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EC number: 201-182-6 | CAS number: 79-16-3
- 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
- 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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-methylacetamide
- EC Number:
- 201-182-6
- EC Name:
- N-methylacetamide
- Cas Number:
- 79-16-3
- Molecular formula:
- C3H7NO
- IUPAC Name:
- N-methylacetamide
- Details on test material:
- - Name of test material (as cited in study report): N-METHYLACETAMIDE, 98/392-1
- Physical state: Colorless solid
- Analytical purity: 99.82% (GC)
- Lot/batch No.: Tank 143
- Date of manufacturing: September 24, 1998
- Stability: Reanalysis: stable until January 1999.
- Storage condition of test material: at room temperature (approx. 20°C) away from direct
sunlight.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombes F-0 1400 Chatillon sur Chalaronne
- Number of animals: 1 male, 2 females
- Age at study initiation: 15 weeks
- Weight at study initiation: male: 2.605 kg, females: 2.817 and 2.794 kg
- Housing: Individually in stainless steel cages with an automatic cleaning system equipped with feed hoppers, drinking water bowls, with haysticks and wood for gnawing.
- Diet (e.g. ad libitum): Pelleted standard Kliba 3410 rabbit maintenance diet ad libitum (batch no. 62/98). Provimi Kliba AG, 4303 Kaiseraugst, Switzerland.
- Water (e.g. ad libitum): Community tap water from Itingen, ad libitum, provided by water bowls.
- Acclimatization period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±3
- Humidity (%): 40-70
- Air changes (per hr): 10-15 air changes per hour,
- Photoperiod (hrs dark / hrs light): 12 hour Iight/dark cycle.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye remained untreated and served as the reference control.
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- TREATMENT
On the day of treatment, the test article (undiluted) was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of test article.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eyes were rinsed gently with bidistilled water.
- Time after start of exposure: approximately 24 hours after administration.
SCORING SYSTEM: The ocular reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992 at approximately 1, 24, 48 and 72 hours and 7, 14 and 21 days after administration.
TOOL USED TO ASSESS SCORE: Varta Cliptrix diagnostic-lamp (A. Riegger, Basel, Switzerland).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.11
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: for details see table below
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: for details see table below
Any other information on results incl. tables
Exposition: Single application to the conjunctival sac of the eyelid; the substance was washed out after 24 h |
||||||
Animal |
Reading |
Cornea Opacity |
Iris |
Conjunctiva |
Additional findings |
|
Redness |
Chemosis |
|||||
1 |
1 h |
0 |
0 |
2 |
1 |
nictitating membrane swollen, moderate watery discharge, sclera: blood vessels hyperemic. |
2 |
1 h |
0 |
0 |
2 |
1 |
nictitating membrane swollen, moderate watery discharge; sclera: blood vessels hyperemic. |
3 |
1 h |
0 |
0 |
2 |
1 |
nictitating membrane swollen, moderate watery discharge; sclera: blood vessels hyperemic. |
1 |
24 h |
0 |
0 |
1 |
1 |
slight swelling, blood vessels hyperemic. |
2 |
24 h |
0 |
0 |
2 |
1 |
nictitating membrane swollen, moderate watery discharge; sclera: blood vessels hyperemic. |
3 |
24 h |
0 |
0 |
2 |
1 |
nictitating membrane swollen, moderate watery discharge; sclera: blood vessels hyperemic. |
1 |
48 h |
0 |
0 |
1 |
0 |
- |
2 |
48 h |
0 |
0 |
1 |
0 |
- |
3 |
48 h |
0 |
0 |
1 |
0 |
sclera: blood vessels hyperemic. |
1 |
72 h |
0 |
0 |
1 |
0 |
- |
2 |
72 h |
0 |
0 |
0 |
0 |
- |
3 |
72 h |
0 |
0 |
1 |
0 |
sclera: blood vessels hyperemic. |
1 |
7 d |
0 |
0 |
1 |
0 |
- |
2 |
7 d |
0 |
0 |
0 |
0 |
- |
3 |
7 d |
0 |
0 |
1 |
0 |
sclera: blood vessels hyperemic. |
1 |
14 d |
0 |
0 |
0 |
0 |
- |
2 |
14 d |
0 |
0 |
0 |
0 |
- |
3 |
14 d |
0 |
0 |
0 |
0 |
sclera: blood vessels hyperemic.- |
1 |
21 d |
0 |
0 |
0 |
0 |
|
2 |
21 d |
0 |
0 |
0 |
0 |
|
3 |
21 d |
0 |
0 |
0 |
0 |
sclera: blood vessels hyperemic. |
mean animal 1 |
24 - 72 h |
0.00 |
0.00 |
1.00 |
0.33 |
|
mean animal 2 |
24 - 72 h |
0.00 |
0.00 |
1.00 |
0.33 |
|
mean animal 3 |
24 - 72 h |
0.00 |
0.00 |
1.33 |
0.33 |
|
mean |
24 - 72 h total |
0.00 |
0.00 |
1.11 |
0.33 |
|
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Conclusions:
- Due to irreversibility of the hyperemia of the scleral blood vessels in one animal and according to the conditions of the test, the test substance has to be classified as irritating to the eye following the GHS (Category 2 (A)) requirements.
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