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EC number: 942-639-6 | CAS number: -
- 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:
- 06 October 2015 - 10 October 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- This deviation is considered to have no impact on the outcome of the study and interpretation of the results.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-({2-[bis({2-[(oxiran-2-yl)methoxy]phenyl})methyl]phenoxy}methyl)oxirane; 2-({2-[bis({4-[(oxiran-2-yl)methoxy]phenyl})methyl]phenoxy}methyl)oxirane; 2-{[2-({2-[(oxiran-2-yl)methoxy]phenyl}({4-[(oxiran-2-yl)methoxy]phenyl})methyl)phenoxy]methyl}oxirane
- EC Number:
- 942-639-6
- IUPAC Name:
- 2-({2-[bis({2-[(oxiran-2-yl)methoxy]phenyl})methyl]phenoxy}methyl)oxirane; 2-({2-[bis({4-[(oxiran-2-yl)methoxy]phenyl})methyl]phenoxy}methyl)oxirane; 2-{[2-({2-[(oxiran-2-yl)methoxy]phenyl}({4-[(oxiran-2-yl)methoxy]phenyl})methyl)phenoxy]methyl}oxirane
- Test material form:
- solid
- Details on test material:
- Name: EPICLON EXA-7250
Batch/Lot number: B006
Appearance: Brown solid (in smaller amount colour is yellow)
Purity: >99%
Manufacture date: 02 October 2014
Expiry date: 02 March 2017
Storage condition: Room temperature 15-25°C, below 70 RH%
Safety precautions: Routine safety precautions (lab coat, gloves, safety glasses, face
mask) for unknown materials were applied to assure personnel
health and safety.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source:S&K-LAP Kft. 2173 Kartal, Császár út 135, Hungary
- Age at study initiation:13 weeks old (young adult)
- Weight at study initiation:3584 g – 3841 g
- Housing:Rabbits were individually housed in AAALAC approved metal wire rabbit cages. Cages were of an open wire structure and cages were placed together to allow some social interaction with rabbit(s) in adjoining cages
- Diet (e.g. ad libitum):Animals received UNI diet for rabbits produced by Cargill Takarmány Zrt., H-5300 Karcag, Madarasi út 0399, Hungary, ad libitum
- Water (e.g. ad libitum):The animals received municipal tap water, as for human consumption, ad libitum, from an automatic system.
- Acclimation period:at least 22 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):19.4 –22.6 °C
- Humidity (%):36 – 80 %
- Air changes (per hr):15-20 air exchanges/hour
- Photoperiod (hrs dark / hrs light):12 hours daily, from 6.00 a.m. to 6.00 p.m.
IN-LIFE DATES: From:06 October 2015 To:10 October 2015
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- An amount of the 0.1 g of test item EPICLON EXA-7250 was administered to the animals.
- Duration of treatment / exposure:
- As the solid test item remained in the eye sac at the one hour observation time point, the treated eye of test animals was rinsed with physiological saline solution in all animals.
- Observation period (in vivo):
- The eyes were examined at 1, 24, 48 and 72 hours after treatment. The duration of the observation period was sufficient to identify reversibility or irreversibility of changes.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eye of test animals was rinsed with physiological saline solution in all animals.
- Time after start of exposure: 1 hour
SCORING SYSTEM:The eye irritation scores were evaluated according to the scoring system by Draize (1977) and OECD 405 (02 October 2012).
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- no indication of irritation
- Other effects:
- MORTALITY
There was no mortality observed during the study.
BODY WEIGHTS
The body weight of the animals was considered to be within the normal range of variability.
CLINICAL OBSERVATION
General daily examination
There were no clinical signs observed that could be related to treatment.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item EPICLON EXA-7250, applied to rabbit eye mucosa, caused conjunctival effects at one hour after application which were fully reversible within 24 hours.
According to Regulation (EC) No 1272/2008, EPICLON EXA-7250 does not require classification as an eye irritant.
According to the UN Globally Harmonised System of Classification and Labelling of Chemicals, EPICLON EXA-7250 does not require classification as an eye irritant. - Executive summary:
An acute eye irritation study of the test item EPICLON EXA-7250 was performed in three New Zealand White rabbits. The irritation effects of the test item were evaluated according to the Draize method (OECD No.: 405, 2012). Rabbits were treated with analgesic and anaesthetic as per the regulatory guideline. Three animals were used to make the classification.
The test item was placed into the conjunctival sac of the left eye of each animal. The untreated right eye served as control. A single amount of 0.1 g of the test item was administered as a single dose.
The eyes were examined at 1, 24, 48 and 72 hours after application.
No Initial Pain Reaction (IPR) or any Pain Reaction (PR) was observed during the experimental period.
Animal 1 (No: 837) clinical observation
At one hour after the application, conjunctival redness (score 1) and discharge (score 1) were noted in the rabbit. Test item remained in the eye sac.
At 24 hours after the application, no clinical signs, and no conjunctival or corneal effects were observed.
At 48 hours after the application, no clinical signs, and no conjunctival or corneal effects were observed.
At 72 hours after the application, no clinical signs, and no conjunctival or corneal effects were observed.
Animal 2 (No: 835) clinical observation
At one hour after the application, conjunctival redness (score 1) and discharge (score 1) were noted in the rabbit. Test item remained in the eye sac.
At 24 hours after the application, no clinical signs, and no conjunctival or corneal effects were observed.
At 48 hours after the application, no clinical signs, and no conjunctival or corneal effects were observed.
At 72 hours after the application, no clinical signs, and no conjunctival or corneal effects were observed.
Animal 3 (No: 832) clinical observation
At one hour after the application, conjunctival redness (score 1) and discharge (score 1) were noted in the rabbit. Test item remained in the eye sac.
At 24 hours after the application, no clinical signs, and no conjunctival or corneal effects were observed.
At 48 hours after the application, no clinical signs, and no conjunctival or corneal effects were observed.
At 72 hours after the application, no clinical signs, and no conjunctival or corneal effects were observed.
The general state and behaviour of animals were normal throughout the study period. No mortality occurred during the study. The body weights of all rabbits were considered to be within the normal range of variability.
The animals’ individual mean scores for all aniamls (considering readings at 24, 48 and 72 hours after the treatment) were as follows:
Chemosis 0.00
Discharge 0.00
Redness 0.00
Cornea 0.00
Iris 0.00
The test item EPICLON EXA-7250, applied to rabbit eye mucosa, caused conjunctival effects at one hour after application which were fully reversible within 24 hours. According to Regulation (EC) No 1272/2008, EPICLON EXA-7250 does not require classification as an eye irritant. According to the UN Globally Harmonised System of Classification and Labelling of Chemicals, EPICLON EXA-7250 does not require classification as an eye irritant.
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