Registration Dossier

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 405
GLP compliance:
yes

Test animals / tissue source

Species:
other: rbt, New Zealand White

Test system

Amount / concentration applied:
CA 100 MG
Number of animals or in vitro replicates:
4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Score:
0.33
Max. score:
1
Remarks on result:
other: Max. duration: 48 h; Max. value at end of observation period: 0
Irritation parameter:
chemosis score
Basis:
mean
Score:
0.41
Max. score:
3
Remarks on result:
other: Max. duration: 72 h; Max. value at end of observation period: 0
Irritation parameter:
cornea opacity score
Basis:
mean
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0
Irritation parameter:
iris score
Basis:
mean
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 9 days
Other effects:
Leichte bis mittelgradige Sekretion, Rötung und Schwellung
des äußeren Augenlids, Lidschluß, gering- bis hochgradige
Rötung, Schwellung der konjunktiven Injektion von
Blutgefäßen in konjunktive einschließlich Membrana
nicktitans, Injektion von Blutgefäßen in der Sklera.

"ENGLISH"

Slight to middle secretion, redness and swelling of the
outer eyelid, eyelid closure, slight to high degree rednsee,
swelling of the conjunctival injection of bloodvessels in
conjuntivae including membrana nicktitans, injection of
bloodvessel in the sclera.

Applicant's summary and conclusion

Interpretation of results:
other: not classified