Registration Dossier
Registration Dossier
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EC number: 700-989-5 | CAS number: -
Developmental toxicity / teratogenicity
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:
- 1 987
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
- 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 #.
Constituent 1
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
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