Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 205-582-1 | CAS number: 143-07-7
Direct observations: clinical cases, poisoning incidents and other
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:
- 1 988
- 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 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
Constituent 1
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
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.
