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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 429-370-5 | CAS number: 220410-74-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999-01-13 to 1999-04-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant Guideline study.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
- Reference Type:
- other: Amendment Final Report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted July 17, 1992
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 429-370-5
- EC Name:
- -
- Cas Number:
- 220410-74-2
- Molecular formula:
- C34H67N3O13
- IUPAC Name:
- tris(1,4-dihydroxy-2,2,6,6-tetramethylpiperidin-1-ium) 2-hydroxypropane-1,2,3-tricarboxylate
- Test material form:
- other: Ivory-peach flakes
- Details on test material:
- - Identification: TKA 45021
- Appearance: Ivory-peach flakes
- Analytical purity: 93.64 %
- Lot/batch No.: pax2068 / RD100
- Test Item arrived at Test Facility: 1998-11-25
- Expiration date of the lot/batch: none provided
- Storage conditions: at room temperature, dessicated
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Myrtle's Rabbitry, Thompson Station, TN, USA
- Age at study initiation: approximately seven weeks
- Weight at study initiation: ranging from 2552 to 2704 g for males and 2220 to 2477 g for females
- Fasting period before study: no
- Housing: individually in suspended stainless steel cages.
- Diet: PMI Certified Rodent Chow® #5322 (Purina Mills, Inc.) ad libitum
- Water: municipal tap water ad libitum
- Acclimation period: minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 18°C to 20°C
- Humidity: 26 to 49%
- Air changes: 10 to 15 air changes per hour
- Photoperiod: 12-hour light / 12-hour dark cycle
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: by animal clipper
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g per animal
VEHICLE
- Amount(s) applied: 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- approximately 1, 24, 48 and 72 hours after exposure
- Number of animals:
- 6 (3 male and 3 female)
- Details on study design:
- TEST SITE
- Area of exposure: approximately 1 inch x 1 inch (2.54 x 2.54 cm)
- % coverage: not specified
- Type of wrap if used: a nonirritating tape fixed a gauze patch, both covered by an elastic wrap over the trunk and test area, further secured with adhesive tape around the trunk at the cranial and caudal ends
REMOVAL OF TEST SUBSTANCE
- Washing: using gauze moistened with deionized water, followed by dry gauze
- Time after start of exposure: 4 hours
SCORING SYSTEM: Macroscopic Dermal Grading System based on Draize (erythema /edema score).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hours (mean)
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hours (mean)
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hours (mean)
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: 24, 48, 72 hours (mean)
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: 24, 48, 72 hours (mean)
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: 24, 48, 72 hours (mean)
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 (mean, all animals)
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: Fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours (mean all animals)
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Based on the Regulation (EC) No 1272/2008 (CLP) , the test item is considered to be a nonirritant to the skin of the rabbit based on both, the erythema and edema score.
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.
