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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Test material

Constituent 1
Reference substance name:
Automatically generated during migration to IUCLID 6, no data available
IUPAC Name:
Automatically generated during migration to IUCLID 6, no data available
Details on test material:
Nature of substance: Powder

Test animals / tissue source

Species:
other: Rabbit (New Zealand White)

Test system

Amount / concentration applied:
CA 54 MG
Number of animals or in vitro replicates:
3

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:
3
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
3
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
3
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Max. score:
3
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 3 (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:
2
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
1.3
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:
2
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
1.3
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.7
Irritation parameter:
cornea opacity score
Max. score:
2
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 2 (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:
1
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.7
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.7
Irritation parameter:
iris score
Max. score:
1
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 1 (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 21 days
Other effects:
Instillation of 54 mg of the test substance into one eye of
each of three rabbits resulted in effects on the
conjunctivae, cornea and iris.


Conjunctivae irritation was seen as redness, chemosis and
discharge. Redness was also observed at the outside of the
eyelids in one animal between 1 and 2 hours. Irritation of
the conjunctivae had completely resolved within 21 days in
all animals.


Corneal injury was seen as opacity and epithelial damage. As
a result of the corneal injury, pannus was apparent 7 days
or 14 days in the respective animal. Reduced elasticity of
the eyelids was noted in all animals after either 2, 3, 7
and 14 days respectively.


There was no evidence of ocular corrosion.


No staining of peri-ocular tissues by the test substance was
observed.

Remnants of the test substance were present in the eyes of
all animals on day 1.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information