Triethoxyisobutylsilane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17.03.1987 to 31.03.1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to a test protocol that is comparable to the appropriate OECD test guideline and EU test method, and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

Limited details on the test substance, no control

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Triethoxyisobutylsilane

EC Number:

402-810-3

EC Name:

Triethoxyisobutylsilane

Cas Number:

17980-47-1

Molecular formula:

Hill formula: C10H24O3Si CAS formula: C10H24O3Si

IUPAC Name:

triethoxy(2-methylpropyl)silane

Details on test material:

- Name of test material (as cited in study report): Isobutyltriethoxysilane
- Substance type: Alkoxysilane
- Physical state: Colourless liquid
- Stability under test conditions: Not determined
- Storage condition of test material: Ambient temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Interfauna UK Ltd, England
- Age at study initiation: 7-10 weeks
- Weight at study initiation: 200-226 g
- Fasting period before study: No
- Housing: Individually in metal cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-22
- Humidity (%): 47%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 17.03.1987 to 31.03.1987

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Dorso-lumbar region
- % coverage: 10%
- Type of wrap if used: Occlusive

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): 2000 mg/kg bw

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

Five

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed soon after dosing then at frequent intervals for the remainder of Day 1. On subsequent days the animals were observed at least twice per day. Clinical signs were recorded at each observation. Bodyweights were measured on Days 1, 8 and 15.
- Necropsy of survivors performed: yes. All animals on the study were killed on Day 15 and a macroscopic examination was performed.
- Other examinations performed: The treated areas of skin were examined daily for signs of dermal irritation and scored according to an arbitrary scoring system.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No deaths occurred.

Mortality:

There were no deaths.

Clinical signs:

other: There were no clinical signs of systemic reaction to treatment.

Gross pathology:

There were no abnormal findings.

Other findings:

- Organ weights: Not measured
- Histopathology: Not conducted
- Potential target organs: None identified
- Other observations: There were no signs of irritation or dermal changes at the site of application.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In an acute dermal toxicity study conducted using a protocol comparable to OECD 402 and to GLP (reliability score 1) the LD50 for triethoxyisobutylsilane was >2000 mg/kg bw in rats. There were no systemic effects and no signs of dermal irritation.