Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
1981
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

Constituent 1
Chemical structure
Reference substance name:
Octanoic acid
EC Number:
204-677-5
EC Name:
Octanoic acid
Cas Number:
124-07-2
Molecular formula:
C8H16O2
IUPAC Name:
octanoic acid
Details on test material:
- RIFM No.: 77-62
- Analytical purity: no specified

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