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EC number: 242-217-5 | CAS number: 18328-90-0
- 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:
- 8-15 October 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Data presented as a summary report to TSCA under the Section 8 (e) Compliance Audit Programme for Reportable Adverse Effects. A full study report is not available for evaluation of the overall study reliability but the data summary presented to TSCA is adequate to determine the acute endpoint.
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- N-ethyl methyl allylamine
- IUPAC Name:
- N-ethyl methyl allylamine
- Reference substance name:
- N-ethylmethacrylamine
- EC Number:
- 242-217-5
- EC Name:
- N-ethylmethacrylamine
- Cas Number:
- 18328-90-0
- Molecular formula:
- C6H13N
- IUPAC Name:
- N-ethyl-2-methylprop-2-en-1-amine
- Test material form:
- other: clear yellowish liquid
- Details on test material:
- - Name of test material (as cited in study report): C-1033 (N ethyl methyl allylamine)
- Physical state: clear yellowish liquid
- Analytical purity: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Storage condition of test material: 60-85°F (circa 16-30°C)
- Other: Specific Gravity stated as 0.78 g/mL
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: No data
- Age at study initiation: No information
- Weight at study initiation: No data
- Fasting period before study: No data
- Housing: No information
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: animals received on 2 September 1986 and dosed on 8 October 1986
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Room monitored over temperature range of circa 16-30°C
- Humidity (%): No information
- Air changes (per hr): No information
- Photoperiod (hrs dark / hrs light): no data
IN-LIFE DATES: From: 8 October 1986 To: 15 October 1986
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 mL undiluted
- Duration of treatment / exposure:
- No indication of rinsing of the treated eye
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 4, two males and two females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no details
- Time after start of exposure: no data
SCORING SYSTEM: No details provided
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 6
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 5
- Remarks on result:
- positive indication of irritation
- Remarks:
- The cornea was completely opaque and ulcerated.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 40
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24 h
- Remarks on result:
- other: Unable to evaluate due to the severity of the corrosion.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 80
- Max. score:
- 4
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24 h
- Remarks on result:
- other: Unable to evaluate due to the severity of the corrosion.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 80
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24 h
- Remarks on result:
- other: Unable to evaluate due to the severity of the corrosion.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24 h
- Remarks on result:
- other: Unable to evaluate due to the severity of the corrosion.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 80
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24 h
- Remarks on result:
- other: Unable to evaluate due to the severity of the corrosion.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24 h
- Remarks on result:
- other: Unable to evaluate due to the severity of the corrosion.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 2, 3 and 4
- Time point:
- 7 d
- Remarks on result:
- not determinable
- Remarks:
- Test terminated. The animals were killed for humane reasons.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: all animals
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Remarks:
- Measurements not taken at this timepoint.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: All animals
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Remarks:
- Measurements not taken at this timepoint.
- Irritation parameter:
- iris score
- Basis:
- animal: All animals
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Remarks:
- Measurements not taken at this timepoint.
- Irritation parameter:
- iris score
- Basis:
- animal: All animals
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Remarks:
- Measurements not taken at this timepoint.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: All animals
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Remarks:
- Measurements not taken at this timepoint.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: All animals
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Remarks:
- Measurements not taken at this timepoint.
- Irritant / corrosive response data:
- C-1033 was corrosive to the eye. Three of the four animals vocalized after test material administration, and at two hours exhibited corrosion of the conjunctivae (necrosis, ulceration) and the cornea was completely opaque and ulcerated.
Due to the opacity, the iris could not be evaluated. These animals were therefore killed for humane reasons. The fourth animal exhibited only slight conjunctival irritation, iritis, corneal opacity and ulceration at 24 hours. The lower outer eye lid was noted to be necrotic. Except for this necrosis and corneal stippling, this animal was free of ocular irritation by Day 7. It appears the test material did not remain in the eye long enough to produce as severe a response as noted in the other three animals.
Any other information on results incl. tables
|
Pre-test Obs. |
Rabbit 0876 F |
Pre-test Obs. |
Rabbit 0879 M |
|||||
R |
L |
24 h |
Day 7 |
R |
L |
24 h |
Day 7 |
||
Conjunc-tiva |
Redness |
0 |
0 |
1 |
0 |
0 |
0 |
NE |
Terminated |
Chemosis |
0 |
0 |
1 |
0 |
0 |
0 |
3 |
||
Discharge |
0 |
0 |
1 |
0 |
0 |
0 |
3 |
||
Necrosis |
0 |
0 |
0 |
0 |
0 |
0 |
N |
||
Ulceration |
0 |
0 |
0 |
0 |
0 |
0 |
U |
||
Score |
0 |
0 |
6 |
0 |
0 |
0 |
-- |
||
Iris |
Iris |
0 |
0 |
1 |
0 |
0 |
0 |
NE |
|
Score |
0 |
0 |
5 |
0 |
0 |
0 |
-- |
||
Cornea |
Opacity |
0 |
0 |
2 |
0 |
0 |
0 |
4 |
|
Area |
0 |
0 |
4 |
0 |
0 |
0 |
4 |
||
Stippling |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
||
Ulceration |
0 |
0 |
2 |
0 |
0 |
0 |
4 |
||
Fluorescein |
0 |
0 |
F |
F |
0 |
0 |
F |
||
Score |
0 |
0 |
40 |
0 |
0 |
0 |
80 |
|
Pre-test Obs. |
Rabbit 0891 M |
Pre-test Obs. |
Rabbit 0888F |
|||||
R |
L |
24 h |
Day 7 |
R |
L |
24 h |
Day 7 |
||
Conjunc-tiva |
Redness |
0 |
0 |
NE |
Terminated |
0 |
0 |
NE |
Terminated |
Chemosis |
0 |
0 |
3 |
0 |
0 |
3 |
|||
Discharge |
0 |
0 |
3 |
0 |
0 |
3 |
|||
Necrosis |
0 |
0 |
N |
0 |
0 |
N |
|||
Ulceration |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Score |
0 |
0 |
-- |
0 |
0 |
-- |
|||
Iris |
Iris |
0 |
0 |
NE |
0 |
0 |
NE |
||
Score |
0 |
0 |
-- |
0 |
0 |
-- |
|||
Cornea |
Opacity |
0 |
0 |
4 |
0 |
0 |
4 |
||
Area |
0 |
0 |
4 |
0 |
0 |
4 |
|||
Stippling |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Ulceration |
0 |
0 |
4 |
0 |
0 |
4 |
|||
Fluorescein |
0 |
0 |
F |
0 |
0 |
F |
|||
Score |
0 |
0 |
80 |
0 |
0 |
80 |
NE not evaluated due to severity of response
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Necrotic lesions indicatine a corrosive effect were observed in all treated eyes.
- Executive summary:
Four rabbits were treated by instillation of 0.1 mL of undiluted C-1033 (N-ethylmethylallylamine) to one eye. Lesions, including corneal opacity and conjunctival necrosis, developed in three of the eyes resulting in termination of the rabbits within two hours of dosing. The fourth eye also developed opacity and necrosis but the effects were slightly less severe. However the lesions, including an area of necrosis, persisted at day 7.
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