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:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.1g
Observation period (in vivo):
1, 24, 48, 72 hours
Number of animals or in vitro replicates:
3 male animals

Results and discussion

In vivo

Results
Remarks on result:
other: please see "any other information on results incl. tables"
Remarks:
please see "any other information on results incl. tables"

Any other information on results incl. tables

OCULAR REACTION OBSERVED TREATED EYE

TISSUE TIME AFTER ADMINSTRATION  RABBIT NO 367  RABBIT NO 368
 cornea  60 minutes  0  0
   24 hours  0  0
   48 hours  0  0
   72 hours  0  0
 Iris  60 minutes  0  0
   24 hours  0  0
   48 hours  0  0
   72 hours  0  0
 Conjunctivae Congestion  60 minutes  1  0
   24 hours  0  0
   48 hours  0  0
   72 hours  0  0
 Conjunctivae Chemosis  60 minutes  0  0
   24 hours  0  0
   48 hours  0
   72 hours  0  0

Cornea: No abnormality was observed during the confirmatiory test

Iris: No abnormality was observed during the confirmatiory test

Conjunctivae (Congestion): Some blood vessels definitely hyperaemic were observed in the treated eye of the rabbit n. 367. No abnormality was observed in the treated eye of the rabbit N.368 during the confirmatory test.

Conjunctivae (Chemosis): Any swelling above normal was observed/ 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU