[No public or meaningful name is available]

Endpoint summary

Description of key information

Acute Oral studies:
The Acute Oral toxicity of the chemical  LD50 value of the test chemical in Rats (Sprague-Dawley) was found to be 2400 mg/kg b w( 2413 mg/kg bw) as per EEC directive 91/325.

Acute Inhalation:
In a study, conducted in accordance with generally accepted scientific standards and probably according to GLP, male and female rats exposed to a 60% aqueous solution of the test substance achieved an LC50 of over 7.35 mg/l after four hours.

Acute Dermal:
The LD 50 value of chemical test 3-aminopropyltriethoxysilane in rabbits at a dose of 8.0mg /kg bw was found to be 4290 mg/kg bw(equivalent to 3800 mg/kg bw).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Remarks:

Read across data

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data is taken from a secondary source

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Acute oral toxicity study in rats

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Specific details on test material used for the study:

Not specified

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Rationale for alternative/additional species to rat (if applicable)
- Source: Lesser Ketones Manufacturing Association Leesburg, VA
- Females (if applicable) nulliparous and non-pregnant: [yes/no] No data available
- Rationale for use of males (if applicable) No data available
- Age at study initiation:e No data available
- Weight at study initiation: No data available
- Fasting period before study: No data available
- Housing:No data available
- Historical data:No data available
- Diet (e.g. ad libitum): No data available
- Water (e.g. ad libitum):No data available
- Acclimation period:No data available
- Microbiological status when knownNo data available
- Method of randomisation in assigning animals to test and control groups 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:

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

VEHICLE
- Concentration in vehicle: No data available
- Amount of vehicle (if gavage): No data available
- Justification for choice of vehicle: No data available
- Lot/batch no. (if required): No data available
- Purity: No data available
Doses per time period: One
Post dose observation period: 72 hours

MAXIMUM DOSE VOLUME APPLIED: No data available

DOSAGE PREPARATION (if unusual): No data available

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:

Doses:

0.84, 1.04, 1.35, 1.75, 2.28, 2.96, 3.85 ml/kg bw

No. of animals per sex per dose:

5animal /sex/dose

Control animals:

no

Details on study design:

Not specified

Statistics:

Not specified

Sex:

female

Dose descriptor:

LD50

Effect level:

1.68 mL/kg bw

Based on:

test mat.

95% CL:

>= 1.52 - <= 1.86

Remarks on result:

other: limited time to observe

Sex:

male

Dose descriptor:

LD50

Effect level:

2.25 mL/kg bw

Based on:

test mat.

95% CL:

>= 1.91 - <= 2.66

Remarks on result:

other: limited time to observe

Mortality:

In females LD 50 value found at 1.68ml/kg bw while in males the LD50 value was found to be 2.25ml/kg bw

Clinical signs:

other:

Body weight:

other body weight observations

Gross pathology:

Necropsy findings, including quantities, severity, and the number of animals affected, were as follows: It was noted that red-colored sores and apoplexy occurred in the gastric glandular, and the intestine wall began to discolor. Values [LD50 or LC50] with confidence limits when calculated: Males received 2.25 ml/kg body weight with 95% confidence limits and females received 1.68 ml/kg body weight with 95% confidence limits.

Interpretation of results:

other: Not Classified

Conclusions:

The oral LD50 values were identified as 2.25 ml/kg bw in males and 1.68 ml/kg bw in females according to a relatively limited citation of a study without guidelines or good laboratory practices compliance and observation apparently only for 72 hours.

Executive summary:

In accordance with guideline 401, a test of acute oral toxicity of 1,2-ethanediamine, N-[3-(trimethoxysilyl)propyl] (CAS number: 1760-24-3) was conducted using Rat of Wistar species at various dose levels 0.84, 1.04, 1.35, 1.75, 2.28, 2.96, 3.85 ml/kg bw.

The test sample was administered to all animals in five species/sex/doses. Clinical findings reviles sedation, diarrhea, and watery eyes were observed within the 2.96 and 3.85 ml/kg groups.

Necropsy findings, including quantities, severity, and therefore the number of animals affected, were as follows: It was noted that red-colored sores and apoplexy occurred within the gastric glandular, and therefore the intestine wall began to discolor. Values [LD50 or LC50] confidently limits when calculated: Males received 2.25 ml/kg weight with 95% confidence limits and females received 1.68 ml/kg weight with 95% confidence limits. No mortality was observed. 

