Bis(2-propylheptyl) phthalate

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Di(isononyl) phthalate (DINP) and di(isodecyl) phthalate (DIDP) are not mutagenic

Author:

McKee et al.

Year:

2000

Bibliographic source:

Journal of Applied Toxicology Volume 20 Issue 6, Pages 491 - 497, 2000

Reference 2

Reference Type:

secondary source

Title:

EU Risk Assessment Report, DIDP (CAS Nos.: 685151-49-1; 26761-40-0)

Author:

EU

Year:

2003

Bibliographic source:

Volume 36

Reference 3

Reference Type:

study report

Title:

Unnamed

Year:

1994

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)

Deviations:

no

GLP compliance:

yes

Type of assay:

other: Mammalian Erythrocyte Micronucleus Test

Test material

Test material information

Constituent 1

Reference substance name:

Di-''isodecyl'' phthalate

EC Number:

247-977-1

EC Name:

Di-''isodecyl'' phthalate

Cas Number:

26761-40-0

Molecular formula:

C28H46O4

IUPAC Name:

bis(7,7-dimethyloctyl) phthalate

Constituent 2

Reference substance name:

1,2-Benzenedicarboxylic acid, di-C9-11-branched alkyl esters, C10-rich

EC Number:

271-091-4

EC Name:

1,2-Benzenedicarboxylic acid, di-C9-11-branched alkyl esters, C10-rich

Cas Number:

68515-49-1

IUPAC Name:

bis(8-methylnonyl) phthalate

Test animals

Species:

mouse

Strain:

CD-1

Sex:

male/female

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

- Vehicle(s)/solvent(s) used: corn oil

Duration of treatment / exposure:

24, 48 and 72 hours

Frequency of treatment:

one application

Post exposure period:

24, 48, 72 h

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

1 250 mg/kg bw/day (nominal)

Doses / concentrations 2

Dose / conc.:

2 500 mg/kg bw/day (nominal)

Doses / concentrations 3

Dose / conc.:

5 000 mg/kg bw/day (nominal)

No. of animals per sex per dose:

5

Control animals:

yes

Positive control(s):

cyclophosphamide
- Doses / concentrations: 80 mg/kg

Examinations

Tissues and cell types examined:

bone marrow

Results and discussion

Test results

Sex:

male/female

Genotoxicity:

negative

Toxicity:

no effects

Vehicle controls validity:

not specified

Negative controls validity:

not specified

Positive controls validity:

valid

Any other information on results incl. tables

Results:

All DIDP dosed groups appeared normal immediately after dosing and remained healthy until the appropriate harvest time. No effect was observed except a slight increase in the percentage of the micronucleated polychromatophile erythrocytes with decreasing of the polychromatophile/normochromatic ratio in male (0.13 ± 0.03 vs. 0.05 ± 0.02 in controls) mice dosed with 1,250 mg/kg at harvest time of 24 hours but not statistically significant. At the other dose levels, no difference in percentages of the micronucleated polychromatophile erythrocytes was observed in male and female mice (0.08 ± 0.02 at 2,500 mg/kg and 0.07 ± 0.02 at 5,000 mg/kg/d vs. 0.05 ± 0.02 in controls). Positive control produced a statistically significant increase in the percentage of the micronucleated polychromatophile erythrocytes (1.91 ± 0.21 vs. 0.05 ± 0.02 in controls). Jayflex DIDP is considered negative in the mouse bone marrow micronucleus assay.