague-Dawley rats and Syrian hamsters. An overnight culture of Salmonella, +/- S-9 fraction and DTDP were plated onto minimal agar at 37 Celsius for two days, after which the histidine revertant colonies were machine counted. Five different concentrations of DTDP were used. No mutagenic activity was observed at doses up to 10 mg/plate in Salmonella strains TA 98, TA 100, TA 1535 and TA 1537 with or without metabolic activation.

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