Registration Dossier
Registration Dossier
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EC number: 436-710-6 | CAS number: 756-13-8
Endpoint summary
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
- 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
- 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 chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- 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
- Interpretation of results:
- other: not classified
Referenceopen allclose all
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.
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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