Registration Dossier

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

Reference
Name:
Unnamed
Type:
Constituent

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.