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: Non-guidleine, non-GLP study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
No data.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
gas under pressure: refrigerated liquefied gas

Test animals / tissue source

Species:
rabbit

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 ml of undiluted test substance administered to the eye of each animal.
Duration of treatment / exposure:
5 minute exposure and 24-hour exposure
Observation period (in vivo):
Observations at 5 mins, 24hours and 48 hours.
30 days recovery.
Number of animals or in vitro replicates:
2 groups of 8

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 5 minutes
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 5-minute exposure
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 hours
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 5 minute and and 24 hour exposures
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 hours
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 5 minute and and 24 hour exposures
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 hours
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 24 hour exposure
Irritant / corrosive response data:
The substance is severely corrosive to the eyes of rabbits. Effects were immediate and severe, and irrevesible after a 30-day recovery period.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is severely corrosive to the eyes of rabbits. Effects were immediate and severe, and irrevesible after a 30-day recovery period.