The LD50 value of the test sample was 2.25 ml/kg bw for males and 1.68 ml/kg bw for females. Hence the test chemical cannot be classified according to CLP Criteria for classification.

Reference 2

Endpoint:

acute toxicity: oral

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 is taken from secondary source

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1966

Principles of method if other than guideline:

The study appears to be similar to the now deleted OECD TG 401, but the level of detail in the report is such that this cannot be confirmed.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Specific details on test material used for the study:

Not specified

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Rationale for alternative/additional species to rat (if applicable)
- Source: Epona Associates LLC
- Females (if applicable) nulliparous and non-pregnant: [yes/no]: No data avaiable
- Rationale for use of males (if applicable)
- Age at study initiation: 3-4 weeks
- Weight at study initiation: 90 - 120 grams
- Fasting period before study:not fasted prior to dosing
- Housing:No data avaiable
- Historical data:No data avaiable
- Diet (e.g. ad libitum): No data avaiable
- Water (e.g. ad libitum):No data avaiable
- Acclimation period:No data avaiable
- Microbiological status when knownNo data avaiable
- Method of randomisation in assigning animals to test and control groups : Rats were divided into 4 groups

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

IN-LIFE DATES: From: To:

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Not specified

Doses:

2.0, 4.0, 8.0 and 16.0 ml/kg

No. of animals per sex per dose:

5animal/sex/dose

Control animals:

no

Details on study design:

Not specified

Statistics:

Not specified

Preliminary study:

Not specified

Sex:

male

Dose descriptor:

LD50

Effect level:

7.46 mL/kg bw

Based on:

test mat.

95% CL:

>= 5.15 - <= 5.15

Remarks on result:

other: LD50 was found to be 7.46 ml/kg bw

Mortality:

Mortality was observed at dose range of 7.46ml/kg bw

Clinical signs:

other:

Body weight:

other body weight observations

Remarks:

All surviving animals gained weight

Gross pathology:

Observations included congestion throughout the lungs and therefore the abdominal viscera with some hemorrhage present within the intestines. The surface of the livers, stomachs and intestines were whitish in appearance.

Table 1 Summary of mortality data

Dose (ml/kg)	Dead/total	Days to death	Weight Change
16.0	5/5	0	NA
8.0	3/5	2	The surviving two animals gained weight
4.0	0/5	-	All animals gained weight
2.0	0/5	-	All animals gained weight

Interpretation of results:

other: Not classified

Conclusions:

The LD50 for N-(3-(trimethoxysilyl)propyl)ethylenediamine (CAS 1760-24-3) in a short-term acute oral toxicity study, which resembled the now deleted OECD 401 but was conducted without GLP, was 7.46 ml/kg bw in male rats.

Executive summary:

In accordance with guideline 401, a RA substance of acute oral toxicity of 1,2-ethanediamine, N-[3-(trimethoxysilyl)propyl](CAS 1760-24-3) was conducted using Rat of Wistar species at various dose levels 2.0, 4.0, 8.0 and 16.0 ml/kg

The test sample was administered to all animals in five species/sex/doses. body weight of all the  survived was increased 

Necropsy findings, including congestion throughout the lungs and therefore the abdominal viscera with some hemorrhage present within the intestines. The surface of the livers, stomachs, and intestines were whitish in appearance.
The LD50 value of the test sample was 7.46ml/kg. Hence the test chemical cannot be classifed according to CLP Criteria for classification.

Reference 3

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Remarks:

Read across Data

Adequacy of study:

supporting study

Study period:

Not specified

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data is taken from a secondary source

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1992

Principles of method if other than guideline:

Acute oral toxicity study was carried out using rat for the given chemical

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Specific details on test material used for the study:

Not specified

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Rationale for alternative/additional species to rat (if applicable)
- Source: Wacker
- Females (if applicable) nulliparous and non-pregnant: [yes/no] No data avaiable
- Rationale for use of males (if applicable) No data avaiable
- Age at study initiation: No data avaiable
- Weight at study initiation: No data avaiable
- Fasting period before study: No data avaiable
- Housing: No data avaiable
- Historical data: No data avaiable
- Diet (e.g. ad libitum): No data avaiable
- Water (e.g. ad libitum): No data avaiable
- Acclimation period: No data avaiable
- Microbiological status when known No data avaiable
- Method of randomisation in assigning animals to test and control groups No data avaiable

