Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to the OECD Guideline and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Batch No GST 4-20079
HLPC charakterization 99.8%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
undiluted , moistened
amound applied 100 mg (0.1 ml)
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
24, 48 and 72 hours, 6, 8, 10, 13, 15, 17, 21 days after administration (p.a.)
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h
Score:
1 - <= 1.7
Max. score:
1.7
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 6 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h
Score:
>= 1 - <= 3
Max. score:
3
Reversibility:
not fully reversible within: 21 days

Any other information on results incl. tables

The following scors were calculated for the individuell examinations:

cornea:                            1.3, 1.0, 1.7

Iris:                                   1.0 in all animals

Conjunctivae, redness       3.0, 3.0, 2.7

conjunctivae, chemiosis       1.7, 3.0, 2.3

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The testsubstance "DA 010894" Pyrazole DHE does require the risk phrase R 36 Irrtating to eyes
Executive summary:

According to the OECD Guideline 405 this Acute Eye Irritatio/Corrosion study was perfomed using 3 rabbits. The equivalent of 0.1 ml of test substance was instilled into the conjunctival sac of one eye of each 3 rabbits. The eyes were rinsed with warm water after 24h.

Eye examination 1, 24, 48, 72 and 6, 8, 10, 13, 15, 17, 21 days after administration (p.a.) of the test substance (ending individually, when animal was free of alterations.

Results:

The following scors were calculated for the individuell examinations:

cornea:                            1.3, 1.0, 1.7

Iris:                                   1.0 in all animals

Conjunctivae, redness       3.0, 3.0, 2.7

conjunctivae, chemiosis       1.7, 3.0, 2.3

Therfore the test subtance "DA 010894" Pyrazole DHE does require the risk phrase -Irritating to eyes.

Considering lesions, which were still noted 21 d after instillationin 1/3 animals, a serious damage to eyes cannot be excludet.