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EC number: 221-254-0 | CAS number: 3047-32-3
- 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
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- Endpoint summary
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- 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
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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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- not specified
- Principles of method if other than guideline:
- Not relevant
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-ethyloxetane-3-methanol
- EC Number:
- 221-254-0
- EC Name:
- 3-ethyloxetane-3-methanol
- Cas Number:
- 3047-32-3
- Molecular formula:
- C6H12O2
- IUPAC Name:
- (3-ethyloxetan-3-yl)methanol
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): TPM oxetane, 2-ethyl-2-hydroxylmethyl oxetane
-CAS 3047-32-3
- Physical state: Colourless liquid.
- Analytical purity: No information provided.
- Purity test date: No information provided.
- Lot/batch No.: No information provided. JNS 980121 F 1-3
- Stability under test conditions: No information provided.
- Storage condition of test material: Stored in a refrigerator at 2 - 8°C in the dark.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, Stolzenseeweg 32-36, D-88353 Kisslegg, Germany.
- Age at study initiation: No information provided.
- Weight at study initiation: 2.8kg
- Housing: Individually housed in PPO/HIPS cages (floor area of 2576 cm2) with perflorated floor.
- Diet (e.g. ad libitum): A pelleted complete rabbit diet (Altromin 2123) was available ad libitum.
- Water (e.g. ad libitum): Free access to bottles with domestic quality drinking water acidified with hydrochloric acid to pH 2.5 to prevent microbial growth.
- Acclimation period: At least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): 10 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark.
IN-LIFE DATES: From: 4th May 1998 To: 18th May 1998
Test system
- Vehicle:
- not specified
- Controls:
- other: Untreated eye acted as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- Single exposure.
- Observation period (in vivo):
- 14 days.
- Number of animals or in vitro replicates:
- One
- Details on study design:
- 0.1ml of the test article was placed in the left eye of the rabbit by gently pulling the lower lid away from the eyeball to form a cup into which the article was dropped. The lids were then gently held together for 1 second. The eye was examined and the grade of ocular reaction was recorded 1 and 24 hours later. After the 24 hour reading, Fluorescein was instilled. After rinsing with 20ml 0.9% sodium chloride solution the eye was examined again using UV light to detect possible corneal damage. The eye was also examined 48 and 72 hours as well as 7 and 14 days after treatment. Because of the corneal damage observed at the 24 hour examination, fluorescein was also used at subsequent examinations.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No information provided.
- Time after start of exposure: No information provided.
SCORING SYSTEM: Scored between 1 and 4.
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days.
- Irritation parameter:
- iris score
- Remarks:
- lesion
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable.
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days.
- Irritant / corrosive response data:
- Marked signs of conjunctival irritation (chemosis, redness and discharge) were observed 1 hour to 7 dys after termination of exposure. Cornea showed diffuse opacity during the same period. From 1 to 72 hours after termination of exposure, superficial damage to more that 2/3 of the cornea was observed when oculoguttae fluoresceini was installed. At the 7 day reading, the suoperficial damage only involved 1/4 of the eye.
- Other effects:
- No other abnormalities were observed after 14 days.
Any other information on results incl. tables
No additional information.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, TPM oxetane was found to be irritating to the eyes and meets the criteria for clasification as an eye irrtant.
- Executive summary:
The eye irritant effect of TMP oxetane was investigated in rabbit eye. One albino rabbit was exposed to 0.1ml of the test material in the left eye. The eye was examined and the changes were graded according to a numerical scale 1, 24, 48 and 72 hours as well as 7 and 14 days after dosing. Marked signs of corneal and conjunctival irritation were observed in the rabbit 1 hour to 7 days after termination of exposure. On day 14, no abnormalities were observed in the rabbit. The following mean values based on the 24, 48 and 72 hour readings are 1.0 for corneal opacity, 0 for iris lesions, 3.0 for conjunctiva oedema and 3.0 for conjunctival redness. Under the conditions of this study, TMP oxetane was found to be irritating to the eyes and meets the criteria for classification as an eye irritant.
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