3-(trimethoxysilyl)propiononitrile

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

No data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

Lack of details on test substance and environmental conditions of animals. Only four animals per dose used (guideline requires 5).

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-(trimethoxysilyl)propiononitrile

EC Number:

219-764-3

EC Name:

3-(trimethoxysilyl)propiononitrile

Cas Number:

2526-62-7

Molecular formula:

C6H13NO3Si

IUPAC Name:

3-(trimethoxysilyl)propanenitrile

Constituent 2

Reference substance name:

3-(trimethoxysilyl)propionitrile

IUPAC Name:

3-(trimethoxysilyl)propionitrile

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: 2-3 kg
- 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: Trunk
- % coverage: No data
- Type of wrap if used: Impervious 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): 16 and 8 ml/kg
- Constant volume or concentration used: yes, undiluted

Duration of exposure:

24 Hours

Doses:

Males: 16 ml/kg bw.
Females: 16 and 8 ml/kg bw.

No. of animals per sex per dose:

Four

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: after one hour, 7 days and 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: body weights (0, 7 and 14 days) and clinical signs.

Statistics:

The LD50 was calculated using the moving averages method and are based on a 14 -day observation period.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 16 mL/kg bw

Based on:

test mat.

Mortality:

The maximum dermal application of the test substance (16 ml/kg bw) lead to one death in male rabbits and no deaths in female rabbits. Therefore, an LD50 could not be determined.

Clinical signs:

other: None

Gross pathology:

At necropsy there were signs of lung infection in the males that died before the end of the 14 day observation period: lung and upper thoracic cavity fluid-filled and covered with yellow puss. Some males and females were found to have red patches in the trachea and lungs.

Other findings:

Capillary injection, erythema, oedema were observed one day after exposure in male and female animals. By 7 and 14 days scabs and desquamation were observed in females only.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute dermal toxicity study conducted using a protocol similar to OECD 402, but not to GLP (reliability score 2), the dermal LD50 for 3-(trimethoxysilyl)propiononitrile was greater than 16 ml/kg bw (15520 mg/kg bw, based on relative density of 0.97 g/cm3) in rabbits.