Registration Dossier
Registration Dossier
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EC number: 264-119-1 | CAS number: 63393-93-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented study which meets basic scientific principles.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 970
- Report date:
- 1970
- Reference Type:
- secondary source
- Title:
- Final Report on the Safety Assessment for Isopropyl Lanolate
- Author:
- CIR
- Year:
- 1 980
- Bibliographic source:
- Journal of environmental pathology, toxicology and oncology;4/4, 121-132, 1980
Materials and methods
- Principles of method if other than guideline:
- A 0.1 % solution/suspension of the tests substance is injected intra-cutaneously 10 times (three times a week). 24 hours after each injection scorings are recorded. A re-injection (challenge) is done 2 weeks after the tenth injection.
- GLP compliance:
- no
- Type of study:
- other: Landsteiner and Jacobs procedure (1935)
- Justification for non-LLNA method:
- The study was performed before REACH entered into force.
Test material
- Reference substance name:
- Fatty acids, lanolin, iso-Pr esters
- EC Number:
- 264-119-1
- EC Name:
- Fatty acids, lanolin, iso-Pr esters
- Cas Number:
- 63393-93-1
- Molecular formula:
- UVCB
- IUPAC Name:
- Fatty acids, lanolin, isopropyl esters
- Details on test material:
- - Name of test material (as cited in study report): Distilled Isopropyl Lanolate
- Analytical purity: no data
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: white
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 300 - 500 g
- Housing: individually
- Diet: commercial rabbit pellets, greens and carrots, ad libitum
- Water: ad libitum
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- 0.1 %
Challengeopen allclose all
- Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- 0.1 %
- No. of animals per dose:
- 10
- Details on study design:
- RANGE FINDING TESTS: no data
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 24 hours, (injections were done 3 times weekly)
- Test groups: 10 single injections, 1st injection: 0.05 mL, 2nd - 10th injection: 0.1 mL
- Control group: 10 single injections, same procedure as test group but using just vehicle
- Site: back of the animals (hair was removed by electric clipper if necessary)
- Frequency of applications: 3 times a week
- Concentrations: 0.1 %
B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: 2 weeks after 10th induction exposure
- Exposure period: 24 hours
- Test groups: test substance in vehicle
- Control group: vehicle only
- Site: on the back, just below the ten sensitizing injections
- Concentrations: 0.1 %
- Evaluation (hr after challenge): 24
OTHER: 24 hours after each injection scoring were recorded for the diameter, height and redness of the reaction (if any). - Challenge controls:
- The control group is actually a challenge control.
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Group:
- negative control
- Remarks on result:
- other: No information available
- Group:
- positive control
- Remarks on result:
- other: No information available
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- DSD: not classified
CLP: not classified
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