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

IN-LIFE DATES: From: To:

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Doses per time period: 1

Doses:

0, 2009, 2519, 3162 mg/kg bw

No. of animals per sex per dose:

5 animal/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: Fifteen minutes after dosing, at 1, 2, 4 hours post-dosing, daily for 14 days.
- Frequency of observations and weighing: once daily
- Necropsy of survivors performed: yes
- Clinical signs including body weight no data avaiable
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: no data avaiable

Statistics:

no data avaiable

Preliminary study:

Not specified

Sex:

female

Dose descriptor:

LD50

Effect level:

2 451 mg/kg bw

Based on:

test mat.

95% CL:

>= 2 154 - <= 2 702

Remarks on result:

other: LD50 was observed at 2451mg/kg bw

Sex:

male

Dose descriptor:

LD50

Effect level:

2 400 mg/kg bw

Based on:

test mat.

95% CL:

>= 2 154 - <= 2 702

Remarks on result:

other: 2413 mg/kg (2154-2702 mg/kg) by Bliss' method; 2451 mg/kg (2147 - 2798 mg/kg) by Litchfield & Wilcoxon's method

Mortality:

Mortality: No deaths were observed among the control animals. One male animal died on Day 2 in the 2009 mg/kg dose group. Three males died on Day 2 and an additional male died on Day 4 in the 2519 mg/kg dose group, while one female died on Day 1 and three females died on Day 2. Three males and one female died on Day 1 in the 3162 mg/kg dose group, with three additional males and three females dying on Day 2.

Clinical signs:

other:

Body weight:

other body weight observations

Remarks:

Mean body weight gains for males for the period from Day 1 to Day 15 were 11.6 and 118.75 g for 0mg/kg and 2009mg/kg for females' body weight gains for females for the period from Day 1 to Day 15 were 55.8 and 45.6 g or 0mg/kg and 2009mg/kg

Gross pathology:

Gross Necropsy findings, included doses affected, severity and number of animals affected: changes were noted as follows: red colored sores and apoplexy in the glandulae gastricae, and discoloration in the wall of the intestine.

Mean body weight (g):
Males:

	Day1	Day 1	Day 8	Day 15
Group 1(0 mg/kg)	183.4	171.4 2	244.2	295
Group 2(2009 mg/kg)	183.6	174	242.25	303.25
Group 3(2519 mg/kg)	186.2	163.6	-	-
Group 4(3162 mg/kg)	186	171.4	-	-

Females:

	Day1	Day 1	Day 8	Day 15
Group 1(0 mg/kg)	176.2	162.8	210	232
Group 2(2009 mg/kg)	175.8	162.6	198	221.4
Group 3(2519 mg/kg)	177.2	162.6	-	–
Group 4(3162 mg/kg)	176.8	165.8	–	-

Interpretation of results:

other: Not Classified

Conclusions:

The Oral LD50 value of the test chemical in Rats (Sprague-Dawley) were found to be 2400 mg/kg b w( 2413 mg/kg bw).

Executive summary:

In accordance with guideline 401, a test of acute oral toxicity of 1,2-ethanediamine, N-[3-(trimethoxysilyl)propyl](CAS number:1760-24-3)was conducted using Rat of Sprague Dawley species at various dose levels 0, 2009, 2519, 3162 mg/kg bw ml/kg bw.

The test sample was administered to all animals in five species/sex/doses.No deaths were observed among the control animals. One male animal died on Day 2 in the 2009 mg/kg dose group. Three males died on Day 2 and an additional male died on Day 4 in the 2519 mg/kg dose group, while one female died on Day 1 and three females died on Day 2. Three males and one female died on Day 1 in the 3162 mg/kg dose group, with three additional males and three females dying on Day 2.
Clinical findings include the severity, time of onset, and duration of clinical signs at each dose level:
In 2009 mg/kg subdued behavior was noted in all animals at 4 hours. Surviving animals were normal on Day 2:At 2519 mg/kg subdued behavior was noted on Day 1. In some cases, calm demeanor, tremors, and diarrhea were reported between Days 2 and 4. All surviving animals were normal by
Day 4: At 3162 mg/kg All animals showed subdued behavior on Day 1. All surviving animals were normal on Day 2
Gross Necropsy findings, included doses affected, severity and number of animals affected: changes were noted as follows: red-colored sores and apoplexy in the glandulae gastricae, and discoloration in the wall of the intestine. Mean body weight gains for males for the period from Day 1 to Day 15 were 11.6 and 118.75 g for 0mg/kg and 2009mg/kg for females, the body weight gains for the period from Day 1 to Day 15 were 55.8 and 45.6 g or 0mg/kg and 2009mg/kg.

