Registration Dossier
Registration Dossier
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EC number: 425-220-8 | CAS number: 5945-33-5
Developmental toxicity / teratogenicity
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: final full study
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.3700 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 425-220-8
- EC Name:
- -
- Cas Number:
- 5945-33-5
- Molecular formula:
- C39H34O8P2
- IUPAC Name:
- 4-(2-{4-[(diphenoxyphosphoryl)oxy]phenyl}propan-2-yl)phenyl diphenyl phosphate; 4-{2-[4-({[4-(2-{4-[(diphenoxyphosphoryl)oxy]phenyl}propan-2-yl)phenoxy](phenoxy)phosphoryl}oxy)phenyl]propan-2-yl}phenyl diphenyl phosphate
- Details on test material:
- CN-1985, lot #3706-28-01, purity 98.5%.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD(R) (SD)BR
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- gestation days 6 through 19
- Frequency of treatment:
- daily
- Duration of test:
- Duration of test: terminated gestation day 20
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
125
Basis:
no data
mg/kg/day
- Remarks:
- Doses / Concentrations:
500
Basis:
no data
mg/kg/day
- Remarks:
- Doses / Concentrations:
1000
Basis:
no data
mg/kg/day
- No. of animals per sex per dose:
- three groups of 25 bred females once daily from gestation day 6 through day 19
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- Test article in corn oil was administered by gavage to three groups of 25 bred females once daily from gestation day 6 through day 19
Results and discussion
Results (fetuses)
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
All females survived to the scheduled necropsy. Clinical signs observed appeared to be an aversion to the taste or the test article or a local irritative effecy not signs of systemic toxicity. Body weight gains and food consumption were unaffected.
Intrauterine growth and survival were unaffected. The fetal malformations observed were considered spontaneous in origin. The fetal developmental variations were infrequent or at a similar frequency in the control group.
The NOAEL for maternal toxicity and developmental toxicity was 1000 mg/kg/day.
Applicant's summary and conclusion
- Conclusions:
- The NOAEL for maternal toxicity and developmental toxicity was 1000 mg/kg/day.
- Executive summary:
The NOAEL for maternal toxicity and developmental toxicity was 1000 mg/kg/day.
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