Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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: 270-298-7 | CAS number: 68424-37-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 29 Jan - 04 Feb 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- application under occlusion; 4 animals used
- GLP compliance:
- yes
Test material
- Reference substance name:
- Palmitic acid
- EC Number:
- 200-312-9
- EC Name:
- Palmitic acid
- Cas Number:
- 57-10-3
- Molecular formula:
- C16H32O2
- IUPAC Name:
- palmitic acid
- Details on test material:
- - Name of test material (as cited in study report): Edenor C16
- Physical state: white powder
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Kleinrusse, Chbb: HM
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Fa. Thomae, Biberach/D.
- Weight at study initiation: mean: 2452.5 g
- Housing: individually housed in rabbit batteries, Fa. Heinkel, 7343, Kuchen, D
- Diet: Zucht- /Haltungsdiät 20 ZH 5, Fa. Nohrlin GmbH, 4902 Bad Salzuflen; ad libitum
- Water (ad libitum): tap water
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 20 - 21
- Humidity (%): ca. 45 - 50
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 3 days; since no scores could be observed within 3 days the experiment was cancelled due to animal welfare reasons; therefore the short observation period of 3 days does not represent a deviation to the OECD guideline)
- Number of animals:
- 4
- Details on study design:
- TEST SITE
- Area of exposure: ~2.5 x 2.5 cm
- Type of wrap if used: plastic foil with adhesive plasters and an acrylastic band aid
SCORING SYSTEM: Skin irritation/corrosion was evaluated according to Draize.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, 2, 3, 4
- Time point:
- other: 4 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- edema score
- Basis:
- animal: #1, 2, 3, 4
- Time point:
- other: 4 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritant / corrosive response data:
- No skin reactions were observed.
- Other effects:
- no data
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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.
