Trimethoxyphenylsilane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not stated

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

The study was well documented and meets generally accepted scientific principles, but was not conducted in compliance with GLP for the structural analogue substance triethoxy(phenyl)silane (CAS: 780-69-8).The restrictions were that only 4 animals per dose were used and no analytical purity was reported.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1972

Report date:

1972

Reference 2

Reference Type:

publication

Title:

Range-Finding Toxicity Data: List VIII.

Author:

Carpenter CP; Weil CS; Smyth HF Jr

Year:

1974

Bibliographic source:

Toxicology and Applied Pharmacology 28(2): 313-9.

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

; 4 animals per dose, analytical purity not reported

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Triethoxy(phenyl)silane

EC Number:

212-305-8

EC Name:

Triethoxy(phenyl)silane

Cas Number:

780-69-8

Molecular formula:

C12H20O3Si

IUPAC Name:

Triethoxy(phenyl)silane

Test animals

Species:

rabbit

Strain:

other: albino (no other details)

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Mellon Institute
- Age at study initiation: 3-5 months
- Weight at study initiation: No data
- Fasting period before study: No
- Housing: No data
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

IN-LIFE DATES: No data

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: No data
- % coverage: No data
- Type of wrap if used: Polyethylene sheeting

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Up to 16 mL/kg

Duration of exposure:

24 hours

Doses:

2, 4, and 16 mL/kg

No. of animals per sex per dose:

2 and 4 mL/kg: Four animals
16 mL/kg: Two animals

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: No
- Other examinations performed: clinical signs, gross pathology

Statistics:

No data

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

3 014 mg/kg bw

Based on:

test mat.

95% CL:

>= 1 920 - <= 5 128

Remarks on result:

other: dose given in ml/kg, converted using a specific density of 0.99 g/ml

Mortality:

No deaths in the 2 mL/kg bw group. In the 4 mL/kg bw group 3/4 animals died and in the both animals in the 16 mL/kg bw group died. In the highest dose group deaths were within one day of dosing. The three animals that died in the 4 mL/kg bw died on Days 2 and 4 following removal of dressings.

Clinical signs:

other: Two rabbits in the 4 mL/kg bw group were found prostate one day after dosing.

Gross pathology:

Congestion throughout the lungs and the abdominal viscera were observed. The liver and kidneys were mottled.

Other findings:

Erythema of the skin.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008.

Conclusions:

In an acute dermal toxicity study conducted using a protocol that was similar to OECD 402, but not in compliance with GLP (reliability score 2) the LD50 for the structural analogue substance triethoxy(phenyl)silane (CAS: 780-69-8). was 3.18 mL/kg bw in rabbits (equivalent to 3014 mg/kg bw based on a specific density of 0.99 g/mL).