Registration Dossier

Administrative data

Description of key information

Skin irritation/Corrosion: Not irritating (84/449/EWG,B.4;GLP)

Eye irritation: Not irritating (84/449/EWG,B.5;GLP)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin 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
Qualifier:
according to guideline
Guideline:
other: 84/449/EWG, B.4
GLP compliance:
yes
Species:
other: rbt, New Zealand WhiteChbb:NZW
Type of coverage:
semiocclusive
Vehicle:
other: Keines "ENGLISH" None
Duration of treatment / exposure:
4h
Number of animals:
3
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean score1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean score 2
Time point:
24/48/72 h
Score:
1
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean score 3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Max. score:
1
Remarks on result:
other: Max. duration: 72 d; Max. valueat end of observation period: a(related to all animals)
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean score 1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean score 2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean score 3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Max. score:
0
Remarks on result:
other: Max. duration: d; Max. valueat end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 7 days
Interpretation of results:
other: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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
Qualifier:
according to guideline
Guideline:
other: 84/449/EWG, B.5
GLP compliance:
yes
Species:
other: rbt, New Zealand WhiteChbb:NZW
Amount / concentration applied:
0.1mL
Number of animals or in vitro replicates:
3
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

 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)
Interpretation of results:
other: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin irritation

There are no in vitro skin irritation/corrosion studies available. There is one in vivo study in rabbits available.

In a primary dermal irritation study (84/449/EWG, B.4/GLP), 3 New Zealand WhiteChbb:NZW rabbits were dermally exposed (semi-occlusive) to 0.5 mL of the substance for 4 hours. The mean erythema scores at 24, 48 and 72 hr timepoints for animal 1 and 3 were 0; the mean erythema scores at 24, 48 and 72 hr timepoints for animal 2 were 1. The mean odema scores at 24, 48 and 72 hr timepoints for all animals was 0. Changes fully reversible within 7 days. The substance was not irritating.

Eye irritation

There is no in vitro eye irritation study available. There is one in vivo study in rabbits available.

In a primary eye irritation study (84/449/EWG, B.5/GLP), 0.1 mL of the substance was instilled into the eye of 3 New Zealand White Chbb:NZW rabbits. The conjunctiave score (redness) for animal 1 was 0 and for animals 2 and 3 was 1. The chemosis score for animal 1 was 0.67 and for animals 2 and 3 was 0. The cornea opacity and iris score for all animals was 0. Changes were fully reversible within 14 days. The substance was not irritating.

Justification for classification or non-classification

Based on the available information in the dossier, the substance is not classified for skin irritation/corrosion or for serious eye damage/irritation, when considering the criteria outlined in Annex I of 1272/2008/EC.