Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 225-806-1 | CAS number: 5089-72-5
- 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 (OECD 404): irritating
Eye irritation (OECD 405): corrosive
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to an appropriate OECD test guideline, and in compliance with GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Freie und Hansestadt Hamburg, Behörde für Arbeit, Gesundheit uns Soziales, Hamburg, Germany
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: LPT, Laboratory of Pharmacology and Toxicology KG, Loehndorf, Germany
- Age at study initiation: approximately 4 months
- Weight at study initiation: 1.9 kg
- Fasting period before study: no
- Housing: Single housing before and after the exposure period. During exposure the animals were kept singly in restrainers, which allowed free movement of the head but prevented a complete body turn.
- Diet: ssniff K-H (ssniff Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 55± 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 17 June 2002 To: 22 Aug 2002 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin site served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 days; reading time points: 1, 24, 48, and 72 h after patch removal
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: approximately 6 cm²
- Type of wrap if used: Test site covered with a gauze patch, which was held in contact to the skin by means of a semi-occlusive dressing (non-irritating tape).
REMOVAL OF TEST SUBSTANCE
No residual test substance had to be removed.
SCORING SYSTEM: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- Erythema grade 1 (2/3 animals) and 2 (1/3 animals) were observed 60 min after patch removal. Very slight oedema reactions (grade 1) were observed in all 3 animals 60 min after removal of the patch but were fully reversible within 24 h (2/3) and 72 h (1/3), respectively. Skin induration was observed in all 3 animals from day 4 until the end of the study. A dark brown discoloured application area was observed in one animal from 4 days to the end of the study. Peeling of the application site was observed in 3/3 animals after 9 days and persisted until the end of the study. Laceration of skin induration was observed in 1/3 animals at day 6, 7, and 9.
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- A reliable study performed in accordance with OECD 404 and GLP found the test material to be irritating to the skin of rabbits. Erythema grade 1 (2/3 animals) and 2 (1/3 animals) were observed 60 min after patch removal. Very slight oedema reactions (grade 1) were observed in all 3 animals 60 min after removal of the patch but were fully reversible within 24 h (2/3) and 72 h (1/3), respectively. Skin induration was observed in all 3 animals from day 4 until the end of the study. A dark brown discoloured application area was observed in one animal from 4 days to the end of the study. Peeling of the application site was observed in 3/3 animals after 9 days and persisted until the end of the study. Laceration of skin induration was observed in 1/3 animals at day 6, 7, and 9. No systemic effects were reported.
Reference
Table 1: Individual results of the skin irritation test.
Rabbit No. |
1 |
2 |
3 |
|||
Observation time |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
1 h |
2 |
1 |
1 |
1 |
1 |
1 |
24 h |
2 |
1 |
1 |
0 |
1 |
0 |
48 h |
2 |
1 |
1 |
0 |
1 |
0 |
72 h |
2 |
0 |
1 |
0 |
1 |
0 |
14 d |
2 a,b,c |
0 |
1 a,c |
0 |
1 a,c |
0 |
Mean value |
2 |
0.66 |
1 |
0 |
1 |
0 |
24 + 48 + 72 h |
a: skin induration
b: application site dark brown discoloured
c: peeling of the application site
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
- Adequacy of study:
- key study
- Study period:
- 10 May - 4 July 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to an appropriate OECD test guideline, and in compliance with GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (adopted 1987)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Freie und Hansestadt Hamburg, Behörde für Arbeit, Gesundheit uns Soziales, Hamburg, Germany
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: LPT, Laboratory of Pharmacology and Toxicology KG, Loehndorf, Germany
- Age at study initiation: approximately 4 months
- Weight at study initiation: 2.1 kg
- Fasting period before study: no
- Housing: Single housing before and after the exposure period. For 8 h following the test substance application the animals were kept singly in restrainers, which allowed free movement of the head but prevented a complete body turn, wiping of the eyes with the paws and excluded irritation of the eye by excrements and urine.
