Hexanedioic acid, mixed benzyl and 2-(2-methoxyethoxy)ethyl diesters

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Link to relevant study records

Reference

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

7 May to 6 June 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Data is based on GLP compliant data accordingly to internationally recognised and EU guidelines.

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

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Vehicle / solvent:

dimethyl sulphoxide

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

N-ethyl-N-nitro-N-nitrosoguanidine

benzo(a)pyrene

other: 2-Aminoanthracene, 4-Nitroquinoline-1-oxide

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not valid

Positive controls validity:

valid

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

The test material caused no visible reduction in the growth of the bacterial backgroundlawn at any dose level. The test material was, therefore, tested up to the maximum recommended dose level of 5000 µg/plate.  A slight, oily precipitate was observed at 5000µg/plate under an inverted microscope only. This observation did not prevent the scoring of revertant colonies.  

No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, at any dose level either with or without metabolic activation.    

All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies thus confirming the activity of the S9-mix and the sensitivity of the bacterial strains.

Conclusions:

Interpretation of results (migrated information):
negative

The substance is not mutagenic

Executive summary:

The mutagenic activity of the substance was assessed by means of the reverse mutation Ames test according to OECD 471 using four strains of salmonella and one strain of E. coli up to a maximum dose of 5000 µg/ plate with and without metabolic activation. The substance caused no revertant colonies and is considered to be non mutagenic under the conditions of the test.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Justification for classification or non-classification

Data is currently available from one in vitro assay in accordance with the requirements of Annex VII of REACH. The substance produced no revertant colonies within the Ames test and is considered non mutagenic.