Diphenylsilanediol

Acute Toxicity: dermal

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

Test material information

Constituent 1

Reference substance name:

000947-42-2

Cas Number:

000947-42-2

IUPAC Name:

000947-42-2

Constituent 2

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:

other: None

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.