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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:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Ames Test
Principles of method if other than guideline:
The test was performed according to Ames et al. (Mutation Research 31 (1975) 347-364), Methods for detecting carcinogens and mutagens wlth the salmonella/mammalian microsome mutagenicity test. Guideline was not available at the time the test was performed.
GLP compliance:
no
Remarks:
Study was conducted prior to GLP.
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

Method

Species / strain
Species / strain / cell type:
S. typhimurium, other: TA 98, TA 100, TA 1535, TA 1537, TA 1538
Metabolic activation:
with and without
Metabolic activation system:
Aroclor-induced and Phenbarbitol-induced rat liver S9
Test concentrations with justification for top dose:
Test substance: 2.7 / 27 / 270 / 2700 µg/plate
Positive controls: 67.5 µg/plate (o-nitro-p-phenylendiamin, 270 µg/plate (p-toluol-sulfonic acid hydrazide)
Solvent controls: 100 µl H2O + 100 µl acetone or 100 µl H2O + 100 µl DMSO, resp.
Untreated controls
Vehicle / solvent:
Water/acetone or water/DMSO, resp.
Controlsopen allclose all
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
water/acetone or water/DMSO, resp.
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: o-Nitro-p-phenylendiamine
Remarks:
Strains TA 1537, TA 1538, TA 98
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
water/acetone or water/DMSO, resp.
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: p-toluolsulfonamidehydrazide
Remarks:
TA 100 and TA 1535
Evaluation criteria:
A substance is considered positive if at least one of the tested concentrations results in 2.5-times increase in the number of visible colonies relative to the solvent control in at least one test strains.

Results and discussion

Test results
Key result
Species / strain:
S. typhimurium, other: TA 98, TA 100, TA 1535, TA 1537, TA 1538
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
Additional information on results:
Activity of Aroclor induced S9 was confirmed by testing TA 98 with Benzo-a-pyrene: 580 back mutations were induced. TA 100 induced 720 back mutations with 2-anthramine

Applicant's summary and conclusion

Conclusions:
HEDP-2Na has been tested for reverse mutation in bacteria, using a method that is similar to OECD 471. No evidence for mutagenicity was obtained under the conditions of the study up to 2700 µg/plate.