Registration Dossier

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02 June to 24 June 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Remarks:
Study was not conducted in compliance with GLP, but is well documented and sufficient to cover this endpoint (conduction close to OECD 405).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
6 animals (3M / 3F) were used.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2,6,6-tetramethylpiperidinooxy
EC Number:
219-888-8
EC Name:
2,2,6,6-tetramethylpiperidinooxy
Cas Number:
2564-83-2
Molecular formula:
C9H18NO
IUPAC Name:
2,2,6,6-tetramethylpiperidin-1-ol
Test material form:
solid
Remarks:
color: orange
Details on test material:
purchased from Sigma Chemical Company, Munich, Germany.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Species/Strain: Rabbit (New Zealand albino)
- Source: R and B Enterprise, Hamilton OH
- Body weigth: 2.9 to 3.2 kg
- Housing: single housing in stainless steel cages
- Diet: Purina Lab Rabbit Chow HF #5325, 150 g daily
- Water: Water supplied from a reverse-osmosis purifier, ad libitum
- Acclimation period: 14 days befor the first test-substance application

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C
- Humidity (%): 40 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 g undiluted test item
Duration of treatment / exposure:
Test substance was not removed.
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
3M / 3F
Details on study design:
Undiluted test substance (0.1 g) was placed in the conjunctival sac of one eye, the other served as control. Test substance was not removed. Evaluation of results 1, 2, 3, 4, 7, 14 and 21 days after instillation of the test substance.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Remarks:
Animal was sacrificed after 7 days.
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Remarks:
Animal was sacrificed after 7 days.
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Remarks:
Animal was sacrificed after 7 days.
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Remarks:
Animal was sacrificed after 7 days.
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Remarks:
Animal was sacrificed after 7 days.
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Remarks:
Animal was sacrificed after 7 days.
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.33
Max. score:
3
Reversibility:
fully reversible within: 21 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Remarks:
Animal was sacrificed after 7 days.
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Remarks:
Animal was sacrificed after 7 days.
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 21 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Remarks:
Animal was sacrificed after 7 days.
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.67
Max. score:
4
Reversibility:
fully reversible within: 21 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Remarks:
Animal was sacrificed after 7 days.
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Remarks:
Animal was sacrificed after 7 days.
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
3.33
Max. score:
4
Reversibility:
fully reversible within: 21 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
3.33
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Remarks:
Animal was sacrificed after 7 days.
Irritant / corrosive response data:
In treated eyes an inceased density of opacity was noted, in 3 out of 6 animals the finding was reversible, however, in the other 3 animals density was increasing again starting day 4 or 7. For the iris, the conjunctiva and chemosis scores, a comparable trend was observed. Due to the severity of those findings, the 3 rabbits with the deteriorating process were euthanized after the 7-day examination.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
As a consequence of the instillation of 2,2,6,6-tetramethylpiperidinooxy into the rabbit eye, effects were noted on cornea, iris and conjunctiva in all animals. In half of the animals effects deteriorated after an initial improvement and became so severe that the animals needed to be sacrificed on day 7. Thus, the effects were not expected to reverse within the observation period of 21 days.
As a conclusion, the test substance is classified for this endpoint in accordance to the CLP Regulation (EC) No 1272/2008 in Category 1 (Irreversible Effects on the Eye).