Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Skin irritation: not irritating (EU Method B.4)

Eye irritation: not irritating (EU Method B.5)

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: EU Method B.4
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
other: Substance moistened with water
Controls:
not specified
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Number of animals:
3
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean score 1
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean score 2
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean score 3
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
erythema score
Max. score:
0
Remarks on result:
other: Max. duration: d; Max. value at end of observation period: 0
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean score 1
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean score 2
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean score 3
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
edema score
Max. score:
0
Remarks on result:
other: Max. duration: d; Max. value at end of observation period: 0
Other effects:
No signs of skin irritation were observed at any time during the study.
Interpretation of results:
other: not classified
Conclusions:
No signs of skin irritation were observed at any time during the study thus the substance is 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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: EU Method B.5
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
40 mg
Number of animals or in vitro replicates:
3
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
mean score 1
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
mean score 2
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
mean score 3
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Max. score:
0
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
mean score 1
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
mean score 2
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
mean score 3
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
chemosis score
Max. score:
0
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
mean score 1
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
mean score 2
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
mean score 3
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Max. score:
0
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
mean score 1
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
mean score 2
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
mean score 3
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
iris score
Max. score:
0
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 1 days
Other effects:
Very slight conjunctival irritation was observed at one hour after treatment, but had resolved by the end of the first day.
Interpretation of results:
other: not classified
Conclusions:
Very slight conjunctival irritation was observed at one hour after treatment, but had resolved by the end of the first day, thus the substance is not classified.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

In Skin irritation test (EU Method B.4), the average score of edema score and erythema score is 0.

In Eye irritation test (EU Method B.5), the average score of conjunctivae score, chemosis score and cornea opacity score

is 0.

Justification for classification or non-classification

Based on the available information in the dossier, the substance 6'-(dibutylamino)-3'-methyl-2'-(phenylamino)spiro[isobenzofuran-1(3H),9-(9H)-xanthen]-3-one (CAS No. 89331-94-2) does not need to be classified for skin irritation/corrosion or serious eye damage/eye irritation when considering the criteria outlined in the CLP Regulation (Annex I of 1272/2008/EC).