[No public or meaningful name is available]

Endpoint summary

Description of key information

Skin Irritation:

Based on the studies on test chemicals, it can be concluded that the erythema and edema were 1.5, for skin irritation  Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified as a skin irritant

Eye Irritation: 
Based on the studies on test chemicals, it can be concluded that the average  score of was found to be The average (24+48+72 hrs) was:
3.00 for chemosis to conjuntiva
2.50 for enanthema to the conjunctiva
1.00 for congestion to the iris
2.00 for opacity to the cornea.  Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified

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

Remarks:

Read across data

Adequacy of study:

weight of evidence

Study period:

Not specified

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data was taken from secondary source

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1989

Principles of method if other than guideline:

Acute skin irrtiation test for the given sample was carried out in rabbits

GLP compliance:

not specified

Specific details on test material used for the study:

Not specified

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Epona Associates, LLC
- Age at study initiation: No data available
- Weight at study initiation: No data available
- Housing:No data available
- Diet (e.g. ad libitum): No data available
- Water (e.g. ad libitum): No data available
- Acclimation period:No data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%): No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light):No data available

IN-LIFE DATES: From: To:No data available

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

undiluted

Duration of treatment / exposure:

4 hrs

Observation period:

14 days

Number of animals:

6 animals

Details on study design:

Not specified

Irritation parameter:

edema score

Basis:

mean

Remarks:

6 animals

Time point:

other: 24hrs, 48 hrs and 72 hrs

Score:

1.5

Max. score:

4

Reversibility:

not fully reversible within: 10days

Remarks on result:

other: edema score was found to be 1.5

Irritation parameter:

erythema score

Basis:

mean

Remarks:

all 6 animals

Time point:

other: 24hrs,48 hrs and 72 hrs

Score:

1.5

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: Erythema score was found to be 1.5

Irritant / corrosive response data:

After 4hrs applications of a test sample to occluded rabbit skin resulted in minor to moderated formation of erythema and minor to severe edema in all 6 animals. Ecchymosis was observed in one animal after 5 hrs of application. In 3 animals’ necrosis was noted on another day, and on the remaining animals, it was noted after 7 days; still evident in 3 at 10 days it was no longer evident at 14 days. No erythema or edema was noted in the animal on the 10th day of the study. At this point, ulceration was evident in one animal and alopecia was observed in most of the animals. Desquamation, alopecia, and ulceration (on one) persisted through 14 days.

Other effects:

Necrosis was observed on 3 animals by one day and on another animal by 7 days. There was no erythema or edema evident on any animal at 10 days. At this time ulceration was evident on one animal and alopecia was observed on most. Desquamation, alopecia and ulceration (on one) persisted through 14 days. This material was considered corrosive to the skin by the Department of transportation (DOT) definition.

Not specified

Interpretation of results:

Category 1 (corrosive) based on GHS criteria

Conclusions:

An unfailing study, like OECD 404, found that test material was corrosive when in occluded contact for 4 h in rabbits

Executive summary:

An unfailing study, like OECD "Acute Dermal Irritation/Corrosion" was performed for the RA chemical 3-aminopropyltriethoxysilane using rabbits.
The test chemical was applied to all the animals at a dose of 0.5ml, and observed for 4 hrs . After 4hrs applications of a test sample to occluded rabbit skin resulted in the minor moderated formation of erythema and minor to severe edema in all 6 animals. Ecchymosis was observed in one animal after 5 hrs of application. In 3 animals’ necrosis was noted on another day, and on the remaining animals, it was noted after 7 days; still evident in 3 at 10 days it was no longer evident at 14 days. No erythema or edema was noted in the animal on the 10th day of the study. At this point, ulceration was evident in one animal and alopecia was observed in most of the animals. Desquamation, alopecia, and ulceration (on one) persisted through 14 days.
Necrosis was observed on 3 animals in one day and on another animal in 7 days. There was no erythema or edema evident on any animal at 10 days. At this time ulceration was evident on one animal and alopecia was observed on most. Desquamation, alopecia, and ulceration (on one) persisted through 14 days. The erythema and edema score was found to be 1.5; hence, the given chemicals come under category 1 based on the GHS classification.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Remarks:

Read across data

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data was taken from secondary source

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1993

Deviations:

not specified

Principles of method if other than guideline:

OECD Guide-line 405 "Acute Eye Irritation/Corrosion"
- Principle of test: Effect of test chemical on the eye of the animal was studied
- Short description of test conditions: chemical is applied to lower eyelid of animal, commonly rabbit were used, effect of chemicalon cornea, irris and conjuctiva was noted
- Parameters analysed / observed: Redness, erthyma, blisters

GLP compliance:

not specified

Specific details on test material used for the study:

