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Diss Factsheets

Administrative data

Description of key information

The key acute oral toxicity study, conducted according to OECD Test Guideline 401 and in compliance with GLP, reports an LD50 of >2000 mg/kg (Dow Corning Corporation, 2000a).

The key acute dermal toxicity, conducted according to OECD Test Guideline 402 and in compliance with GLP, reports an LD50of >2000 mg/kg (Dow Corning Corporation, 2000b).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May 1999 - February 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
The room temperature fell below the lower range specified in the study protocol; dosing of one female rat was delayed 24 h as a result of some rat diet being found in its cage. The deviations did not affects the overall result of the study.
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: information not in study report
- Age at study initiation: not stated
- Weight at study initiation: 70 - 150 g
- Fasting period before study: overnight prior to and ca. 4 hours after dosing
- Housing: individually in metal cages with wire mesh floors
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 51-69.5
- Air changes (per hr): minimum 19
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 1.8 ml/kg bw

Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5/sex
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All rats were observed at least twice daily for mortality and morbidity. Body weights recorded on Days 1, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
One female died on Day 3 of the study.
Clinical signs:
other: Piloerection (observed in all animals), hunched posture and walking on toes (two females), abnormal respiration, increased lacrimation and blue/cold extremities (one female), increased salivation (five males and four females), increased sensitivity to tou
Gross pathology:
Macroscopic pathology of one decedent revealed congestion in the subcutaneous tissue, brain, heart, lungs, liver, spleen and kidneys, with gaseous distension observed in the stomach, duodenum and small intestine. There were no abnormalities observed among animals sacrificed at study termination.
Interpretation of results:
GHS criteria not met
Conclusions:
An acute oral toxicity study, conducted according to OECD TG 401 and in compliance with GLP, reported an LD50 of >2000 mg/kg bw.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Klimish score of 1

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
no data
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Removed from study report
- Age at study initiation: 12 weeks
- Weight at study initiation: 2428-2661 g
- Fasting period before study: Not mentioned in report so assumed no fasting.
- Housing: Individually in suspended metal cages with perforated floors.
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: 13 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23.5
- Humidity (%): 31-45
- Air changes (per hr): 18
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 100 x 100 mm
- Coverage: approximately 10% of the total body surface area.
- Type of wrap if used: the treatment area was covered with porous gauze held in place with a non-irritating dressing and further covered by a waterproof dressing encircled firmly around the trunk of the animal.

REMOVAL OF TEST SUBSTANCE
- At the end of the 24 hour exposure period the dressings were carefully removed and the treated area of skin wiped with a towel moistened with warm water at 39°C to remove residual test substance.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.802 mL/kg
- Concentration (if solution): undiluted
- Constant volume or concentration used: yes



Duration of exposure:
24 hours
Doses:
2000 mg/kg bw/day
No. of animals per sex per dose:
Five
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All rabbits were observed at least twice daily for mortality and morbidity. The body weight of each animal was recorded on days 1 (prior to dosing), 8 and 15. Animals were observed immediately after dosing and at approximately hourly intervals for the remainder day 1 (approximately six hours). On subsequent days, animals were observed once in the morning and again at the end of the experimental day (with the exception of day 15 - morning only). The nature and severity of the clinical signs and time were recorded at each observation. All animals were observed for 14 days after dosing.
- Necropsy of survivors performed: yes. After the final observation, all the rabbits were sacrificed and subjected to a macroscopic examination which consisted of examination of the treated skin site and underlying tissue, and opening the cranial, thoracic and abdominal cavities. The macroscopic appearance of all examined organs was recorded.
- Other examinations performed: The treated skin of each rabbit was examined once daily on day 2 through to day 15. At each interval, dermal irritation was assessed for erythema, eschar formation, oedema and any other lesion. Dermal responses were assessed using the Draize scoring system. Animals were clipped as needed to evaluate dermal responses. The nature and severity of the clinical signs and time were recorded at each observation. All animals were observed for 14 days after dosing.
Statistics:
Group mean body weights were calculated. No other statistical analyses were carried out.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred.
Clinical signs:
other: No clinical signs were observed in any animal.
Gross pathology:
No abnormalities found.
Other findings:
Dermal responses: A predominantly well-defined level of irritation (erythema/oedema grade 2) was evident in all rabbits following removal of the dressings. A similar level of response was persistent during the first week of the study. By week two of the study, reactions had ameliorated in the majority of animals and although some erythema/oedema was still evident in five animals at study termination (day 15), reactions had resolved in the remaining five animals by the day of termination. These reactions were accompanied by some localised including necrosis, spots/scabbing and desquamation. These latter responses were still evident in nine of the ten animals at study termination.
Interpretation of results:
GHS criteria not met
Conclusions:
The key study for acute dermal toxicity, conducted according to OECD TG 402 and in compliance with GLP (Dow Corning Corporation, 2000b), LD50 for alkoxy exchange product of vinyltriacetoxysilane and glycidoxypropyltrimethoxysilane was greater than 2000 mg/kg bw/day. The dermal reactions suggested that the test substance might cause severe irritation/corrosion following prolonged occlusive exposure.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Klimish score of 1

Additional information

The key study for acute oral toxicity was conducted according to OECD TG 401 and in compliance with GLP (Dow Corning Corporation, 2000a). An LD50 of >2000 mg/kg bw was identified in the study. The clinical signs reported in the study included piloerection, hunched posture and walking on toes, abnormal respiration, increased lacrimation and blue/cold extremities, increased salivation, increased sensitivity to touch and hyperactivity. Resolution was complete in all animals that survived treatment by Day 6. All rats surviving treatment were considered to have achieved satisfactory bodyweight gains throughout the study. One animal died during treatment, the macroscopic pathology revealing congestion in the subcutaneous tissue, brain, heart, lungs, liver, spleen and kidneys, with gaseous distension observed in the stomach, duodenum and small intestine. There were no macroscopic abnormalities observed among the rest of the animals which were sacrificed at study termination.

The key study for acute dermal toxicity was conducted according to OECD TG 402 and in compliance with GLP (Dow Corning Corporation, 2000b). The registered substance was administered (under occlusive conditions) as supplied at a dose level of 2000 mg/kg bw/day to the dorsal-lumbar region of five male and five female rabbits. The treated area of skin was cleaned with a towel moistened with warm water (30 -40oC) 24 hours after application of the test substance. Rabbits were assessed for dermal irritation from day 2 (following test substance administration/removal of the dressings) through to day 15 (study termination).

There were no deaths and no systemic responses to treatment observed in any animal throughout the study. Body weight gains in the majority of animals were considered satisfactory throughout the study with a weight loss notable in one female on day 8 only and a low gain in one further female on day 8 and day 15. There were no abnormalities revealed in the macroscopic examination.

A predominantly well-defined level of irritation (erythema/oedema grade 2) was evident in all rabbits following removal of the dressings. A similar level of response was persistent during the first week of the study. By week two of the study, reactions had ameliorated in the majority of animals and although some erythema/oedema was still evident in five animals at study termination (day 15), reactions had resolved in the remaining five animals by the day of termination. These reactions were accompanied by some localised including necrosis, spots/scabbing and desquamation. These latter responses were still evident in nine of the ten animals at study termination. Under the conditions of this study, the acute LD50 of the registered substance was demonstrated to be greater than 2000 mg/kg bw/day.


Justification for classification or non-classification

Based on the available data, reaction products of 3-(2,3-epoxypropxy)propyltrimethoxysilane and triacetoxyvinylsilane is not classified for acute toxicity in accordance with Regulation (EC) No. 1272/2008.