Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
GRO 266
SAT 080010
Batch-No.: GRO-RN-9810-003

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: second eye served as control
Amount / concentration applied:
undiluted
Amount applied: 0.1 g
Duration of treatment / exposure:
24 hour(s)
Observation period (in vivo):
24, 48, 72 hours
Number of animals or in vitro replicates:
3
Details on study design:
Comment: not rinsed

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 hour
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
other: animal #1 and #3
Time point:
other: 48 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 48 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: redness
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 hour
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: chemosis
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: chemosis

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based upon the reffered clasification criteria (Commossion Directive 2001/59/EC of August 06, 2001), GRO 266 is considered to be "not irritating" tothe rabbit eye.
based upon the Kay and Calandra classification criteria, GRO 266 is considered to be "slightly irritating" to the rabbit eye (Maximum Average Score = 8.00).
Executive summary:

The primary eye irritation of GRO 266 was investigated according to OECD test guideline no. 405. The test item was applied by instillation of 0.1 g into the left eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test item instillation.

The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for the conjunctivae were 0.33, 0.67 and 0.33 for reddening and 0.00 for chemosis for each of the three animals.

The instillation of GRO 266 into the eye resulted in mild to moderate, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, discharge and chemosis. These effects were reversible and were no longer evident 72 hours after treatment in all animals. No abnormal findings were observed in the cornea or iris of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. No staining of the treated eyes by the item was observed and no clinical signs were observed.

Thus, the test item did not induce significant or irreversible damage to the rabbit eye.

Based upon the referred classification criteria (Commission Directive 2001/59/EC of August 06, 2001), GRO 266 is considered to be "not irritating" to the rabbit eye.

Based upon the Kay and Calandra classification criteria, GRO 266 is considered to be "slightly irritating" to the rabbit eye (Maximum Average Score = 8.00).