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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: Near-guideline study, pre-GLP, methods and results only briefly described but generally acceptable.

Data source

Reference
Reference Type:
publication
Title:
Primary mutagenicity screening of food additives currently used in Japan
Author:
Ishidate M, Sofuni K, Yoshikawa K, Hayashi M, Nohmi T, Sawada M and Matsuoka A
Year:
1984
Bibliographic source:
Food Cosmet. Toxicol. 22: 623-636.

Materials and methods

Principles of method if other than guideline:
In accordance with the method of Ames, McCann and Yamasaki (1975).
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): propylene glycol
- Analytical purity: 99%
- Supplier: the Japan Food Additives Association, Tokyo

Method

Target gene:
his
Species / strain
Species / strain / cell type:
other: TA 92, TA 94, TA 98, TA 100, TA 1535, TA 1537
Metabolic activation:
with
Metabolic activation system:
rat S9
Test concentrations with justification for top dose:
up to 10 mg/plate (concentration range not specified; in total 6 different concentrations were tested)
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
not specified
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Preincubation period: 20 min
- Exposure duration: 20 min
- Expression time (cells in growth medium): 2 days

NUMBER OF REPLICATIONS: duplicate plates for each test concentration


Evaluation criteria:
The result was considered positive if the number of colinies found was twice the number in the control (exposed to the appropriate solvent or untreated).

Results and discussion

Test results
Species / strain:
other: TA 92, TA 94, TA 98, TA 100, TA 1535, TA 1537
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
other: Of the other substances tested, 14 gave a positive result in at least one tester strain, validating the responsiveness of the assay.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
CL-Freetext:
Propylene glycol was not mutagenic in Salmonella typhimurium
TA92, TA94, TA98, TA100, TA1535 and TA 1537, in the presence
of an S-9 fraction, under the conditions of this test.