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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 415-430-8 | CAS number: 86403-32-9 CYASORB UV-3853 LIGHT STABILIZER; DASTIB 845; SANDUVOR 845
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study obtained through inquiry process. SNIF file obtained from ECHA.
Data source
Reference
- Reference Type:
- other: SNIF
- Title:
- Unnamed
- Year:
- 1 992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- A mixture of: 2,2,6,6-tetramethylpiperidin-4-yl-hexadecanoate; 2,2,6,6-tetramethylpiperidin-4-yl-octadecanoate
- EC Number:
- 415-430-8
- EC Name:
- A mixture of: 2,2,6,6-tetramethylpiperidin-4-yl-hexadecanoate; 2,2,6,6-tetramethylpiperidin-4-yl-octadecanoate
- Cas Number:
- 86403-32-9
- Molecular formula:
- C25H49NO2 and C27H53NO2
- IUPAC Name:
- Reaction mass of 2,2,6,6-tetramethylpiperidin-4-yl hexadecanoate and 2,2,6,6-tetramethylpiperidin-4-yl octadecanoate
Constituent 1
Test animals
- Species:
- other: rat, Wistar (Han: WIST)
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- corn oil
- Details on oral exposure:
- Method of administration:
gavage - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Test duration: 28 days
- Frequency of treatment:
- Dosing regime: 7 days/week
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
40 mg/kg bw/d
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
200 mg/kg bw/d
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
1000 mg/kg bw/d
Basis:
actual ingested
- No. of animals per sex per dose:
- Male: 10 animals at 0 mg/kg bw/day, 5 animals at 40 mg/kg bw/day, 5 animals at 200 mg/kg bw/day, 10 animals at 1000 mg/kg bw/day .
Female: 10 animals at 0 mg/kg bw/day, 5 animals at 40 mg/kg bw/day, 5 animals at 200 mg/kg bw/day, 10 animals at 1000 mg/kg bw/day - Control animals:
- yes, concurrent vehicle
- Details on study design:
- Standard design with three dose groups. A two-week recovery group was added.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Salivation increased among mid and high dose animals. Some high dose animals displayed some decreases in reflex response.
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- Salivation increased among mid and high dose animals. Some high dose animals displayed some decreases in reflex response.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- High dose males showed decreased body weight
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- In the high dose, males demonstrated a decrease in food consumption during the entire 28 day dosing period, and females showed decreased food consumption during the first two weeks.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Mid and high dose females displayed an increase in thrombocytes. In all males, and in females of the high dose group, prothrombin time was increased.
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- In high dose females, glucose and triglyceride values were elevated. Males and females showed reduced blood protein levels. High dose males showed increased ALAT levels.
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Stomach and duodenum showed effects of oral exposure: white areas and redness of the stomach lining, and swelling of duodenal septum.
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- In mid and high dose animals, hyperplasia of the duodenal mucosa was observed. No similar effects were seen in the recovery group.
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- Clinical observations: In the intermediate and high dose group, dose-dependent increased salivation was observed.
The animals of the high dose group showed bright feces from the second week and at the end of the treatment, reduced activity, skin turgor and righting reflex. Two females of the high dose group did not show the ear reflex.
The discolouration of the feces was seen in the discovery group till the end of the first week of the recovery period. One male of the low dose group showed a reduced righting reflex at day 15. At the examination on day 26 a reduced righting reflex was observed at one male of the intermediate dose and at two male of the low dose group.
In the males of the high dose group a reduced body weight development was measured at the end of the study. The food consumption of these animals was reduced during the whole application period, in the females of the high dose group a reduced food consumption was observed during the first two weeks of the treatment.
Laboratory findings: Haematology: In the females of the intermediate and high dose group an increase of the number of thrombocytes. A prolongation of the prothrombin time in the males in all dose groups (without relation to the doses) and in females of high and low dose group was observed.
Clinical chemistry: In females of the high dose group the values for glucose and triglycerides were increased and in both sexes the protein values were reduced. In the males of the high dose group increased activities for ALAT was determined.
Effects in organs: On the animal body white areas and redness of the mucosa of the stomach and a swelling of the duodenum septum in all animals of the high dose groups were seen. One animal of the intermedium dose group showed a swollen duodenum too.
Microscopically in the animals of the intermediate and high dose group a hyperplasia of the mucosa in the duodenum was
detected. In the recovery groups no treatment related changes were observed.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 40 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Local irritation effects in the stomach and duodenum from gavage administration
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- This substance was studied in an OECD guideline study (407) for 28-days of oral gavage exposure at doses of 40, 200 and 1000 mg/kg bw/d in Wistar rats. Primary effects involved local irritation in the stomach and duodenum which resolved during the two-week recovery period, with hyperplasia of the duodenum in mid and high dose groups. The NOAEL is conservatively set at 40 mg/kg bw/d.
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.