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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

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:
BASF internal testing method
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
50 mg
Duration of treatment / exposure:
1 hour
Observation period (in vivo):
1, 24, 144 hours
Number of animals or in vitro replicates:
no data
Details on study design:
SCORING SYSTEM:
Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 96 h
Remarks on result:
probability of weak irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 96 h
Remarks on result:
probability of weak irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The substance causes slight reversible cornea opacity and inflammation on iris. All pathological findings and irritations were fully reversible within 4 days.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In this study, slight reversible cornea opacity and inflammation of the iris was observed. All pathological findings and irritations were fully reversible within 4 days. The substance is not classifiable.
Executive summary:

In a primary eye irritation study, the test material was applied to the rabbit eye. Animals were observed for 6 days. Slight reversible cornea opacity and inflammation of the iris was observed. All pathological findings and irritations were fully reversible within 4 days.