Amino functional alkoxysilanes

Endpoint summary

Description of key information

In the key skin irritation study, conducted according to OECD Test Guideline 404 and in compliance with GLP, the test material trimethoxy(methyl)silane and its reaction products with [3-(2,3-epoxypropoxy)propyl]trimethoxysilane and 3-(trimethoxysilyl)propylamine (EC 701 -408 -8) was reported to be not irritating to skin (Dow Corning Corporation, 1990c).

In the key eye irritation study, conducted according to OECD Test Guideline 405 and in compliance with GLP, the test material, trimethoxy(methyl)silane and its reaction products with [3-(2,3-epoxypropoxy)propyl]trimethoxysilane and 3-(trimethoxysilyl)propylamine, was reported to be irritating to eyes (Dow Corning Corporation, 1990d).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

7 August 1990 to 10 August 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1981

Deviations:

no

GLP compliance:

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 item was applied 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: The test item was applied undiluted.
- Preliminary purification step: none
- 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

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hazelton, Kalamazoo, Michigan
- Age at study initiation: young, no further information given
- Weight at study initiation: 2.27 - 2.33 kg
- Housing: All rabbits were housed individually in clean, stainless steel cages
- Diet (e.g. ad libitum): Purina Lab Rabbit Chow, ad libitum
- Water (e.g. ad libitum): fresh water, as libitum
- Acclimation period: one week

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

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): not applicable

VEHICLE: Not used
NEGATIVE CONTROL: Not used
POSITIVE CONTROL: Not used

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

4

Details on study design:

TEST SITE
- Area of exposure: dorsal area
- % coverage: approximately 6 cm², percentage not specified
- Type of wrap if used: porous gauze dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with tap water
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
at 1, 24, 48 and 72 hours

SCORING SYSTEM:
- Method of calculation: Draize scoring system

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No effects on body weight gain, food consumption or behaviour were observed in any of the test animals. No skin irritation was observed in any of the test animals.

Other effects:

- Other adverse local effects: no effects
- Other adverse systemic effects: no effects

Interpretation of results:

GHS criteria not met

Conclusions:

In the skin irritation study, conducted according to OECD Test Guideline 404 and in compliance with GLP, the test material trimethoxy(methyl)silane and its reaction products with [3-(2,3-epoxypropoxy)propyl]trimethoxysilane and 3-(trimethoxysilyl)propylamine was reported to not be irritating to skin.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2 August 1990 to 01 October 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1987

Deviations:

no

GLP compliance:

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 item was applied 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: The test item was applied undiluted.
- Preliminary purification step: none
- 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

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hazelton, Kalamazoo, Michigan
- Age at study initiation: young, no further information given
- Weight at study initiation: 2.27 - 2.33 kg
- Housing: All rabbits were housed individually in clean, stainless steel cages
- Diet: Purina Lab Rabbit Chow, ad libitum
- Water: fresh water, as libitum
- Acclimation period: one week

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

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): not applicable

VEHICLE: not used

Duration of treatment / exposure:

single instillation

Observation period (in vivo):

up to 14 days

Number of animals or in vitro replicates:

two groups of three animals

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: no washing done for group one and washing done for group two 30 seconds after instillation.

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: Fluorescein

Irritation parameter:

cornea opacity score

Remarks:

unwashed eye

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.66

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Irritation parameter:

cornea opacity score

Remarks:

unwashed eye

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.66

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Irritation parameter:

cornea opacity score

Remarks:

unwashed eye

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.66

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Irritation parameter:

iris score

Remarks:

unwashed eye

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Irritation parameter:

iris score

Remarks:

unwashed eye

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Irritation parameter:

iris score

Remarks:

unwashed eye

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Irritation parameter:

conjunctivae score

Remarks:

unwashed eye

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 14 days

Remarks on result:

positive indication of irritation

Irritation parameter:

conjunctivae score

Remarks:

unwashed eye

Basis:

animal #2

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Irritation parameter:

conjunctivae score

Remarks:

unwashed eye

Basis:

