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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
Eye irritation
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- 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
Test material
- Reference substance name:
- Y-4036
- IUPAC Name:
- Y-4036
- Reference substance name:
- beta-(3,4 epoxycyclohexyl)ethyltriethoxysilane
- IUPAC Name:
- beta-(3,4 epoxycyclohexyl)ethyltriethoxysilane
- Details on test material:
- - Name of test material (as cited in study report): Y-4036
- Physical state: clear, colourless liquid
- Analytical purity: 98.3 %
- Purity test date: 1995-09-27
- Lot/batch No.: 16912-29
- Storage condition of test material: original container at room temperature, under these conditions the substance is stable for several years
Constituent 1
Constituent 2
Test animals / tissue source
- 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
Test system
- 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.
Results and discussion
In vivo
Resultsopen allclose all
- 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
Any other information on results incl. tables
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
Applicant's summary and conclusion
- 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.
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