Triethoxy(vinyl)silane

Endpoint summary

Description of key information

Oral (OECD 401), rat: LD50 >5000 mg/kg bw
Dermal (OECD 402), rat: LD50 >2000 mg/kg bw (limit test)
Inhalation: only RL4 studies available, LC50 = 4500 ppm (34976 mg/m³)

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:

05 May to 27 Aug 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Labs Inc., Portage, MI, USA
- Age at study initiation: 8-12 wk
- Weight at study initiation: 216-349 g
- Fasting period before study: 18-20 h
- Housing: 1/suspended wire mesh cage
- Diet: certified rodent LabDiet5002, PMI Nutrition International, ad libitum
- Water: municipal water, ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.6 to 22.3
- Humidity (%): 41.3-61.0
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From 1998-05-13 To 1998-06-12

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 5.56 ml/kg bw

Doses:

3846, 5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation for mortality 1, 3, 4 h, then twice daily for 14 days; clinical observations 1, 3, 4 h then daily for 14 days; body weights on days -1, 0, 7, 14.
- Necropsy of survivors performed: yes, the major organ systems of the cranial, thoracic and abdominal cavities were examined for all animals.

Statistics:

None given.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

Dose-related mortality. 2 males and 1 female died at the highest tested dose of 5000 mg/kg bw, and 2 females of the lower dose group died. (See also table below.) All deaths occured within four days of dosing.

Clinical signs:

other: The majority of animals had wet or dry deposits round the mouth, anogenital or urogenital areas, or on the trunk or limbs. Impaired coordination, hypoactivity and tremors occured in both sexes. Mucoid faeces, ocular discharge or laboured breathing occured

Gross pathology:

No clear treatment-related effect. One female that died had an unspecified 'white precipitate' in the kidneys. At terminal necropsy no gross findings for any animal were observed.

Table 1: Number of animals dead and with evident toxicity, and time range within which mortality occurred

Dose (mg/kg bw)	Mortality (# dead/total)			Time range of deaths (days)	Number with evident toxicity (#/total)
	Male	Female	Combined			Male	Female	Combined
3846	0/5	2/5	2/10	0-4	Impaired coordination Hypoactive Tremors mucoid faeces Ocular discharge Laboured breathing	2/5 3/5 0/5 0/5 0/5 0/5	5/5 4/5 4/5 0/5 2/5 1/5	7/10 7/10 4/10 0/10 2/10 1/10
5000	2/5	1/5	3/10	3-4	Impaired coordination Hypoactive Tremors mucoid faeces Ocular discharge Laboured breathing	5/5 4/5 1/5 1/5 0/5 0/5	5/5 2/5 2/5 0/5 4/5 0/5	10/10 6/10 3/10 1/10 4/10 0/10

 

Interpretation of results:

other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008

Conclusions:

In an acute oral toxicity study conducted in compliance with the now deleted OECD 401, and in accordance with GLP, an LD50 in excess of 5000 mg/kg bw was identified. There was evidence of systemic toxicity at 5000 and 3846 mg/kg bw; impaired muscle coordination, hypoactivity, tremors and clear ocular discharge. Mucoid feces and laboured breathing were each noted for animals that died. All surviving animals appeared normal by day 13 of the observation period.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The available information comprises an adequate and reliable study, and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

other justification

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Quality of whole database:

There are no reliable data for the inhalation route. However, there are two studies with reliability scores of 4.

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:

20 May 1998 to 3 June 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute 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: Charles River Labs Inc., Portage, MI, USA
- Age at study initiation: young adults
- Weight at study initiation: 211-308 g
- Housing: 1/suspended mesh-bottomed cage
- Diet: standard diet. ad libitum
- Water: drinking water. ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.9-22.3
- Humidity (%): 41.3-61.0
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1998-05-21 To: 1998-06-03

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- % coverage: 16-20
- Type of wrap if used: gauze bandage held with non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing: removed with damp paper towel
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 2.22 ml/kg bw (0.90 g/ml)
- Concentration: neat (100%)

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations for mortality at 1, 3 and 4 h then twice daily for 14 d; clinical observations at 1, 3, and 4 h then once daily for 14 days; dermal observations at 30-60 mins then daily for 13 days; body weights on days 0 (before treatment), 7 and 14.
- Necropsy of survivors performed: yes, the major organ systems of the cranial, thoracic and abdominal cavities were examined for all animals.

