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EC number: - | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
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
- 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.
- 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.
Reference
Not specified
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- 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
- 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 corneaHence 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)
Reference
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
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)
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