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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:
1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study, similar to OECD guideline No. 471.

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
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
2-methoxy-1-methylethyl acetate
EC Number:
203-603-9
EC Name:
2-methoxy-1-methylethyl acetate
Cas Number:
108-65-6
Molecular formula:
C6H12O3
IUPAC Name:
2-methoxy-1-methylethyl acetate
Details on test material:
- Name of test material (as cited in study report): Dowanol PM acetate ( propylene glycol methyl ether acetate)
- Molecular formula (if other than submission substance): C6H12O3
- Molecular weight (if other than submission substance): 132.16
- Purity : 99.97%
- Lot/batch No.: MM82-324

Method

Species / strain
Species / strain / cell type:
other: Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, TA1538
Metabolic activation:
with and without
Metabolic activation system:
Rat liver homogenate (S9)
Test concentrations with justification for top dose:
50, 10, 1, 0.1 mg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: N-ethyl-N-nitro-N-nitrosoguanidine ( TA 100 & TA 1535 -S9), nitrofluorene ( TA98 & TA 1538 -S9), quinacrine mustard.2HCl ( TA 1537 -S9) 2-anthramine ( TA 100 & TA 1535 +S9), 2-acetylaminofluorene ( TA98 & TA 1538 +S9), 8-aminoquinoline (TA 1537
Remarks:
N-ethyl-N-nitro-N-nitrosoguanidine ( TA 100 & TA 1535 -S9), nitrofluorene ( TA98 & TA 1538 -S9), quinacrine mustard.2HCl ( TA 1537 -S9) 2-anthramine ( TA 100 & TA 1535 +S9), 2-acetylaminofluorene ( TA98 & TA 1538 +S9), 8-aminoquinoline (TA 1537
Details on test system and experimental conditions:
METHOD OF APPLICATION: in medium; preincubation
DURATION
- Preincubation period:30 min
- Incubation period: 48 hours

NUMBER OF REPLICATIONS:
3 replicates per dose

DETERMINATION OF CYTOTOXICITY
- Method: bacterial background lawn evaluation
- cytotoxcity was evident at 50mg test chemical per plate in all strains of bacteria, both with and without metabolic activation system


Evaluation criteria:
Concentrations of the test chemical which are overtly toxic are easily visualized as showing no bacterial growth on the plate (i.e. absence of background lawn). Lower levels of toxicity may be seen as a thin or sparse bacterial lawn, a reduction in the number of revertants, or the appearance of microcolonies (overgrown background lawn). Positive and negative controls were run concurrently with the test chemical, and appropriate responses for these controls are prerequesites for evaluating the response of the bacteria to the test chemical.

A test chemical is considered a bacterial mutagen if both the mean number of revertant colonies observed is at least three times higher than the mea

Results and discussion

Test results
Species / strain:
other: Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, TA1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: cytotoxcity was evident at 50mg test chemical per plate in all strains of bacteria, both with and without metabolic activation system
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
cytotoxcity was evident at 50mg test chemical per plate in all strains of bacteria, both with and without metabolic activation system.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

See the attached word document for tables and figures:

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Propylene glycol methyl ether acetate (DOWANOL PMA) did not cause mutations in the Ames Salmonela reverse mutation assay both with or without S-9 metabolic activation. Hence, the test material was classified as negative in the Ames test under the experimental conditions used.
Executive summary:

Propylene glycol methyl ether acetate was evaluated in the Salmonella/mammalian-microsome bacterial mutagenicity assay (Ames test) using a preincubation assay. The test was conducted using Salmonella typhimurium bacterial tester strains TA98, TA100, TA1535, TA 1537 and TA1538 at 4 doses in triplicate. The test agent was assayed 50, 10, 1, 0.1 mg/plate in all the tester strains both in the presence and absence of external metabolic activation system.

All solvent (negative) control plates and positive control plates gave frequencies of induced revertants within expected ranges. Cytotoxcity was evident at 50mg test chemical per plate in all strains of bacteria, both with and without metabolic activation system.

The test material did not induce a mutagenic response in any of the tester strains in the assays as judged by the frequencies of histidine-independent (his+) revertants. Hence, the test material was classified as negative in the Ames test under the experimental conditions used.

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