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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: see 'Remark'
Remarks:
Study is comparable to guideline study with the following acceptable restrictions: other positive control substance used for TA98; only 4 bacteria strains tested, no strain used sensitive to oxidative damage; sufficient documentation of testing procedure and test results; study acceptable as key study for mutagenicity testing in strains TA98, TA100, TA1535, and TA1537
Cross-reference
Reason / purpose:
reference to same study

Data source

Referenceopen allclose all

Reference Type:
review article or handbook
Title:
Salmonella mutagenicity test results for 250 chemicals.
Author:
Haworth S, Lawlor T, Mortelmans K, Speck W, Zeiger E
Year:
1983
Bibliographic source:
Environ Mutagen 5 (Suppl 1), 1 - 142
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
(other positive control for TA98; only 4 bacteria strains tested, no strain used sensitive to oxidative damage)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): hydroquinone
- Analytical purity: not specified (label purity: " purified ")
- Stability under test conditions: test solutions were prepared immediately before use

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:
Aroclor 1254-induced S9 from male Syrian hamster liver or male Sprague-Dawley rat liver
Test concentrations with justification for top dose:
0, 10, 33, 100, 333, 666 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: solubility
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: without S9: 4-nitro-o-phenylenediamine with TA98, sodium azide with TA100 and TA1535, 9-aminoacridine with TA1537; with S9: 2-aminoanthracene with all strains
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation); preincubation

DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h

SELECTION AGENT (mutation assays): histidine

NUMBER OF REPLICATIONS: 3 plates/assay, and 2 assays

DETERMINATION OF CYTOTOXICITY
- Method: viability or reduced number of revertant colonies per plate
Evaluation criteria:
Positive response indicated by reproducible, dose-related increase, whether it would be two-fold over background or not

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
Remarks:
revertant rates similar to controls at all tested concentrations
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
in all strains without metabolic activation from 333 µg/plate up
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
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:
Interpretation of results (migrated information):
negative

There was no indication of a mutagenic activity in S. typhimurium strains TA98, TA100, TA1535, and TA1537.
Executive summary:

Hydroquinone (10 - 666 µg/plate) was tested in a Salmonella typhimurium reverse mutation assay with strains TA98, TA100, TA1535, and TA1537 applying a preincubation test protocol comparable to OECD Guideline 471. There was no indication of mutagenic activity up to cytotoxic concentrations (333 and 666 µg/plate) both in the absence and presence of metabolic activation (S9 mix from Aroclor 1254 -induced hamster or rat liver).