Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No GLP defined.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid
Details on test material:
IUCLID4 Test substance: as prescribed by 1.1 - 1.4
content: 99.9 %

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 3,4- 3,5 kg.
- Housing: individually
- Diet ad libitum
- Water ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
not specified
Controls:
other: the untreated second eye served as control
Amount / concentration applied:
100 µl (bulk volume = ca 90 mg test substance)
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
Ca 90 mg ofundissolved test substance was applied into the conjunctival sac of one eye (ther other served as control) of each of 3 rabbits; lids were pressed together for one second. 24 hours later the treated eyes were rinsed with saline solution and observed for further 7 days. Eye reactions were evauated according to Draize.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 7d
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: not irritant or corrosive
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 7d
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: not irritant or corrosive
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 7d
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: not irritant or corrosive
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 7d
Score:
ca. 0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: not irritant or corrosive
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 7d
Score:
ca. 0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: not irritant or corrosive
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 7d
Score:
ca. 0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: not irritant or corrosive
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 7d
Score:
ca. 0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: not irritant or corrosive
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: up to 48h
Score:
ca. 1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: a reddening an swelling was observed
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 7d
Score:
ca. 0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: not irritant or corrosive
Irritant / corrosive response data:
No irritating effects were observed

Any other information on results incl. tables

no irritant or corrosive effect in rabbit eye.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

Eye irritation was tested in rabbits using the OECD TG 405. Ca 90 mg of undissolved test substance was applied into the conjunctival sac of one eye (the other served as control) of each of 3 rabbits and lids were pressed together for one second. 24 hours later the treated eyes were rinsed with saline solution and observed for further 7 days. Eye reactions were evauated according to Draize.

P-dichlorobenzene had no irritating or corrosive effect in adult rabbit eyes.Therefore no local risk potential for eyes of rabbits exists