Registration Dossier
Registration Dossier
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EC number: 204-317-7 | CAS number: 119-36-8
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study summarised in peer-reviewed paper.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Reference Type:
- review article or handbook
- Title:
- Fragrance material review on methyl salicylate
- Author:
- Lapczynski A, Jones L, McGinty D et al
- Year:
- 2 007
- Bibliographic source:
- Food Chem Toxicol 45:S428-S452
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Human maximization procedure
- GLP compliance:
- no
Test material
- Reference substance name:
- Methyl salicylate
- EC Number:
- 204-317-7
- EC Name:
- Methyl salicylate
- Cas Number:
- 119-36-8
- Molecular formula:
- C8H8O3
- IUPAC Name:
- methyl salicylate
Constituent 1
Method
- Type of population:
- not specified
- Subjects:
- 25 volunteers
- Route of administration:
- dermal
Results and discussion
- Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed: No evidence of sensitization
Applicant's summary and conclusion
- Conclusions:
- The incidence of positive reactions in patients with existing dermatitis was low . The highest incidence (3%) was seen in a study of 585 eczema patients. In two large studies (3109 and 1825 allergy patients), the incidence of positive reactions was lower (0.19% and 0.4%).
- Executive summary:
In a review of MeS as a fragrance ingredient (Lapczynski et al, 2007), summaries are reported of 12 publications describing diagnostic studies on dermatitis patients, using several internationally-approved patch testing protocols. The test concentration of MeS was generally 2% in petrolatum.
The incidence of positive reactions in patients with existing dermatitis was low . The highest incidence (3%) was seen in a study of 585 eczema patients. In two large studies (3109 and 1825 allergy patients), the incidence of positive reactions was lower (0.19% and 0.4%).
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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