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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 study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 3,4-Dichloranilin
- Physical state: solid, crystalline
- Analytical purity: not reported
- Lot/batch No.: GEAC 40, December 1985
- Storage condition of test material: 22 °C, dark, 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, conventional breeding
- Age at study initiation: 3-5 months
- Weight at study initiation: 1.9-3.0 kg
- Housing: individually in cages, marked by ear tags
- Diet: ad libitum, Altromin 2123, 15 g hay per day
- Water: ad libitum, deionized, chlorinated

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

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
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): physiological saline solution, 37 °C
- Time after start of exposure: 24h and after every examination with fluorescein


SCORING SYSTEM: according to OECD guideline 404

TOOL USED TO ASSESS SCORE: fluorescein 0.01 %

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: average over 24, 48 and 72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: average over 24, 48 and 72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 d
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: average over 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: average over 24, 48 and 72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: average over 24, 48 and 72 h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 7 d
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: average over 24, 48 and 72 h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: average over 24, 48 and 72 h
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: average over 24, 48 and 72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: average over 24, 48 and 72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: average over 24, 48 and 72 h
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: average over 24, 48 and 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: average over 24, 48 and 72 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible within: 7 d
Other effects:
Fluorescein test (elucidation of cornea under UV-light after fluorescein treatment of the eye):
0= no elucidation
1= punctual to 1/4 of cornea elucidated
2= more than 1/4 to 1/2 of cornea elucidated
3= more than 1/2 to 3/4 of cornea elucidated
4= more than 3/4 to all of cornea elucidated

Result:
mean score (max. score) : 1.83 (3.5)
fully recovered within 7 days

one animal showed vascularisation of the cornea after 7 days

Any other information on results incl. tables

1 h post treatment the treated corneas of the rabbits were swollen and red and clear discharge was evident.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Xi/ R41
Conclusions:
Classification: risk of serious damage to eyes
Executive summary:

Hofmann, T and Weigand, W, 1986

The testing of 3,4 -dichloroaniline for eye irritation/ corrosion on three New Zealand White rabbits according to OECD guideline 405/ EU B.5 did result in mild irritation. Nevertheless vascularisation of the cornea was observed in one animal as late as 7 days post application. Vascularisation of the cornea is to be considered a severe damage to the eye, since it leads to destruction of corneal transparency. Therefore 3,4 -dichloroaniline was classified as irritating.