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EC number: 203-227-5 | CAS number: 104-68-7
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted in according to OECD TG 405 and in accordance with the principles of GLP.
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:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- U.S. EPA Health Effects Test Guidelines, OPPTS 870.2400 (1998), JMAFF 12-Nouan-8147, November 2000 and Official Journal of the European Communities. Methods for the Determination of Toxicity, Part B.5 (Eye Irritation), Directive 2004/73/EC, 29 April 2004.
- Deviations:
- no
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-(2-phenoxyethoxy)ethanol
- EC Number:
- 203-227-5
- EC Name:
- 2-(2-phenoxyethoxy)ethanol
- Cas Number:
- 104-68-7
- Molecular formula:
- C10H14O3
- IUPAC Name:
- 2-(2-phenoxyethoxy)ethan-1-ol
- Details on test material:
- - Name of test material: Diethylene glycol mono phenyl ether
- Physical state: Liquid
- Analytical purity: No Certificate of Analysis; Gas Chromatogram indicates 99.5% by area DiEPh
- Lot/batch No.: 200602920-11
- Expiration date of the lot/batch: 19-Feb-2009
- Storage condition of test material: Ambient (+18 to +36°C)
- pH : 3.5 – 7.5 (3% aq. Soln)
- Solubility in water/Miscibility : 3% wt.
- Stability : Test substance was expected to be stable for the duration of testing.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Toxicology, Department of Safety Assessment, Advinus Therapeutics Private Limited, Bangalore 560 058, INDIA
- Age at study initiation: 5-6 months
- Weight at study initiation: 2.20 to 2.39 kg
- Housing: The rabbits were housed individually in rabbit cages (approx. size: L 65 x B 65 X H 45 cm) with Noryl shallow cage body and noryl perforated raised shelf for enrichment and facilities for pelleted food (Stainless steel feed hopper) and drinking water (750 ml markrolon bottle fitted with sipper tube). The litter collection tray (noryl waste tray) were washed daily with water (except on sundays). The water bottle and feed hopper were changed once a week.
- Diet (e.g. ad libitum): The animals were offered rabbit feed (Nutrilab®) manufactured by Tetragon Chemie Pvt.Ltd., KHB Industrial Area, Yelahanka, New
Town, Bangalore - 64, India.
- Water (e.g. ad libitum): Deep bore-well water passed through activated charcoal filter and exposed to UV rays in Aquaguard on-line water filter-cum
purifier, manufactured by Eureka Forbes Ltd., Mumbai- 400001, was provided to animals in Markrolon bottles with stainless steel sipper tubes.
- Acclimation period: One rabbit RB6926 was acclimatized for 14 days while the other two (RB6927 and RB6928) rabbits were acclimatized for 15 days
under laboratory conditions after physical examination.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22°C,(except on one day the maximum temperature was 23°C)
- Humidity (%): 30-70%
- Air changes (per hr): 12-15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hour light and 12 hour dark cycle
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
Prior to instillation, both eyes of each rabbit were examined with the aid of a pen light for irritation and ocular defects. The eyes were then checked for opacity using ophthalmic fluorescein sodium. One drop was instilled into each eye and the eyes were then irrigated with enough physiological saline (0.9% NaCl) to
remove any excess fluorescein (approximately 30 seconds). Using an ultraviolet lamp, the eyes were checked and evaluated for preexisting corneal damage.
One tenth of a milliliter of the test item (undiluted) was placed in the everted lower lid (conjunctival sac) of the left eye of each rabbit. The eye lids were gently held together for about one second, in order to minimize loss of the test item. - Duration of treatment / exposure:
- 72 hrs
- Observation period (in vivo):
- A single rabbit was initially exposed to the test item. Since the test item was not corrosive or severely irritating at 24 hours observation, hence, the test was conducted using two additional animals.
- Number of animals or in vitro replicates:
- Three female rabbits
- Details on study design:
- Ocular lesions were evaluated with the illumination of a white light source at intervals of approximately 1, 24, 48 and 72 hours post-instillation of the test substance according to the "Scale for Scoring Ocular Lesions".
