Registration Dossier
Registration Dossier
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EC number: 700-991-6 | CAS number: 8007-24-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: FHSA standard 16 CFR 1500.41
- GLP compliance:
- yes (incl. QA statement)
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
- Details on test material:
- - Name of test material (as cited in study report): Distilled CNSL
- Lot/batch No.: 1500-1, AF6155, 100-1, 1650-1
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Millbrook Breeding Labs
- Age at study initiation: Young adult
- Weight at study initiation: 2.1 - 2.7 kg
- Housing: 1/cage in suspended cages
- Diet (e.g. ad libitum): Fresh PMI Rabbit Chow
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 1 male/ 2 female
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: Plastic
REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle wiping
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- Sample 1500-1
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- Sample 1500-1
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- Sample 1500-1
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- Sample 1500-1
- Time point:
- 72 h
- Score:
- > 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- Sample 1500-1
- Time point:
- 72 h
- Score:
- > 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- Sample 1500-1
- Time point:
- 72 h
- Score:
- > 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- Sample 1500-1
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- Sample 1500-1
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- Sample 1500-1
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- Sample 1500-1
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- Sample 1500-1
- Time point:
- 72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- Sample 1500-1
- Time point:
- 72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Samples 1500-1 and AF6155 were irritating, however, samples 1600-1 and 1650-1 were not irritating.
- Executive summary:
In a primary dermal irritation study, 3 young adult New Zealand white rabbits were dermally exposed to Cashew Nutshell Extract, Decarboxylated, Distilled (Distilled Grade) for 24 hours. Animals then were observed for 72 hours. Irritation was scored by the method of Draize.
In this study, Cashew Nutshell Extract, Decarboxylated, Distilled (Distilled Grade) is a dermal irritant.
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.
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