Stearic acid, monoester with glycerol

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in mammalian cells

Remarks:

Type of genotoxicity: gene mutation

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented publication which meets basic scientific principles.

Data source

Reference

Reference Type:

publication

Title:

The genotoxic activity of glycerol in an in vitro test battery

Author:

Doolittle, D.J. et al.

Year:

1988

Bibliographic source:

Food Chem Toxicol. 1988 Jul;26(7):631-5

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)

Deviations:

yes

Remarks:

limited documentation; the highest concentration was 1000 µg/mL without evidence of precipitate and/or cytotoxicity.

GLP compliance:

not specified

Type of assay:

mammalian cell gene mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Glycerol

EC Number:

200-289-5

EC Name:

Glycerol

Cas Number:

56-81-5

Molecular formula:

C3H8O3

IUPAC Name:

glycerol

Details on test material:

- Name of test material (as cited in study report): glycerol
- Analytical purity: > 99.5%

Method

Target gene:

HPRT locus

Species / strain

Species / strain / cell type:

Chinese hamster Ovary (CHO)

Metabolic activation:

with and without

Metabolic activation system:

rat S-9

Test concentrations with justification for top dose:

100, 200, 400, 600, 800 and 1000 µg/mL

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: water

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

water

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: -S9: ethyl methanesulphonate; +S9: dimethylbenzanthracene

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium

DURATION
- Exposure duration: 5h
- Expression time (cells in growth medium): not reported
- Selection time: not reported
- Fixation time (start of exposure up to fixation or harvest of cells): not reported

SELECTION AGENT: not reported
STAIN: not reported

NUMBER OF REPLICATIONS: 1

DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency

Evaluation criteria:

A test result was considered positive if the test material induced at least a three-fold increase in mutation frequency above the solvent control in a dose-dependent manner.

Results and discussion

Test results

Species / strain:

Chinese hamster Ovary (CHO)

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
The increase in mutation frequency observed at 800 and 1000 µg/mL in the absence of metabolic activation were not considered biologically significant and did not fulfil the criteria set for a positive response due to the lack of a dose-response relationship.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Table 1. Results of the HGPRT assay

	Cloning efficiency (%)	No. of mutants	Mutation Frequency (x10(-6))
	Without metabolic activation
Negative control	75	4	5
Solvent control	84	2	2
Glycerol (µg/mL)
100	87	0	0
200	85	1	1
400	85	1	1
600	79	4	5
800	83	20	24*
1000	83	5	6*
Ethyl methanesulphonate (100 µg/mL)	79	122	153*
	With metabolic activation
Negative control	96	2	2
Solvent control	76	6	7
Glycerol (µg/mL)
100	65	6	7
200	66	0	0
400	77	2	3
600	63	3	4
800	72	7	9
1000	80	12	15
Dimethylbenzanthracene (5 µg/mL)	77	178	200*

 

* At least three-fold increase compared with the solvent control

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative