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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Several methodological deficiencies. The study was not conducted in compliance with GLP.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
3-trimethoxysilylpropane-1-thiol
EC Number:
224-588-5
EC Name:
3-trimethoxysilylpropane-1-thiol
Cas Number:
4420-74-0
Molecular formula:
C6H16O3SSi
IUPAC Name:
3-(trimethoxysilyl)propane-1-thiol
Details on test material:
- Name of test material (as cited in study report): Organofunctional Silane Y-9616 (gamma-mercaptopropyltrimethoxysilane)
- Substance type: Organosilane
- Physical state: Liquid
- Stability under test conditions:
- Storage condition of test material: No data

Test animals

Species:
rat
Strain:
Sprague-Dawley
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: 200-300 g
- Fasting period before study: yes, overnight
- 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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: Dose was varied by altering the volume.

Doses:
Male rats: 2.0, 1.0, 0.71 and 0.5 ml/kg bw.
Female rats: 1.0, 0.71, 0.5 and 0.25 ml/kg bw
No. of animals per sex per dose:
Five (two in highest dose males)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Weighing at day 0 (prior to dosing), day 7 and day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,gross pathology
Statistics:
LD50s calculated using the moving averages method .

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 0.88 mL/kg bw
Remarks on result:
other: 0.88 ml/kg x 1.015 (SG) = 893 mg/kg bw
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 0.73 mL/kg bw
Remarks on result:
other: 0.73 ml/kg x 1.015 (SG) = 741 mg/kg bw
Mortality:
For males, both of the highest dose and 4/5 of the 1.0 mg/kg bw groups died within the first day after dosing (one died on Day 2). For females all of the highest dose, and 2/5 of the 0.71 mg/kg bw group died within the first day after dosing.
Clinical signs:
Sluggishness, unsteady gait, lacrimation, yellow or red wetness or stains on the periurogenital fur, blood in the urine, a red crust around the nose and eyes, and prostration (in two animals).
Body weight:
No effects on body weight reported.
Gross pathology:
Animals that died revealed discoloured and/or mottled lungs (pink, red or salmon-coloured), discoloured stomachs and intestines (white to yellow, red or grey), gas and liquid filled stomachs and intestines, dark red or mottled tan livers, dark red to brown kidneys, liquid-filled abdominal cavities, one bladder filled with red liquid and blood in urine. Survivors had mottled pink to red lungs. One male had small mottled testes with cream-coloured foci and red submandibular lymph nodes.
Other findings:
- Histopathology: The kidneys and urinary bladders from two male and two female rats from all dosages were examined histologically. There was tubular proteinosis in the kidneys of male rats from each dose. No significant lesions were found in the male rat bladders or in the female kidneys or bladders.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
In a summary of an acute oral toxicity study (reliability score 2; not to GLP) the oral LD50 for 3-trimethoxysilylpropane-1-thiol in Sprague-Dawley rats, was 0.88 ml/kg bw for males and 0.73 ml/kg bw for females.
Executive summary:

3-trimethoxysilylpropane-1-thiol was given to Sprague-Dawley rats by oral gavage at doses of 2.0, 1.0, 0.71 and 0.5 ml/kg bw for male rats and 1.0, 0.71, 0.5 and 0.25 ml/kg bw for female rats. Animals were then observed for 14 days. Body weights were determined immediately prior to dosing and on days 7 and 14. At the end of the observation period all surviving animals were killed and a gross pathological examination performed on each animal. Animals that died were similarly examined. Kidneys and urinary bladder from two males and two females from each exposure group were subjected to a detailed histopathology examination. For males, both of the highest dose, and 4/5 of the 1.0 ml/kg bw groups died within the first day after dosing (one died on Day 2). For females all of the highest dose, and 2/5 of the 0.71 ml/kg bw group died within the first day after dosing. Clinical signs were sluggishness, unsteady gait, lacrimation, yellow or red wetness or stains on the periurogenital fur, blood in the urine, a red crust around the nose and eyes, and prostration (in two animals). Animals that died revealed discoloured and/or mottled lungs (pink, red or salmon-coloured), discoloured stomachs and intestines (white to yellow, red or grey), gas and liquid filled stomachs and intestines, dark red or mottled tan livers, dark red to brown kidneys, liquid-filled abdominal cavities, one bladder filled with red liquid and blood in urine. Survivors had mottled pink to red lungs. One male had small mottled testes with cream-coloured foci and red submandibular lymph nodes. Detailed histopathological examination of the kidneys and urinary bladders revealed tubular proteinosis in the kidneys of male rats from each dose. No significant lesions were found in the male rat bladders or in the female kidneys or bladders. There were no effects on body weights. The LD50s for males and females were 0.88 and 0.73 ml/kg bw, respectively.