3-(triethoxysilyl)propyl methacrylate

Endpoint summary

Description of key information

The key study for acute oral toxicity reports an LD50 of >5000 mg/kg bw in rat (WIL, 1995). The study was conducted according to current guideline and in compliance with GLP.

The key study for acute dermal toxicity reports an LD50 of >2000 mg/kg bw in rat (WIL, 1995). The study was conducted according to current guideline and in compliance with GLP.

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 October 1995-08 May 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

other: U.S. EPA FIFRA/TSCA and Japanese MAFF guidelines

GLP compliance:

yes

Limit test:

yes

Species:

rat

Strain:

other: Crl:CDBR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, NY
- Age at study initiation: young adult
- Weight at study initiation: 217 - 278 g
- Fasting period before study:
- Housing: Individual housing, suspended wire mesh cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum of 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 71.3-72.1
- Humidity (%): 42.3-62.5
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 5.05 ml/kg

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5M/5F

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the rats were observed 1, 3 and 4 hours post-dose on day 0 and twice daily thereafter. Body weights were obtained and recorded on study days -1, 0, 7, 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Major organ systems of the cranial, thoracic and abdominal cavities were examined for all animals.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths during the study.

Clinical signs:

other: All clinical findings were within three days of dosing. Wet yellow urogenital staining was observed for nine animals. Mucoid faeces and soft stool were each noted for single animals. One rat had dried red material on the forelimbs. There were no other cli

Gross pathology:

Enlarged cervical lymph nodes were observed for a single animal at the terminal necropsy. There were no other necropsy findings.

Interpretation of results:

GHS criteria not met

Conclusions:

An LD50 of >5000 mg/kg bw is reported for the registered substance in a study that was conducted according to current guideline and in compliance with GLP.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

The study was conducted according to current guideline and in compliance with GLP.

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:

May - July 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

other: U.S. EPA FIFRA/TSCA and Japanese MAFF guidelines

GLP compliance:

yes

Limit test:

yes

Species:

rat

Strain:

other: Crl:CDBR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, NY
- Age at study initiation: young adult
- Weight at study initiation: 239 - 269 g
- Housing: Individual housing, suspended wire mesh cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum of 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 71.3-72.1
- Humidity (%): 42.3-62.5
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: back and flank
- % coverage: 20-25
type of wrap: gauze bandage
:

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males, 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the rats were observed 1, 3 and 4 hours post-dose on day 0 and twice daily thereafter. Body weights were obtained and recorded on study days 0, 7 and 14. The application sites were examined for erythema, edema and other dermal findings ca. 30-60 minutes after bandage removal and daily thereafter for thirteen days. The rats were clipped to facilitate dermal observations on study days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: Major organ systems of the cranial, thoracic and abdominal cavities were examined for all animals.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths during the study.

Clinical signs:

other: Clinical findings were limited to wet yellow urogenital staining for five rats and dried red material around the eye(s) and/or nose for four rats. These findings are typically noted in association with the bandage/collar application procedures and were no

Gross pathology:

Dark, red lungs were present for one female. There were no gross necropsy findings for all examined tissues.

Interpretation of results:

GHS criteria not met

Conclusions:

An LD50 of >2000 mg/kg bw is reported in a study which was conducted according to current guideline and in compliance with GLP.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

The study was conducted according to current guideline and in compliance with GLP.

Additional information

The key study for acute oral toxicity reports an LD50 of >5000 mg/kg bw, in a study which was conducted according to current guideline and in compliance with GLP (WIL, 1995). There were no deaths during the study. All clinical findings were within three days of dosing. Wet yellow urogenital staining was observed for nine animals. Mucoid faeces and soft stool were each noted for a single animal. One rat had dried red material on the forelimbs. There were no other dermal findings. All animals appeared normal by day 4 or earlier and throughout the remainder of the study. There were no remarkable changes or differences in body weights. Enlarged cervical lymph nodes were observed for a single animal at the terminal necropsy. There were no other necropsy findings.

Acute oral toxicity studies with the analogous substances, 3-(trimethoxysilyl)propyl methacrylate (CAS 2530 -85 -0) and 3-(trimethoxysilyl)methyl methacrylate (CAS 54586-78-6) have been included in the data set for completeness (Dow Corning Corporation, 2001; Bioservice, 2003; WIL, 2001) to support read-across of skin sensitisation data.

The key study for acute dermal toxicity reports an LD50 of >2000 mg/kg bw, in a study which was conducted according to current guideline and in compliance with GLP (WIL, 1995). There were no deaths during the study. Clinical findings were limited to wet yellow urogenital staining for five rats and dried red material around the eye(s) and/or nose for four rats. These findings are typically noted in association with the bandage/collar application procedures and were not a result of test material application. There were no other clinical findings. All animals appeared normal by day 2 or earlier and throughout the study. The test material induced very slight erythema on seven animals. There was no edema. Desquamation was present on two animals on day 7. There were no other dermal findings. All dermal irritation completely subsided by day 8 or earlier. There were no remarkable changes or differences in body weights. Dark, red lungs were present for one female. There were no gross necropsy findings for all examined tissues.

 

Justification for classification or non-classification

Based on the available data, no classification is required for acute toxicity in accordance with Regulation (EC) No. 1272/2008.