- Diet: ssniff K-H (ssniff Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 55± 15
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated left eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- single application without rinsing
- Observation period (in vivo):
- 21 days; reading time points: 1, 24, 48, and 72 h after administration
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein
The test substance was placed in the conjunctival sac of the right eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second in order to prevent loss of the material. The eyes were examined ophthalmoscopically with a slit lamp prior to the administration and 1, 24, 48, and 72 hours after the administration. 24 h after administration the eyes were treated additionally with fluorescein and examined. - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.66
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 9 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 9 days
- Irritation parameter:
- iris score
- Basis:
- other: mean out of all animals
- Time point:
- 24/48/72 h
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Evaluation not possible (no justification given in the study report).
- Irritation parameter:
- chemosis score
- Basis:
- other: mean out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritant / corrosive response data:
- Corneal opacity was observed at 1 h in all 3 animals (grade 1: 2/3; grade 2: 1/3). Opacity increased after 24 and 48 h (grade 3: 2/3; grade 2: 1/3). From 72 h until 21 days opacity (grade 2) was observed in all animals. Iris evaluation was not possible at 24 and 48 h in all animals. At 72 h iris scores of 1 and 2 were observed in one animal each (no evaluation possible in the third animal). From day 4 until day 21 the iris scores persisted (grade 1) in all animals. Redness was observed after 1 h and was fully reversible within 8 and 9 days, respectively. Chemosis was observed after 1 h (grade 3) and was fully reversible within 6 days. In addition, hair loss around the eyes was observed in 2 animals from 24 h until day 11 and in one animal from 48 h until day 12. White deposits, (probably pus) in the conjunctival sac were observed in 2/3 animals 72 h to 6 days after instillation, and in 1/3 animals from 24 h to 8 days after instillation. Enlargement of the bulbus due to accumulation of fluid below the cornea was noted in 2/3 animals from day 8 to 21 and in 1/3 animals from day 7 to 21. 1/3 animals showed oedematous cornea 14 to 17 days after instillation.
- Other effects:
- No systemic intolerance reactions were observed.
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- A reliable study performed in accordance with OECD 405 and GLP found the test material to be corrosive to the eye of rabbits. Mean values (over 24, 48, 72 h) for cornea score were 2, 2.66, and 2.66 in animal 1, 2, and 3, respectively. Mean values for redness (over 24, 48, 72 h) was 1 in all animals. Mean values (over 24, 48, 72 h) for chemosis score were 1.33 in all animals. Iris evaluation was not possible up to 48 in all animals. Effects on cornea (grade 2) and iris (grade 1) were not reversible within 21 days.
Reference
Table 1: Individual results of the eye irritation study in rabbits.
Rabbit # |
Time |
Conjunctivae |
Iris |
Cornea |
|
Redness |
Swelling |
||||
1 |
1 h |
0 |
3 |
0 |
1 |
24 h |
1 |
2 |
- |
2 |
|
48 h |
1 |
1 |
- |
2 |
|
72 h |
1 |
1 |
- |
2 |
|
21 days |
0 |
0 |
1 |
2 |
|
mean (24, 48, 72 h) |
1 |
1.33 |
|
2 |
|
2 |
1 h |
0 |
3 |
0 |
1 |
24 h |
1 |
2 |
- |
3 |
|
48 h |
1 |
1 |
- |
3 |
|
72 h |
1 |
1 |
1 |
2 |
|
21 days |
0 |
0 |
1 |
2 |
|
mean (24, 48, 72 h) |
1 |
1.33 |
|
2.66 |
|
3 |
1 h |
0 |
3 |
0 |
2 |
24 h |
1 |
2 |
- |
3 |
|
48 h |
1 |
1 |
- |
3 |
|
72 h |
1 |
1 |
2 |
2 |
|
21 days |
0 |
0 |
0 |
2 |
|
mean (24, 48, 72 h) |
1 |
1.33 |
|
2.66 |
-: no evaluation possible (no justification given in the study report)
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A skin irritation test is available with N-[3-(triethoxysilyl)propyl]ethylenediamine (CAS 5089-72-5), which was performed in Himalayan rabbits according to OECD 404 and in compliance with GLP (LPT, 2002a). Pure test substance (0.5 ml) was applied to a 6 cm² application site (shaved) for 4 h under semi-occlusive conditions. No residual test substance had to be removed. Sixty minutes and 24, 48, 72 h after patch removal the application site was examined. Erythema grade 1 (2/3 animals) and 2 (1/3 animals) were observed 60 min after patch removal. Very slight edema reactions (grade 1) were observed in all 3 animals 60 min after removal of the patch but were fully reversible within 24 h (2/3) and 72 h (1/3), respectively. Skin induration was observed in all 3 animals from day 4 until the end of the study. A dark brown discoloured application area was observed in one animal from 4 days to the end of the study. Peeling of the application site was observed in 3/3 animals after 9 days and persisted until the end of the study. Laceration of skin induration was observed in 1/3 animals at day 6, 7, and 9. No systemic effects were reported. In summary, the mean erythema scores over 24, 48, and 72 h were 2, 1, and 1 for animals #1 -3, and the mean edema scores over 24, 48, and 72 h were 0.66, 0, and 0 for animals #1 -3, respectively. Thus, N-[3-(triethoxysilyl)propyl]ethylenediamine is concluded to be irritating to the skin under the conditions of the test.
