Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,3-dichloroaniline
EC Number:
210-157-9
EC Name:
2,3-dichloroaniline
Cas Number:
608-27-5
Molecular formula:
C6H5Cl2N
IUPAC Name:
2,3-dichloroaniline
Details on test material:
- Name of test material (as cited in study report): 2, 3-dichloroaniline pure
- Physical state: liquid
- Analytical purity: 99.5%
- Lot/batch No.: 1
- Stability under test conditions: guaranteed for the study period
- Storage condition of test material: refrigerator

Test animals / tissue source

Species:
rabbit
Strain:
other:

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated eye served as control
Amount / concentration applied:
undiluted
Amount applied: 0.1 ml
Duration of treatment / exposure:
24 hour(s)
Observation period (in vivo):
1, 24, 48, and 72 hours, and 7 and 14 days
Number of animals or in vitro replicates:
3
Details on study design:
Comment: rinsed after (see exposure time)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
0.3
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
0.3
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
0.3
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
1.7
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
1.3
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
2
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
1.3
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Other effects:
-reaction of the mucous membranes occurred in all 3 rabbits: redness-score: 1.7/1.3/2.0 of max. 3,chemosis-score: 1.3/1.3/1.3 of max 4 -effects of the cornea in 2/3 rabbits: medium score: 1.0/0.3 of max. 4 -iris was transiently affected in 2/3 rabbits: medium score 0.3/0.3 of max. 2 -discharge was observed in all 3 rabbits

Applicant's summary and conclusion