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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: GLP-Guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
Cited as Directive 84/449/EEC, B.5
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-chloroaniline
EC Number:
202-426-4
EC Name:
2-chloroaniline
Cas Number:
95-51-2
Molecular formula:
C6H6ClN
IUPAC Name:
2-chloroaniline
Details on test material:
- Name of test material (as cited in study report): 2-chloroaniline
- Physical state: yellow liquid
- Analytical purity: >99 %
- Lot/batch No.: October 1985
- Storage condition of test material: dark at room temperature under fume hood

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund
- Age at study initiation: 3-5 months
- Weight at study initiation: 2,2-3,1 kg
- Housing: air-conditioned, individually, marked by ear tag
- Diet: ad libitum, altromin 2123, 15 g hay
- Water: ad libitum, tap water
- Acclimation period: in house

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: not required, right eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
24 h
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): yes, 37°C warm physiological saline
- Time after start of exposure: 24 h


SCORING SYSTEM: according to EU Method B4 (edema score and erythema score for 3 individual animals)


TOOL USED TO ASSESS SCORE: hand-slit lamp fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48 and 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 d
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48 and 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 d
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48 and 72 h
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48 and 72 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48 and 72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48 and 72 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48 and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48 and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h

Any other information on results incl. tables

time post-application  1 h  24 h  48 h  72 h  7 d
animal no.  1/2/3  1/2/3  1/2/3  1/2/3  1/2/3
chemosis score  3/2/2  1/1/0  0/0/0  0/0/0  0/0/0
conjunctivae score  1/2/1  2/2/2  1/2/1  1/1/1  0/0/0
 iris score  0/0/0  1/1/1  1/1/0  1/1/1 0/0/0 
 cornea score  1/1/1 1/1/1   1/1/1  1/1/1  0/0/0
 fluorescein test*  -  3/3/2    3/2/4  0/0/0
 Eye discharge, clear  x/x/x        
 Eye discharge white    -/-/x      
 Iris, reddening    x/x/x  x/x/-  x/x/x  

* elucidation of cornea under UV light after fluorescein administration to the eye.

0= no elucidation

1= punctual to 1/4 of cornea elucidated

2= >1/4 to 2/4 of cornea elucidated

3= >2/4 to 3/4 of cornea elucidated

4= >3/4 to 4/4 of cornea elucidated

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Xi R36 Criteria used for interpretation of results: EU
Conclusions:
Classification: irritating
Executive summary:

Hofmann, W and Weigand, W (1986)

The test for eye irritation according to EU method B.5 with 0.5 mL o-chloroaniline on 3 New Zealand White rabbits resulted in reversible (7 days) conjungtivitis, opacity and reddening of the iris in such a way that o-chloroaniline should be classified as irritating to the eye.