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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
experimental study
Adequacy of study:
other information
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

Constituent 1
Chemical structure
Reference substance name:
Lauric acid
EC Number:
205-582-1
EC Name:
Lauric acid
Cas Number:
143-07-7
Molecular formula:
C12H24O2
IUPAC Name:
dodecanoic acid
Details on test material:
- Name of test material (as cited in study report): Edenor C12 98/100 (Fettsäure C12)
- Analytical purity: not given

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
 
Fissure
0 - no fissures
1 – very superficial epidermal separation
2 – single or few fissures
3 – deep fissures with bleeding and exudation

Results and discussion

Clinical signs:
The test substance induced erythema, edema and scaling. The scores for erythema and edema were 69.15 % and 72.50 % of the values induced by the control Texapon N 25, respectively.
Results of examinations:
SKIN IRRITATION
All readings of the subjects were used for calculation (Sum / Mean+/-SEM) of the overall score:
- Erythema: 64 / 3.25 +/- 3.82
- Edema: 10 / 0.5 +/- 1.15
- Scaling: 2 / 0.1 +/- 0.31
- Fissures: 0 / 0

No single scores were provided.

Applicant's summary and conclusion