Registration Dossier
Registration Dossier
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EC number: 247-987-6 | CAS number: 26762-92-5
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: limited details on study design (exposure time, application type, scoring system), study in patients with known reactions to turpentine oil
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 970
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline followed
- GLP compliance:
- no
Test material
- Reference substance name:
- Menthane, monohydroperoxy derivative
- EC Number:
- 247-987-6
- EC Name:
- Menthane, monohydroperoxy derivative
- Cas Number:
- 26762-92-5
- Molecular formula:
- C10H20O2
- IUPAC Name:
- menthane, monohydroperoxy derivative
- Reference substance name:
- p-menthane hydroperoxide
- IUPAC Name:
- p-menthane hydroperoxide
- Details on test material:
- commercial sample which is a mixture of p-menthane-1-hydroperoxide and p-menthane-8-hydroperoxide
Constituent 1
Constituent 2
Method
- Type of population:
- other: patients with known turpentine oil allergy
- Ethical approval:
- confirmed, but no further information available
- Subjects:
- 11 volunteers 27-64 year
8 males, 3 females - Clinical history:
- no data except on turpentine oil allegy
- Controls:
- controls were not included in the experiment, but were stated to have been included to assess the irritant concentration of 1% test susbtance
- Route of administration:
- dermal
- Details on study design:
- Subjects were exposed to 0.1% and 0.4% of the test substance in parafin oil. 48 hours after exposure skin reactions were measured.
Results and discussion
- Results of examinations:
- 0.4% challenge
- Number of subjects with positive reactions: 1 (+ 2 marginally reactions)
- Number of subjects with negative reactions: 8
0.1% challenge
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 11
Applicant's summary and conclusion
- Conclusions:
- very weak sensitizer under the conditions of the test
- Executive summary:
Eleven subjects with known allegic reaction to turpentene oil were challenged with 0.1% and 0.4% test substance. With 0.4% very slight effects were seen. A challenge with 0.1% did not induce any effects. The test substance is considered a very weak sensitizer under the conditions of the test.
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