Registration Dossier
Registration Dossier
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EC number: 246-073-4 | CAS number: 24199-46-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Scientifically acceptable.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- The sensitization potential of some perfume ingredients tested using a modified Draize procedure
- Author:
- Sharp DW
- Year:
- 1 978
- Bibliographic source:
- Toxicology, 9(3), 261-271
- Reference Type:
- secondary source
- Title:
- No information
- Author:
- Sharp DW
- Year:
- 2 008
- Bibliographic source:
- RIFM database
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The method is modified from Draize [17]. In the Draize test sensitization is induced by 10 intradermal injections of test material at the ICC given over a 3 week period, whereas in this method the equivalent total dose was administered on one occasion as 4 intradermnal injections, each 2.5 times the ICC.
- GLP compliance:
- not specified
- Type of study:
- other: modified Draize test
Test material
- Reference substance name:
- 6-methylhept-5-en-2-one
- EC Number:
- 203-816-7
- EC Name:
- 6-methylhept-5-en-2-one
- Cas Number:
- 110-93-0
- IUPAC Name:
- 6-methylhept-5-en-2-one
- Details on test material:
- - Name of test material (as cited in study report): Methyl heptenone
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Hartley strain albino
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: own colony
- Weight at study initiation: average 350 g
- Housing: in pairs of the same sex
- Diet (e.g. ad libitum): ad libitum, pelleted guinea pig diet, cabbage, hay
- Water (e.g. ad libitum): ad libitum
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- no data
Challenge
- Route:
- intradermal and epicutaneous
- Vehicle:
- no data
- No. of animals per dose:
- 10
- Details on study design:
- RANGE FINDING TESTS:
-> 7.3.1 Sharp1978a.Skin irritation / corrosion.guinea pig
-> 7.3.1 Sharp1978.Skin irritation / corrosion.guinea pig intradermal
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: 14 days
- Test groups: 10
- Control group: 4 untreated
- Site: at 4 sites which overlie the 2 auxillary and 2 inguinal lymph nodes.
- Concentrations: 0.1 %; 0.1 ml aliquot
B. CHALLENGE EXPOSURE
- No. of exposures: 2; intradermal injection of 0.1 ml 0.1 % (ICC) test material into one flank and a topical open application of 20 % (ACC) test material on the other flank
- Day(s) of challenge: 15, 22
- Control group: 4 previously untreated animals of the same sex and similar weight to the test animals were treated intradermally and topically on opposite flanks with 0.1 ml aliquots of test substance at the ICC and ACC respectively
- Evaluation (hr after challenge): 24
SCORING
- Reactions were examined under a Philips colour-matching unit.
- Each injection was given a total score based on size (2 largest diameters), erythema and oedema.
- Individual reactions were considered positive when their total score was significantly greater than the average total score for control reactions.
- Application reactions were scored on a 0 to +++ scale and individual reactions were considered positive if they were + or greater and there were no erythema reactions in controls:
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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