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EC number: 201-758-7 | CAS number: 87-62-7
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:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 12 May 1981
- Deviations:
- yes
- Remarks:
- observation period (8 d)
- GLP compliance:
- no
Test material
- Reference substance name:
- 2,6-xylidine
- EC Number:
- 201-758-7
- EC Name:
- 2,6-xylidine
- Cas Number:
- 87-62-7
- Molecular formula:
- C8H11N
- IUPAC Name:
- 2,6-dimethylaniline
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 2,6-Dimethylanilin
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach/Main, D
- Mean weight at study initiation: male 3.03 kg; females 2.92 kg
- Housing: individually
- Diet (ca. 130g/ animal*d): Ovator Solikanin, Musaktor-Werke, Duesseldorf, D
- Water (ca. 250 mL/animal*d): tap water
- Acclimation period: ca. 8 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- unspecified
- Observation period (in vivo):
- 8 d
- Number of animals or in vitro replicates:
- 3 (one male, two females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no removal
SCORING SYSTEM: OECD Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24-48-72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 d
- Remarks on result:
- other: see table for details
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-48-72 h
- Score:
- 0.44
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 d
- Remarks on result:
- other: see table for details
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24-48-72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 d
- Remarks on result:
- other: see table for details
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24-48-72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 d
- Remarks on result:
- other: see table for details
Any other information on results incl. tables
| Exposition: | unspecified | |||||||
| Animal | Reading | Opacity | Cornea area | Iritis | Redness | Chemosis | Discharge | Symptoms |
| 1 | 1 h | 0 | 0 | 1 | 3 | 2 | 3 | pupil constricted |
| 2 | 1 h | 0 | 0 | 1 | 3 | 2 | 3 | pupil constricted |
| 3 | 1 h | 0 | 0 | 1 | 3 | 2 | 3 | pupil constricted |
| 1 | 24 h | 1 | 4 | 0 | 2 | 1 | 0 | |
| 2 | 24 h | 1 | 4 | 0 | 2 | 1 | 2 | purulence |
| 3 | 24 h | 1 | 3 | 1 | 2 | 1 | 1 | |
| 1 | 48 h | 1 | 4 | 0 | 2 | 1 | 0 | |
| 2 | 48 h | 1 | 4 | 0 | 2 | 1 | 2 | purulence |
| 3 | 48 h | 1 | 3 | 1 | 2 | 1 | 1 | |
| 1 | 72 h | 1 | 4 | 1 | 2 | 1 | 1 | pupil constricted |
| 2 | 72 h | 1 | 3 | 0 | 2 | 1 | 1 | pupil constricted/purulence/ scar on the eyelid |
| 3 | 72 h | 1 | 2 | 1 | 2 | 1 | 1 | pupil constricted/ scar on the eyelid |
| 1 | 8 d | 0 | 0 | 0 | 1 | 0 | 0 | |
| 2 | 8 d | 0 | 0 | 0 | 1 | 0 | 0 | scar on the eyelid |
| 3 | 8 d | 0 | 0 | 0 | 0 | 0 | 0 | scar on the eyelid |
| mean animal 1 | 24 - 72 h | 1.00 | 0.33 | 2.00 | 1.00 | |||
| mean animal 2 | 24 - 72 h | 1.00 | 0.00 | 2.00 | 1.00 | |||
| mean animal 3 | 24 - 72 h | 1.00 | 1.00 | 2.00 | 1.00 | |||
| overall mean | 24 - 72 h | 1.00 | 0.44 | 2.00 | 1.00 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Conclusions:
- Based on the effect of the temporarily constricted eyelids as sign for iritis and the moderate conjunctivae redness, 2,6 -xylidine has to be considered as eye irritant Cat. 2A according to GHS requirements).
- Executive summary:
The study was performed according to OECD 405. Three rabbits were exposed to 0.1 mL test substance; eyes were not washed out. The animals were observed for 8 d.
Slight corneal opacity, iritis and chemosis were completely reversible within 8 d. Moderate conjunctivae redness was not fully reversible in 2/3 animals within 8 d. However, a clear trend over time for decreasing effect strength was observable, and in 1/3 animals the redness was completely reversible. As additional effect, contracted pupils as reversible effect in all animals (a sign for iritis) and scars on the eyelid in 2/3 animals at the end of the observation period were observed. Since a observation period of 21 d was not exhausted as recommended in the actual guideline, the complete reversibility of the relevant conjunctivae redness can only be assumed.
Conclusion: Based on the effect of the temporarily constricted eyelids as sign for iritis and the moderate conjunctivae redness, 2,6 -xylidine has to be considered as eye irritant Cat. 2 according to GHS requirements).
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