Registration Dossier
Registration Dossier
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EC number: 208-873-1 | CAS number: 544-60-5
Direct observations: clinical cases, poisoning incidents and other
Administrative data
- Endpoint:
- direct observations: clinical cases, poisoning incidents and other
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well documented publication, acceptable for assessment with restrictions (no test substance purity given). For justification of read across see section 13.
Data source
Reference
- Reference Type:
- publication
- Title:
- The chamber scarification test for irritancy
- Author:
- Frosch, P. Kligmann, A.
- Year:
- 1 976
- Bibliographic source:
- Contact Dermatitis 1976: 2: 314-324
Materials and methods
- Study type:
- study with volunteers
- Endpoint addressed:
- skin irritation / corrosion
Test guideline
- Qualifier:
- no guideline followed
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Oleic acid
- EC Number:
- 204-007-1
- EC Name:
- Oleic acid
- Cas Number:
- 112-80-1
- Molecular formula:
- C18H34O2
- IUPAC Name:
- octadec-9-enoic acid
Constituent 1
Method
- Type of population:
- general
- Subjects:
- - Number of subjects exposed: no data
- Sex: no data
- Age: young adults
- Race: light skinned Caucasoids
- Other: "hyper reactors" were selected (especially vulnerable to irritants) - Ethical approval:
- not applicable
- Route of exposure:
- dermal
- Reason of exposure:
- intentional
- Exposure assessment:
- measured
- Details on exposure:
- 0.1 mL of the read across substance was applied to the probands' skin after scarification of the skin using a needle. Ethanol was used as a vehicle. For a test duration of 3 days the test site was occluded by a Duhring chamber sealed to the skin with non-occlusive tape.
- Examinations:
- - Other: The test sites were examined for signs of irritancy.
- Medical treatment:
- none
Results and discussion
- Clinical signs:
- The substance in a concentration of 5 % (vehicle: ethanol) lead to a moderate irritation (score 1.5-2.4) whereas a concentration of 25 % in ethanol lead to a marked irritation (irritation score 2.5-4) on scarified skin. No data on unscarified skin are available but the scarification index SI (ratio of threshold concentrations on intact/scarified skin) of the substance was determined to be 6.
- Effectivity of medical treatment:
- not applicable
- Outcome of incidence:
- not applicable
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
