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EC number: 217-164-6 | CAS number: 1760-24-3
- 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
The key skin irritation study (Dow Corning Corporation, 2000c) found mild irritation to the skin of rabbits, that did not meet the EU criteria for classification. There were no clinical signs of toxicity. The eye irritation study (Hazelton France, 1993) reported serious damage to rabbit eyes, with effects that were not fully reversed in five of six during the 21-day observation period.
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
- Study period:
- 15.10.1998 to 10.02.2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Ltd, England
- Age at study initiation: At least 11 weeks
- Weight at study initiation: 2193-2616 g
- Housing: Individually in suspended metal cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-22
- Humidity (%): 44-78
- Air changes (per hr): 18
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 20.10.1998 To: 02.11.1998 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- Four hours
- Observation period:
- Up to 14 days
- Number of animals:
- Three
- Details on study design:
- TEST SITE
- Area of exposure: Dorso-lumbar region
- % coverage: 10% approx.
- Type of wrap if used:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: Four hours with warm water
SCORING SYSTEM: Draize - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.11
- Max. score:
- 8
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 11 days
- Remarks on result:
- other: Desquamation from Day 7
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 13 days
- Remarks on result:
- other: Desquamation from Day 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other: Desquamation from Day 5
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 9 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No edema
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No edema
- Irritant / corrosive response data:
- Well-defined erythema in all three animals and slight edema. Desquamation of the stratum corneum developed in all animals. Dermal reactions resolved completely in all animals by Day 10, 11 or 13.
- Other effects:
- No deaths or clinical signs of a systemic reaction to treatment.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a skin irritation study conducted to EPA OPPTS 870.2500 (Acute Dermal Irritation) and to GLP (reliability score 1) N-(3-(trimethoxysilyl)propyl)ethylenediamine was mildly irritating to the skin of rabbits, but this irritation did not meet the EU criteria for classification. There were no clinical signs of toxicity.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not 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:
- 09.09.1992 to 29.01.1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River, France
- Age at study initiation: Three months
- Weight at study initiation: 2.5± 0.2 kg
- Housing: Individual in stainless steel cages
- Diet (e.g. ad libitum): 150 g/animal/day
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19± 3
- Humidity (%): Minimum 50%
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 09.09.1992 To: 29.01.1993 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- Eyes not rinsed
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- Six
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
SCORING SYSTEM: OECD 405 - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Ulceration. Presence of a whitish humour on the side of the lids of the treated eye.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: Animals 2, 3, 4, 5 and 6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: Ulceration. Presence of a whitish humour on the side of the lids of the treated eye. Varying areas of neovascularisation of the cornea.
- Irritation parameter:
- iris score
- Basis:
- animal: all animals
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- other: Animals 1 reversed between Day 14 and 21, but all others had Grade 1 on Day 21. Circumcorneal injections with/out congestion of the iris. Also some animals had permanent myosis with preservation of the direct photomotor reflex.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: Grade 1 on Day 21
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: Grade 2 on Day 21
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: Grade 2 on Day 21
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: Grade 2 on Day 21
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: 2, 3 and 5
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: Grade 1 on Day 21
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: Grade 1 on Day 21. Depilation area around the lids of the treated eye.
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: Grade 2 on Day 21. Depilation area around the lids of the treated eye.
- Irritant / corrosive response data:
- Five of the six tested rabbits had effects on the eye that were not reversible in within the 21 day observation period.
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- In an eye irritation study conducted to OECD 405 and to GLP (reliability score 1) N-(3-(trimethoxysilyl)propyl)ethylenediamine caused serious damage to rabbit eyes, with effects that were not fully reversed in five of six during the 21-day observation period.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
There are several studies for each of skin and eye irritation. In both cases the supporting data support the findings of the key data.
In a skin irritation study conducted to EPA OPPTS 870.2500 (Acute Dermal Irritation) and to GLP (Dow Corning Corporation, 2000c) N-(3-(trimethoxysilyl)propyl)ethylenediamine was mildly irritating to the skin of rabbits, but this irritation did not meet the EU criteria for classification. Well-defined erythema and slight edema was seen in all three animals, as well as desquamation of the stratum corneum. Dermal reactions resolved completely in all animals by Day 10, 11 or 13. There were no deaths or clinical signs of toxicity.
Four reliable supporting studies for skin irritation were also available, all conducted according to current guidelines and in compliance with GLP. At most mild irritation was evident which was in all cases reversible and did not meet the EU criteria for classification (TNO, 1998, Hüls, 1993, Huntingdon 1993, Hazleton, 1992).
In the key study for eye irritation conducted to OECD 405 and to GLP (Hazleton, 1993) N-(3-(trimethoxysilyl)propyl)ethylenediamine was severely irritating (irreversible) to the eyes of rabbits. Five of the six tested rabbits had serious effects on the eye that were not reversible in within the 21 day observation period. These effects included ulceration and congestion of the cornea and circumcorneal injections.
Several reliable supporting studies for eye irritation were also available, all conducted according to current guidelines and in compliance with GLP. The majority of the studies reported severe, irreversible effects on the eyes of the animals (CIT 1994, Hüls 1993). Corrosive effects reported included a delayed manifestation of a grade 4 corneal lesion lasting until the end of the observation period. Conjunctival blistering was also reported (Toxicogenics Inc., 1981). Irreversible effects in the eyes of rabbits were reported even following washing of the eyes four seconds after treatment (TNO, 1984). Supporting studies which were not reliable or reliability was not assignable are also included in the data set which indicate corrosivity and support the key findings (Industrial Biotest Laboratories 1976, SEHSC 2003). In addition, a reliable pre-GLP eye irritation study which administered the test substance neat caused what was described as minor irritation to the eyes of rabbits (Mellon 1975).
Justification for classification or non-classification
Based on the available information, the registered substance is classified: 'Eye Damage Category 1' with the hazard statement 'H318: Causes serious eye damage' in accordance with the Regulation (EC) No 1272/2008.
The registered substance is not classified for skin irritation according to Regulation (EC) No 1272/2008.
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.
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