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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
Study period:
not specified
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study was conducted prior to GLP and test guidelines, but sufficient data is available for interpretation of results

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
results from only two strains reported. No mention of other strains being tested.
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
epichlorohydrin obtained from Fluka.

Method

Target gene:
his operon in Salmonella typhimurium
Test concentrations with justification for top dose:
0.254, 0.635 and 2.54 umol/plate without S9 and 2.54, 6.34 and 25.4 umol/plate with S9.
Vehicle / solvent:
DMSO
Details on test system and experimental conditions:
Three aromatic epoxy resins were tested by the plate incorporatian assay with bstidine-requiring mutants of S. typhimurium. The test was carried our as described by Ames et al. The S9 mix was prepared from rat liver activated with sodium phenobarbital and containing NADP.

Epichlorohydrin (ECH) was included as positive control. Only results from epichlorhydrin are included here.
Evaluation criteria:
Not stated.
Statistics:
No information provided.

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA100 and TA1535
Metabolic activation:
with and without
Genotoxicity:
positive
Remarks:
positive with and without metabolic activation
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Additional information on results:
Without S9, the response was elevated at the lowest dose examined, 0.254 umol/plate. With S9, the response was slightly elevated from control values at 2.54 umol/plate. At higher doses, a greater response was observed.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Without S9, the response was elevated at the lowest dose examined, 0.254 umol/plate. With S9, the response was slightly elevated from control values at 2.54 umol/plate. At higher doses, a greater response was observed.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
positive

Epichlorohydrin is a direct acting mutagen.
Executive summary:

Epichlorohydrin (ECH) is a direct acting mutagen with a positive response noted at the lowest dose tested, 0.254 umol/plate.