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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guideline study; GLP

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995
Reference Type:
publication
Title:
Differential Prenatal Toxicity of Branched Phthalate Esters in Rats
Author:
Hellwig, J. et al.
Year:
1997
Bibliographic source:
Food Chem. Toxicol., 35, 501-512

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Di-''isononyl'' phthalate
EC Number:
249-079-5
EC Name:
Di-''isononyl'' phthalate
Cas Number:
28553-12-0
Molecular formula:
C26H42O4
IUPAC Name:
1,2-bis(7-methyloctyl) benzene-1,2-dicarboxylate
Constituent 2
Reference substance name:
DINP
IUPAC Name:
DINP
Details on test material:
DINP2, at least 95% of the main alcohol component is from alkyl-substituted octanol or heptanol

Test animals

Species:
rat
Strain:
Wistar

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Duration of treatment / exposure:
day 6 through 15 post coitum (p.c.)
Frequency of treatment:
daily
Duration of test:
up to day 20 p.c.
Doses / concentrations
Remarks:
Doses / Concentrations:
40, 200, 1000 mg/kg/d
Basis:

No. of animals per sex per dose:
9-10
Control animals:
yes, concurrent vehicle
Details on study design:
Sex: female

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Dose descriptor:
NOEL
Effect level:
200 mg/kg bw/day
Basis for effect level:
other: maternal toxicity

Results (fetuses)

Effect levels (fetuses)

Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day
Basis for effect level:
other: teratogenicity

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion