Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
05/09/1988 - 12/02/1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study according to international guidelines (OECD guideline 401, EU Method B.1) under GLP. No deviations from the guidelines were reported. Chemical identity and purity of the test substance are not reported.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
Principles of method if other than guideline:
Not relevant
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 3-[(diphenoxyphosphoryl)oxy]phenyl triphenyl 1,3-phenylene bis(phosphate) and tetraphenyl 1,3-phenylene bis(phosphate)
EC Number:
701-337-2
Cas Number:
not available
Molecular formula:
C30H24O8P2
IUPAC Name:
Reaction mass of 3-[(diphenoxyphosphoryl)oxy]phenyl triphenyl 1,3-phenylene bis(phosphate) and tetraphenyl 1,3-phenylene bis(phosphate)
Details on test material:
- Name of test material (as cited in study report): CR 733-S
- Physical state: Liquid
- Storage condition of test material: At ambient temperature in the dark, in a dry place

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, FRG
- Age at study initiation: 9 weeks
- Fasting period before study: animals were fasted overnight
- Housing: polycarbonate cages containing purified sawdust (Woody Clean supplied by Broekman Institute, Someren, The Netherlands) as bedding material
- Diet (e.g. ad libitum): standard pelleted laboratory animal diet (RMH-B, pellet diameter 10 mm, Hope Farms, Woerden, The Netherlands), ad libitum
- Water (e.g. ad libitum): tap-water, ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 20
- Humidity (%): 60 - 75
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 5-09-1988 To: 19-09-1988

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 3.8 ml/kg body weight
Doses:
5000 mg/kg bodyweight
No. of animals per sex per dose:
5 male and 5 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: daily; weighing: weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, necropsy
Statistics:
Not relevant

Results and discussion

Preliminary study:
Not relevant
Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No mortality occured during the 14-day observation period.
Clinical signs:
No signs of toxicity were observed during the 14-day observation period.
Body weight:
All animals showed body weight gain during the study period.
Gross pathology:
Macroscopic examination of all animals at termination did not reveal any changes that were considered to have arisen as a result of treatment.
Other findings:
No data

Any other information on results incl. tables

Not relevant

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral toxicity (LD50) of CR 733-S towards Wistar rats is > 5000 mg/kg bodyweight under the conditions of this study.
Executive summary:

The acute oral toxicity of CR 733 -S towards Wistar rats was investigated according to international guidelines (OECD guideline 401, EU Method B.1) under GLP. Five male and five female rats were exposed to a concentration of 5000 mg/kg bodyweight of the test substance. After 14 days no deaths or signs of toxicity were recorded, neither did macroscopic necropsy reveal any results caused by the treatment. The oral LD50 for both male and female rats was determined to be > 5000 mg/kg bodyweight.