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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)
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:
- OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Dastib 845
- IUPAC Name:
- Dastib 845
- Details on test material:
- Lot No.: 040109-02
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
- Weight at study initiation: (P) Males: x-x g; Females: x-x g; (F1) Males: x-x g; Females: x-x g
- Fasting period before study: no data
- Housing:all animals were kept in cages with the bedding in experimental animal house with the standard condition. The sanitation was made according to SOP. Temperature was 22±2°C, reelative humidity 45-65% (central monitoring and regulation), light 12/dark12,
- Use of restrainers for preventing ingestion (if dermal): yes/no
- Diet (e.g. ad libitum):conventional laboratory diet
- Water (e.g. ad libitum):ad libidum
- Acclimation period: 6days, identical conditions to experiment conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C):22±2°C
- Humidity (%):45-65%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
DIET PREPARATION
- Rate of preparation of diet (frequency):
- Mixing appropriate amounts with (Type of food): conventional laboratory diet
- Storage temperature of food:
VEHICLE
- Justification for use and choice of vehicle (if other than water): substance is insoluble in water
- Amount of vehicle (if gavage): 0.5 mL/100g body weight
- Lot/batch no. (if required): 809182
- Purity:Ph.Eur. 5.0 - Details on mating procedure:
- Normally, 1:2 (male:female) ,ating were used in this study. P and F1 females were placed with the same P and F1 male until the pregnancy occurs or 21 days have elapsed. Every morning during the mating period all females were examined for the presence of sperms or vaginal plugs. The day 0 of pregnancy was defined as the day a vaginal plug or sperm are found. The pregnant female was keeping individually up to the weaning of pups. in case of pairing was unsuccessful, re-mating of females with the successful males of the same group was considered. For mating the F1 offspring the best representative pups of the litters control and all dose group were selected to produce F2 generation. Mating of siblings in animals F1 generation was no tolerable.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- P generation: acclimatisation: 7days
application/ males: 70 days before mating
application/ females: 14 days before mating, 21 days during mating , 22-24 days during birds, 21 days during weaning F1
F1 genaration:
application/ males: 70 days before mating
application/ females: 70 days before mating, 21 days during mating , 22-24 days during birds, 21 days during weaning F1 - Frequency of treatment:
- Dosing regime P0: daily (males)
Dosing regime P0: daily (females) Dosing regime F1: daily (males) Dosing regime F1: daily (females)
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
25 mg/kg
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
125 mg/kg
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
250 mg/kg
Basis:
nominal conc.
- No. of animals per sex per dose:
- control: 12 males / 24 females
dose 25 mg/kg: 12 males / 24 females
dose 125 mg/kg: 12 males / 24 females
dose 250 mg/kg: 12 males / 24 females - Control animals:
- yes, concurrent vehicle
Examinations
- Statistics:
- The results obtained during the study were statistically evaluated by the statistical programme Statgraphics. For the identification homogeneity the groups were used the Bartletts test. In case of homogenity One-Way Analysis of variance with consecutive Multiple Rangers test was accomplished. In the case of non homogeneity Kruskal-Wallis One Way Analysis by Ranks was applied.
The relative weight of the observed organs was calculated from the formula:
R(%) = A (g) / Body weight (g) * 100
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
open allclose all
- Dose descriptor:
- LOAEL
- Effect level:
- 250 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- NOAEL
- Effect level:
- 125 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LOAEL
- Effect level:
- > 250 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- NOAEL
- Effect level:
- > 250 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
Results: F1 generation
Effect levels (F1)
open allclose all
- Dose descriptor:
- LOAEL
- Generation:
- F1
- Effect level:
- > 250 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- > 250 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Considering results of this study following were made:
The test article Dastib 845 administered in dose 25 , 125 and 250 mg/kg
* did not cause treatment - related the deaths of P and F1 animals
* did not cause visible treatment-related the signs of intoxication
* did not cause treatment - related changes in the monitored parameters
* did not cause the pathological changes related to the effect of Dastib 845
The test article Dastib 845 administered in dose 250mg/kg
* caused the increase relative weight of liver in female P generation
* LOAEL is 250 mg/kg bw/day and NOAEL is 125 mg/kg bw/day for females P generation
* LOAEL and NOAEL is > 250 mg/kg bw/day for F1 generation and males P generation - Executive summary:
please, check attached background material Summary -test
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