Decyl acetate

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

The test substance is not mutagenic.

Link to relevant study records

Reference

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Target gene:

Histidine

Species / strain / cell type:

S. typhimurium TA 1535

Details on mammalian cell type (if applicable):

- Histidine mutation: hisG46
- Additional Mutation Repair LPS-Coat: uvrB- rfa
- Mutation type detected: Base Pair

Species / strain / cell type:

S. typhimurium TA 98

Details on mammalian cell type (if applicable):

- Histidine mutation: hisD3052
- Additional Mutation Repair LPS-Coat: uvrB- rfa
- Affecting R-Factor: pKM101
- Mutation type detected: Frameshift

Species / strain / cell type:

S. typhimurium TA 1537

Details on mammalian cell type (if applicable):

- Histidine mutation: hisC3076
- Additional Mutation Repair LPS-Coat: uvrB- rfa
- Mutation type detected: Frameshift

Species / strain / cell type:

S. typhimurium TA 102

Details on mammalian cell type (if applicable):

- Histidine mutation: hisAG8476 rfa, hisG428 on plasmid pAQ1
- Affecting R-Factor: pKM101, + pAQ1
- Mutation type detected: Base Pair Substitution

Species / strain / cell type:

S. typhimurium TA 100

Details on mammalian cell type (if applicable):

- Histidine mutation: hisG46
- Additional Mutation Repair LPS-Coat: uvrB-
- Affecting R-Factor: pKM101
- Mutation type detected: Substitution

Metabolic activation:

with and without

Metabolic activation system:

liver homogenates (S9)

Test concentrations with justification for top dose:

1.5 - 1500 µg/plate in presence of S9 and 1.5 - 5000 µg/plate in the absence of S9

Vehicle / solvent:

- Vehicle: ethanol

Positive controls:

yes

Positive control substance:

9-aminoacridine

2-nitrofluorene

sodium azide

mitomycin C

other: 2-aminoantracene

Remarks:

9-Aminoacridine, mitomycin C, and sodium azide were dissolved in distilled water. 2-Aminoanthracene, and 2-nitrofluorene were dissolved in DMSO.

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation): Vogel-Bonner minimal plates enriched with histidine (264M), biotin (3p.M) and ampicillin.

DURATION
- Exposure duration: Plates were kept for 48 to 72 h at 37°C in the dark

EXAMINATION:
- counting of the number of revertant colonies (his+revertants)
- normal background lawn and/or precipitates
- microscopically: microcolony growth
- genotype of revertant colonies are spot-checked by picking and streaking on histidine free plates, if relevant.

OTHER: The experiment was repeated in full after an interval of at least 3 days.

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

without metabolic activation at 500 µg/plate, with at 1500 µg/plate

Positive controls validity:

valid

Species / strain:

S. typhimurium TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

with and without metabolic activation at 500 µg/plate

Positive controls validity:

valid

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

without metabolic activation at 1500 µg/plate, with at 500 µg/plate

Positive controls validity:

valid

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

without metabolic activation at 5000 µg/plate, with at 1500 µg/plate

Positive controls validity:

valid

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Positive controls validity:

valid

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 1500 µg/plate

Positive controls validity:

valid

Additional information on results:

The results with the positive control substances confirmed the known reversion properties and specificity of the tester strains as well as the full activity of the metabolizing system.

Conclusions:

The results indicate that test item was not mutagenic to Salmonella typhimurium strains TA1535, TA1537, TA98, TA100, and TA102 in the presence and absence of a metabolizing system, under the experimental conditions described. No precipitation was observed.

Executive summary:

In the present study, the substance was investigated using the standard plate incorporation procedure according to Ames et al., (1975) (OECD 471). The number of revertant colonies on the plates, with and without the test compound, were compared to evaluate mutagenicity.

The mutagenicity of the test substance was studied with five mutant strains of Salmonella typhimurium (TA1535, TA1537, TA98, TA100, and TA102). The investigations were carried out using the standard plate incorporation assay with and without liver homogenate (S9) from Aroclor 1254 pretreated male rats as metabolic activation system.

The test item was dissolved in ethanol and tested in concentrations of 1.5 to 1500 µg per plate in the presence of S9 and 1.5 to 5000 µg per plate in the absence of S9.

In the absence of S9-mix the test item was bacteriotoxic towards the strains TA100 (500 µg/plate), TA102 (500 µg/plate), TA1537 (1500 µg/plate) and TA98 (5000 µg/plate).

In the presence of S9-mix the substance was bacteriotoxic towards the strains TA1537 (500 µg/plate), TA102 (500 µg/plate), TA1535 (1500 µg/plate), TA98 (1500 µg/plate), and TA100 (1500 µg/plate).

Precipitation of the test compound on the plates was not observed.

Sodium azide, 2-nitrofluorene, 9-aminoacridine, mitomycin C, and 2-aminoanthracene served as positive controls to confirm the reversion properties and the specificity of the bacterial strains as well as the efficacy of the metabolizing system.

In the concentration range investigated, the test substance did not induce a significant increase in the mutation frequency of the test strains in the presence and absence of a metabolic activation system.

In conclusion, these results indicate that the test substance, under the experimental conditions described, was not mutagenic to Salmonella typhimurium strains TA1535, TA1537, TA98, TA100, and TA102 in the presence and absence of a metabolizing system.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Additional information

For this endpoint there is 1 study available (2000) in which genotoxic effects of the test item were assessed using the standard plate incorporation procedure according to OECD 471. Five mutant strains of Salmonella typhimurium (TA1535, TA1537, TA98, TA100, and TA102) were used and tested with and without liver homogenate (S9) as metabolic activation system. The test item was dissolved in ethanol and tested in concentrations of 1.5 to 1500 µg/plate in the presence of S9 and 1.5 to 5000 µg/plate in the absence of S9.

In the absence of S9-mix the test item showed cytotoxicity at or above 500 µg/plate

towards strains TA100, TA102, TA1537 and TA98. In the presence of S9-mix the test item showed cytotoxicity at or above 500 µg/plate towards strains TA1537, TA102, TA1535, TA98, and TA100. Precipitation of the test compound on the plates was not observed. The positive controls confirmed the reversion properties and the specificity of the bacterial strains as well as the efficacy of the metabolizing system. In the concentration range investigated, the test substance did not induce a significant increase in the mutation frequency of the test strains with and without a metabolic activation system.

In conclusion, the test substance, under the experimental conditions described, was not mutagenic to Salmonella typhimurium strains TA1535, TA1537, TA98, TA100, and TA102 in the presence and absence of a metabolizing system.

Justification for classification or non-classification

According to section 3.5.2.3. of Annex I of the CLP Regulation N° 1272/2008 the test results of in vitro genotoxic test shall be considered for the classification of the test item for mutagenicity. As the test substance was negative in the standard plate incorporation test with and without metabolic activation, the test substance needs not to be classified as genotoxic/mutagenic based on the available information.