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EC number: 203-704-8 | CAS number: 109-78-4
- 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: Comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the safety of chemicals in food, drugs and cosmetics, FDA, Draize, 1959
- Deviations:
- not specified
- Principles of method if other than guideline:
- Information about the method, described in the study report ( Draize test: eye irritation), is given in the free text field "methods and materials".
- GLP compliance:
- no
Test material
- Reference substance name:
- 3-hydroxypropiononitrile
- EC Number:
- 203-704-8
- EC Name:
- 3-hydroxypropiononitrile
- Cas Number:
- 109-78-4
- Molecular formula:
- C3H5NO
- IUPAC Name:
- 3-hydroxypropanenitrile
- Details on test material:
- - Name of test material (as cited in study report): Ethylencyanhydrin
- Substance type: Aliphatic Nitrile
- Physical state: liquid
- Analytical purity: as supplied by producer: purity in the test report not mentioned, but probably > 98,5%
- Impurities (identity & concentrations): no data availible by the study report, but according to the current product information sheet the
impurities are: glykol <1%, formic acid: max 0.06%, HCN: max 0.0010% , water: max 0.10%.
- Stability under test conditions: no data
- Storage condition of test material: no data
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data available
- Weight at study initiation: 2.4-2.6 kg
- Housing: individual housing
- Diet (e.g. ad libitum): standard diet
- Water: ad libitum
- Acclimation period: no data availible
- Air changes (per hr): no data availible
- Photoperiod (hrs dark / hrs light): 12 h light/12h dark
- Humidity: 45-55%
- Room temperature: 20 ±1°C
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: second eye without treatment served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml undiluted test substance (ethylencyanhydrin) - Duration of treatment / exposure:
- single application, 7 days of exposure
- Observation period (in vivo):
- 1, 2, 8 hours; 1, 2, 3, 4, 5, 6, 7 days
- Number of animals or in vitro replicates:
- 6 test animals
- Details on study design:
- Test method:
An amount of 0.1 ml undiluted test substance (Ethylene cyanhydrin) was applicated into
the conjunctival sac of the left eye of each test animal. 6 animals were used for the testing.
The second eye served in each case as the control. The occurence of irritant reactions
was recorded and scored according to the scoring system shown in "details on study design".
The final result (according to GHS classification sheme) is calculated as the mean score
(in the categories: corneal opacity, iritis, conjunctival redness, conjunctival chemosis)
following grading after 24, 48 and 72 hours.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing
SCORING SYSTEM:
Cornea:
opacity: degree of density (reading should be taken from most dense area)
No ulceration or opacity : 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre);
deatails of iris clearly visible : 1
Easily discernible translucent area; details of iris slightly obscured: 2
Nacrous area; no details of iris visible; size of pupil barely discernible: 3
Opaque cornea; iris not discernible through the opacity: 4
Iris:
Normal: 0
Markedly deepened rugae, congestion, swelling moderate circumcorneal hyperaemia;
or injection; iris reactive to light : 1
Hemorrhage, gross destruction, or no reaction to light: 2
Conjunctiva:
Redness(refers to palpebral and bulbar conjunctivae; exluding cornea and iris)
Blood vessels normal: 0
Some blood vessels hyperaemia (injected): 1
Diffuse, crimson colour, individual vessels not easily discenible: 2
Diffuse beefy red: 3
Chemosis:
Swelling (refers to lids and/or nictating membranes)
No swelling: 0
Some swelling above normal: 1
Obvious swelling with partial eversion of lids: 2
Swelling with lids about half closed: 3
Swelling with lids more than half closed: 4
Maximum attainable score: 13
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- iris score
- Basis:
- mean
- Score:
- ca. 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 0 hr
- Remarks on result:
- other: Hazard category: none
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 0 hr
- Remarks on result:
- other: Hazard category: none
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Score:
- ca. 0.83
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hr
- Remarks on result:
- other: Hazard category: none
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Score:
- ca. 0.28
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hr
- Remarks on result:
- other: Hazard category: none
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect observed
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Reevaluation of the test results according to GHS criteria for classification:
|
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- According to GHS classification criteria the test substance ethylencyanhydrin has to be classified as non irritating to eyes (hazard category: none).
- Executive summary:
Mean conjunctiva redness and mean conjunctica chemosis score were determined to be 0.83 and 0.28 respectively. The effects were
fully reversible within 72h p.a. No other effects were observed.
Conclusion:
According to GHS classification criteria the test substance ethylencyanhydrin has to be classified as non irritating to eyes (hazard
category: none).
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