Propane-1,2-diol, propoxylated

Genetic toxicity: in vitro

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

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

Test material information

Constituent 1

Reference substance name:

Propane-1,2-diol

EC Number:

200-338-0

EC Name:

Propane-1,2-diol

Cas Number:

57-55-6

Molecular formula:

C3H8O2

IUPAC Name:

1,2-Propanediol

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:

S. typhimurium, 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:

S. typhimurium, 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.