The LD50 value of the test sample was 2413mg/kg bw. Hence the test chemical cannot be classified according to CLP Criteria for classification.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 413 mg/kg bw

Quality of whole database:

The data supports to K4

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

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 is taken from a secondary source

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Version / remarks:

1983

Principles of method if other than guideline:

Acute inhalation of the given test sample was studies in Rats to determine LC50 value

GLP compliance:

not specified

Test type:

other: Standard acute method

Limit test:

no

Specific details on test material used for the study:

Not specified

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Rationale for alternative/additional species to rat (if applicable) No data Avaiable
- Source: Epona Associates, LLC
- Females (if applicable) nulliparous and non-pregnant: [yes/no] No data Avaiable
- Rationale for use of males (if applicable) No data avaiable
- Age at study initiation: Approximately 9 weeks old
- Weight at study initiation: No data avaiable
- Fasting period before study: No data avaiable
- Housing:No data avaiable
- Historical data:No data avaiable
- Diet (e.g. ad libitum): No data avaiable
- Water (e.g. ad libitum): Distill water
- Acclimation period: No data avaiable
- Microbiological status when known No data avaiable
- Method of randomisation in assigning animals to test and control groups No data avaiable

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

IN-LIFE DATES: From: To:

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

whole body

Vehicle:

not specified

Mass median aerodynamic diameter (MMAD):

1.6 µm

Geometric standard deviation (GSD):

2.19

Remark on MMAD/GSD:

Saturated vapors

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Solo-Sphere® nebulizer
- Exposure chamber volume: 120-liter exposure chamber
- Method of holding animals in test chamber: No data avaiable
- Source and rate of air (airflow): No data avaiable
- Method of conditioning air:No data avaiable
- System of generating particulates/aerosols: No data avaiable
- Method of particle size determination: No data avaiable
- Treatment of exhaust air: No data avaiable
- Temperature, humidity, pressure in air chamber: No data avaiable

TEST ATMOSPHERE
- Brief description of analytical method and equipment used: gas chromatographic analysis.
- Samples taken from breathing zone: No data avaiable
- Time needed for equilibrium of exposure concentration before animal exposure No data avaiable

VEHICLE
- Composition of vehicle (if applicable): No data avaiable
- Concentration of test material in vehicle (if applicable): No data avaiable
- Justification of choice of vehicle: No data avaiable
- Lot/batch no. (if required): No data avaiable
- Purity: No data avaiable

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: particle size distribution for the test material was determined with a cascade impactor
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): MMAD : 1.6 micrometers with a geometric standard deviation of 2.19

CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration:

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

4 h

Remarks on duration:

Not specified

Concentrations:

Not specified

No. of animals per sex per dose:

5animals /sex/ dose

Control animals:

not specified

Details on study design:

Not Specified

Statistics:

standard deviation

Sex:

male/female

Dose descriptor:

LC50

Effect level:

7.35 mg/L air

Based on:

test mat.

95% CL:

>= 6.65 - <= 9.52

Exp. duration:

4 h

Remarks on result:

other: SD 0.92

Mortality:

LC50 was note at 7.35mg/L

Clinical signs:

other: During exposure, a dense fog was present within the animal chamber, preventing observation of the test animals. After exposure, slow righting reflex, labored breathing, hypoactivity, ataxia and discharge from the mouth, nose, and eyes were apparent.

Body weight:

All animal gain weight during study

Gross pathology:

Necropsy findings, included doses affected, severity and number of animals affected: No remarkable gross pathologic findings were seen.

