2-ethylhexyl hydrogen maleate

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Ames test: negative

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Species / strain / cell type:

E. coli WP2 uvr A

Additional strain / cell type characteristics:

not specified

Species / strain / cell type:

S. typhimurium, other: TA98, TA100, TA1535, TA1537, TA1538

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254 induced rat liver S-9 fraction

Test concentrations with justification for top dose:

4, 20, 100, 500, 2500 and 10000 µg/plate

Vehicle / solvent:

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

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: -S9-mix: 9-Aminoacridine (TA 1537), 2-Aminoanthracene (TA 1537), Methylhydrazone Derivative (TA98, TA1538, TA100), Streptocotocine (TA1535), ENNG (E. coli WP 2 uvr A)

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: + S9-mix: 2-Aminoanthracene (TA 1537, TA 98, TA 1538, TA 100, TA 1535, E. coli WP 2 uvr A)

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: The plates were incubated at 37 °C for 2 days

NUMBER OF REPLICATIONS: 4

Evaluation criteria:

A chemical is considered to have a positive response if the number of induced revertants is more than double the spontaneous mutations

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Conclusions:

Under the conditions of this test, the test substance showed no mutagenic activity.

Executive summary:

A bacterial reverse mutation assay (Ames test), equivalent to OECD guideline 471, is available to investigate the mutagenicity of the test substance. The test was performed with five histidine-requiring strains of Salmonella typhimurium (TA1537, TA98, TA1538, TA100, TA1535) and with the tryptophan-requiring strain, Escherichia coli WP2 uvr A. The test was performed with the following test item concentrations (in DMSO) with and without metabolic activation (S9- mix): 4, 20, 100, 500, 2500 and 10000 µg/plate. Under the conditions of this study, the test substance showed no mutagenic activity in strains of Salmonella typhimurium and Escherichia coli with and without metabolic activation.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

A bacterial reverse mutation assay (Ames test), equivalent to OECD guideline 471, is available to investigate the mutagenicity of the test substance (Hoechst AG, 1981). The test was performed with five histidine-requiring strains of Salmonella typhimurium (TA1537, TA98, TA1538, TA100, TA1535) and with the tryptophan-requiring strain, Escherichia coli WP 2 uvr A. The test was performed with the following test item concentrations (in DMSO) with and without metabolic activation (S9- mix): 4, 20, 100, 500, 2500 and 10000 µg/plate. Under the conditions of this study, the test substance showed no mutagenic activity in strains of Salmonella typhimurium and Escherichia coli with and without metabolic activation.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available read-across data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on genetic toxicity, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776.