Registration Dossier

Administrative data

Endpoint:
eye irritation, other
Remarks:
In vivo study available.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1997-04-07 to 1997-04-12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: A well conducted study according to guidelines and done in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report):4-Oxotempo
- Physical state: Liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Chesire, UK
- Age at study initiation:12-16 weeks
- Weight at study initiation: 2.6-3.04 kg
- Housing:Suspended metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-22
- Humidity (%): 43-56
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 ml


Duration of treatment / exposure:
The upper and lower eyelids were held together for about one second immediately after instillation, to prevent loss of
the test material, and then released.
Observation period (in vivo):
1, 24, 48, 72 hours
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Remarks:
group
Time point:
other: 1 hour
Score:
8.7
Max. score:
18
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Kay and Calandra Classifiation System
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 hours

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
2,2,6,6-Tetramethyl-4-oxopiperidinooxy instilled into the eyes of three rabbits resulted in mild to moderate conjunctival irritation, diffuse corneal
opacity and iridial inflammation. All effects cleared by 48 or 72 hours. The test material was mildly irritating according to the Kay and Calandra
classification system. It was not classified as irritating by OECD GHS standards.
classified as irritating by OECD GHS criteria.
Executive summary:

A GLP study was performed in accordance with OECD guideline 405, to assess the effect of 2,2,6,6,-tetramethyl-4 -oxopiperindinooxy when administered to the eye.

 A single dose of 0.1 ml of test material was applied to the right eye of three New Zealand white rabbits. Assessment of the animals was made at 1 hour, 24, 48 and 72 hours after treatment.

The test material produced a maximum group mean score of 8.7 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye using a modified Kay and Calandra classification system.

No classification with respect to eye irritancy is required.