Registration Dossier

Toxicological information

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 based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented study report which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
skin irritation / corrosion
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Closed epicutaneous test, where 20 substances were investigated for skin irritation in 20 healthy volunteers
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Edenor C16 92/94 (Fettsäure C16)
- Analytical purity: no data

Method

Type of population:
general
Subjects:
- Number of subjects exposed: 20
- Sex: 12 females, 8 males
- Age: 21 - 50 years
- Other: healthy volunteers
Route of exposure:
dermal
Reason of exposure:
intentional
Exposure assessment:
not specified
Details on exposure:
10µl of the substance at concentration of 50% was applied to the back of the volunteers for 24 hours using a Large Finn Chamber on Scanpor (Herma).
Examinations:
READINGS
The readings of reaction were performed 1, 6, 24, 48, 72, and 144 hours after removal of the chambers.

SCORING
0 - no erythema
1 - very slight erythema (barely perceptible)
2 - well-defined erythema (diameter: 12 mm)
3 - moderate to severe erythema
4 - severe erythema (beet redness) to slight eschar formation (injuries in deep)
 
Edema:
0 - no edema
1- very slight edema (barely perceptible)
2 - slight edema (edges of area well defined by definite raising)
3 - moderate edema (raised appr. 1 mm)
4 - severe edema (raised >1 mm and extending beyond area of exposure)
 
Scaling:
0 - no scaling
1 – dryness
2 – fine scaling
3 – moderate scaling
4 - severe scaling
 
Fissures
0 - no fissures
1 – very superficial epidermal separation
2 – single or few fissures
3 – deep fissures with bleeding and exsudation

Results and discussion

Clinical signs:
The test substance did not induce erythema, edema or scaling. The scores for erythema and edema were 0 and 0 % of the values induced by the control Texapon N 25, respectivly.
Results of examinations:
SKIN IRRITATION
All readings of the subjects were used for calculation (Sum / Mean+/-SEM).
- Erythema: 0 / 0
- Edema: 0 / 0
- Scaling: 0 / 0
- Fissures: 0 / 0

Applicant's summary and conclusion