Di-''isononyl'' phthalate

Genetic toxicity: in vivo

Administrative data

Endpoint:

genetic toxicity in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Secondary literature

Data source

Reference

Reference Type:

publication

Title:

1,2-benzenedicarboxylic acid, di-C8-10- branched alkyl esters, C9-rich and di-“isononyl” phthalate (DINP)

Author:

European Commission

Year:

2003

Bibliographic source:

Risk Assessment Report Vol. 35 (EUR 20784 EN)

Materials and methods

Test material

Test material information

Constituent 1

Reference substance name:

DINP

IUPAC Name:

DINP

Administration / exposure

Doses / concentrations

Remarks:

Doses / Concentrations:

Basis:

Results and discussion

Test results

Genotoxicity:

negative

Toxicity:

not specified

Vehicle controls validity:

not specified

Negative controls validity:

not specified

Positive controls validity:

not specified

Applicant's summary and conclusion

Executive summary:

In an in vivo cytogenetic assay, DINP (R-1218, CAS 28553-12-0) was administered orally to 3 groups of Fisher 344 rat at doses of 5-1.7-0.5 ml/kg/d, diluted in corn oil, during 5 days (Microbiological Associates, 1981d). Samples of femoral bone marrow were analysed for chromosomal aberrations after the treatment period. Concurrent olive oil and triethylenemelamine dosed animals served as negative and positive controls, respectively. In a preliminary range finding study, no toxic effects were detected at levels up to 10 ml/kg DINP. There were no changes in the mitotic index at any dose tested. No changes were observed (only one animal had chromosomal abnormality at dose of 1.7 mg/kg/d (chromatid breaks) and the test was considered to be negative. However, cytogenetic analysis has been performed on only 50 cells/animal and mitotic index calculated by observation of 100 cells only, such values are low and can weaken the significance of the test.