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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:
2001
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study is described in the SIDS Initial Assessment Report for SIAM 30 which is peer-review by the Japanese government. The study followed OECD TG 471 and was performed under GLP. The Klimisch rating was taken over from the SIDS dossier. However as the full study report and full individual data were not available for full reliability assessment, a Klimisch 2 reliability for this study is proposed in the dossier.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
2001
Reference Type:
secondary source
Title:
SIDS Initial Assessment Report For SIAM 30
Author:
OECD SIDS
Year:
2010
Bibliographic source:
OECD HPV Chemical Programme, SIDS Dossier, approved at SIAM 30 (20-22 April 2010)
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Purity: 99.16%
- Manufacture: Yamamoto Chemicals Inc.
- Lot/batch No.: 98-11056

Method

Species / strain
Species / strain / cell type:
other: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100, E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
Rat liver, induced with phenobarbital and 5,6-benzoflavone
Test concentrations with justification for top dose:
-S9 mix; 0, 156, 313, 625, 1250, 2500, 5000 μg/plate(all strains)
+S9 mix; 0, 2.44, 4.88, 9.77, 19.5, 39.1, 78.1, 156 μg/plate(TA100)
+S9 mix; 0, 156, 313, 625, 1250, 2500, 5000 μg/plate(TA1535, TA98, TA1537)
+S9 mix; 0, 39.1, 78.1, 156, 313, 625, 1250, 2500, 5000 μg/plate(WP2 uvrA)
+S9 mix(confirmative test, 1st); 0, 2.44, 4.88, 9.77, 19.5, 39.1, 78.1, 156, 313, 625, 1250, 2500, 5000 μg/plate(TA100)
+S9 mix(confirmative test, 2nd); 0, 156, 313, 625, 1250, 2500, 5000 μg/plate(TA100)
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: -S9 mix: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide (TA100, TA98 and WP2 uvrA), Sodium azide (TA1535) and 9-Aminoacridine hydrochloride (TA1537). +S9 mix: 2-Aminoanthracene (all strains)
Remarks:
- Vehicle(s)/solvent(s) used: DMSO
Details on test system and experimental conditions:
METHOD OF APPLICATION
pre-incubation

DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 hours

- plate/dose: 3
Evaluation criteria:
The chemicals were considered to be mutagenic when a dose-related increase in revertant colony count was observed and the number of revertant colonies per plate with the test substance was more than twice that of the negative control and when a reproducibility of test result was observed.
Statistics:
Not conducted

Results and discussion

Test results
Species / strain:
other: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100. E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

See "attached background material"

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

2-ethylanthraquinone did not induce gene mutations in bacteria under the conditions of this study.
Executive summary:

Reverse mutation assays using microorganisms (Salmonella typhimurium, Escherichia coli) were conducted to assess the potential of 2-ethylanthraquinone to induce gene mutations. 2-ethylanthraquinone did not induce gene mutations in bacteria under the conditions of this study.