Statistics:

None given - limit test.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No deaths.

Mortality:

None.

Clinical signs:

other: Yellow deposits on urogenital area of 4 female rats on dosing day but not thereafter. [Said in the report to be typical of "bandage/collar application procedures".] No other potentially treatment-related effects.

Gross pathology:

No evidence of treatment-related effects.

Other findings:

- Other observations:
Very slight erythema (redness) in 3 females - days 4-6.
Focal eschar (scabbing or sloughing) in 3 females - days 5-10.
Desquamation (shedding of skin) in 3 males and 5 females - from day 4 and still evident in 1 female on day 14.

Table 1: Number of animals dead [and with evident toxicity]

Dose (mg/kg bw)	Mortality (# dead/total)			Number with evident toxicity (#/total)
	Male	Female	Combined	Male	Female	Combined
2000	0/5	0/5	0/10	No toxicity only local effects reported

 

Interpretation of results:

other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008

Conclusions:

In an acute dermal toxicity study conducted in compliance with OECD 402 and in accordance with GLP (reliability score 1), no mortality or systemic effects were seen at 2000 mg/kg bw. Although there were some signs of local irritation, there were no adverse systemic effects.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The available information comprises adequate, reliable (Klimisch score 1-2) and consistent studies, and is thus sufficient to fulfil the standard information requirements set out in Annex VIII, 8.5, of Regulation (EC) No 1907/2006.

Additional information

Acute toxicity: oral

In an acute oral toxicity study (WIL Research Labs Inc., 1998a) conducted in compliance with the now deleted OECD 401, and in accordance with GLP, an LD50 in excess of 5000 mg/kg bw was identified. 5 male and 5 female rats were treated by oral gavage with 3846 and 5000 mg/kg bw. In the high dose group 2/5 males and 1/5 females died, whereas in the 3846 mg/kg bw dose group 2/5 females were found dead. There was evidence of systemic toxicity at 5000 and 3846 mg/kg bw including impaired muscle coordination, hypoactivity, tremors and clear ocular discharge. Mucoid faeces and laboured breathing were each noted for animals that died. All surviving animals appeared normal by day 13 of the observation period.

 

Acute toxicity: dermal

In an acute dermal toxicity study conducted in compliance with OECD 402 and in accordance with GLP (WIL Research Labs Inc., 1998b), no mortality or systemic effects were seen after treatment of 5 male and 5 female rats with the limit dose of 2000 mg/kg bw for 24 h under semiocclusive conditions. Although there were some signs of local irritation, no adverse systemic effects have been observed.

 

Acute toxicity: inhalation

There are no reliable data for the inhalation route. However, there are two studies with reliability scores of 4. Both of these studies were missing critical information, but both suggested that there is no need to classify for inhalation exposure. In the first study (Dow Corning Corporation, 1972) rats of unknown sex and number were exposed to a saturated atmosphere of the test substance for 7 h (approximately 2300 ppm vapour). No mortality occurred and a LD50 of >2300 ppm was deduced, which corresponds to 17 876 mg/m³, based on a molecular weight of 190.3 g/mol at 25°C. In the other study (prepared for GE and Bayer by Collette Bement, Epona Associates, LLC, 2000) deaths were observed after exposure of rats to 4500 ppm for 4 h. No further details were given. Thus a LC50 of 4500 ppm (equivalent to 34 976 mg/m³ at 25°C, based on a molecular weight of 190.3 g/mol) was deduced.

Justification for classification or non-classification

The available data on oral and dermal acute toxicity of the test substance do not meet the criteria for classification according to Regulation (EC) No. 1272/2008, and are therefore conclusive but not sufficient for classification.