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Toxicological information

Eye irritation

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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:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
observation period (8 d)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- 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 24 - 72 h 1.00   0.33 2.00 1.00    
mean 24 - 72 h 1.00   0.00 2.00 1.00    
mean 24 - 72 h 1.00   1.00 2.00 1.00    
mean 24 - 72 h 1.00   0.44 2.00 1.00    

Applicant's summary and conclusion

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, 2,6 -xylidine has to be considered as eye irritant Cat. 2A according to GHS requirements). The criteria are not met for R36 according to EU classification.