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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 219-291-2 | CAS number: 2403-88-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hüls AG, Marl, Germany
Test material
- Reference substance name:
- 2,2,6,6-tetramethylpiperidin-4-ol
- EC Number:
- 219-291-2
- EC Name:
- 2,2,6,6-tetramethylpiperidin-4-ol
- Cas Number:
- 2403-88-5
- Molecular formula:
- C9H19NO
- IUPAC Name:
- 2,2,6,6-tetramethylpiperidin-4-ol
- Details on test material:
- - Lot/batch No.: 113
- Physical state: solid, white
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2.1-2.5 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
according to guideline
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g with 0.5 mL water to 6cm2
- Duration of treatment / exposure:
- animal 1: 4 hours, thereafter the bandage was removed and the site washed with water
animal 2: 3 min: open patch
animal 3: 1 hour: semiocculsive, observation up to 6 days - Observation period:
- animal 1: up to 72 hours post application. Due to the high corrosvitiy, the animal was killed after 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: gatze fixed with non irritating adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to Guideline
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48, 72 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- other: animal was killed after 3 days
- Remarks on result:
- other: 4 hour test
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48, 72 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- other: animal was killed after 3 days
- Remarks on result:
- other: 4 hour test
- Irritation parameter:
- overall irritation score
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: 3 min test
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean 24, 48, 72 hours
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: 1 hour test
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48, 72 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: 1 hour test
Any other information on results incl. tables
1 hour exposure time: After 30 to 60 min and after 24 hours clear erythema and very slight edema were seen. After 48 and 72 hours only dry skin and very slight desquamation were observed. Irritation scores: Erythema: 0.67, Edema: 0.33 After 6 days the effects were reversible. 4 hours exposure time: Direct after patch removal and 30 to 60 min strong subcutaneous bleeding and redbroun discoloration of the skin were observed. The skin was hardened and the animal showed a very strong erythema and edema Necrosis appeared 24 hours p.a. The animal was killed three days p.a..
Applicant's summary and conclusion
- Interpretation of results:
- Category 1C (corrosive) based on GHS criteria
- Conclusions:
- Under conditions tested, the test item is regarded to be corrosive.
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.
