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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
Eye irritation
Administrative data
- 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.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- 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
Test material
- Reference substance name:
- N-[3-(triethoxysilyl)propyl]ethylenediamine
- EC Number:
- 225-806-1
- EC Name:
- N-[3-(triethoxysilyl)propyl]ethylenediamine
- Cas Number:
- 5089-72-5
- Molecular formula:
- C11H28N2O3Si
- IUPAC Name:
- N-[3-(triethoxysilyl)propyl]ethylenediamine
Constituent 1
Test animals / tissue source
- 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
Test system
- 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.
Results and discussion
In vivo
Resultsopen allclose all
- 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.
Any other information on results incl. tables
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)
Applicant's summary and conclusion
- 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.
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