Amino functional alkoxysilanes

Endpoint summary

Description of key information

In the key acute oral toxicity study with trimethoxy(methyl)silane and its reaction products with [3-(2,3-epoxypropoxy)propyl]trimethoxysilane and 3-(trimethoxysilyl)propylamine (EC 945 -567 -3), conducted according to the now-deleted OECD Test Guideline 401 and in compliance with GLP, an LD50 value of greater than 2000 mg/kg bw was concluded (Dow Corning Corporation 1990a).

In the key acute dermal toxicity study with trimethoxy(methyl)silane and its reaction products with [3-(2,3-epoxypropoxy)propyl]trimethoxysilane and 3-(trimethoxysilyl)propylamine, conducted according to OECD Test Guideline 402 and in compliance with GLP, an LD50 value of greater than 2000 mg/kg bw was concluded (Dow Corning Corporation, 1990b).

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:

02 August 1990 to 22 October 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: not specified
- Stability under test conditions: not specified
- Solubility and stability of the test substance in the solvent/vehicle: The test substance was administered undiluted.
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: not specified
- Preliminary purification step (if any): not specified
- Final dilution of a dissolved solid, stock liquid or gel: not applicable
- Final preparation of a solid: not applicable

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Laboratories, Michigan
- Females (if applicable) nulliparous and non-pregnant: not specified
- Age at study initiation: young adults
- Weight at study initiation: 205-267 g
- Fasting period before study: 16 hours
- Housing: Housed individually in conventional design stainless steel, wire mesh bottom cages.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): not specified
- Humidity (%): not specified
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): not specified

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: not specified

DOSAGE PREPARATION: undiluted

CLASS METHOD
- Rationale for the selection of the starting dose: standard method used

Doses:

2000 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: Observed frequently on the day of dosing and twice a day thereafter. Animals were weighed prior to dosing, then at 24 hours after dosing and on days 7 and 14 thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

One female died spontaneously. No other deaths were recorded.

Clinical signs:

other: No clinical signs of systemic toxicity were noted in any of the animals.

Gross pathology:

The female that died spontaneously showed gross tissue changes consistent with acute gastritis with regurgitation and inspiration of test material. No such lesions were reported in the rest of the animals. Therefore, this change was considered to be due to gavage treatment. No gross macroscopic changes were noted in the rest of the animals.

Other findings:

- Organ weights: not examined
- Histopathology: not examined
- Potential target organs: not examined

Interpretation of results:

GHS criteria not met

Conclusions:

In the acute oral toxicity study, conducted according to the now-deleted OECD Test Guideline 401 and in compliance with GLP, an LD50 value of >2000 mg/kg bw was concluded.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

Quality of whole database:

Klimisch score 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:

14 August 1990 to 28 August 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1987

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: not specified
- Stability under test conditions: not specified
- Solubility and stability of the test substance in the solvent/vehicle: The test substance was administered undiluted.
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: not specified
- Preliminary purification step (if any): not specified
- Final dilution of a dissolved solid, stock liquid or gel: not applicable
- Final preparation of a solid: not applicable

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Langshaw Farms, Augusta, Michigan
- Females (if applicable) nulliparous and non-pregnant: not specified
- Age at study initiation: young, no further information given
- Weight at study initiation: 2.2 - 2.6 kg
- Fasting period before study: none
- Housing: Housed individually in clean, stainless steel cages.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): not specified
- Humidity (%): not specified
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): not specified

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal area
- % coverage: 10%
- Type of wrap if used: porous gauze dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with tap water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw, volume not specified
- Constant volume or concentration used: yes

Duration of exposure:

24 hours

Doses:

2000 mg/kg 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: The animals were observed frequently after dosing, then twice daily thereafter. All rabbits were weighed at 1, 7 and 14 days after the application of the test material.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

Not used.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the study period.

Clinical signs:

other: No clinical signs of toxicity occurred during the study period.

Gross pathology:

All animals had changes in skin and changes were not uniformly distributed in the dermal test site. The distribution of skin changes strongly suggest causation by mechanical trauma of handling and/or restrained of the animals.

Other findings:

- Organ weights: not examined
- Histopathology: not examined
- Potential target organs: not examined
:

Interpretation of results:

GHS criteria not met

Conclusions:

In the acute dermal toxicity study, conducted according to OECD Test Guideline 402 and in compliance with GLP, an LD50 value of greater than 2000 mg/kg bw was concluded.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

Quality of whole database:

Klimisch score of 1

Additional information

In the key acute oral toxicity study with trimethoxy(methyl)silane and its reaction products with [3-(2,3-epoxypropoxy)propyl]trimethoxysilane and 3-(trimethoxysilyl)propylamine, conducted according to the now-deleted OECD Test Guideline 401 and in compliance with GLP, an LD50 value of greater than 2000 mg/kg bw was concluded (Dow Corning Corporation, 1990a). Following a single oral gavage administration of 2000 mg/kg bw undiluted test material to 5 male and 5 female rats, no test substance-related mortality, clinical signs of toxicity or body weight changes occurred. There were no gross macroscopic abnormalities noted. One female died prior to end of the observation period and its death was attributed to the gavage procedure.

In the key acute dermal toxicity study with trimethoxy(methyl)silane and its reaction products with [3-(2,3-epoxypropoxy)propyl]trimethoxysilane and 3-(trimethoxysilyl)propylamine, conducted according to OECD Test Guideline 402 and in compliance with GLP, an LD50 value of greater than 2000 mg/kg bw was concluded (Dow Corning Corporation, 1990b). Following a 24-hour dermal application of 2000 mg/kg bw undiluted test material to the dorsal area of 5 male and 5 female rabbits, no test substance-related mortality, clinical signs of toxicity or body weight changes occurred. Additionally, no gross macroscopic abnormalities were noted.

Justification for classification or non-classification

Based on the available data, no classification is required for trimethoxy(methyl)silane and its reaction products with [3-(2,3-epoxypropoxy)propyl]trimethoxysilane and 3-(trimethoxysilyl)propylamine for acute toxicity according to Regulation (EC) No. 1272/2008.