Registration Dossier

Toxicological information

Eye irritation

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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, GLP compliance

Data source

Reference
Reference Type:
other: inquiry result from ECHA
Title:
Unnamed
Year:
2011

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 84/449/EWG, B.5
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
bis[2,2,6,6-tetramethyl-1-(octyloxy)piperidin-4-yl] decanedioate
EC Number:
687-535-9
Cas Number:
122586-52-1
Molecular formula:
C44H84N2O6
IUPAC Name:
bis[2,2,6,6-tetramethyl-1-(octyloxy)piperidin-4-yl] decanedioate

Test animals / tissue source

Species:
other: rbt, New Zealand WhiteChbb:NZW

Test system

Amount / concentration applied:
0.1mL
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
Remarks:
mean score 1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Remarks:
mean score 2
Time point:
24/48/72 h
Score:
1
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Remarks:
mean score 3
Time point:
24/48/72 h
Score:
1
Irritation parameter:
conjunctivae score
Max. score:
1
Remarks on result:
other: Max. duration: h; Max. valueat end of observation period: 0 (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
mean score 1
Time point:
24/48/72 h
Score:
0.67
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
mean score 2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
mean score 3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Score:
1
Remarks on result:
other: Max. duration: 48 h; Max. valueat end of observation period: 0 (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
mean score 1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
mean score 2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
mean score 3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Max. score:
0
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0 (related to ail animals)
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
mean score 1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
mean score 2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
mean score 3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Max. score:
0
Remarks on result:
other: Max. duration: h; Max.value at end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 14 days

Any other information on results incl. tables

 Irritation parameter  max score  remarks
 conjunctivae score(redness)  1  Max. duration: h; Max. valueat end of observation period: 0 (related to allanimals)
 chemosis score  0  Max. duration: 48 h; Max. valueat end of observation period: 0 (related to allanimals)
 cornea score iris score  0 0  Max. duration: h; Max. value at end of observation period: 0 (related to ailanimals)Max. duration: h; Max.value at end of observation period: 0 (related to allanimals)

Applicant's summary and conclusion

Interpretation of results:
other: not classified