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Toxicological information

Genetic toxicity: in vivo

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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

Referenceopen allclose all

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 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 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

Constituent 1
Chemical structure
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
Chemical structure
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 / concentrationsopen allclose all
Dose / conc.:
1 250 mg/kg bw/day (nominal)
Dose / conc.:
2 500 mg/kg bw/day (nominal)
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.

 

Applicant's summary and conclusion

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