Propyl 3,4,5-trihydroxybenzoate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro cytogenicity / chromosome aberration study in mammalian cells

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Scientific Opinion on the re-evaluation of propyl gallate (E 310) as a food additive

Author:

European Food Safety Authority (EFSA)

Year:

2014

Bibliographic source:

EFSA Journal 12(4), 3642

Reference 2

Reference Type:

publication

Title:

Final Report on the Amended Safety Assessment of Propyl Gallate

Author:

Cosmetic Ingredient Review (CIR) Expert Panel

Year:

2007

Bibliographic source:

International Journal of Toxicology 26 (Suppl. 3), 89–118

Reference 3

Reference Type:

other: unpublished study

Title:

Mutagenic evaluation of compound FDA 71-39, propyl gallate

Author:

Litton Bionetics

Year:

1974

Bibliographic source:

(PB-245 441):1–138

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

In a study from Litton Bionetics (1974), as cited by CIR (2007) and EFSA (2014), three different assays, a host-mediated assay, a cytogenetic assay and a dominant lethal assay, were used to evaluate the mutagenicity of Propyl gallate. In particular, in the in vitro cytogenetic study, human embryonic lung cultures (WI-38) were used. Doses tested were 0.5, 5 and 50 μg/mL. The cells were examined at 24, 48 and 72 hours. One hundred metaphases or anaphases per concentrations were examined.

GLP compliance:

no

Type of assay:

in vitro mammalian chromosome aberration test

Test material

Test material information

Constituent 1

Reference substance name:

Propyl 3,4,5-trihydroxybenzoate

EC Number:

204-498-2

EC Name:

Propyl 3,4,5-trihydroxybenzoate

Cas Number:

121-79-9

Molecular formula:

C10H12O5

IUPAC Name:

propyl 3,4,5-trihydroxybenzoate

Specific details on test material used for the study:

no data

Method

Target gene:

NA

Species / strain

Species / strain / cell type:

other: Human embryonic lung cultures (WI-38)

Additional strain / cell type characteristics:

not specified

Metabolic activation:

not specified

Test concentrations with justification for top dose:

0.5, 5 and 50 µg/mL

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: no data

Controls

Untreated negative controls:

yes

Positive controls:

yes

Details on test system and experimental conditions:

- Cells were examined at 24, 48 and 72 hours.
- One hundred metaphases or anaphases per concentration were examined.

Rationale for test conditions:

no data

Evaluation criteria:

Chromosomal damage was scored.

Statistics:

no data

Results and discussion

Test results

Species / strain:

other: Human embryounic lung cultures (WI-38)

Metabolic activation:

not specified

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Additional information on results:

The low and high doses caused 2% and 3% chromosomal aberrations, respectively, compared to 1% in the negative control; these variations were not considered as significant. Anaphase preparations were examined in this test. There was no demonstration of a clastogenic effect with 0, 3 and 2% cells with aberrations at 0.5, 5 and 50 μg/mL respectively, vs. 2% in the negative control.

Any other information on results incl. tables

According to the EFSA (2014) report, this study applied a limited experimental protocol, which was based on the examination of only 100 metaphases or 100 anaphases per concentration.

Applicant's summary and conclusion

Conclusions:

Based on an in vitro cytogenetic study from Litton Bionetics (1974), as cited by EFSA (2014) and CIR (2007), Propyl gallate is considered to be non-mutagenic.

Executive summary:

In an in vitro cytogenetic study from Litton Bionetics (1974), as cited by EFSA (2014) and CIR (2007), Propyl gallate was added to human embryonic lung cultures in anaphase at doses of 0.5, 5 and 50 µg/mL. The cells were examined at 24, 48 and 72 hours. One hundred metaphases or anaphases per concentrations were examined. Chromosomal damage was scored. The low and high doses caused 2% and 3% chromosomal aberrations, respectively, compared to 1% in the negative control; these variations were not considered as significant. Anaphase preparations were examined in this test. There was no demonstration of a clastogenic effect with 0, 3 and 2% cells with aberrations at 0.5, 5 and 50 μg/mL, respectively vs. 2% in the negative control. Based on this study, Propyl gallate is considered to be non-mutagenic.