Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 245-010-8 | CAS number: 22457-23-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- LLNA not available at time of testing.
Test material
- Reference substance name:
- 5-methylheptan-3-one oxime
- EC Number:
- 245-010-8
- EC Name:
- 5-methylheptan-3-one oxime
- Cas Number:
- 22457-23-4
- Molecular formula:
- C8H17NO
- IUPAC Name:
- 5-methylheptan-3-one oxime
- Reference substance name:
- (E)-3,4-dimethylhexan-2-one oxime
- IUPAC Name:
- (E)-3,4-dimethylhexan-2-one oxime
- Reference substance name:
- (Z)-3,4-dimethylhexan-2-one oxime
- IUPAC Name:
- (Z)-3,4-dimethylhexan-2-one oxime
- Test material form:
- liquid
Constituent 1
impurity 1
impurity 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: 10% Ethanol
- Concentration / amount:
- 100, 30, 10, 3% in 10% ethanol
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: 10% Ethanol
- Concentration / amount:
- 100, 30, 10, 3% in 10% ethanol
- No. of animals per dose:
- 6
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 5
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Single application test
Slovent: ethanol
Lowest irritant concentration = 100%
Highest non irritant concentration = 30%
Repeated applications over 21 successive days
| Concentration % | Skin irritation after days | ||
| 7 | 14 | 21 | |
| 100 | (+) | (+) | + |
| 30 | - | (+) | (+) |
| 10 | - | - | - |
| 3 | - | - | - |
Degree of skin irritation:
–= none
+= slight
++= moderate
+++= strong
Capacity to induce allergic sensitization
| After daily applications over three weeks Concentration in % |
Sensitisation rate Number of animals Positive/Total |
|
| Day 21 | Day 35 | |
| 100 | 0/6 | 0/6 |
| 30 | 0/6 | 0/6 |
| 10 | 0/6 | 0/6 |
| 3 | 0/6 | 0/6 |
Results:
STEMONE is a well-tolerated preparation. The highest non-irritant solution after single application is 30%,after repeated applications 10% in ethanol. The 30% solution causes only very slight skin irritation beginning after one week's treatment. No sensitization occurs with STEMONE in the guinea pig under conditions of the OET.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No sensitization occurs with STEMONE in the guinea pig under conditions of the OET.
- Executive summary:
Open Epicutaneous Test
Test Material is applied epicutaneously, uncovered, undiluted, and if possible and relevant, dissolved in concentrations of 30, 10, 3% in ethanol. Constant volumina of each concentration are applied with a pipette on standard areas of the clipped flank of each animal.
STEMONE is a well-tolerated preparation. The highest non-irritant solution after single application is 30%,after repeated applications 10% in ethanol. The 30% solution causes only very slight skin irritation beginning after one week's treatment. No sensitization occurs with STEMONE in the guinea pig under conditions of the OET.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
