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Diss Factsheets
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EC number: - | CAS number: -
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Read-across from GLP-compliant guideline study performed with similar substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS Sprague Dawley rats, strain Crl:CD(SD)
- Source: Charles River (UK) Ltd.
- Age at study initiation: approx. 70 days (Day 0 of gestation)
- Weight at study initiation: 227-278 g
- Fasting period before study: none
- Housing: one cage per animal during gestation
- Diet (e.g. ad libitum): ad libitum (pelleted diet)
- Water (e.g. ad libitum): ad libitum (tap water)
- Acclimation period: five days before commencement of pairing
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23°C
- Humidity (%): 40-70%
- Photoperiod (hrs dark / hrs light): 12 h light, 12 h dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
VEHICLE
- Justification for use and choice of vehicle (if other than water): corn oil allows good dispersion of test substance, experience from other gavage studies
- Concentration in vehicle: 50, 150, 500 mg/ml
- Amount of vehicle (if gavage): 2 ml/kg body weight - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- - Chemical analysis of test material formulations by high performance liquid chromatography (HPLC/UV) using an external standard technique.
- Concentrations (verified for first and last preparation) of the test material formulations were confirmed at each dose level.
- Chemical analysis confirmed that the prepared formulations were within 4% of the corresponding nominal concentration. - Details on mating procedure:
- - M/F ratio per cage: 1 : 1 with identified stock males
- Length of cohabitation: until positive evidence of mating was detected
- Proof of pregnancy: ejected copulation plugs and vaginal smears were checked for presence of sperm; when positive then referred to as day 0 of pregnancy - Duration of treatment / exposure:
- females were treated from Day 6 to Day 19 (inclusive)
- Frequency of treatment:
- once daily
- Duration of test:
- animals were killed on Day 20 after mating
- No. of animals per sex per dose:
- 20 animals per group
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: based on result of reproduction toxicity screening study
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: once daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: at least twice daily
BODY WEIGHT: Yes
- Time schedule for examinations: Days 0, 3 and 6-20 after mating
FOOD CONSUMPTION AND COMPOUND INTAKE : Yes
- Food consumption for each animal determined for days: 0-2, 3-5, 6-9, 10-13, 14-17 and 18-19
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day # 20
- Organs examined: detailed necropsy and macroscopic examination of tissues - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes
- Number of fetuses: Yes - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: half per litter
- Skeletal examinations: Yes: half per litter
- Head examinations: No - Statistics:
- The analyses were carried out using the individual animal as the basic experimental unit. For litter/fetal findings the litter was taken as the treated unit and the basis for statistical analysis and biological significance was assessed with relevance to the severity of the anomaly and the incidence of the finding within the background control population.
The following data types were analysed at each timepoint separately:
Body weight, using absolute values and gains over appropriate study periods
Gravid uterine weight and adjusted body weight
Food consumption, over appropriate study periods
Litter size and survival indices
Fetal, placental and litter weight
A sequence of statistical tests was used for body weight, gravid uterine weight, food consumption, corpora lutea, implantations, live young, fetal, placental and litter weight data.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
The incidence of major and minor visceral and skeletal abnormalities and skeletal variants showed no relationship to treatment.
Across all treated groups there was a slightly higher incidence of incompletely ossified hyoid and 13/14 14/14 short supernumerary ribs compared to concurrent control but was within Historical Control Data (HCD) (see attachment "historical control data").
At 1000 mg/kg/day there was also a slightly higher incidence of incompletely ossified sacrocaudal vertebrae compared to concurrent control but again this was within HCD.
These findings are therefore considered to be unrelated and incidental, showing no clear treatment relationship.
Effect levels (fetuses)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: teratogenicity
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: embryotoxicity
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: fetotoxicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
There was no effect of WS400128 on body weight and body weight change as well as food consumption during gestation (Tables 2, 3, 4 in the attachment "result tables from OECD 414 study with WS400128).
There was no effect of WS400128 on implantations, early or late resorptions, live young or sex ratio (Table 5 in the attachment "result tables from OECD 414 study with WS400128).
There was no effect of treatment on placental weight or litter weight (Table 6 in the attachment "result tables from OECD 414 study with WS400128).
The incidence of major and minor visceral and skeletal abnomalities ans skeletal variants showed no relationship to treatment (Tables 7, 8, 9 in the attachment "result tables from OECD 414 study with WS400128).
As outlined in the „Validity Assessment Report“ for the read-across approach (see IUCLID Section 13) read-across from testing data obtained with the UVCB substance WS400128 is considered appropriate for the safety evaluation as well as classification and labelling of the UVCB substance WS400136 based on the close chemical similarity between the two substances.
Applicant's summary and conclusion
- Conclusions:
- As outlined in the „Validity Assessment Report“ for the read-across approach (see IUCLID Section 13) read-across from testing data obtained with the UVCB substance WS400128 is considered appropriate for the safety evaluation as well as classification and labelling of the UVCB substance WS400136 based on the close chemical similarity between the two substances.
The NOAEL for maternal toxicity, embryo-fetal survival, growth and development of 1000 mg/kg/day as derived with the read-across source substance WS400128 also can be used for the read-across target substance WS400136 for the regulatory purposes of REACH.
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.
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