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Diss Factsheets
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EC number: 700-792-4 | 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
- Study period:
- 15 June 2012 to 20 July 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted at a GLP compliant lab according to OECD guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, Skin Irritation (2-1-4), 12 Nohsan No. 8147,
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of 1,2,2,6,6-pentamethylpiperidin-4-yl hexadecanoate and 1,2,2,6,6-pentamethylpiperidin-4-yl octadecanoate
- EC Number:
- 700-792-4
- Molecular formula:
- C26H51NO2, C28H55NO2
- IUPAC Name:
- Reaction mass of 1,2,2,6,6-pentamethylpiperidin-4-yl hexadecanoate and 1,2,2,6,6-pentamethylpiperidin-4-yl octadecanoate
- Test material form:
- other: SOLID
- Details on test material:
- - Name of test material (as cited in study report): t-1640l
- Physical state: solid
- Analytical purity:98.74%
- Purity test date:
- Lot/batch No.: 23-04-2013
- Expiration date of the lot/batch:12 Aoril 2013
- Radiochemical purity (if radiolabelling):
- Stability under test conditions: stable
- Storage condition of test material: +4C in the dark under dry conditions
- Other:
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Reputable industrial supplier
- Age at study initiation: 31 - 34 weeks
- Weight at study initiation: 3.83 - 4.76 kg
- Housing: Housed individually in plastic cages witrh perforated floors
- Diet (e.g. ad libitum): standard laboratory rabbit diet 125g/day
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 10-15 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-20C
- Humidity (%): 40-70%
- Air changes (per hr): not recorded
- Photoperiod (hrs dark / hrs light): 12h light/ 12h dark
IN-LIFE DATES: From: To: 15 June 2012 to 20 July 2012
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca 0.5g applied as is to "wetted" treatment site
- Concentration (if solution): N/a
VEHICLE
- Amount(s) applied (volume or weight with unit): N/a
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity: - Duration of treatment / exposure:
- A single animal (number 20) received three exposures of three minutes, one or four hours
duration in a step-wise manner and acted as a preliminary screen. In the absence of a severe
effect on removal of the dressings the next exposure was initiated. In the absence of a severe
effect in this animal, two further animals were committed to the study receiving an exposure
of four hours. - Observation period:
- Examination of the treated skin was made on removal of the dressings (for 3 minute or one hour exposures) and approximately 1, 24, 48 and 72 hours later. Only the data for the four hour exposure are reported, the data from the three minute and one hour exposures are not reported. Additional observations of persistent effects of treatment were made daily to Day 12 in two animals.
- Number of animals:
- 3 animals in total used
- Details on study design:
- TEST SITE
- Area of exposure: 25mm x 25mm area on dorso-lumbar region
- % coverage: 100%
- Type of wrap if used: 2-ply 25 mm x 25 mm porous gauze pad secured with ‘blenderm’ surgical tape. For exposures of one hour or more each treatment site was covered with cotton wool and "Tubigrip" elasticated bandage dressing for the duration of the exposure period.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period the treatment site was washed with lukewarm water (30-40°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.
- Time after start of exposure: 4 hours
SCORING SYSTEM:
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: erythema noted in one rabbit only
- Irritant / corrosive response data:
- Very-slight or well-defined erythema was apparent in one animal throughout the first six days after bandage removal; exfoliation was evident for the following five days. No dermal reaction was observed in the remaining animals throughout the duration of the study.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The Primary Irritation Index was calculated to be 0.7; T-1640L was classified as ‘mildly irritating’ according to the criteria of the ECETOC and did not require labelling in accordance with Commission Regulation 1272/2008.
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.
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