Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
eye irritation
Adequacy of study:
other information

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD-guideline No. 405 (February 24, 1987. Adopted.) EEC Directive 67/548/EEC, Annex V, B.5.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Nature of substance: solid

Test animals / tissue source

Species:
other: rabbits

Test system

Amount / concentration applied:
100 MG
Number of animals or in vitro replicates:
1

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Max. score:
1
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 1 (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
3
Irritation parameter:
chemosis score
Max. score:
3
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 3 (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
4
Irritation parameter:
cornea opacity score
Max. score:
4
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 4 (related to all animals)
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
2
Irritation parameter:
iris score
Max. score:
2
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 2 (related to all animals)
Other effects:
At 1 hour after conjunctival application opalescence was
visible on the entire cornea. The iris was also affected.
The conjunctiva was very pale; blood vessels could not be
observed. Obvious chemosis with the eye lids about half
closed was noted.

At 24 hours after conjunctival application the cornea was
completely opaque. The iris could hardly be seen. Very
slight conjunctival erythema and marked chemosis were noted.

Attendant eye reactions such as increased lacrimation,
abnormal reflection to light and increased discharge were
present at 1 hour and 24 hours after conjunctival
application.

Because of the extreme eye irritation and the attendant
ocular reactions it was decided to sacrifice the rabbit
after the readings at 24 hours after conjunctival
application to avoid further suffering of the rabbit.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information