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EC number: 220-395-5 | CAS number: 2752-17-2
- 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:
- 1983-09-02 - 1983-10-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,2'-oxydi(ethylamine)
- EC Number:
- 220-395-5
- EC Name:
- 2,2'-oxydi(ethylamine)
- Cas Number:
- 2752-17-2
- Molecular formula:
- C4H12N2O
- IUPAC Name:
- 2-(2-aminoethoxy)ethan-1-amine
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 5601-22-1, Order #J-170
- Substance type: clear liquid
- Physical state: liquid
- Purity: responsibility of the sponsor
- Stability under test conditions: There was no apparent change in the physical state of the test article during administration
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Sgarlat's Rabbitry, Harvey's Lake, Pennsylvania
- Weight at study initiation: 2 - 3 kilograms
- Housing: Rabbits were housed individually in cages sized in accordance with the "Guide for the Care and Use of Laboratory Animals" of the Institute of Laboratory Resources, National Research Council.
- Diet (e.g. ad libitum): Wayne Rabbit Ration, ad libitum, checked daily and added or replaced as needed. Feeders are designed to reduce soiling, bridging and scattering.
- Water (e.g. ad libitum): Availability - fresh tap water, fit for human consumption, ad libitum, using 16 ounce glass bottles with rubber stopper and stainless steel sipper tube or an automatic watering system supplied by Edstrom Industries, Inc., Waterford, Wisconsin.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 30 to 70%
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the contralateral eye remained untreated and served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- frequency and duration of administration: once
The upper and lower lids were then gently held together for one second to prevent loss of material. - Observation period (in vivo):
- The eyes were examined at 1, 24, 48 and 72 hours and 7, 10 and 13 days after treatment. The grades of ocular reaction were recorded at each examination.
- Number of animals or in vitro replicates:
- six animals (three males and three females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: No data
SCORING SYSTEM: An animal exhibited a positive reaction when the test substance produced one or more of the following signs: ulceration of the cornea (other than a fine stippling), 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 and a diffuse crimson color with individual vessels not easily discernible. Grading of irritation is according to the method of Draize, J.H., et al., J. Pharm, Exp. Ther. 82: 377-390, (1944).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: Day 13
- Score:
- 98.4
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 13 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 7
- Max. score:
- 12
- Reversibility:
- not fully reversible within: 13 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 11
- Max. score:
- 12
- Reversibility:
- not fully reversible within: 13 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 11
- Max. score:
- 12
- Reversibility:
- not fully reversible within: 13 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 12
- Max. score:
- 12
- Reversibility:
- not fully reversible within: 13 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 8
- Max. score:
- 12
- Reversibility:
- fully reversible within: 13 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 12
- Max. score:
- 12
- Reversibility:
- not fully reversible within: 13 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 5
- Max. score:
- 10
- Reversibility:
- not fully reversible within: 13 days
- Remarks on result:
- other: see "Remarks"
- Remarks:
- beyond this time point, high degree of opacity prevented scoring of iris
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 10
- Max. score:
- 10
- Reversibility:
- not fully reversible within: 13 days
- Remarks on result:
- other: see 'Remarks'
- Remarks:
- beyond this time point, high degree of opacity prevented scoring of iris
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 10
- Max. score:
- 10
- Reversibility:
- not fully reversible within: 13 days
- Remarks on result:
- other: see 'Remarks'
- Remarks:
- beyond this time point, high degree of opacity prevented scoring of iris
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 10
- Max. score:
- 10
- Reversibility:
- not fully reversible within: 13 days
- Remarks on result:
- other: see 'Remarks'
- Remarks:
- beyond this time point, high degree of opacity prevented scoring of iris
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 10
- Max. score:
- 10
- Reversibility:
- not fully reversible within: 13 days
- Remarks on result:
- other: see 'Remarks'
- Remarks:
- beyond this time point, high degree of opacity prevented scoring of iris
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 46
- Max. score:
- 60
- Reversibility:
- not fully reversible within: 13 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 50
- Max. score:
- 60
- Reversibility:
- not fully reversible within: 13 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 54
- Max. score:
- 60
- Reversibility:
- not fully reversible within: 13 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 50
- Max. score:
- 60
- Reversibility:
- not fully reversible within: 13 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 50
- Max. score:
- 60
- Reversibility:
- not fully reversible within: 13 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 42
- Max. score:
- 60
- Reversibility:
- not fully reversible within: 13 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 7
- Max. score:
- 12
- Reversibility:
- not fully reversible within: 13 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 8
- Max. score:
- 12
- Reversibility:
- not fully reversible within: 13 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 10
- Max. score:
- 12
- Reversibility:
- not fully reversible within: 13 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 8
- Max. score:
- 12
- Reversibility:
- not fully reversible within: 13 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 9
- Max. score:
- 12
- Reversibility:
- not fully reversible within: 13 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 6
- Max. score:
- 12
- Reversibility:
- not fully reversible within: 13 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Reversibility:
- not fully reversible within: 13 days
- Remarks on result:
- other: see 'Remarks'
- Remarks:
- high degree of opacity prevented scoring of iris
- Irritant / corrosive response data:
- Positive ocular responses were observed at 1, 24, 48 and 72 hours and on Days 7, 10 and 13. Rupture of the globe, conjunctival necrosis and decreased body tone were observed during the course of the study.
- Other effects:
- One rabbit was found dead on Day 6 of the study. Necropsy revealed distended intestines filled with mucous and gelatinous material. The death was determined to be non-compound related (mucoid enteritis).
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The substance was instilled in the right eye of six rabbits. Ocular readings were observed at 1, 24, 48 and 72 hours and 7, 10 and 13 days following administration of the test article. Positive ocular responses were recorded at 1, 24, 48 and 72 hours and on Days 7, 10 and 13. Rupture of the globe, conjunctival necrosis and decreased body tone were observed during the course of the study. The Draize score was observed to be 98.4. Based on the test results and the criteria of the CLP Regulation, the substance should be classified in category 1 (irreversible effects on the eye).
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