Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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: 434-880-6 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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:
- guideline study
- Remarks:
- Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do no effect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 434-880-6
- EC Name:
- -
- Cas Number:
- 3637-10-3
- Molecular formula:
- C9H19NO2
- IUPAC Name:
- 2,2,6,6-tetramethylpiperidine-1,4-diol
- Test material form:
- solid: crystalline
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Three New Zealand White rabbits were supplied by David Percival ltd, Moston, Sandbach, Cheshire, UK.
- Age at study initiation: twelve to sixteen weeks old
- Weight at study initiation: At the start of the study the animals weighed 2.61 to 2.90 kg
- Housing: The animals were individually housed in suspended cages.
- Diet (e.g. ad libitum): Free access to food (Stanrab SQC Rabbit diet supplied by Special Diets Services Ltd, Witham, Essex, UK) was allowed throughout the study.
- Water (e.g. ad libitum): Free access to mains drinking water was allowed throughout the study.
- Acclimation period: At least five days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study.
- Air changes (per hr): At least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): Lighting was controlled by a time switch to give twelve hours continuous light and twelve hours darkness.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped free of fur
- Vehicle:
- other: Test material moistened with 0.5ml dried arachis oil
- Controls:
- other: Dried arachis oil applied to a separate skin site of animal also treated with test material
- Amount / concentration applied:
- TEST MATERIAL
For the purpose of the study the test item was ground to a powder before use.
At each test site a quantity of 0.5 g of the test item, moistened with 0.5 ml of dried arachis oil was introduced under a 2.5 cm x 2.5cm gauze patch. - Duration of treatment / exposure:
- 4 hours (all animals)
- Observation period:
- 1 hour, 24 hours, 48 hours, 72 hours and on Day 7.
- Number of animals:
- 2 males and 1 female
- Details on study design:
- PROCEDURE:
On the day before the test each rabbit was clipped free of fur from the dorsal/flank area using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study.
On the day of the test a suitable test site was selected on the back of each rabbit. A quantity of 0.5 g of the test item, moistened with 0.5 ml of dried arachis oil, was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the left shorn flank. Similarly a quantity 0.5ml of dried arachs oil was applied to a separate skin silte on the shorn right flank. The patches were secured in position with a strips of surgical adhesive tape. To prevent the animals interfering with the patches, the trunk of the rabbit was wrapped in an elasticated corset for the duration of the exposure period.
4 hours after application the corset and patches were removed from each animal and any residual test item and control material removed by gentle swabbing with cotton wool soaked in dried arachis oil followed by 74% industrial methylated spirits..
SCORING SYSTEM:
Approximately 1 hour following removal of the patches and 24, 48 and 72 hours later, the test and control sites were examined for evidence of primary irritation and scored according to the Draize scale (see evaluation of skin reactions below).
Any other skin reactions if present, were also recorded.
An additional observation was made on Day 7 to assess the reversibility of skin reactions.
Individual bodyweights were recorded on Day 0 (the day of treatment.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (animal #1 - 22)
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: Test material
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal # 1 - 22
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Test material
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #2 - 23
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: Test material
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal # 2 - 23
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Test material
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal # 3 - 30
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Test material
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal # 3 - 30
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Test material
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal # 1 - 22
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: Control arachis oil
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal # - 22
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Control arachis oil
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal # 2 - 23
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: Control arachis oil
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal # - 23
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Control arachis oil
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal # 3 - 30
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Control arachis oil
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal # 3 - 30
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Control arachis oil
- Irritant / corrosive response data:
- For individual skin reacions see attached background information.
Test material
Very slight erythema was noted at two treated skin sites at the 24, 48 and 72 hour observations.
Control material - dried arachis oil
Very slight erythema was noted at two treated skin sites at the 24 and 48 hour observations and persisted at one treated skin site at the 72 hour observation. - Other effects:
- Test material
Loss of skin elasticity was noted at two treated skin sites at t he 72 hour observation. Slight desquamation. was noted in one treated skin site at the 7 day observation. Two treated skin sites appeared normal at the 7 day observation
Control material - dried arachis oil
Loss of skin elasticity was noted at one treated skin site at the 72 hour observation. Slight desquamation was noted in one treated skin site at the 7 day observation. Two treated skin sites appeared normal at the 7 day observation.
Any other information on results incl. tables
Results summary
Treatment | Primary irritation index | Classifcation |
Test material | 0.7 | Mild irrtant |
Control arachis oil | 0.5 | Mild irriatnt |
The test material does not meet the criteria for classifciation as irritant or corrosive according to CLP regulations.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No corrosive effects were noted.The test item produced a primary irritation index of 0.7 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme. The test item did not meet the criteria for classification according to the Classification, Labelling and Packaging Regulation (CLP) or the Globally Harmonised Classification System.
- Executive summary:
Introduction.
The study was performed to assess the irritancy potential of the test item to the skin of the New Zealand White rabbit. The method was designed to be compatible with the following:
- OECD Guidelines for the Testing of Chemicals No. 404 “Acute Dermal Irritation/Corrosion” (adopted 17 July 1992)
- Method B4 Acute Toxicity (Skin Irritation) of Commission Directive 92/69/EEC
Results.
A single 4-hour, semi-occluded application of the test item to the intact skin of three rabbits produced very slight erythema. Other skin reactions noted were loss of skin elasticity and slight desquamation.
A single 4-hour, semi-occluded application of the vehicle control dried arachis oil to the intact skin of three rabbits produced very slight erythema. Other skin reactions noted were loss of skin elasticity and slight desquamation.
Conclusion.
The test item did not present any significantly greater risk than the control material..
The test item produced a maximum individual mean score of 1.0 and therefore did not meet the criteria for classification according to the Classification, Labelling and Packaging Regulation (CLP) or the Globally Harmonised Classification System.
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.