Registration Dossier

Administrative data

Description of key information

Skin irritation/corrosion (in vivo): Not irritating (OECD 404/GLP)

Serious eye damage/eye irritation (in vivo): Not irritating (OECD 405/GLP)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
other: other guideline: EC Directive 92/69/EEC, B.4 OECD 404, 1992
GLP compliance:
yes
Species:
other: Rabbit, New Zealand White
Type of coverage:
semiocclusive
Vehicle:
other: none
Amount / concentration applied:
500mg
Duration of treatment / exposure:
4h
Number of animals:
3
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
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:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
0
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
Other effects:
None.
Interpretation of results:
other: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
other: other guideline: EC Directive 92/69/EEC, B.5 OECD 405, 1987
GLP compliance:
yes
Specific details on test material used for the study:
Nature of substance: liquid
Species:
other: Rabbit, New Zealand White
Amount / concentration applied:
.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:
0
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
redness
Max. score:
1
Remarks on result:
other: Max. duration: 1 h; Max. value at 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
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
Max. score:
0
Remarks on result:
other: Max. duration: h; Max. value at 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 all 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 1 days
Other effects:
Instillation of the test substance resulted in irritation of the conjunctivae in one rabbit, which was seen as redness. The irritation had completely resolved within 24 hours.
Interpretation of results:
other: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation/corrosion:

There is one in vivo skin irritation study in rabbits available.

In a primary dermal irritation study (OECD 404/GLP), 3 New Zealand white rabbits were dermally exposed to 0.5 mL 1,1,1,2,2,4,5,5,5-nonafluoro-4-(trifluoromethyl )-3-pentanone for 4 hrs.  Animals were scored at 24, 48 and 72 hrs. There was no erythema or edema at any timepoint in any animal. The substance is not irritating.

Serious eye damage/eye irritation:

There is one in vivo eye irritation study in rabbits available.

In a primary eye irritation study (OECD 405/GLP), 0.1mL of 1,1,1,2,2,4,5,5,5-nonafluoro-4-(trifluoromethyl )-3-pentanone was instilled into the eye of 3 New Zealand white rabbits. The eyes were examined at 24h, 48h and 72hrs. Instillation of the test substance resulted in irritation of the conjunctivae in one rabbit, which was seen as redness (max score = 1). The irritation had completely resolved within 24 hours. There was no other irritation noted. Therefore, the substance is not irritating.

The results from these studies are acceptable to use in the human health risk assessment.

Justification for classification or non-classification

Based on the available information in the dossier, the substance 1,1,1,2,2,4,5,5,5-nonafluoro-4-(trifluoromethyl )-3-pentanone (CAS No. 756-13-8) does not need to be classified for skin irritation/corrosion or serious eye damage/eye irritation when the criteria outlined in Annex I of 1272/2008/EC are applied.