Sex	Analytical Conc. (mg/l)	Mortality (No./total)	Mean body weight change (g) 0-7 days	Mean body weight change (g) 0-14 days	Overt toxicity	Number with remarkable gross pathology
males	7.35 (6.65-9.52)	0/5	12 (8-17)	28 (24-30)	On completion of exposure: slow righting reflex, labored breathing, hypoactivity, ataxia. Red encrustation around nose, mouth, or eyes that remained for 1 or 2 days. No abnormalities were detected on day 3.	0/5
females	7.35 (6.65-9.52)	0/5	2 (2-8)	9 (5-12)	On completion of exposure: slow righting reflex, labored breathing, hypoactivity, ataxia. Red encrustation around nose, mouth,or eyes that remained for 1 or 2 days. No abnormalities were detected on day 3.	0/5

Table 1: Concentrations, mortality or evident toxicity

LC50 (males and females): > 7.35 mg/l (mean concentration)

Mean ethanol concentration was 3253 (standard deviation of 1621) ppm (equivalent to around 6.1 mg/l)

Interpretation of results:

other: Not Classified

Conclusions:

In a study, conducted in accordance with generally accepted scientific standards and probably according to GLP, male and female rats exposed to a 60% aqueous solution of the test substance achieved an LC50 of over 7.35 mg/l after four hours.

Executive summary:

The Read across sample was administered to all animals in five species/sex/doses. The body weight of all the surviving animals was found to be increased. On completion of exposure: slow righting reflex, labored breathing, hypoactivity, ataxia. Red encrustation around nose, mouth, or eyes that remained for 1 or 2 days. No abnormalities were detected on day 3. Necropsy findings, including doses affected, severity, and a number of animals affected: No remarkable gross pathologic findings were seen. Five rats were exposed for four hours to 7.35 mg/l of a 60% of test solution. The animals were observed during the subsequent 14-day post-exposure period. After exposure, slow righting reflex labored breathing, hypoactivity, ataxia, and discharge from the mouth, nose, and eyes were apparent. At 3 days, the animals were fully recovered Hence the test chemical cannot be classified according to CLP Criteria for classification.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

7.35 mg/L air

Physical form:

inhalation: aerosol

Quality of whole database:

The data supports to K4

Acute toxicity: via dermal route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Remarks:

Read across data

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data is taken from a secondary source

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1966

Principles of method if other than guideline:

The study appears to be similar to OECD TG 402, but the level of detail in the report is such that this cannot be confirmed.

GLP compliance:

not specified

Test type:

standard acute method

Specific details on test material used for the study:

Not specified

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Rationale for alternative/additional species to rat (if applicable) No data Avaiable
- Source: Epona Associates, LLC
- Females (if applicable) nulliparous and non-pregnant: [yes/no] No data Avaiable
- Rationale for use of males (if applicable) No data Avaiable
- Age at study initiation: three to five months
- Weight at study initiation: No data Avaiable
- Fasting period before study: No data Avaiable
- Housing: No data Avaiable
- Historical data: No data Avaiable
- Diet (e.g. ad libitum): No data Avaiable
- Water (e.g. ad libitum): No data Avaiable
- Acclimation period: No data Avaiable
- Microbiological status when known No data Avaiable
- Method of randomisation in assigning animals to test and control groups No data Avaiable

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

IN-LIFE DATES: From: To:

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure:
- % coverage:
- Type of wrap if used: polyethylene sheeting

REMOVAL OF TEST SUBSTANCE
- Washing (if done): done
- Time after start of exposure: 24 hrs

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 16.0 (2 animals) or 8.0 (4 animals) ml/kg
- Concentration (if solution): No data avaiable
- Constant volume or concentration used: yes/no No data avaiable
- For solids, paste formed: yes/no

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

Duration of exposure:

24 hours

Doses:

16 and 8 ml/kg bw

No. of animals per sex per dose:

8 ml/kg: 4
16 ml/kg: 2

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days (or other?) 14 days
- Frequency of observations and weighing: No data avaiable
- Necropsy of survivors performed: yes
- Clinical signs including body weight No data avaiable
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Statistics:

average method based

Sex:

male

Dose descriptor:

LD50

Effect level:

16 mL/kg bw

Based on:

test mat.

