Registration Dossier
Registration Dossier
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EC number: 484-470-6 | CAS number: 623-40-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- A non-LLNA test is available that was performed prior to the current data requirements, stipulated in Regulation (EC) No 1907/2006. In accordance with the same Regulation, the data was included to avoid unnecessary testing.
Test material
- Reference substance name:
- -
- EC Number:
- 484-470-6
- EC Name:
- -
- Cas Number:
- 623-40-5
- Molecular formula:
- C5H11NO
- IUPAC Name:
- N-pentan-2-ylidenehydroxylamine
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Elm Hill Breeding Labs, Chelmsford, MA
- Weight at study initiation: 292-352 gms
- Housing:
- Diet: ad libitum
- Water:ad libitum
- Acclimation for at least 5 days
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hrs
IN-LIFE DATES: From: 01/04/2009 To: 08/05/09
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 100%
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 25%
- No. of animals per dose:
- 10 M/10 F
- Details on study design:
- RANGE FINDING TESTS: non irritating dose = 25%
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Frequency of applications: once a week
- Duration: 3 weeks
- Concentrations: 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 weeks following last induction
- Concentrations: 25%
- Evaluation (hr after challenge): 24 and 48 hours - Positive control substance(s):
- yes
- Remarks:
- HCA
Results and discussion
- Positive control results:
- Testing with 85% hexylcinnamaldehyde are confirmed in the laboratory every 6 months. Data from the study conducted in summer 2009 included with results as expected.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Group:
- positive control
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- 2-PO (MPKO) is not a skin sensitizer under conditions of this study.
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