animal #3

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Irritation parameter:

chemosis score

Remarks:

unwashed eye

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Irritation parameter:

chemosis score

Remarks:

unwashed eye

Basis:

animal #2

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Irritation parameter:

cornea opacity score

Remarks:

washed eye

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Remarks:

washed eye

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Remarks:

washed eye

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Remarks:

washed eye

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Remarks:

washed eye

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Remarks:

washed eye

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

2

Reversibility:

fully reversible within: 72 hours

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Remarks:

washed eye

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible within: 7 days

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Remarks:

washed eye

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Remarks:

washed eye

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Remarks:

washed eye

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Remarks:

washed eye

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Remarks:

washed eye

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No effects were observed in body weight gain or food consumption of the rabbits. Eye irritation was noted in group one animals with unwashed eyes after instillation. No eye irritation was noted in group two animals with washed eyes following treatment (30 seconds after instillation).

Group 1 (unwashed):

Slight to moderate swelling and iritis and slight damage to cornea were noted at 24, 48 and 72 hours. All eyes appeared normal by day 14 of observation period.

Group 2 (washed after 30 seconds):
Slight to severe pain after instillation of the test material. At 1 and 24 hours, slight to moderate conjunctival redness with swelling in all rabbits and slight corneal injury was observed in one animal at 24 hours. At 48 hours observation, slight redness with swelling was seen in 2/3 rabbits and one animal still showed slight corneal injury and slight iritis. All treated eyes appeared normal by day 7 of the observation period.

Other effects:

Not specified

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

In the eye irritation study, conducted according to OECD Test Guideline 405 and in compliance with GLP, the test material, trimethoxy(methyl)silane and its reaction products with [3-(2,3-epoxypropoxy)propyl]trimethoxysilane and 3-(trimethoxysilyl)propylamine, was reported to be irritating to eyes.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

In the key skin irritation study, conducted according to OECD Test Guideline 404 and in compliance with GLP, the test material trimethoxy(methyl)silane and its reaction products with [3-(2,3-epoxypropoxy)propyl]trimethoxysilane and 3-(trimethoxysilyl)propylamine was reported to be not irritating to skin (Dow Corning Corporation, 1990c). Following a single 4-hour application of 0.5 ml of undiluted test item onto the previously clipped dorsal area of 4 rabbits, no signs of erythema or oedema were noted in any of the test animals. Furthermore, no effects were observed on body weight gain, food consumption or behaviour in any of the test animals.

In the key eye irritation study, conducted according to OECD Test Guideline 405 and in compliance with GLP, the test material, trimethoxy(methyl)silane and its reaction products with [3-(2,3-epoxypropoxy)propyl]trimethoxysilane and 3-(trimethoxysilyl)propylamine, was reported to be irritating to eyes (Dow Corning Corporation, 1990d). Following a single instillation of 0.1 ml undiluted test item into the right eye of two groups of three rabbits, no effects were observed in body weight gain or food consumption of the rabbits. When the eyes were washed 30 seconds after instillation, no eye irritation occurred. Although, animals experienced slight to severe pain after instillation of the test material. In the animals with unwashed eyes following instillation, slight to moderate swelling, iritis and slight damage to cornea were noted at 24, 48 and 72 hours. All eyes appeared normal by day 14 of the observation period. At 1 and 24 hours, slight to moderate conjunctival redness with swelling in all rabbits and slight corneal injury was observed in one animal at 24 hours. At 48 hours observation, slight redness with swelling was seen in 2/3 rabbits and one animal still showed slight corneal injury and slight iritis. All treated eyes appeared normal by day 7 of the observation period.

Justification for classification or non-classification

Based on the available data for trimethoxy(methyl)silane and its reaction products with [3-(2,3-epoxypropoxy)propyl]trimethoxysilane and 3-(trimethoxysilyl)propylamine, no classification is required for skin irritation, and classification Category 2, "H319: Causes serious eye irritation" is required for eye irritation according to Regulation (EC) No. 1272/2008.