Registration Dossier
Registration Dossier
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EC number: 288-306-2 | CAS number: 85711-46-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: read across substance, well documented, according to GLP and OECD guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Principles of method if other than guideline:
- Based on a modified version of dermal sensitization developed by E.V. Buehler (1965)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
Test material
- Reference substance name:
- 1309959-24-7
- Cas Number:
- 1309959-24-7
- IUPAC Name:
- 1309959-24-7
- Test material form:
- liquid: viscous
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Cri:HA
- Sex:
- not specified
- Details on test animals and environmental conditions:
- - Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Weight at study initiation: 300 g
- Housing: 2-3 per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- 50% in PEG E 400, induction
10% in PEG E 400, challenge
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- 50% in PEG E 400, induction
10% in PEG E 400, challenge
- No. of animals per dose:
- test group is consisting of 20 animals and the control group includes 10 animals
- Details on study design:
- RANGE FINDING TESTS: The suitable concentrations of the test item are determined in a preliminary investigation for skin irritation using an additional group of guinea pigs. The minimal irritant concentration is chosen for induction.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3, days 0, 7 and 14
- Exposure period: 6h
- Test groups: 20 animals
- Control group: 10 animals
- Site: flank
- Concentrations:
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 28
- Exposure period: 6h
- Site: flanks
- Concentrations:
- Evaluation (hr after challenge): skin reactions are examined 24 hrs and 48 hrs after the completion of the challenge and potential rechallenge - Challenge controls:
- the challenge is performed on all animals of the test and control group
- Positive control substance(s):
- yes
- Remarks:
- alpha-Hexylcinnamaldehyde
Results and discussion
- Positive control results:
- 13/20 animals (65%) with positive skin reactions
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 9.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 8.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
In the test group, a discrete or patchy erythema (grade 1) was observed in 11/20 animals (55%) on the test field treated with 10% test item during the challenge after 24h and/or 48h.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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