Registration Dossier

Administrative data

Endpoint:
eye irritation, other
Remarks:
in vivo study
Type of information:
other: read across from supporting substance
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago. The summary received is from migrated NONS dossier

Data source

Reference
Reference Type:
other: body responsible for the test
Title:
Unnamed
Year:
1999

Materials and methods

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

Test material

Constituent 1
Reference substance name:
refer to confidential details on test material
IUPAC Name:
refer to confidential details on test material

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Amount / concentration applied:
1 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
Time point:
other: mean value 24, 48 and 72h
Score:
ca. 1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean value 24, 48 and 72h
Score:
ca. 1
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Remarks:
redness
Basis:
animal #1
Time point:
other: mean value 24, 48 and 72h
Score:
ca. 0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean value 24, 48 and 72h
Score:
ca. 0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean value 24, 48 and 72h
Score:
ca. 0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean value 24, 48 and 72h
Score:
ca. 0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean value 24, 48 and 72h
Score:
ca. 0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: mean value 24, 48 and 72h
Score:
ca. 0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean value 24, 48 and 72h
Score:
ca. 0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: mean value 24, 48 and 72h
Score:
ca. 0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: mean value 24, 48 and 72h
Score:
ca. 0
Other effects:
the orange discolouration of the iris and of the cornea was observde while the effect was irrevesible after 21 days for the conjunctiva and sclera.

Applicant's summary and conclusion

Interpretation of results:
other: classified under Regulation 1272/2008
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The substance was tested for eye irritation following OECD 405. Under the experimental conditions the substance showed irreversible discolouration of the conjunctiva.
Executive summary:

The substance was tested for eye irritation following OECD 405. Under the experimental conditions the substance showed irreversible discolouration of the conjuncitvae after 21 days of observation.