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EC number: 203-224-9 | CAS number: 104-66-5
- 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:
- Start of Treatment: 04 May 2011; End of Experiment: 18 May 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Performed according to GLP, OECD Guidelines followed and no deviations reported
- Justification for data waiving:
- other:
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,2-diphenoxyethane
- EC Number:
- 203-224-9
- EC Name:
- 1,2-diphenoxyethane
- Cas Number:
- 104-66-5
- Molecular formula:
- C14H14O2
- IUPAC Name:
- (2-phenoxyethoxy)benzene
- Reference substance name:
- 1, 2-Di-phenoxyethane
- IUPAC Name:
- 1, 2-Di-phenoxyethane
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): KS-235
- Molecular formula (if other than submission substance): C14H14O2
- Molecular weight (if other than submission substance): 214.27
- Physical state: White crystalline powder
- Analytical purity: 99.9%
- Lot/batch No.: 91014
- Expiration date of the lot/batch: October 2014
- Storage condition of test material: Room temperature (15-25°C)
- Other:
- Manufacture date: October 2009
- Safety Precautions: Routine safety precautions (gloves, goggles, face mask, lab coat) for unknown materials were applied to assure personnel health and safety
- The pH of Test Item was measured as 5.5
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: S&K - LAP Kft.
2173 Kartal, Császár út 135, Hungary
- Age at study initiation: ~ 11 weeks old (young adult)
- Weight at study initiation:
- beginning of the life phase: 2607 - 2629 g
- end of the life phase: 3260 - 3550 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): Animal received PURINA Base - Lap gr. diet for rabbits produced by AGRIBRANDS Europe Hungary PLC, H-5300 Karcag, Madarasi road, Hungary, ad libitum. Contents of PURINA Base-Lap gr. diet for rabbits see in Appendix 4 of attached report.
- Water (e.g. ad libitum): The animals received municipal tap water, as for human consumption, ad libitum, from an automatic system. The quality control analysis is performed once every three months and microbiological assessment is performed monthly, by Veszprém County Institute of State Public Health and Medical Officer Service (ANTSZ, H-8201 Veszprém, Jozsef A.u.36., Hungary). The quality control results are retained in the archives of LAB Research Ltd.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 – 70 (relative humidity)
- Air changes (per hr): 15-20 air exchanges/hour
- Photoperiod (hrs dark / hrs light): Light 12 hours daily, from 6.00 a.m. to 6.00 p.m
The environmental parameters were recorded twice daily during the study.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: contralateral eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A single dose of 0.1 g of the solid test item KS-235 was administered to each animal - Duration of treatment / exposure:
- 1 hour
- Observation period (in vivo):
- The eyes were examined at 1, 24, 48, 72 hours, 1 week and 2 weeks after treatment. The duration of the observation period was sufficient to identify reversibility or irreversibility of changes. Any clinical signs of toxicity or signs of ill- health during the study were recorded.
At the end of the observation period, each animal was sacrificed by intramuscular injections of CP-Ketamin 10% and CP-Xylazin 2% followed by iv. Euthasol® 40% anaesthesia (see details in attached report). Death was verified by checking pupil and cornea reflex, absence of respiration and pulse.
Individual body weight was recorded at the beginning and end of the experiment (see Table 3 of attached report). - Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eye of the rabbits was rinsed with physiological saline solution.
- Time after start of exposure: at 1 hour after application
SCORING SYSTEM: The eye irritation scores were evaluated according to the scoring system by Draize (1977) and OECD 405 (24 April 2002) shown in Appendix 1 of attached report.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.9
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- The eyes were examined at 1, 24, 48, 72 hours and 1 and 2 weeks after the application.
- Initial Pain Reaction (IPR) (score 2 or 3) was observed in two animals.
- One hour after the application, conjunctival redness (score 1 or 2) was observed in all animals and discharge (score 2) was seen in all rabbits.
- At 24 hours after treatment, conjunctival redness (score 1 or 2) was observed in all animals and discharge (score 3) was seen in two rabbits.
- At 48 hours after treatment, conjunctival redness (score 1) was observed in two animals and discharge (score 1 or 3) was seen in two rabbits.
- At 72 hours after treatment, conjunctival redness (score 1) was observed in one animal and discharge (score 1 or 3) was seen in two rabbits.
- At one week after treatment, conjunctival redness (score 1) was observed in one animal and discharge (score 1) was seen in one rabbit.
- At two weeks after treatment, there were no clinical signs observed.
- The animal’s individual mean scores (considering readings at 24, 48 and 72 hours after the treatment) were as follows:
Chemosis: 0.00, 0.00, 0.00
Discharge: 0.00, 1.67, 3.00
Redness: 0.33, 1.00, 1.33
Cornea opacity: 0.00, 0.00, 0.00
Iris: 0.00, 0.00, 0.00
Any other information on results incl. tables
MORTALITY: There was no mortality observed during the study.
BODY WEIGHTS: The body weight and body weight change were considered to be normal with no indication of treatment related effect.
CLINICAL OBSERVATION:
- General daily examination: There were no clinical signs observed that could be related to treatment.
- As there were no clinical signs observed, the study was terminated after the two weeks observation.
- During the study, the control eye of all animals was symptom-free. The general state and behaviour of animals were normal throughout the study period.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item KS-235 (Batch No.: 91014), applied to rabbits’ eye mucosa, caused significant conjunctival irritant effects which were reduced at 1 week after application. The effects were fully reversible within 2 weeks.
According to Regulation (EC) No 1272/2008, KS-235 does not require classification as an eye irritant. - Executive summary:
An acute eye irritation study of the test item KS-235 was performed in New Zealand White rabbits. The irritation effects of the test item were evaluated according to the Draize method (OECD No.: 405, 2002).
The test item was placed into the conjunctival sac of the left eye of each animal. The untreated right eye served as control. An amount of 0.1 g of the test item was administered as a single dose. The treated eye of the rabbits was rinsed at 1 hour after application with physiological saline solution.
The eyes were examined at 1, 24, 48, 72 hours and 1 and 2 weeks after the application. Initial Pain Reaction (IPR) (score 2 or 3) was observed in two animals.
One hour after the application, conjunctival redness (score 1 or 2) was observed in all animals and discharge (score 2) was seen in all rabbits.
At 24 hours after treatment, conjunctival redness (score 1 or 2) was observed in all animals and discharge (score 3) was seen in two rabbits.
At 48 hours after treatment, conjunctival redness (score 1) was observed in two animals and discharge (score 1 or 3) was seen in two rabbits.
At 72 hours after treatment, conjunctival redness (score 1) was observed in one animal and discharge (score 1 or 3) was seen in two rabbits.
At one week after treatment, conjunctival redness (score 1) was observed in one animal and discharge (score 1) was seen in one rabbit.
At two weeks after treatment, there were no clinical signs observed.
As there were no clinical signs observed, the study was terminated after the two weeks observation.
During the study, the control eye of all animals was symptom free.
The general state and behaviour of animals were normal throughout the study period.
The body weight changes were considered to be normal during the study period.
The animal’s individual mean scores (considering readings at 24, 48 and 72 hours after the treatment) were as follows:
chemosis: 0.00, 0.00, 0.00
discharge: 0.00, 1.67, 3.00
redness: 0.33, 1.00, 1.33
cornea opacity: 0.00, 0.00, 0.00
iris: 0.00, 0.00, 0.00
The test item KS-235 (Batch No.: 91014), applied to rabbits’ eye mucosa, caused significant conjunctival irritant effects which were reduced at 1 week after application. The effects were fully reversible within 2 weeks.
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