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 guideline study, no GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Method: other: BASF-Test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUCLID4 Test substance: as prescribed by 1.1 - 1.4

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Observation period (in vivo):
up to 8 days

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Time point:
other: 24 hrs
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
chemosis score
Time point:
other: 24 hrs
Score:
1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Time point:
other: 24 hrs
Score:
1
Max. score:
1
Reversibility:
fully reversible

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information
Conclusions:
On the basis of the findings, the test substance must be described as moderately irritating to the eyes.
Executive summary:

On the basis of the findings, the test substance must be described as moderately irritating to the eyes. When the test substance acts on the eyes, corneal opacity must be expected. The pathological findings on the eye and the signs of irritation to the eye substantially subsided within 8 days.