Tris(2-butoxyethyl) phosphate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in mammalian cells

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study report was not available although data have been peer-reviewed in reference work (EHC 218, 2000).

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1985

Reference 2

Reference Type:

review article or handbook

Title:

Unnamed

Year:

1992

Report date:

1992

Reference 3

Reference Type:

review article or handbook

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

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

GLP compliance:

not specified

Type of assay:

mammalian cell gene mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Tris(2-butoxyethyl) phosphate

EC Number:

201-122-9

EC Name:

Tris(2-butoxyethyl) phosphate

Cas Number:

78-51-3

Molecular formula:

C18H39O7P

IUPAC Name:

tris(2-butoxyethyl) phosphate

Method

Species / strain

Species / strain / cell type:

Chinese hamster Ovary (CHO)

Metabolic activation:

with and without

Test concentrations with justification for top dose:

50, 100, 150, 225 and 300 micrograms per ml with 5% S9; 5, 50, 75, 100 and 130 micrograms per ml in the absence of S9

Details on test system and experimental conditions:

HGPRT assay

Results and discussion

Test results

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: Observed at the highest dose level with a dose-related trend both in presence and absence of S9

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'. Remarks: CHO

Applicant's summary and conclusion

Conclusions:

TBEP was not genotoxic under the conditions of this test system either with or without metabolic activation.

Executive summary:

To evaluate the potential of TBEP for mutagenicity in mammalian cells, the substance was tested in the Chinese Hamster Ovary HGPRT mammalian cell forward gene mutation assay with and without metabolic activation. Test concentrations were 50, 100, 150, 225 and 300 micrograms per ml with 5% S9; 5, 50, 75, 100 and 130 micrograms per ml in the absence of S9. Cytotoxicity was observed at the highest dose level with a dose-related trend both in presence and absence of S9. There was no evidence of mutagenicity at any dose tested, with or without metabolic activation.

The study report was not available, however the data have been peer-reviewed in two reference works (IPCS EHC 218, 2000 and ECETOC JACC report 21, 1992). The data reported in these publications is considered adequate to satisfy the requirements for this endpoint.