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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Toxicological information

Developmental toxicity / teratogenicity

Currently viewing:

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:
1998

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

Constituent 1
Chemical structure
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%.

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.