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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:
September 1983
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
No follow-up experiments were done for confirmation of negative results
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Target gene:
In the Salmonella typhimurium strains (TA 1535, TA 100, TA 1537, TA 1538, TA 98) the amino acid histidine locus is the target gene.
In the Escherichia coli strain (WP2 uvrA) the amino acid tryptophan locus is the target gene.
Species / strain
Species / strain / cell type:
other: Salmonella typhimurium TA98, TA100, TA1535, TA1537, TA1538, Escherichia coli WP2 uvrA
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
Rat liver S-9 mix from Arochlor 1254 induced rats
Test concentrations with justification for top dose:
0.8, 4, 20, 100, 250, 500, 1000 µg/plate
Vehicle / solvent:
- Vehicle/solvent used: DMSO
Controlsopen allclose all
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
yes
Remarks:
2-aminoanthracene (-S9: 0.5 µg/plate; TA98, TA100, TA1538)
Positive controls:
yes
Remarks:
TA98, TA100, TA1538
Positive control substance:
other: -S9: methylhydrazone derivative (5 µg/plate), +S9: 2-aminoanthracene (0.5 µg/plate)
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
yes
Remarks:
2-aminoanthracene (-S9: 1 µg/plate (TA1535, TA 1537), 10 µg/plate (WP2 uvr A))
Positive controls:
yes
Remarks:
TA 1557, TA 1535, WP2 uvr A
Positive control substance:
other: -S9: streptocotocine (5 µg/plate (TA 1535)), 9-aminoacridine (100 µg/plate (TA 1537)), N-ethyl-N-nitro-N-nitrosoguanidine (2 µg/plate, WP2 uvr A); +S9: 2-amioanthracene (1 µg/plate (TA 1535, TA1537), 2-amioanthracene 10 µg/plate (WP2 uvr A))
Details on test system and experimental conditions:
METHOD OF APPLICATION: Overlay (soft) agar (plate incorporation method)
Evaluation criteria:
The test substance is considered positive in this assay if the following criteria is met:
- Doubling of the revertant colonies compared to controls

Results and discussion

Test results
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: Without metabolic activation: >= 500 µg/plate, with metabolic activation: >= 1000 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Executive summary:

In a reverse gene mutation assay in bacteria Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, TA1538 and Escherichia coli strain WP2 uvrA were exposed to p-chlorobenzylchloride at concentrations of 0, 0.8, 4, 20, 100, 250, 500, 1000 µg/plate in the presence and absence of mammalian metabolic activation. No preincubation was performed. There was no evidence of induced mutant colonies over background up to a concentration of 1 mg p-chlorobenzyl chloride / plate. The positive controls induced the appropriate responses in the corresponding strains. In conclusion, p-chlorobenzyl chloride did not show any mutagenic activity in any tester strains regardless of metabolic activation.