Registration Dossier

Administrative data

Description of key information

Skin sensitisation (in vivo): Not sensitisting (OECD406/GLP; Buehler test)

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
other: other guideline: EC Directive 96/54, B.6, Buehler study OECD 406, 1992 EPA OPPTS 870.2600, 1998.
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
existing data
Species:
other: Guinea Pig, Dunkin-Hartley
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Reading:
other: positive control not included
Hours after challenge:
0
Group:
positive control
Dose level:
0
No. with + reactions:
0
Total no. in group:
0
Remarks on result:
not measured/tested

Maximum concentration not causing irritating effects in preliminary test: 100 %

Signs of irritation during induction: No signs of irritation observed.

Evidence of sensitisation of each challenge concentration: 0%

Other observations: None.

Interpretation of results:
other: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

There is no in vitro skin sensitisation data available. There is one in vivo skin sensitisation study in guinea pigs available.

In a dermal sensitization study (OECD406/GLP) with 1,1,1,2,2,4,5,5,5-nonafluoro-4-(trifluoromethyl )-3-pentanone, Dunkin-Hartley guinea pigs were tested in a Buehler assay. A maximisation study could not be performed due to the physico-chemical properties of the substance. No proper vehicle could be found, since in the vehicle, the test substance was not homogenous. Also, during a Preliminary Irritation Test, injection with the undiluted test substance resulted in necrosis (diameter of 5 mm). A 100% test substance concentration did therefore not comply with the selection criteria for dose level selection for the main study of the Guinea Pig Maximization Test. The Buehler Test is the preferred test after the Guinea Pig Maximization Test. No irritation was observed after epidermal application of the undiluted test substance (100%). The evaluation of skin reactions after challenge was carried out at 24 and 48 hrs. There were no signs of irritation observed during induction. There was no evidence of sensitisation during challenge in test (0/20) or control (0/10) animals. There were no other observations. The substance was not sensitising.

The results from this study are acceptable to use in the human health risk assessment.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

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 sensitisation when the criteria outlined in Annex I of 1272/2008/EC and Annex I of 286/2011/EC are applied.