95% CL:

>= 8 - <= 16

Remarks on result:

other: Effective level was found to be 16 ml/kg bw

Mortality:

THe LD50 was found to be 16mL/kg bw

Clinical signs:

other:

Body weight:

other body weight observations

Remarks:

The surviving animal dosed at 16.0 mg/kg and three of the four animals dosed at 8.0 mg/kg gained weight during the study

Gross pathology:

Gross Pathology observations included congested lungs, liver and spleen, and pale kidneys

Other findings:

Not specified

Table No 1 Mortality Rate

Dose (ml/kg)	Death	Days to Death
16	1/2	7
8	0/4	Not applicable

Interpretation of results:

other: Not Classified

Conclusions:

The LD50 for N-(3-(trimethoxysilyl)propyl)ethylenediamine ( CAS number: 1760-24-3) was at least 16.0 ml/kg body weight in male rabbits in an acute dermal toxicity study reported as a summary, but similar to OECD 402 (not GLP, reliability score 4).

Executive summary:

In accordance with guideline 402, an acute dermal toxicity of 1,2-ethanediamine, N-[3-(trimethoxysilyl)propyl] (CAS number: 1760-24-3)was conducted using Rabbit New Zealand species at dose levels 16 and 8 ml/kg bw.

The RA sample was applied to all animals in groups 16ml/kg bw (2 animals) and 8 ml/kg bw (4 animals ) mortality was noted one out of two animals was found to be dead on 7th day of observation at a dose range of 16ml/kg bw, while all the 4 animals were survived at a dose range of 8 ml/kg bw

Necropsy findings, including Gross Pathology observations, included congested lungs, liver and spleen, and pale kidneys

The LD50 value of the test sample was 16.0 ml/kg bw for animals. Hence the test chemical cannot be classified according to CLP criteria.

Reference 2

Endpoint:

acute toxicity: dermal

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 is taken from a secondary source

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Principles of method if other than guideline:

Acute dermal study of test chemical in Rabbit
There are many similarities between this study and OECD 402, including observations for 14 days. However, the group numbers and doses tested are lower than recommended, and the exposure is occluded rather than semi-occluded. No details are given on the purity of the test substance.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Specific details on test material used for the study:

Not specified

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Rationale for alternative/additional species to rat (if applicable) No data avaiable
- Source: Epona Associates, LLC
- Females (if applicable) nulliparous and non-pregnant: [yes/no] No data avaiable
- Rationale for use of males (if applicable) No data avaiable
- Age at study initiation: No data avaiable
- Weight at study initiation: No data avaiable
- Fasting period before study: No data avaiable
- Housing: No data avaiable
- Historical data: No data avaiable
- Diet (e.g. ad libitum): No data avaiable
- Water (e.g. ad libitum): No data avaiable
- Acclimation period: No data avaiable
- Microbiological status when known No data avaiable
- Method of randomisation in assigning animals to test and control groups No data avaiable

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

IN-LIFE DATES: From: To:

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Not specified

Duration of exposure:

24hrs

Doses:

1.0,2.0,4.0, and 8.0 ml/kg bw

No. of animals per sex per dose:

5 animal/sex/dose

Control animals:

no

Details on study design:

Not specified

Statistics:

Not specified

Sex:

male/female

Dose descriptor:

LD50

Effect level:

4 290 mL/kg bw

Based on:

test mat.

95% CL:

>= 2 900 - <= 6 340

Remarks on result:

other: Equivalent to 3800 mg/kg bw.

Mortality:

LD50 was noted at 4290ml/kg bw

Clinical signs:

other:

Gross pathology:

Necrosis finding includies doses affected, severity, and a number of animals affected: gross pathologic findings included discolored lungs (red, pink, or mottled), lungs with red foci (in one), mottled tan livers, stomachs with dark areas of hemorrhages, stomachs with black foci (in one), tan or hemorrhaged kidneys, ureters and urethra with hemorrhages (in one), bladders filled with red liquid (1 with a dark red clot) and the untreated skin of 2 animals stained red.

Interpretation of results:

other: Not Classified

Conclusions:

The LD 50 value of test chemical 3-aminopropyltriethoxysilane (CAS number: 919-30-2) in rabbits at a dose of 8.0mg /kg bw was found to be 4290 mg/kg bw(equivalent to 3800 mg/kg bw).

Executive summary:

In accordance with guideline 402, a test of acute dermal toxicity of 3-aminopropyltriethoxysilane(CAS number: 919-30-2) was conducted using Rabbit New Zealand species at dose levels 1.0,2.0,4.0 and 8.0 ml/kg bw.

