Registration Dossier

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1998/11/11-1999/06/11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to or similar to guideline study OECD 471: GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Target gene:
Not applicable
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
S. typhimurium TA 102
Metabolic activation:
with and without
Metabolic activation system:
S9 liver fractions from Aroclor exposed rats
Test concentrations with justification for top dose:
Tests (done in triplicate) with and without Metabolic Activation: Acetone (vehicle control), 0,128, 320, 800, 2000, 5000 ug/plate
Vehicle control: 0.1 ml/plate acetone
Positive controls: 2-nitrofluorene (2NF): 5ug/plate (TA98; -S9); Sodium azide - 2ug/plate (TA100, TA1535; -S9); 9-aminoacridine (9AA): 50ug/plate (TA1537; -S9); Glutaraldehyde (GLU): 25.0ug/plate (TA102; -S9); 2-aminoanthracene (2AA): 5ug/plate (TA98; +S9)
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: acetone
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
0.1 ml/plate Acetone
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-nitrofluorene (2NF): 5ug/plate (TA98; -S9); Sodium azide - 2ug/plate (TA100, TA1535; -S9); 9-aminoacridine (9AA): 50ug/plate (TA1537; -S9); Glutaraldehyde (GLU): 25.0ug/plate (TA102; -S9); 2-aminoanthracene (2AA): 5ug/plate (TA98; +S9)
Details on test system and experimental conditions:
These platings were achieved by the following sequence of additions to 2.5 mL molten agar at 46°C:

0.1 mL bacterial culture
0.025 mL test article solution or control
0.5 mL 10% 8-9 mix or buffer solution

followed by rapid mixing and pouring on to Minimal Davis agar plates. When set, the plates were inverted and incubated at 37°C in the dark for 3 days. Following incubation, these plates were examined for evidence of toxicity to the background lawn, and where possible revertant colonies were counted.
Evaluation criteria:
The test article was considered to be mutagenic if: 1) the assay was valid, 2) Dunnett’s test gave a significant response (p<0.01), and the data set(s) showed a significant dose-correlation, and 3) the positive responses described in 2) were reproducible.
Statistics:
The m-statistic was calculated to check that the data were Poisson-distributed, and Dunnett’s test was used to compare the counts of each dose with the control. The presence or otherwise of a dose response was checked by linear regression analysis.

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Remarks:
not cytotoxic up to 5000ug/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Remarks:
not cytotoxic up to 5000ug/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
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

The test to assess the genotoxicity of the test material was negative. This finding does not warrant the classification of this test material as a genotoxin under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Executive summary:

No SHELLSOL TD treatments of any of the test strains, either in the absence or in the presence of S-9, resulted in a statistically significant increase in revertant numbers, when the data were analysed at the 1% level using Dunnetts test. This study was therefore considered to have provided no indication of any SHELLSOL TD mutagenic activity. The test to assess the genotoxicity of the test material was negative. This finding does not warrant the classification of this test material as a genotoxin under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.