Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
A mixture of: bis(2,2,6,6-tetramethyl-1-octyloxypiperidin-4-yl)-1,10-decanedioate; 1,8-bis[(2,2,6,6-tetramethyl-4-((2,2,6,6-tetramethyl-1-octyloxypiperidin-4-yl)-decan-1,10-dioyl)piperidin-1-yl)oxy]octane
EC Number:
406-750-9
EC Name:
A mixture of: bis(2,2,6,6-tetramethyl-1-octyloxypiperidin-4-yl)-1,10-decanedioate; 1,8-bis[(2,2,6,6-tetramethyl-4-((2,2,6,6-tetramethyl-1-octyloxypiperidin-4-yl)-decan-1,10-dioyl)piperidin-1-yl)oxy]octane
Cas Number:
129757-67-1
Molecular formula:
C44 H84 N2 O6 + C80 H150 N4 O12 737.16 g/mol + 1360.1 g/mol
IUPAC Name:
2,2,6,6-tetramethyl-1-(octyloxy)piperidin-4-yl 2,2,6,6-tetramethyl-1-{[8-({2,2,6,6-tetramethyl-4-[(10-oxo-10-{[2,2,6,6-tetramethyl-1-(octyloxy)piperidin-4-yl]oxy}decanoyl)oxy]piperidin-1-yl}oxy)octyl]oxy}piperidin-4-yl decanedioate 2,2,6,6-tetramethyl-1-(octyloxy)piperidin-4-yl 2,2,6,6-tetramethyl-4-{[8-({2,2,6,6-tetramethyl-1-[(10-oxo-10-{[2,2,6,6-tetramethyl-1-(octyloxy)piperidin-4-yl]oxy}decanoyl)oxy]piperidin-4-yl}oxy)octyl]oxy}piperidin-1-yl decanedioate bis[2,2,6,6-tetramethyl-1-(octyloxy)piperidin-4-yl] decanedioate
Details on test material:
- State of aggregation: liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GMBH, Biberach/Riss
- Age at study initiation: approx. 12-14 weeks old
- Weight at study initiation: 2500 to 2770 g
- Housing: individually
- Diet (e.g. ad libitum): standard rabbit pellet (Nafag, No. 814, Gossau, Switzerland), ad libitum
- Water (e.g. ad libitum): fresh water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 hours/12 hours

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye remained untreated and served as a control.
Amount / concentration applied:
0.1 ml
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: OECD scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not relevant
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: Slight redness after one hour.
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: Slight chemosis after one hour.
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: Slight chemosis after one hour.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met