The RA sample was applied to all animals in groups mortality was noted at days to death for the five male animals in the 8 g/kg group were 1,1,1,2,2. All other deaths occurred more than 24 hours after dosing. Clinical findings state that Local cutaneous effects included erythema, edema, ecchymosis, necrosis, desquamation, fissuring, ulceration, alopecia, and scabs. Blood in several animals is apparent in rectal and urogenital areas (especially at 4 g/kg). Hemorrhaging under the skin is evident at 4 g/kg. Other signs of toxicity included sluggishness, salivation (in one), unsteady gait (in 2), prostration, and diarrhea (in one). Survivors recovered in 2 to 4 days.
Necropsy findings, including doses affected, severity, and the number of animals affected: gross pathologic findings included discolored lungs (red, pink, or mottled), lungs with red foci (in one), mottled tan livers, stomachs with dark areas of hemorrhages, stomachs with black foci (in one), tan or hemorrhaged kidneys, ureters and urethra with hemorrhages (in one), bladders filled with red liquid (1 with a dark red clot) and the untreated skin of 2 animals
The LD50 value of the test sample was found to be 4 mg/kg bw for animals. Hence the test chemical belongs to the unclassified category.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

4 290 mg/kg bw

Quality of whole database:

The data supports to K4

Additional information

Acute Oral Studies:
Study no:1
In accordance with guideline 401, a test of acute oral toxicity of 1,2-ethanediamine, N-[3-(trimethoxysilyl)propyl](CAS 1760-24-3) was conducted using Rat of Wistar species at various dose levels 2.0, 4.0, 8.0 and 16.0 ml/kg. The test sample was administered to all animals in five species/sex/doses. body weight of all the survived was increased Necropsy findings include congestion throughout the lungs and therefore the abdominal viscera with some hemorrhage present within the intestines. The surface of the livers, stomachs, and intestines was whitish in appearance.
The LD50 value of the test sample was 7.46ml/kg. Hence the test chemical cannot be classified according to CLP criteria.
Study No:2

In accordance with guideline 401, a test of acute oral toxicity of 1,2-ethanediamine, N-[3-(trimethoxysilyl)propyl](CAS number:1760-24-3)was conducted using Rat of Sprague Dawley species at various dose levels 0, 2009, 2519, 3162 mg/kg bw ml/kg bw.The test sample was administered to all animals in five species/sex/doses.No deaths were observed among the control animals. One male animal died on Day 2 in the 2009 mg/kg dose group. Three males died on Day 2 and an additional male died on Day 4 in the 2519 mg/kg dose group, while one female died on Day 1 and three females died on Day 2. Three males and one female died on Day 1 in the 3162 mg/kg dose group, with three additional males and three females dying on Day 2.
Clinical findings include the severity, time of onset, and duration of clinical signs at each dose level: In 2009 mg/kg subdued behavior was noted in all animals at 4 hours. Surviving animals were normal on Day 2:At 2519 mg/kg subdued behavior was noted on Day 1. In some cases, calm demeanor, tremors, and diarrhea were reported between Days 2 and 4. All surviving animals were normal by Day 4: At 3162 mg/kg, All animals showed subdued behavior on Day 1. All surviving animals were normal on Day 2 Gross Necropsy findings, included doses affected, severity, and the number of animals affected: changes were noted as follows: red-colored sores and apoplexy in the glandulae gastricae, and discoloration in the wall of the intestine. Mean body weight gains for males for the period from Day 1 to Day 15 were 11.6 and 118.75 g for 0mg/kg and 2009mg/kg for females, the body weight gains for the period from Day 1 to Day 15 were 55.8 and 45.6 g or 0mg/kg and 2009mg/kg. The LD50 value of the test sample was 2413mg/kg bw. Hence the test chemical cannot be classified according to CLP criteria.
Study No:3
In accordance with guideline 401, a test of acute oral toxicity of 1,2-ethanediamine, N-[3-(trimethoxysilyl)propyl] (CAS number: 1760-24-3) was conducted using Rat of Wistar species at various dose levels 0.84, 1.04, 1.35, 1.75, 2.28, 2.96, 3.85 ml/kg bw. The test sample was administered to all animals in five species/sex/doses. Clinical findings reveal sedation, diarrhea, and watery eyes were observed within the 2.96 and 3.85 ml/kg groups. Necropsy findings, including quantities, severity, and therefore the number of animals affected, were as follows: It was noted that red-colored sores and apoplexy occurred within the gastric glandular, and consequently, the intestine wall began to discolor. Values [LD50 or LC50] confidently limits when calculated: Males received 2.25 ml/kg weight with 95% confidence limits and females received 1.68 ml/kg weight with 95% confidence limits. No mortality was observed.  The LD50 value of the test sample was 2.25 ml/kg bw for males and 1.68 ml/kg bw for females. Hence the test chemical cannot be classified according to CLP criteria.
Acute Inhalation Studies:

