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EC number: 425-050-4 | CAS number: 10217-34-2
- 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
In a reliable skin irritation/corrosion study, a single irritation was found. The irritation was reversible and completely subsided by day 4. The primary Irritation Index was calculated to be 0.0. The test material received a descriptive rating classification of nonirritating.
In a reliable eye irritation study, the Maximum Average Score of the substance was 5.2 at one hour post-instillation. All irritations were reversible and completely subsided by termination (day 3) or earlier. The test material received a descriptive rating classification of nonirritating.
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:
- 1995-09-21 to 1996-03-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed under GLP and the study was conducted in general compliance with the US EPA OPP (Section 81-5) and TSCA Health Effects Test Guidelines, 40 CFR 798.4470
- Qualifier:
- according to guideline
- Guideline:
- other: EPA Guidelines for Registering Pesticides in the U.S.(Pesticide Assessment Guidelines, Subdivision F, Hazard Evaluation: Human and Domestic Animals, Section 81-5)
- Qualifier:
- according to guideline
- Guideline:
- other: TSCA Health Effects Test Guidelines, 40 CFR 798.4470
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Agricultural Chemicals Laws and Regulations Testing Guidelines for Toxicology Studies published by the Society of Agricultural Chemical Industry, under the auspices of MAFF
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Products, Inc. Denver, PA
- Age at study initiation: Young adult
- Weight at study initiation: 2339 to 2705 grams
- Housing: Individual suspended wire-mesh cages. The animals were maintained by the animal husbandry staff of WIL Research Laboratories, Inc., in accordance with Standard Operating Procedures.
- Diet (e.g. ad libitum): Purina® Certified Rabbit Chow® #5322 ad libitum
- Water (e.g. ad libitum): municipal water ad libitum
- Acclimation period: a minimum of six days
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 67.7 - 68.1 °F)
- Humidity (%): 35.6 - 56.1%
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- none
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml/site - Duration of treatment / exposure:
- 4 h
- Observation period:
- Mortality: The rabbits were observed twice daily (morning and afternoon) for mortality for the duration of the study
Dermal Observation: The application sites were observed for erythema, edema and other dermal findings approximately 30 - 60 minutes and 24, 48, and 72 hours after patch removal and on day 4 if irritation persisted. - Number of animals:
- 6, two males and four females
- Details on study design:
- TEST SITE
- Area of exposure: approximately 1" x 1"
- % coverage: no data
- Type of wrap if used: a secured two-ply gauze patch that was overwrapped with a gauze binder and secured with Dermiform® tape. Plastic restraint collars were applied and remained on the animals for the duration of the exposure period.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with disposable paper towels moistened with deionized water
- Time after start of exposure: at the end of 4 hours
SCORING SYSTEM:
Dermal irritation was graded in accordance with the method of Draize:
Evaluation of Dermal Reactions
Value
Erythema and Eschar Formation
0 No erythema
1 Very slight erythema (barely perceptible, edges of area not well defined)
2 Slight erythema (pale red in color and edges definable)
3 Moderate to severe erythema (definite red in color and area well defined)
4 Severe erythema (beet or crimson red) to slight eschar formation (injuries in depth)
4 Total possible erythema score
Edema Formation
0 No edema
1 Very slight edema (barely perceptible, edges of area not well defined)
2 Slight edema (edges of area well defined by definite raising)
3 Moderate edema (raised approximately 1 mm)
4 Severe edema (raised more than 1 mm and extending beyond area of exposure)
4 Total possible erythema score
8 Total possible Primary Irritation Score
Descriptive Ratings
Mean Primary Dermal Irritation Index
Range of Values Descriptive Rating
0 Nonirritating
0.1 - 2.0 Slightly Irritating
2.1 - 5.0 Moderately Irritating
5.1 - 8.0 Severely Irritating - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- other: 72
- Score:
- 1
- Reversibility:
- fully reversible within: 1 day
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- other: 72h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- female
- Time point:
- other: 72h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Remarks:
- female
- Time point:
- other: 72h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Remarks:
- female
- Time point:
- other: 72h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Remarks:
- female
- Time point:
- other: 72h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- other: 96h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- other: 72h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- female
- Time point:
- other: 72h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Remarks:
- female
- Time point:
- other: 72h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Remarks:
- female
- Time point:
- other: 72h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Remarks:
- female
- Time point:
- other: 72h
- Score:
- 0
- Other effects:
- One female had a body weight loss of 129 grams (5%) from day 0 to day 3. A body weight loss of this magnitude is common in animals which have been bandaged and collared for four hours, and was not attributed to test material.
There were no other remarkable body weight changes during the study period. - Interpretation of results:
- not classified
- Remarks:
- Migrated information
- Conclusions:
- Very slight erythema was observed on a single male animal at 72 hours post-dose. There was no edema or other dermal findings. The irritation was reversible and completely subsided by day 4.
The primary Irritation Index was calculated to be 0.0. The test material, Y-4036, received a descriptive rating classification of nonirritating. - Executive summary:
The primary dermal irritation potential of Y-4036 was evaluated in this study with New Zealand White rabbits.
Single 0.5 -ml doses of the test material were applied to the clipped, intact skin of six albino rabbits under semi-occlusive dressings for a four-hour exposure period. At completion of exposure, the bandages were removed and the sites washed. Application sites were evaluated in accordance with the method of Draize at approximately 30 -60 minutes and 24, 48 and 72 hours after patch removal and on day 4 if irritation persisted.
Very slight erythema was observed on a single male animal at 72 hours post-dose. There was no edema or other dermal findings. The irritation was reversible and completely subsided by day 4.
