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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 700-503-1 | CAS number: 101238-01-1
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and OECD guideline compliant study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- (December 17, 2001)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (Bioassay, Labor für biologische Analytik GmbH, Heidelberg)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 2,2,6,6-tetramethylpiperidin-4-yl dodecanoate
- EC Number:
- 700-503-1
- Cas Number:
- 101238-01-1
- Molecular formula:
- C21 H41 N O2
- IUPAC Name:
- 2,2,6,6-tetramethylpiperidin-4-yl dodecanoate
- Details on test material:
- - Analytical purity: 94%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: approx. 10 – 11 weeks
- Weight at study initiation: mean weight test group 1: 168.7 +/- 3.51; mean weight test group 2: 179 +/- 1.00;
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Housing: single housing in Makrolon cages, type III
- Diet: VRF1(P); SDS Special Diets Services, Altrip, Germany
- Water: tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 30 – 70%
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 h / 12 h
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2.24 mL/kg bw
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation. Additionally, at day of death in animals that died or were sacrificed moribund starting with study day 1. Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals. A check for any dead or moribund animals was made at least once each workday.
- Necropsy of survivors performed: yes - Statistics:
- Calculations were performed using Microsoft Excel 2003 and checked with a calculator.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 2/6 animals died
- Mortality:
- One animal of the first 2000 mg/kg bw test group was found dead in the cage on study day 2 and one animal of the second 2000 mg/kg bw test group was sacrificed in a moribund state on study day 3.
- Clinical signs:
- other: Clinical signs in the first 2000 mg/kg bw test group revealed in two out of three animals impaired general state and piloerection from study day 1 until study day 6 after administration. In one of these animals dyspnoea and reduced defecation were observe
- Gross pathology:
- The following macroscopic pathologic findings were observed in the animal that died (test group 1):
· Extensive haemorrhage of the glandular stomach
· Red discoloration and reddish content of the small intestine.
· Congestion of the kidneys
The following macroscopic pathologic finding was observed in the animal which was sacrificed in a moribund state (test group 2):
· Red discoloration of the small intestine.
There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Remarks:
- Migrated information
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.