Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 695-757-2 | CAS number: 897381-19-0
- 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:
- 12/07/2013-19/07/2013
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Conducted at a GLP accredited laboratory
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Oxirane, 2-ethyl-, homopolymer, ether with 1,2-ethanediol (2:1)
- IUPAC Name:
- Oxirane, 2-ethyl-, homopolymer, ether with 1,2-ethanediol (2:1)
- Reference substance name:
- 1-[2-(2-hydroxybutoxy)ethoxy]butan-2-ol
- EC Number:
- 695-757-2
- Cas Number:
- 897381-19-0
- Molecular formula:
- UVCB
- IUPAC Name:
- 1-[2-(2-hydroxybutoxy)ethoxy]butan-2-ol
- Test material form:
- other: liquid
- Details on test material:
- Clear light yellow liquid. It stored at room temprature in dark.
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- The animals were randomly assigned to the study based upon sex, body weight and apparent good health. 3 Female rabbit were used.
Age Range: 12 weeks at start of dosing; records of dates of birth for animals used in this study are retained in the Calvert archives.
Body Weight Range: 2.8 to 3.0 kilograms at the outset (Day 1) of the study.
Animal Source: Millbrook
Experimental History: Purpose-bred and experimentally naive at the outset of the study.
Housing: Animals were individually housed in compliance with USDA Guidelines. The room in which the animals were kept was documented in the study records. No other species were kept in the same room.
Lighting: 12 hours light/12 hours dark
Room Temperature: 17-21 C degrees
Relative Humidity: 44 to 81%
Food: All animals had access to PMI Certified Hi-Fiber Rabbit Ojet #5325 as per Calvert SOP. The lot number(s) and specifications of each lot used are archived at Calvert. No contaminants were known to be present in the certified diet at levels that would be expected to interfere with the results of this study. Analysis of the diet was limited to that performed by the manufacturer records of which are maintained in the Calvert archives.
Water: Water was available ad libitum to each animal via an automatic watering device. The water is routinely analyzed for contaminants as per Calvert SOP's. No contaminants were known to be present in the water at levels that would be expected to interfere with the results of this study.
Acclimation: Study animals were acclimated to their housing for a minimum of 7 days prior to dosing.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: left eyes without treatment
- Amount / concentration applied:
- 0.1 mL was placed in the conjuctival sac of the right eye via ocular instillation.
- Duration of treatment / exposure:
- Once
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 0679
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- iris score
- Basis:
- animal: 0679
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 0679
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: 0679
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 0680
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal: 0680
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 0680
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: 0680
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Reversibility:
- fully reversible within: Day6 at late hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 0681
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- iris score
- Basis:
- animal: 0681
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 0681
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: 0681
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- No corneal, iris or conjunctival irritation was observed in the untreated eyes of the rabbits at any time point. Due to the irritation seen in the first animal (0679) at 1 hour post dose, the next two animals (0680 and 0681) were not dosed until the 24 hour scores of the first animal dosed were observed/recorded for animal welfare reasons.
Corneal irritation (opacity scores of 1-2, involving approximately one quarter to greater than three quarters of the cornea, scores of 1 and 4) was observed in the treated eyes of the animals at 1 and 24 hours post dose but resolved by 48 hours post dose. Scores of 1 for iritis were observed in two animals at one hour post dose with resolution by 24 hours post dose. One animal showed scores of 1 for iritis at 24 hours post dose with resolution by 48 hours post dose.
Conjunctival redness (scores of 1) was observed beginning at 1 hour post dose through Day 7 for the first animal dosed (0679) and through Day 6 for the last two animals dosed (0680 and 0681).
A score of 4 for chemosis was observed at one hour post dose for the first animal (0679) dosed with the chemosis decreasing to a score of one 24 hours post dose and persisting through Day 5. Chemosis (scores of 3-4) were observed beginning at 1 hour post dose with full resolution by Day 7 in the last two animals dosed (0680 and 0681). A score of 3 for discharge was observed at 1 hour for the first animal dosed (0679} with the discharge decreasing to a score of one 24 hours post dose and persisting through Day 5. Scores of 3 for discharge were observed at 1 hour post dose for the last two animals (0680 and 0681) dosed with a decrease in discharge seen by 24 hours and full resolution of discharge in both animals by Day 7. Since the first animal dosed (0679) was observed to be normal on Day 8 and the next two animals dosed (0680 and 0681) were observed to be normal on Day 7, the study was terminated. - Other effects:
- No mortality was observed in the animals during the study. There were no treatment-related clinical signs noted.
Any other information on results incl. tables
Scoring: An animal exhibited a positive reaction if the test article produced at any observation one or more of the following signs: opacity of the cornea (other than a slight dulling of the normal luster), inflammation of the iris (other than a slight deepening of the rugae or a light hyperemia of the circumcorneal blood vessels) or an obvious swelling in the conjunctivae (excluding the cornea and iris) with partial eversion of the eyelids or a diffuse crimson color with individual vessels not easily discernible.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Precursor PO 206 was not an irritant to eyes, according to EEC criteria, whilst the subtance was found to fall into the GHS Category 2A-Reversible Eye Effects.
- Executive summary:
The purpose of this study was to determine the potential irritant and/or corrosive effects of the test article on the eyes of rabbits.
The test article Precursor PD 206, was initially instilled into the anesthetized right eye of one male New Zealand White rabbit at a dose of 0.1 mL. Upon instillation of the test article, the eyelids were held closed app.1 second to limit loss of material. The anesthetized left eye was untreated. Following the twenty-four hour scores of the first animal, two additional animals were dosed. Both eyes of all three animals were examined and scored for ocular irritation according to the method of Draize (4) prior to dosing. 1 hour after dosing (+/-15min), at 24, 48, 72 hours (+/-1 hour) through Day 7 (0680 and 0681) and Day 8 (0679) post dose.
No corneal, iris or conjunctival irritation was observed in the untreated eyes of the rabbits at any time point. The ocular irritation detected in the treated eyes were fully reversible in Day 8. Precursor PO 206 was not an irritant to eyes, according to DSD criteria, whilst the subtance was found to fall into the CLP Category 2 - Reversible Eye Effects.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.