Registration Dossier

Toxicological information

Eye irritation

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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
Principles of method if other than guideline:
- Organization for Economic Co-operation and Development
(OECD), OECD Guidelines for Testing of Chemicals, Section 4,
Health Effects, No.405, "Acute Eye Irritation / Corrosion",
Paris Cedex, 2002.


- European Community (EC), Council Directive 67/548/EEC,
Annex V, Part B, Methods for the Determination of Toxicity,
as last amended by Commission Directive 2004/73/EC, B.5:
"Acute Toxicity: Eye Irritation / Corrosion", 2004


- United States Environmental Protection Agency (EPA).
Health Effects Test Guidelines, OPPTS 870.2400, Acute Eye
Irritation. Office of Prevention, Pesticides and Toxic
Substances (7101), EPA 712-C-98-195, August 1998.


- Japanese Ministry of Agriculture, Forestry and Fisheries
(JMAFF), 12 Nousan, Notification No 8147, November 2000,
including the most recent partial revisions.
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: White crystalline powder (grounded)

Test animals / tissue source

Species:
other: New Zealand White albino rabbit

Test system

Amount / concentration applied:
CA 71 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: 99 h; Max. value at end of observation period: 0 (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:
1.7
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
1.3
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Irritation parameter:
chemosis score
Max. score:
4
Remarks on result:
other: Max. duration: 99 h; Max. value at end of observation period: 0 (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:
0.7
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: 99 h; Max. value at end of observation period: 0 (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:
0.7
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.3
Irritation parameter:
iris score
Max. score:
1
Remarks on result:
other: Max. duration: 72 h; Max. value at end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 14 days
Other effects:
No symptoms of systemic toxicity were observed in the
animals during the test period and no mortality occurred.


The corneal injury consisted of opacity (maximum grade 1 or
2) and epithelial damage (maximum 25, 50 or 75 % of the
corneal area). As a result of the corneal injury, pannus
(neovascularisation of the cornea) was apparent in one
animal 7 days after instillation.

The corneal injury had resolved within 72 hours, 7 days or
14 days.

Iridial irritation grade 1 was observed in two animals and
had resolved within 48 hours in one animal and within 72
hours in the other animal.

The irritation of the conjunctivae consisted of redness,
chemosis and discharge and had completely resolved within 14
days.

In one animal, reduced elasticity of the eyelids was
observed and had resolved within 15 days.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information