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Diss Factsheets

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 available
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

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 group (at least 5 recommended), 2 doses (at least 3 recommended), immobilisation not recommended, occlusive application (semi-occlusive recommended), insufficient details to further judge compliance with test guideline)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Triethoxy(3-isocyanatopropyl)silane
EC Number:
246-467-6
EC Name:
Triethoxy(3-isocyanatopropyl)silane
Cas Number:
24801-88-5
Molecular formula:
C10H21NO4Si
IUPAC Name:
triethoxy(3-isocyanatopropyl)silane

Test animals

Species:
rabbit
Strain:
other: albino
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no data available
- Age at study initiation: 3 to 5 months
- Weight at study initiation: no data available
- Fasting period before study: no data available
- Housing: no data available
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data available

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

IN-LIFE DATES: no data available

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: no data available
- % coverage: no data available
- Type of wrap if used: impervious sheeting

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data available
- Time after start of exposure: no data available

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1 or 2 ml/kg bw [980 or 1970 mg/kg bw]
- Constant volume or concentration used: no data available
Duration of exposure:
24 Hours
Doses:
1 or 2 ml/kg bw [980 or 1970 mg/kg bw]
No. of animals per sex per dose:
4 males
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data available
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, skin irritation
Statistics:
No data available

Results and discussion

Preliminary study:
No data available
Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
1.26 mL/kg bw
Based on:
test mat.
95% CL:
>= 0.772 - < 2.06
Remarks on result:
other: Density 1.0007 g/ml; 1.26 ml/kg bw is equivalent to 1261 mg/kg bw; 4/4 deaths at 2 ml/kg bw, 1/4 deaths at 1 ml/kg bw
Mortality:
1/4 animals given 1 mlkg died (on day 2)
4/4 animals given 2 ml/kg died (on day 1)
Clinical signs:
other: No clinical signs were reported for animals given 1.0 ml/kg bw In animals given 2 ml/kg bw, rapid breathing and irritability were noted within the first few hours of treatment
Gross pathology:
Congestion of the lungs
Spleens, livers and kidneys pale
Livers and kidneys mottled
Other findings:
- Other observations: skin erythema and oedema were reported in animals given 1 ml/kg bw. Skin erythema and ecchymosis were reported in animals given 2 ml/kg bw

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
In a study probably similar to that described by OECD Test Guideline 402, triethoxy(3-isocyanatopropyl)silane was harmful to male rabbits following a 24-hour acute dermal administration. An acute dermal LD50 of 1.26 ml/kg bw [1261 mg/kg bw] was derived.
Executive summary:

Two summary reports described an acute dermal toxicity study in rabbits, probably similar to that described by OECD Test Guideline 402 (acute dermal toxicity), with triethoxy(3-isocyanatopropyl)silane.

Groups of four male albino rabbits were exposed to undiluted triethoxy(3-isocyanatopropyl)silane at 1 or 2 ml/kg bw under occlusion for 24 hours. Rabbits were observed for 14 days for mortality and clinical signs of toxicity, before sacrifice and necropsy to identify any gross pathological changes.

One and four animals died in the low and high dose groups respectively. Congestion was noted in the lungs, as well as paleness and mottling in livers and kidneys, and pale spleens. Irritability and rapid breathing were noted in animals from the top dose group within the first few hours of treatment. Skin erythema was seen in all treated animals, while ecchymosis [haemorrhagic spots] was seen in animals treated with 2 ml/kg bw, and oedema in animals given 1 ml/kg bw.

Triethoxy(3-isocyanatopropyl)silane was harmful to male rabbits and an acute dermal LD50 of 1.26 ml/kg bw [1240 mg/kg bw] was derived.