Registration Dossier
Registration Dossier
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EC number: 200-313-4 | CAS number: 57-11-4
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given
Data source
Reference
- Reference Type:
- publication
- Title:
- Monographs on Fragrance Raw Materials
- Author:
- Opdyke, D.L.J.
- Year:
- 1 981
- Bibliographic source:
- Fd Cosmet. Toxicol. Vol. 19, pp237-254
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Human Maximization test with 25 volunteers according to Kligman and Epstein, 1975 (Contact Dermatitis 1975:1:231-239)
- GLP compliance:
- no
Test material
- Reference substance name:
- Octanoic acid
- EC Number:
- 204-677-5
- EC Name:
- Octanoic acid
- Cas Number:
- 124-07-2
- IUPAC Name:
- octanoic acid
- Details on test material:
- - RIFM No.: 77-62
- Analytical purity: no specified
Constituent 1
Method
- Type of population:
- general
- Subjects:
- - Number of subjects exposed: 25
- Controls:
- Petrolatum for challenge control
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive
- Test site: back and forearm
- Description of patch: 2 cm square of cotton cloth patch, sealed with plastic tape (Blenderm) and overlapping stripes (Micropore or Dermiclear)
- Volume applied: 0.3 g
- Vehicle / solvent: petrolatum
- Concentrations: 5% for induction; 1% for challenge
- Testing/scoring schedule: 5 times 24 h for induction; 48 h for challenge
EXAMINATIONS
- Grading/Scoring system: scoring of the challenge 72 and 96 h after challenge application
Results and discussion
- Results of examinations:
- NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0/25
- Number of subjects with negative reactions: 25/25
- Number of subjects with equivocal reactions: 0/25
- Number of subjects with irritating reactions: 0/25
Any other information on results incl. tables
No sensitization reaction was found.
Applicant's summary and conclusion
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