Registration Dossier
Registration Dossier
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EC number: 203-093-8 | CAS number: 103-26-4
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- N/A
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: detailed information performed to non-standard protocol, but contributing to the assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
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:
- Methyl cinnamate
- EC Number:
- 203-093-8
- EC Name:
- Methyl cinnamate
- Cas Number:
- 103-26-4
- Molecular formula:
- C10H10O2
- IUPAC Name:
- methyl 3-phenylacrylate
- Test material form:
- other: solid
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- Twenty-five healthy/ adult volunteers completed the experiment.
- Clinical history:
- N/A
- Controls:
- No data
- Route of administration:
- dermal
- Details on study design:
- Pre-Testing: The material was pre-tested on five subjects in order to determine whether sodium lauryl sulfate treatment was required, A patch of this material was applied to normal sites on the volar forearms for 48 hours under occlusion. No subject had any irritation from this material and it was decided to use SLS pre-treatment in the test.
Maximization Test (J.L.D.; Vol 47: No.5; 393-409; 1966): This material was applied under occlusion to the same site on the volar forearms of all subjects for five alternate day 48 hour periods. The patch site was pre-treated for 24 hours with 5% aqueous sodium lauryl sulfate under occlusion. The challenge sites were read on removal of the patch and 24 hours thereafter.
Results and discussion
- Results of examinations:
- The score of 0 in individual subjects were recorded in the challenge assay.
Applicant's summary and conclusion
- Conclusions:
- There were no instances of contact-sensitization from this material on the Maximization Test in 25 human volunteers.
- Executive summary:
This test was conducted to determine the contact-sensitizing potential of test substance. This study was consisted of pre-test and maximization test. The challenge sites were read on removal of the patch and 24 hours thereafter.The score of 0 from individual subjects was recorded in the challenge assay. There were no instances of contact-sensitization from this material in the Maximization Test. It is unlikely that this material would present a danger of contact-sensitization in normal, intended use.
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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