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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is rated a "1" because it applied GLP, used appropriate testing procedures, and followed an accepted test guideline. Phthalate esters with a carbon backbone of C7 and greater have similar developmental and reproductive toxicity profiles.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.31 (Prenatal Developmental Toxicity Study)
Version / remarks:
Cited as Directive 87/302/EEC, part B, p. 24
GLP compliance:
yes

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:
1,2-benzenedicarboxylic acid, di-isodecyl ester
Details on test material:
IUCLID4 Test substance: other TS: DIDP with different CAS #.

Test animals

Species:
mouse
Strain:
CD-1

Administration / exposure

Route of administration:
oral: gavage
Duration of treatment / exposure:
gestation days 6-13
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:
9650 mg/kg/day
Basis:

Control animals:
yes
Details on study design:
Sex: female

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Dose descriptor:
NOAEL
Effect level:
> 9 650 mg/kg bw/day
Basis for effect level:
other: maternal toxicity

Results (fetuses)

Effect levels (fetuses)

Dose descriptor:
NOAEL
Effect level:
> 9 650 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