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Toxicological information

Direct observations: clinical cases, poisoning incidents and other

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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:
1976
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

Constituent 1
Chemical structure
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

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