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Toxicological information

Acute Toxicity: dermal

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals 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:
None
Body weight:
No effects.
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.