Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity > 99%
Impurities: 2-chlorobenzyl chloride and 2-chlorobenzotrichloride each < 0.2%

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: no data
- Weight at study initiation: 2.8 - 3.5 kg
- Housing: individually
- Diet: Altromin 2013 ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2 °C
- Humidity (%): 55 +/- 10 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of test animal
Amount / concentration applied:
0.1 ml undiluted
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
Eyes were rinsed with physiological saline 24 hours after instillation.

Eyes were inspected for integrity before the testing. A solution of fluorescein, sodium salt (0.01%) was dropped into the eye. Then the cornea was investigated using UV radiation 24 hours before application. Afterwards eyes were rinsed.

24 and 72 hours after application eyes were examined for integrity in the same manner.

Results and discussion

In vivo

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

Any other information on results incl. tables

Animal Region Time after application
No.
1 24 48 72
h h h h
Conjunctivae-
1 Chemosis 1 1 1 0
Conjunctivae-
1 Redness 3 1 0 0
1 Iris 0 0 0 0
1 Cornea 0 0 0 0
Conjunctivae-
2 Chemosis 1 1 1 0
Conjunctivae-
2 Redness 3 1 1 0
2 Iris 0 0 0 0
2 Cornea 0 0 0 0
Conjunctivae-
3 Chemosis 1 1 1 0
Conjunctivae-
3 Redness 3 2 1 0
3 Iris 0 0 0 0
3 Cornea 0 0 0 0

Applicant's summary and conclusion

Conclusions:
Due to the result o-chlorobenzal chloride is not subject to specific labelling under current EU regulations.