Study no 1:

The Read across sample was administered to all animals in five species/sex/doses. The body weight of all the surviving animals was found to be increased. On completion of exposure: slow righting reflex, labored breathing, hypoactivity, ataxia. Red encrustation around nose, mouth, or eyes that remained for 1 or 2 days. No abnormalities were detected on day 3. Necropsy findings, including doses affected, severity, and a number of animals affected: No remarkable gross pathologic findings were seen. Five rats were exposed for four hours to 7.35 mg/l of a 60% of test solution. The animals were observed during the subsequent 14-day post-exposure period. After exposure, slow righting reflex labored breathing, hypoactivity, ataxia, and discharge from the mouth, nose, and eyes were apparent. At 3 days, the animals were fully recovered Hence the test chemical cannot be classified according to CLP Criteria for classification.

Study no 2

An acute inhalation study was carried out using 3- aminopropyltriethoxysilane (CAS no:919-30-2) using Sprague-Dawley rat species.The test sample was given in a dose range of 5 or 16ppm for 6hrs duration by inhalation route for whole-body exposure. During the whole study exposure to a statically generated, substantially saturated vapor produced no deaths of male or female rats during or following the 6-hour test. Clinical signs of Hypoactivity, ataxia, and an alteration of the righting reflex were evident during or following exposure. On the basis, of the whole study the given RA chemical was found to be unclassified as per CLP guidelines.

Acute Dermal Studies:
Study No01:
In accordance with guideline 402, a test of acute dermal toxicity of 3-aminopropyltriethoxysilane(CAS number: 919-30-2) was conducted using Rabbit New Zealand species at dose levels 1.0,2.0,4.0 and 8.0 ml/kg bw. The RA sample was applied to all animals in groups mortality was noted at days to death for the five male animals in the 8 g/kg group were 1,1,1,2,2. All other deaths occurred more than 24 hours after dosing. Clinical findings state that Local cutaneous effects included erythema, edema, ecchymosis, necrosis, desquamation, fissuring, ulceration, alopecia, and scabs. Blood in several animals is apparent in rectal and urogenital areas (especially at 4 g/kg). Hemorrhaging under the skin is evident at 4 g/kg. Other signs of toxicity included sluggishness, salivation (in one), unsteady gait (in 2), prostration, and diarrhea (in one). Survivors recovered in 2 to 4 days. Necropsy findings, including doses affected, severity, and the number of animals affected: gross pathologic findings included discolored lungs (red, pink, or mottled), lungs with red foci (in one), mottled tan livers, stomachs with dark areas of hemorrhages, stomachs with black foci (in one), tan or hemorrhaged kidneys, ureters and urethra with hemorrhages (in one), bladders filled with red liquid (1 with a dark red clot) and the untreated skin of 2 animals. The LD50 value of the RA chemical was found to be 4 mg/kg bw for animals. Hence the test chemical belongs to the unclassified category.

Study No02:

In accordance with guideline 402, a test of acute dermal toxicity of 1,2-ethanediamine, N-[3-(trimethoxysilyl)propyl] (CAS number: 1760-24-3)was conducted using Rabbit New Zealand species at dose levels 16 and 8 ml/kg bw. The RA sample was applied to all animals in groups 16ml/kg bw (2 animals) and 8 ml/kg bw (4 animals ) mortality was noted one out of two animals was found to be dead on the 7th day of observation at a dose range of 16ml/kg bw, while all the 4 animals were survived at a dose range of 8 ml/kg bw. Necropsy findings, including Gross Pathology observations, included congested lungs, liver and spleen, and pale kidneys. The LD50 value of the test sample was 16.0 ml/kg bw for animals. Hence the test chemical cannot be classified according to CLP criteria.

 

 

Justification for classification or non-classification

Based on the above studies and the weight of the evidence data the test chemical can belong to the not classified category as per CLP category for acute oral, acute dermal, and acute inhalation studies