Registration Dossier
Registration Dossier
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EC number: 700-991-6 | CAS number: 8007-24-7
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
- Remarks:
- Study conducted under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This study was already available from 1995.
Test material
- Reference substance name:
- 3-[(7Z)-pentadec-7-en-1-yl]phenol; 3-[(7Z,10Z)-pentadeca-7,10,14-trien-1-yl]phenol; 3-[(7Z,10Z)-pentadeca-7,10-dien-1-yl]phenol; 3-pentadecylphenol
- EC Number:
- 700-991-6
- Cas Number:
- 8007-24-7
- Molecular formula:
- Cardanol (saturated side chain): Formula: C21 H36 O Cardanol (monoene): Formula: C21 H34 O Cardanol (diene): Formula: C21 H32 O Cardanol (triene): Formula: C21 H30 O
- IUPAC Name:
- 3-[(7Z)-pentadec-7-en-1-yl]phenol; 3-[(7Z,10Z)-pentadeca-7,10,14-trien-1-yl]phenol; 3-[(7Z,10Z)-pentadeca-7,10-dien-1-yl]phenol; 3-pentadecylphenol
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall Limited, UK
- Weight at study initiation: 328 to 455 g
- Housing: Solid floor polypropylene cages
- Diet (e.g. ad libitum): Guinea pig FD1 diet ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22°C
- Humidity (%): 44-64%
- Air changes (per hr): 15/hour
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- paraffin oil
- Concentration / amount:
- 1% induction, 5% and 2% challenge
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 1% induction, 5% and 2% challenge
- No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: Day 1, intradermal injection; day 7, occlusive topical application for 48 hours
- Concentrations: 1% intradermal injection, 25% topical application
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 21
- Exposure period: 24 hours
- Site: clipped right flank
- Concentrations: 5% and 2%
- Evaluation (hr after challenge): 24 and 48 hours after challenge removal - Positive control substance(s):
- yes
- Remarks:
- Poison ivy oil
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:
- 14
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 14.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2%
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2%. No with. + reactions: 8.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 1%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 1%. No with. + reactions: 20.0. Total no. in groups: 20.0.
- Group:
- negative control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a dermal sensitisation study with cashew nutshell liquid (distilled grade sample), guinea pigs (20) were tested with in a guinea pig maximisation test.
In this study, Cashew Nutshell Extract, Decarboxylated, Distilled (Distilled Grade) is a dermal sensitiser. - Executive summary:
Positive reactions in 30% of test animals is required for a positive sensitising result in an adjuvant test. A positive response was elicited in 70% of animals when adminsitered 1% induction and challenged with a 5% concentration. Greater than 60% of animals responded at a 1% intradermal induction dose, therefore sub-category 1A is appropriate.
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