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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
Toxicity to reproduction
Administrative data
- Endpoint:
- two-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- 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
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
- 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
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Velaz Praha, Czech Republic
- Age at study initiation: (P) x wks; (F1) x wks
- Mean Weight at study initiation: (P) Males: 216.46g; Females: 218.75 g; (F1) Males: 56.25 g; Females: 49.58 g
- Fasting period before study:
- Housing: 4 animals per cage, mating: 1 male and 2 females; 1 pregnant female individually, 1 female and offspring individually
- Diet : ad libitum
- Water: ad libitum
- Acclimation period: > 6d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 45-65%
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on exposure:
- 0.5 ml/100 g body weight
Lot-no of the vehicle: L 809182 - Details on mating procedure:
- - M/F ratio per cage: 1/2
- Length of cohabitation: max. 21 days
- Proof of pregnancy: vaginal plug / sperm in vaginal smear referred to as day 0 of pregnancy
- After 16 days of unsuccessful pairing replacement of first male by another male with proven fertility (in sum 6 males were replaced).
- After successful mating each pregnant female was caged: individually - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- 2 controls of analysis of sampleas were performed with 3 concentrations, recovery rate was nearly 100%.
- 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:
- 7 days per week.
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
25 mg/kg bw/d
Basis:
actual ingested
0.5 ml/100 g body weight
- Remarks:
- Doses / Concentrations:
125 mg/kg bw/d
Basis:
actual ingested
0.5 ml/100 g body weight
- Remarks:
- Doses / Concentrations:
250 mg/kg bw/d
Basis:
actual ingested
0.5 ml/100 g body weight
- No. of animals per sex per dose:
- 12 males, 24 females
- 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 F! 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
- Parental animals: Observations and examinations:
- During the study, clinical observations and food consumption were recorded. Gross and histological examinations on selected organs were undertaken after termination of the study.
- Oestrous cyclicity (parental animals):
- not examined
- Sperm parameters (parental animals):
- not examined
- Postmortem examinations (parental animals):
- At the end of the study, all animals were sacrificed and underwent histological evaluationo of uterus, ovaries, mammary gland, testes, epididymis, prostate, glandula coagulations, liver, kidney and duodenum.
- Postmortem examinations (offspring):
- At the end of the study, all animals were sacrificed and underwent histological evaluationo of uterus, ovaries, mammary gland, testes, epididymis, prostate, glandula coagulations, liver, kidney and duodenum.
- 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 - Reproductive indices:
- copulation index, fertility index, gestation index, delivery index
- Offspring viability indices:
- Live birth index, viability (Survival) index
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No important visible signs of intoxication were noted. Alopecia and smooth stool in P0 generation 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:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- 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
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- not examined
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- Length of pregnancy 22-24 days. Body weights, number of offspring and sex distribution in F1 and F2 were largely stable. The number of live pups of F1 females in dose groups 25 and 250 mg/kg bw/d were decreased compared to contols. Health condition of
Details on results (P0)
Effect levels (P0)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 125 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: based on increased relative liver weights in females of the 250 mg/kg bw/d group. No adverse effects in fertility parameters were observed at the highest dose tested.
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- clinical signs
Results: P1 (second parental generation)
General toxicity (P1)
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No important visible signs of intoxication were noted. Alopecia and smooth stool in P1 generation were registered, with no dose-response relationship.
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- 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:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
Reproductive function / performance (P1)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
Effect levels (P1)
- 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
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- mortality 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)
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Mean body growth of F1 pups in the mid dose group was slightly decreased compared to controls.
- Food consumption and compound intake (if feeding study):
- not examined
- 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
- Sexual maturation:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
- Description (incidence and severity):
- Histopathology examinations of male and females of the control and high dose groups of both generations showed no changes related to the test material.
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not examined
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not examined
Details on results (F1)
Effect levels (F1)
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 250 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: NOAEL > 250 mg/kg bw/day. No adverse effects in fertility parameters were observed at the highest dose tested.
Results: F2 generation
General toxicity (F2)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- 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
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not examined
Developmental neurotoxicity (F2)
- Behaviour (functional findings):
- not examined
Developmental immunotoxicity (F2)
- Developmental immunotoxicity:
- not examined
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
Any other information on results incl. tables
The results of a two-generation reproductive toxicity study in rats show that Dastib 845, at doses of 25, 125 and 250 mg/kg bw/d, caused no test article-related changes based on the evaluation of the survival, clinical signs, body weight, production parameters, and organ weights. The exception was that P females of the 250 mg/kg bw/d group showed increased relative liver weight. The LOAEL for the P generation is 250 mg/kg bw/d, and the NOAEL is 125 mg/kg bw/d based on these effects. The LOAEL for the P generation males and F1 generation is greater than 250 mg/kg bw/d.
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 based on systemic toxicity.
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