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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

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

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Method B1 of 92/69/EEC and OECD 401
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

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

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Arachis oil BP
Details on oral exposure:

Single application, oral gavage. 14 days observation.
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
Following a range finding test, all animals (5 males and 5 females) were dosed 2000mg/kg bodyweight, once only, by gavage. The animals were
observed for deaths or over sight of toxicity 1/2, 1, 2, and 4 hours after dosing and subsequently once daily for 14 days. At the end of the study, the animals were killed and subjected to gross pathological examination.

Results and discussion

Preliminary study:
2000 mg/kg range finder, no mortalities found
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
other: Signs of toxicity related to dose levels: No signs of systemic toxicity were observed during the observation period.
Gross pathology:
Effects on organs:
No abnormalities were observed at necropsy.

Any other information on results incl. tables

Non

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 > 2000 mg/kg
Executive summary:

The Acute oral toxicity test of Fyrolflex BDP was conducted in male and female rats. There were no deaths during the study. No signs of systemic toxicity were noted. No macroscopic abnormalities were detected. The acute oral median lethal dose (LD50) of the test material Fyrolflex BDP in the Sparague- Dawley CD strain rat was found to be greater than 2000mg/kg body weight.