Not Specified

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Lesser Ketones Manufacturing Association Leesburg, VA
- Age at study initiation: ~ 3 months
- Weight at study initiation: No data available
- Housing: No data available
- Diet (e.g. ad libitum): No data available
- Water (e.g. ad libitum): No data available
- Acclimation period:No data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%): No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available

IN-LIFE DATES: From: To: No data available

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):No data available

VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):No data available
- Lot/batch no. (if required): No data available
- Purity:No data available

Duration of treatment / exposure:

72hrs

Observation period (in vivo):

14 days

Duration of post- treatment incubation (in vitro):

21days

Number of animals or in vitro replicates:

6

Details on study design:

Not specified

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

72 h

Score:

1

Max. score:

4

Reversibility:

not specified

Remarks on result:

not determinable

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

72 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

not determinable

Irritation parameter:

other: enanthema

Basis:

mean

Time point:

72 h

Score:

2.83

Max. score:

4

Reversibility:

not specified

Remarks on result:

not determinable

Irritation parameter:

chemosis score

Basis:

mean

Time point:

72 h

Score:

3

Max. score:

4

Reversibility:

not specified

Remarks on result:

not determinable

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

48 h

Score:

2

Max. score:

4

Reversibility:

not specified

Remarks on result:

not determinable

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

48 h

Score:

1

Max. score:

4

Reversibility:

not specified

Remarks on result:

not determinable

Irritation parameter:

other: enanthema

Basis:

mean

Time point:

48 h

Score:

2.67

Max. score:

4

Reversibility:

not specified

Remarks on result:

not determinable

Irritation parameter:

chemosis score

Basis:

mean

Time point:

48 h

Score:

3

Max. score:

4

Reversibility:

not specified

Remarks on result:

not determinable

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

not specified

Remarks on result:

not determinable

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

not specified

Remarks on result:

not determinable

Irritation parameter:

other: enanthema

Basis:

mean

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

not specified

Remarks on result:

not determinable

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24 h

Score:

3

Max. score:

4

Reversibility:

not specified

Remarks on result:

not determinable

Irritant / corrosive response data:

The lesions observed at 72 hours were still observed in 5 out of 6 rabbits examined on Day 21.

Other effects:

Not Specified

The average (24+48+72 hrs) was:
3.00 for chemosis to conjuntiva
2.50 for enanthema to the conjunctiva
1.00 for congestion to the iris
2.00 for opacity to the cornea

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

In accordance with the test guideline 405 Acute eye irritation/corrosion, the RA chemical was classified as an irritant (category 2 based on GHS classification).

Executive summary:

An unfailing study, like OECD "Acute Eye Irritation/Corrosion" was performed for the RA of chemical N-(3-(trimethoxysilyl)propyl)ethylenediamine (CAS number: 1760-24-3) using rabbits. 

The RA chemical was applied to all the animals at a dose of 0.1ml to the lower eyelid of the animal, one eye serves as a control and the other eye serves as a treatment. The lesions observed at 72 hours were still observed in 5 out of 6 rabbits examined on Day 21. The average  score of was found to be The average (24+48+72 hrs) was:
3.00 for chemosis to conjuntiva
2.50 for enanthema to the conjunctiva
1.00 for congestion to the iris
2.00 for opacity to the cornea

 Hence the RA material was severely irritating to the eye of animals as per the GHS category the chemical belongs to the class Category 2( Irritating to eyes)

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

Skin Irritation: 
Study no 01:
An unfailing study, like OECD "Acute Dermal Irritation/Corrosion" was performed for the RA chemical 3-aminopropyltriethoxysilane using rabbits.
The test chemical was applied to all the animals at a dose of 0.5ml, and observed for 4 hrs.After 4hrs applications of a test sample to occluded rabbit skin resulted in the minor moderated formation of erythema and minor to severe edema in all 6 animals. Ecchymosis was observed in one animal after 5 hrs of application. In 3 animals’ necrosis was noted on another day, and on the remaining animals, it was noted after 7 days; still evident in 3 at 10 days it was no longer evident at 14 days. No erythema or edema was noted in the animal on the 10th day of the study. At this point, ulceration was evident in one animal and alopecia was observed in most of the animals. Desquamation, alopecia, and ulceration (on one) persisted through 14 days.
Necrosis was observed on 3 animals in one day and on another animal in 7 days. There was no erythema or edema evident on any animal at 10 days. At this time ulceration was evident on one animal and alopecia was observed on most. Desquamation, alopecia, and ulceration (on one) persisted through 14 days. The erythema and edema score was found to be 1.5; hence, the given chemicals come under category 1 based on the GHS classification.

Study no 02:

An unfailing study, like OECD "Acute Dermal Irritation/Corrosion" was performed for the RA chemical 3-aminopropyltriethoxysilane(CAS 919-30-2)using rabbits. The RA chemical was applied to all the animals at a dose of 0.5ml and observed for 72  hrs. After 24 hrs applications of a test sample to rabbit skin resulted in Moderate to severe erythema with edema observed on all animals. After 72 hours, irritation became more pronounced on the abraded skin, leading to the formation of eschars. The Primary Irritation Index was calculated to be 6.5. Hence the test material may be classified as irritant to the skin of rabbits.

