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EC number: 601-101-8 | CAS number: 111497-86-0
- 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:
- 28 November 1997 - 09 January 1998
- 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-Propenoic acid, (1-methyl-1,2-ethanediyl) bis[oxy(methyl-2,1-ethanediyl)] ester, reaction products with diethylamine
- EC Number:
- 601-101-8
- Cas Number:
- 111497-86-0
- Molecular formula:
- Molecular formula not available for this UVCB.
- IUPAC Name:
- 2-Propenoic acid, (1-methyl-1,2-ethanediyl) bis[oxy(methyl-2,1-ethanediyl)] ester, reaction products with diethylamine
- Test material form:
- other: Liquid
- Details on test material:
- - Name of test material (as cited in study report): CN386- Physical state: Clear colorless liquid- Lot/batch No.: CK664- Storage condition of test material: At room temperature and humidity
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS- Source: Ace Animals, Boyertown, PA, USA- Weight at study initiation: 2.1 - 2.3 kg- Housing: Individually in suspended metal cages- Diet (e.g. ad libitum): Purina Rabbit Chow (Diet no. 5321)- Acclimation period: At least 5 daysENVIRONMENTAL CONDITIONS- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The contralateral eye remained untreated.
- Amount / concentration applied:
- A 0.1 ml amount of the test substance was placed into the conjunctival sac of the lower everted lid of one eye of each animal.
- Duration of treatment / exposure:
- The eyelids were then gently held together for one second before releasing.
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE- Washing (if done): NoneSCORING SYSTEM: Draize scaleTOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Corneal opacity and conjunctival irritation, noted in 3/3 eyes, cleared by Day 7. Iritis, noted in 3/3 eyes, cleared by Day 3.
- Other effects:
- One instance of diarrhea was the only abnormal physical sign noted during the observation period.
Any other information on results incl. tables
Table 1: Ocular findings and systemic observations | ||||||||
Animal no. | Item | Tissue | Reading | 1 h | 24 h | 48 h | 72 h | 7 d |
1 | A | Cornea | Opacity | 2 | 2 | 2 | 2 | 0 |
B | Area | 2 | 2 | 2 | 1 | 0 | ||
1. Total = (AxB)x5 | 20 | 20 | 20 | 10 | 0 | |||
C | Iris | 0 | 1 | 1 | 0 | 0 | ||
2. Total = Cx5 | 0 | 5 | 5 | 0 | 0 | |||
D | Conjunctiva | Redness | 2 | 2 | 2 | 1 | 0 | |
E | Chemosis | 3 | 3 | 2 | 2 | 0 | ||
F | Discharge | 2 | 2 | 2 | 2 | 0 | ||
3. Total = (D+E+F)x2 | 14 | 14 | 12 | 10 | 0 | |||
Total = 1+2+3 | 34 | 39 | 37 | 20 | 0 | |||
Systemic observations | A | A | A | A | A | |||
Pretest bodyweight | 2.2 kg | |||||||
Animal no. | Item | Tissue | Reading | 1 h | 24 h | 48 h | 72 h | 7 d |
2 | A | Cornea | Opacity | 2 | 2 | 2 | 2 | 0 |
B | Area | 2 | 2 | 2 | 1 | 0 | ||
1. Total = (AxB)x5 | 20 | 20 | 20 | 10 | 0 | |||
C | Iris | 1 | 1 | 0 | 0 | 0 | ||
2. Total = Cx5 | 5 | 5 | 0 | 0 | 0 | |||
D | Conjunctiva | Redness | 2 | 2 | 1 | 1 | 0 | |
E | Chemosis | 2 | 2 | 2 | 2 | 0 | ||
F | Discharge | 2 | 2 | 2 | 0 | 0 | ||
3. Total = (D+E+F)x2 | 12 | 12 | 10 | 6 | 0 | |||
Total = 1+2+3 | 37 | 37 | 30 | 16 | 0 | |||
Systemic observations | A | A | A | D | A | |||
Pretest bodyweight | 2.3 kg | |||||||
Animal no. | Item | Tissue | Reading | 1 h | 24 h | 48 h | 72 h | 7 d |
3 | A | Cornea | Opacity | 2 | 2 | 2 | 2 | 0 |
B | Area | 2 | 3 | 3 | 2 | 0 | ||
1. Total = (AxB)x5 | 20 | 30 | 30 | 20 | 0 | |||
C | Iris | 1 | 1 | 0 | 0 | 0 | ||
2. Total = Cx5 | 5 | 5 | 0 | 0 | 0 | |||
D | Conjunctiva | Redness | 2 | 2 | 1 | 1 | 0 | |
E | Chemosis | 2 | 2 | 2 | 2 | 0 | ||
F | Discharge | 2 | 2 | 2 | 2 | 0 | ||
3. Total = (D+E+F)x2 | 12 | 12 | 10 | 10 | 0 | |||
Total = 1+2+3 | 37 | 47 | 40 | 30 | 0 | |||
Systemic observations | A | A | A | A | A | |||
Pretest bodyweight | 2.1 kg | |||||||
Mean scores | 36 | 41 | 36 | 22 | 0 | |||
A: normal; D: diarrhea |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Under the test conditions, the test substance was considered to be irritating but not corrosive to eyes.
- Executive summary:
A study was performed to assess the eye irritancy potential of the test substance in New Zealand White rabbits according to OECD Guideline 405.
A single ocular dose of 0.1 mL of test substance was applied into the lower everted lid of one eye of each animal. The eyelids were then gently held together for one second before releasing. Examination of the eyes was made 1, 24, 48 and 72 hours post dose, then on Day 7. SCoring was conducted according to the method of Draize. The general health of the animals was monitored at each observation time. Bodyweights were recorded pretest.
Corneal opacity and conjunctival irritation, noted in 3/3 eyes, cleared by Day 7. Iritis, noted in 3/3 eyes, cleared by Day 3. One instance of diarrhea was the only abnormal physical sign noted during the observation period.
Under the test conditions, the test substance was considered to be irritating but not corrosive to eyes.
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