The Primary Irritation Index was calculated to be 0.0. The test material, Y-4036, received a descriptive ranting classification of nonirritanting.
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:
- 1995-09-21 to 1996-03-5
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed under GLP and the study was conducted in general compliance with the US EPA OPP (Section 81-4) and TSCA Health Effects Test Guidelines, 40 CFR 798.4500
- Qualifier:
- according to guideline
- Guideline:
- other: US EPA Pesticide Assessment Guidelines, Subdivision F, Hazard Evaluation: Human and Domestic Aminals, Section 81-4.
- Qualifier:
- according to guideline
- Guideline:
- other: TSCA Health Effects Test Guidelines, 40 CFR 798.4500
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Products, Inc. Denver, PA
- Age at study initiation: Young adult
- Weight at study initiation: 2379 to 2688 grams
- Housing: Individual suspended wire-mesh cages. The animals were maintained by the animal husbandry staff of WIL Research Laboratories, Inc., in accordance with Standard Operating Procedures.
- Diet (e.g. ad libitum): Purina® Certified Rabbit Chow® #5322 ad libitum
- Water (e.g. ad libitum): municipal water ad libitum
- Acclimation period: a minimum of six days
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 67.9 - 68.1 °F)
- Humidity (%): 38.2 - 61.1%
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml/right eye - Duration of treatment / exposure:
- 1 second. The test material was placed directly into the cupped lower conjunctival sac of the rabbit´s right (test) eye. The eyelid was held closed for approximately one second after instillation. Left eyes were manipulated in a similar manner as the right eyes and served as contralateral controls. The eyes of all rabbits remained unwashed.
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after dosing
- Number of animals or in vitro replicates:
- 6, three males and three females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize scale for scoring ocular lesions, as published in the guidelines in Subsection F. Hazard Evaluation: Human and Domestic Animals distributed in 1982 and the OECD Guidelines for Testing of Chemicals distributed in 1987.
TOOL USED TO ASSESS SCORE: After 1, 24,48 and 72 hours after dosing both eyes of the rabbits were examined macroscopically for ocular irritation using a hand-held penlight. In addition sodium fluorescein and ultraviolet light were used prior to the study initiation and after 72h. - Irritation parameter:
- other: M.A.S - Maximum Average Score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 5.2
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- other: M.A.S - Maximum Average Score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- other: M.A.S - Maximum Average Score
- Basis:
- mean
- Time point:
- other: 48h
- Score:
- 0.7
- Reversibility:
- fully reversible
- Irritation parameter:
- other: M.A.S - Maximum Average Score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 0
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Draize scale for scoring ocular lesions
- Conclusions:
- The Maximum Average Score for Y-4036 was 5.2 at one hour post-instillation. An iris reaction was noted in the treated eye of one female animal. There were no corneal findings. Minor conjunctival irritation was noted for all rabbits. All irritation was reversible and completely subsided by termination (day 3) or earlier.
- Executive summary:
The primary ocular irritation potential of Y-4036 was evaluated in this study using New Zealand White rabbits.
Single 0.1 -ml doses of the test material were instilled into the lower conjunctival sac of the right eye of three male and three female albino rabbits. The eyelids were held closed for approximately one second and released. Left eyes were manipulated in a similar manner as the right eyes and served as contralateral controls. The eyes of all rabbits remained unwashed.
The eyes were examined for ocular reactions in accordance with the method of Draize at approximately one, 24, 48 and 72 hours after dosing. Sodium fluorescein was used to aid in revealing possible corneal damage at 72 hours.
The Maximum Average Score of Y-4036 was 5.2 at one hour post-instillation. An iris reaction was noted in the treated eye of one female animal. Minor conjunctival irritation was noted for all rabbits. There were no corneal findings. All irritation was reversible and completely subsided by day 3 or earlier.
There were no deaths or remarkable changes in body weights during the study period.
Reference
An iris reaction was noted in the treated eye of one animal. Minor conjunctival irritation was noted for all rabbits.
0.1 ml/right eye, unwashed | Examination intervals | |||||||||||||
Animl | Sex | Tissue | 1h | 24h | 48h | 72h* | ||||||||
19702 | M | Cornea (O-A) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||
Iris | 0 | 0 | 0 | 0 | ||||||||||
Conjunctiva (R-C-D) | 1 | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | ||
19853 | M | Cornea (O-A) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||
Iris | 0 | 0 | 0 | 0 | ||||||||||
Conjunctiva (R-C-D) | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
19855 | M | Cornea (O-A) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||
Iris | 0 | 0 | 0 | 0 | ||||||||||
Conjunctiva (R-C-D) | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
19870 | F | Cornea (O-A) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||
Iris | 0 | 0 | 0 | 0 | ||||||||||
Conjunctiva (R-C-D) | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
19871 | F | Cornea (O-A) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||
Iris | 1 | 0 | 0 | 0 | ||||||||||
Conjunctiva (R-C-D) | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
19872 | F | Cornea (O-A) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||
Iris | 0 | 0 | 0 | 0 | ||||||||||
Conjunctiva (R-C-D) | 1 | 1 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | ||
Total | 31.0 |
6.0 | 4.0 | 0.0 | ||||||||||
Mean | 5.2 | 1.0 | 0.7 | 0.0 |
O = Opacity; A = Area; R = Redness; C = Chemosis; D = Discharge
*Fluorescein solution applied
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The irritation studies did not indicate that the substance is irritant or corrosive.
Justification for classification or non-classification
Based on reliable in vivo skin and eye irritation data, 2 -(3,4 -epoxycyclohexyl)ethyltriethoxy silane does not meet the criteria for classification as irritant according to EU Directive 67/548/EEC and Regulation 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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