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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study under GLP
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 416: 2-generation reproductive toxicity study
- Principles of method if other than guideline:
- In addiiton to a reproductive and developmental toxicity study (OECD 414), the F1 generation of animals is exposed and mated, producing an F2 generation which is assessed for toxicity.
- 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:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- Additional information on the study is forthcoming.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on exposure:
- Parental males were dosed for 70 days before mating. Parental females were dosed 14 days prior to mating, no more than 21 days during the mating process, 22-24 days during gestation, and 21-28 days during lactation up until the weaning of F1 pups. F1 males and F1 females were dosed according to the this same schedule.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- no data. Additional information on the study is forthcoming.
- Details on mating procedure:
- Additional information on the study is forthcoming.
- Duration of treatment / exposure:
- Parental males were dosed for 70 days before mating. Parental females were dosed 14 days prior to mating, no more than 21 days during the mating process, 22-24 days during gestation, and 21-28 days during lactation up until the weaning of F1 pups. F1 males and F1 females were dosed according to the this same schedule.
- Frequency of treatment:
- once daily
- Duration of test:
- approximately 180 days
- No. of animals per sex per dose:
- 12 males/group; 24 females/group
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- P and F1 adults were weighed weekly. Pups of F1 and F2 generation were weighed 24 hours after birth, and on days 4,7,14 and 21 post-parturition. For mating, F1 offspring were selected litters of the same dose level at weaning to produce F2 generation. Age difference between selected pups was about one week. Since F1 pups were too small in day 21 post-partum, they were weaned in day 28 post-parturition. All animals were monitored for the signs of toxicity during the application of the test substance.
Examinations
- Maternal examinations:
- During the study, clinical observations and food consumption were recorded. Body weights were measured. Organ weights and gross and histological examinations on selected organs were undertaken after termination of the study.
- Ovaries and uterine content:
- Not monitored in P generation, as females were allowed to deliver naturally. The number of corpora lutea and implantation sites in F1 females were assessed. Functional effects were assessed in the P and F1 generations. Additional information on the study is forthcoming.
- Fetal examinations:
- F1 pups were examined for externally-viewed malformations, then weaned, and mated.
- Statistics:
- separately for P and F1 males, females and litters;
Test for homogeneity of the groups: Barlett´s test
in the way of homogeneity: one way analysis with consecutive Multiple Rangers test
no homogeneity: Kruskal-Wallis one way Analysis by ranks - Indices:
- Since the study is a 2 generation study, only obvious malformations were detected
- Historical control data:
- Historical data is available.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No important visible signs of intoxication were noted. Alopecia and smooth stool in P and F1 generations were registered, with no dose-response relationship.
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- One animal died due to a gavage accident.
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Food intake in P females at 250 mg/kg bw/d after the first and second week, and in dose group 125 mg/kg bw/d after the second week pre-mating period was decreased compared to controls.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Females of 250 mg/kg bw/d showed increased relative liver weight.
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- not examined
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- not specified
- Dead fetuses:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Control: 12/153 (dead/alive), 25 mg/kg bw: 7/199 (dead/alive), 125 mg/kg bw: 9/185 (dead/alive), 250 mg/kg bw: 11/184 (dead/alive)
- Changes in pregnancy duration:
- no effects observed
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): no effects observed - Changes in number of pregnant:
- no effects observed
- Details on maternal toxic effects:
- Maternal toxic effects:yes. Remark: Food intake and relative liver weights were increased in the P generation at the high dose of 250 mg/kg bw/d.
Details on maternal toxic effects:
Food intake in P females at 250 mg/kg bw/d after the first and second week, and in dose group 125 mg/kg bw/d after the second week pre-mating period was decreased compared to controls. While there were no significant changes histologically in the P generation, it was noted that there was an increased relative liver weight in females of the 250 mg/kg bw/d group, compared to controls.
Effect levels (maternal animals)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 125 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
Maternal abnormalities
- Key result
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): no effects observed - Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- no effects observed
- External malformations:
- no effects observed
- Skeletal malformations:
- not examined
- Visceral malformations:
- not examined
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
No adverse effects were noted in offspring.
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 250 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effects observed
Fetal abnormalities
- Key result
- Abnormalities:
- not examined
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- A two-generation reproductive toxicity study in Wistar rats on Dastib 845, at doses of 25, 125 and 250 mg/kg bw/d, was undertaken according to OECD guideline 416. Results indicate there was no test article-related changes based on the evaluation of the survival, clinical signs, body weight, production parameters, and organ weights, except for elevated relative liver weights in P females. The NOAEL for the P generation males and F1 generation is greater than 250 mg/kg bw/d; for P females is 125 mg/kg bw/d.
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