Eye irritation
An eye irritation test is available with N-[3-(triethoxysilyl)propyl]ethylenediamine (CAS 5089-72-5), which was performed in Himalayan rabbits according to OECD 405 and in compliance with GLP (LPT, 2002b). Pure test substance (0.1 ml) was placed in the conjunctival sac of the right eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second in order to prevent loss of the material. The eyes were examined ophthalmoscopically with a slit lamp prior to the administration and 1, 24, 48, and 72 hours after the administration. 24 h after administration the eyes were treated additionally with fluorescein and examined. Corneal opacity was observed at 1 h in all 3 animals (grade 1: 2/3; grade 2: 1/3). Opacity increased after 24 and 48 h (grade 3: 2/3; grade 2: 1/3). From 72 h until 21 days opacity (grade 2) was observed in all animals. Iris evaluation was not possible at 24 and 48 h in all animals. At 72 h iris scores of 1 and 2 were observed in one animal each (no evaluation possible in the third animal). From day 4 until day 21 the iris scores persisted (grade 1) in all animals. Redness was observed after 1 h and was fully reversible within 8 and 9 days, respectively. Chemosis was observed after 1 h (grade 3) and was fully reversible within 6 days. In addition, hair loss around the eyes was observed in 2 animals from 24 h until day 11 and in one animal from 48 h until day 12. White deposits, (probably pus) in the conjunctival sac were observed in 2/3 animals 72 h to 6 days after instillation, and in 1/3 animals from 24 h to 8 days after instillation. Enlargement of the bulbus due to accumulation of fluid below the cornea was noted in 2/3 animals from day 8 to 21 and in 1/3 animals from day 7 to 21. 1/3 animals showed edematous cornea 14 to 17 days after instillation. Mean values (over 24, 48, 72 h) for cornea score were 2, 2.66, and 2.66 in animal 1, 2, and 3, respectively. Mean values for redness (over 24, 48, 72 h) was 1 in all animals. Mean values (over 24, 48, 72 h) for chemosis score were 1.33 in all animals. In conclusion, N-[3-(triethoxysilyl)propyl]ethylenediamine was corrosive to the eye under the conditions of the test
Justification for classification or non-classification
The available data on skin irritation/corrosion of the test substance meet the criteria for classification as Category 2 (Causes skin irritation (H315)) according to Regulation (EC) No. 1272/2008.. Basis for the classification was the fact that inflammation, indicated by the occurrence of erythema (grade 1+2), induration, and peeling of the skin, were observed in all 3 animals at the end of the 14-day observation period.
The available data on eye irritation of the test substance meet the criteria for classification as Category 1 (Causes serious eye damage (H318)) according to Regulation (EC) Np. 1272/2008. Basis for the classification was the fact that effects on cornea (grade 2) and iris (grade 1) were observed in all 3 animals at the end of the 21-day observation period.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.