Registration Dossier

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:
2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to OECD guideline and GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

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:
- Name of test substance: Neopentylglykol-Ketal (Stufe 3 der BAS 520 F-Synthese)
- Test subsnatce no.: 29003-138
- Date of manufacture: September 14, 1998
- Degree of purity: 96.2%
- Appearance, consistency: colorless, viscous liquid
- Storage: room temperature (protected from light)

Method

Target gene:
his and trp
Species / strainopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
Liver S9 fractions from Aroclor induced rats.
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
Liver S9 fractions from Aroclor induced rats.
Test concentrations with justification for top dose:
0; 20; 100; 500; 2,500 and 5,000 µg/plate
Vehicle:
DMSO
Controls
Negative controls:
yes
Solvent controls:
yes
Remarks:
DMSO
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: For information on positive and negative controls see below: ""Any other information on materials and methods incl. tables".
Evaluation criteria:
Evalluation criteria

The test chemical is considered positive in this assay if the following criteria are met:

A dose-related and reproducible increase in the number of revertant colonies, i.e. about doubling of the spontaneous mutation rate in at least one tester strain either withaut S-9 mix or after adding a metabolizing system.


A test substance is generally considered nonmutagenic in this test if:

The number of revertants for all tester strains were within the historical negative
control range under all experimental co nditions in two experiments carried out
independently of each other.

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:
other: Bacteriotoxicity was observed in the preincubation assay from about 2,500 µg/plate onward.
Vehicle controls valid:
yes
Negative controls valid:
yes
Positive controls valid:
yes
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
other: Bacteriotoxicity was observed in the preincubation assay from about 2,500 µg/plate onward.
Vehicle controls valid:
yes
Negative controls valid:
yes
Positive controls valid:
yes
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Executive summary:

Thus, under the experimental conditions chosen here, it is concluded that Neopentylglykol-Ketal (Stufe 3 der BAS 520 F-Synthese) is not a mutagenic agent in a bacterial reverse mutation test.