Registration Dossier
Registration Dossier
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EC number: 208-008-8 | CAS number: 505-32-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 970
- Report date:
- 1970
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- BASF-Test, no guideline available at that time.
- GLP compliance:
- no
- Type of study:
- skin painting test
Test material
- Reference substance name:
- 3,7,11,15-tetramethylhexadec-1-en-3-ol
- EC Number:
- 208-008-8
- EC Name:
- 3,7,11,15-tetramethylhexadec-1-en-3-ol
- Cas Number:
- 505-32-8
- Molecular formula:
- C20H40O
- IUPAC Name:
- 3,7,11,15-tetramethylhexadec-1-en-3-ol
- Details on test material:
- - Name of test material (as cited in study report): Isophytol G
- Physical state: fluid
- Analytical purity: ca. 90 %
- Impurities (identity and concentrations): not reported
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: acetone
- Concentration / amount:
- 10 and 1 %, respectively (subsequently in the same treatment group).
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: acetone
- Concentration / amount:
- 10 and 1 %, respectively (subsequently in the same treatment group).
- No. of animals per dose:
- Test group: 10
control group: 3 - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1 + 9
- Test groups: test substance in acetone
- Control group: untreated
- Site: anterior part of the left flank
- Frequency of applications: daily
- Duration: day 1 to 10
- Concentrations: 10 % on day1 and 1 % on days 2-10
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 24
- Test groups: test substance in acetone
- Control group: test substance in acetone
- Site: anterior part of the right flank
- Concentrations: 0.5 %
- Evaluation (hr after challenge): 12 - Challenge controls:
- 0.5 and 1% solution in acetone
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 12
- Group:
- test chemical
- Dose level:
- 0.5 % in acetone
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 12.0. Group: test group. Dose level: 0.5 % in acetone. No with. + reactions: 5.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 12
- Group:
- negative control
- Dose level:
- 0.5 % in acetone
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 12.0. Group: negative control. Dose level: 0.5 % in acetone. No with. + reactions: 0.0. Total no. in groups: 3.0.
- Reading:
- 1st reading
- Hours after challenge:
- 12
- Group:
- negative control
- Dose level:
- 1% in acetone
- No. with + reactions:
- 2
- Total no. in group:
- 3
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 12.0. Group: negative control. Dose level: 1% in acetone. No with. + reactions: 2.0. Total no. in groups: 3.0.
Any other information on results incl. tables
The daily epicutaneous application of test substance over a period of 10 days for induction, induced rough scaling on the application area (flank). For challenge, epicutaneous application of 0.5 % test substance in acetone to the untreated right flank after a treatment-free period of 14 days induced questionable erythema in 5/10 animals.
Applicant's summary and conclusion
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