In addition, all treated eyes were examined using ophthalmic fluorescein sodium at the 24-hour interval. Corneal opacity exists at 24 hours, hence, fluorescein was used as needed, at subsequent scoring intervals, to aid in evaluating the extent of corneal damage.
Irritation persisted in all rabbits at 72 hours, hence, scoring was continued for all rabbits at 4, 7, 10, 14, 17 and 21 days post instillation.
Individual scores were recorded for each rabbit. All scores were calculated as described in the "Scale for Scoring Ocular lesions",and the total possible points (out of 110) were tallied. In addition to the observation of the cornea, iris and conjunctivae, any other lesions that are observed were noted. To aid in the interpretation of data, the average score for all rabbits at each scoring period was calculated.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not reversible
- Remarks:
- See Attachment 1
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks:
- See Attachment 1
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks:
- See Attachment 1
- Irritant / corrosive response data:
- The conjunctival redness, chemosis and discharge were observed in all the animals till termination. The corneal opacity was observed in all the animals till termination. There were no iris reactions. Mild circumcorneal injection was observed in one rabbit from day 10 onwards and in the other two rabbits from day 14 onwards till termination of observation on day 21.
- Other effects:
- The body weights of all rabbits increased slightly through the observation period.
Any other information on results incl. tables
Irritation scores calculated
Cornea opacity | |||||
Animal | Observation time | Mean value | Mean value (over all animals) | ||
24 hours | 48 hours | 72 hours | |||
1 | 1 | 1 | 1 | 1 | 1.0 |
2 | 1 | 1 | 1 | 1 | |
3 | 1 | 1 | 1 | 1 | |
Iris lesion | |||||
Animal | Observation time | Mean value | Mean value (over all animals) | ||
24 hours | 48 hours | 72 hours | |||
1 | 0 | 0 | 0 | 0.0 | 0.0 |
2 | 0 | 0 | 0 | 0 | |
3 | 0 | 0 | 0 | 0.0 | |
Conjunctivae (redness) | |||||
Animal | Observation time | Mean value | Mean value (over all animals) | ||
24 hours | 48 hours | 72 hours | |||
1 | 2 | 2 | 2 | 2 | 2.0 |
2 | 2 | 2 | 2 | 2.0 | |
3 | 2 | 2 | 2 | 2 | |
Conjunctivae (chemosis) | |||||
Animal | Observation time | Mean value | Mean value (over all animals) | ||
24 hours | 48 hours | 72 hours | |||
1 | 1 | 1 | 1 | 1 | 1.7 |
2 | 2 | 2 | 2 | 2 | |
3 | 2 | 2 | 2 | 2 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material was irritating to the eyes with conjuctival chemosis and redness and cornea opacity scores meeting the criteria for CLP category 2a. However the cornea opacity effects persisted until the end of the observation period of 21 days. This therefore meets the criteria for a 'serious effect' and as such category 1 eye irritant is appropriate.
- Executive summary:
The acute eye irritation/corrosion study in New Zealand White rabbits was conducted to evaluate the eye irritation potential of Diethylene glycol mono phenyl ether. One-tenth of a milliliter (0.1 ml) of the undiluted test item was instilled into the conjunctival sac of the left eye of the animal after gently pulling the lower lid away from the eyeball. The eyelids were held together gently for about one second to minimize loss of test item. The right eye remained untreated and served as the reference control. All the rabbits were treated in a similar manner. The ocular lesions were evaluated at 1, 24, 48, 72 hours, 4, 7, 10, 14, 17 and 21 days post instillation according to the scale for scoring ocular lesions. In addition, the treated eyes were examined using ophthalmic fluorescein sodium at 24, 72 hours, at 7 and 14 days post instillation. The total mean scores were 18, 27.34, 27.34, 27.34, 25.34, 22.06, 34.67, 27.33, 27.33 and 18.67 at 1, 24, 48, 72 hours, 4, 7, 10, 14, 17 and 21 days, respectively. Mild circumcorneal injection was observed in one rabbit from day 10 onwards and in the other two rabbits from day 14 onwards till termination of observation (day 21). There were no toxic signs and pre-terminal deaths.
Based on the evidence of irritation and the persistence of effects until the end of the observation period, the test material meets the criteria for Category 1 A according to CLP.
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