Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27 August to 22 September 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was conducted in accordance with an appropriate guideline and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): diphenylsilanediol

Test animals

Species:
rat
Strain:
other: OFA.SD (IOPS Caw)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Iffa-Credo (L'Arbresle, France)
- Age at study initiation: 5 to 7 weeks
- Weight at study initiation: not stated
- Fasting period before study: not stated
- Housing: polycarbonate cages - type FI or MI
- Diet (ad libitum): Rat-mouse pelleted complete maintenance diet (U.A.R., Villemoisson sur Orge, France)
- Water (ad libitum): softened and filtered drinking water
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 3
- Humidity (%): 30 to 70
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To: 27 August to 22 September 1987

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 10% (w/v) gum arabic
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50, 100, 200 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg

Doses:
500, 1000, 2000 mg/kg
No. of animals per sex per dose:
Preliminary study - 2 sex/group at 500, 1000 or 2000 mg/kg
Definitive study - 5 sex/group at 0 or 2000 mg/kg
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observations, body weight on Days -1, 1, 8 and 15
- Necropsy of survivors performed: yes
Statistics:
Means and standard deviations reported.

Results and discussion

Preliminary study:
No mortalities at 500, 1000 or 2000 mg/kg.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
Subdued behaviour and piloerection were noted up to 4 hours after dosing at 2000 mg/kg.
Body weight:
Slight reduction in body weight gain in males at 2000 mg/kg between Days 1 and 8.
Gross pathology:
None.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a study conducted according to OECD 401 and in compliance with GLP, single administration of diphenylsilanediol at doses up to 2000 mg/kg did not result in any mortality or significant effects, therefore the LD50 was stated to be > 2000 mg/kg
Executive summary:

Single oral administration of diphenylsilanediol to 5 male and 5 female rats at 2000 mg/kg was well tolerated and the LD50 is considered to be > 2000 mg/kg.