Study no03:

An unfailing study, like OECD "Acute Dermal Irritation/Corrosion" was performed for the Read across of chemical N-(3-(trimethoxysilyl)propyl)ethylenediamine (CAS number: 1760-24-3)using rabbits. Application of 0.5 ml for 4 hours produced minor to moderate erythema on 6 of 6 rabbits, with minor edema on 4. Desquamation appeared on 3 animals within 3 to 7 days and remained on 2 after 10 days. No erythema or edema was evident at 10 days. Hence the RA chemical material can be classified as an irritant to the skin of rabbits

Eye Irritation:

Study no 01:

An unfailing study, like OECD "Acute Eye Irritation/Corrosion" was performed for the RA of chemical N-(3-(trimethoxysilyl)propyl)ethylenediamine (CAS number: 1760-24-3) using rabbits. The RA chemical was applied to all the animals at a dose of 0.1ml to the lower eyelid of the animal, one eye serves as a control and the other eye serves as a treatment. The lesions observed at 72 hours were still observed in 5 out of 6 rabbits examined on Day 21. The average  score of was found to be The average (24+48+72 hrs) was:
3.00 for chemosis to conjuntiva
2.50 for enanthema to the conjunctiva
1.00 for congestion to the iris
2.00 for opacity to the cornea

Hence the RA material was severely irritating to the eye of animals as per the GHS category the chemical belongs to the class Category 2( Irritating to eyes)

Study no02:
An unfailing study, like OECD "Acute Eye Irritation/Corrosion" was performed for the RA  chemical 3-aminopropyltriethoxysilane(CAS number: 919-30-2)using rabbits. The RA chemical was applied to all the animals at a dose of 0.1ml to the lower eyelid of the animal, one eye serves as a control and the other eye serves as treatment  Unwashed group: Corneal opacities were observed in two animals beginning at 48 hours and were observed in all animals on days 7-14. Corneal necrosis was observed for all animals at 24 hours to day 4 and persisted in three animals on days 13 and 14. Iritis, redness, and chemosis were observed in most or all animals by 24 hours and persisted in at least one animal by day 13. Blistering of the conjunctivae and/or nictitating membrane as well as discoloration of the nictitating membrane was observed for all animals at 24 and 48 hours.
Washed group: Corneal opacities were observed in one animal beginning at 48 hours, and for all animals from 72 hours until day 14. Corneal necrosis was observed for all animals at 24 hours to day 7 and persisted in two animals on days 8 to 10. Iritis, redness, and chemosis were observed in all animals by 24 to 48 hours and persisted in at least one animal by day 13. Blistering of the conjunctivae and/or nictitating membrane was observed for all animals at 24 and 48 hours. Discoloration of the nictitating membrane was observed in one animal at 24 and 48 hours. Hence the test material can be classified as irritating to the eye of the animals.

Study no03:

An unfailing study, like OECD "Acute Eye Irritation/Corrosion" was performed for the RA chemical N-(3-(trimethoxysilyl)propyl)ethylenediamine(CAS number: 1760-24-3)using rabbits. The RA chemical was applied to all the animals at a dose of 0.1ml to the lower eyelid of the animal, one eye serves as a control and the other eye serves as a treatment Unwashed group: Corneal opacities were observed in three animals on days 7 and 8, and four animals on days 9-14. Corneal necrosis was observed for all animals at 24 hours to day 10 and persisted in three animals on days 13 and 14. Iritis was observed for 2-3 animals from 24 hours until day 10. Redness, chemosis, and discharge were observed in all animals by 24 hours and persisted in at least two animals by day 14. Blistering of the conjunctivae was observed for the majority of the animals at 24 and 48 hours and persisted today 7 for some animals. Washed group: Corneal opacity was observed in one animal on days 9 to 14. Corneal necrosis was observed for all animals at 24 and 48 hours and persisted in two animals until study termination. Redness, chemosis, and discharge were observed in all animals by 24 hours and persisted in one animal by day 14. Blistering of the conjunctivae was observed in one animal at 24 and 48 hours. Hence the test material can be classified as irritating to the eye of animals as per the GHS category, the chemical may  belongs to the class Category 2( Irritating to eyes)

Justification for classification or non-classification

Skin Irritation:

Based on all the above-mentioned studies and data of RA substance the given test chemical can be classified as a skin irritant  class 1 category as per CLP regulation

Eye Irritant

 On the basis of all the above studies of the RA substance, The test material may classified as  irritating to the eye of animals as per GHS category the chemical belongs to the class Category 2( Irritating to eyes)