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)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Remarks:
However was subject to Quality Assurance

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
100mg
Duration of treatment / exposure:
Not applicable
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6 animals (3 washed and 3 unwashed)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24/48/72 hours
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: The study report only reports the conjunctival effects as "slight". Thus it is not possible to provide the actual scores.
Irritant / corrosive response data:
In unwashed eyes signs of slight irritation consisted of moderate erythema (3/3) and slight oedema (1/3) of the nictitating membranes. All effects were fully reversible by Day 7.

Any other information on results incl. tables

The report does not provide quantitative eye scoring data.

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria (Reg 1272/2008) are not met
Conclusions:
HQEE was slightly irritating to rabbit eye