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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
31 August to 21 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
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
other: limit test
Limit test:
yes

Test material

Constituent 1
Reference substance name:
000947-42-2
Cas Number:
000947-42-2
IUPAC Name:
000947-42-2
Constituent 2
Chemical structure
Reference substance name:
Diphenylsilanediol
EC Number:
213-427-4
EC Name:
Diphenylsilanediol
Cas Number:
947-42-2
Molecular formula:
C12H12O2Si
IUPAC Name:
diphenylsilanediol
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 or test system 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
- Diet (e.g. ad libitum): Rat-mouse pelleted complete maintenance diet (U.A.R., Villemoisson sur Orge, France)
- Water (e.g. 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: 31 August to 21 September 1987

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: Gum Arabic
Details on dermal exposure:
TEST SITE
- Area of exposure: 10% body surface area
- % coverage: 100
- Type of wrap if used: crimped gauze bandage (Creplux, Laboratoires Molypharm, Veache, France) held in place by adhesive and perforated tape (Peloplast, Laboratoires Fournier, Dijon, France).

REMOVAL OF TEST SUBSTANCE
- Washing: luke warm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied: 5mL/kg
- Concentration: 200 or 400 mg/ml
- Constant volume or concentration used: yes

VEHICLE
- Amount applied: 5mL/kg
Duration of exposure:
24 hours
Doses:
1000 or 2000 mg/kg
No. of animals per sex per dose:
Preliminary study - 2 sex/group at 1000 or 2000 mg/kg
Definitive study - 5 sex/group at 2000 mg/kg
Control animals:
yes, concurrent vehicle
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 calculated.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
None
Body weight:
No effect of treatment.
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 402 and in compliance with GLP, single administration of diphenylsilanediol at doses up to 2000 mg/kg did not result in any significant effects, therefore the LD50 was stated to be > 2000 mg/kg.
Executive summary:

Single dermal 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.