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EC number: 605-296-0 | CAS number: 162627-17-0
- 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

Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was conducted according to internationally accepted technical guidelines and in compliance with GLP in a contract research organization. The study is scientifically valid and the report is fully adequate for assessment, despite some minor restrictions (e.g. due to limited reporting).
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- of 1981
- Deviations:
- yes
- Remarks:
- Due to physicochemical properties of the test material and to achieve the high target doses dose volumes could not be kept constant but increased with increasing dose up to the double volume of that recommended by OECD401 for non-aqueous dose formulations
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, Division of Pharmacology, FDA, 1959
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Wistar rats, strain: Winkelmann, Paderborn (SPF-Quality) with appropriate range of bodyweight at study start.
- Weight at study initiation (day of dosing): Males: minimum 200 g, maximum 216 g,
Females: minimum 195 g, maximum 206 g.
- Housing: Group housing with up to 5 animals by sex in cages.
- Fasting period: From 16 hours before test start
- Diet (except for fasting period): Commercially available standard laboratory animal diet:
"Rat/Mouse Maintenance" from Altromin, Lage, Germany
- Water was provided ad libitum
ENVIRONMENTAL CONDITIONS
The animal room was maintained at:
- Temperature (°C): 22 ± 1°C
- Relative Humidity (%): 45 to 55%
- Photoperiod (artificial lighting): 12 h/day - Route of administration:
- oral: gavage
- Vehicle:
- other: Emulsion in mixture of CMC (carboxymethyl cellulose) and Tween 20 containing 50% of the test substance
- Details on oral exposure:
- - Dose formulation: 50% of the test substance in vehicle, i.e. emulsion at the maximum practical concentration
- Dose volume: The administered volume of test material formulation increased with increasing dose thus achieving quite high target doses.
Individual dose volume was calculated based on individual bodyweight
- For different doses and dose volumes, see Table 1 in "Any other information on materials and methods incl. tables"
- Rationale for doses selected: Based on a pre-test, which was not detailed in the study report. - Doses:
- see Table 1 in "Any other information on materials and methods incl. tables"
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations:
It has not been clearly specified in the report at what time points clinical signs and mortality were recorded, but the following records have been
reported:
Clinidal signs: At least shortly after dosing (Day 0) and at 7 and 14 days post dosing.
Mortality: At least at 24 hours, 7 days and 14 days post dosing.
Weighing of each animal: All animals on Day 0 for calculation of individual dose volume and on Day 14 (end of observation period).
- Necropsy: All animals were necropsied at termination of the study.
- Statistics:
- LD50 was estimated for 24 hours and 14 days post dosing. Determination of a slope function was inappropriate as there were no deaths in both dose groups.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No deaths at 5000 or 10000 mg/kg.
- Mortality:
- There were no deaths during the 14-day observation period post dosing:
Single Dose at: Mortality
5000 mg/kg bw 0/5 (m); 0/5 (f)
10000 mg/kg bw 0/5 (m); 0/5 (f) - Clinical signs:
- Shortly after dosing and 7 and 14 days afterwards clinical signs attributable to the treatment with the test material were not evident.
- Body weight:
- There were no adverse effects on body weight.
- Gross pathology:
- Macroscopic pathology findings attributable to the treatment with the test material were not evident.
- Interpretation of results:
- other: not classified according to EU regulation
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The acute oral toxicity study demonstrated that the LD50 of WS400130 is higher than the limit dose of 2000 mg/kg b.w.
As detailed in the justification for data waiving, the conduct of an acute dermal toxicity study would not have added relevant toxicological hazard information.
The conduct of an acute inhalation toxicity study with WS400130 is not warranted, as the inhalation exposure of humans to WS400130 is unlikely because of its very low vapour pressure and because it is a higly viscous liquid.
Justification for classification or non-classification
In the acute oral toxicity study, all animals survived the dose of 10000 mg/kg. Therefore, classification of WS400130 for acute oral toxicity is not required [REGULATION (EC) 1272/2008].
Non-classification of WS400130 by the dermal route was reasonable, because of the absence of effects indicative of relevant systemic toxicity (apart from the sensitization response) and/or local irritation in all available in vivo toxicity studies with WS400130 and the systemic exposure probably being higher by the oral than by the dermal administration route.
Non-classification of WS400130 by the inhalation route was justified, because WS400130 has a very low vapour pressure and is a highly viscous liquid, making the inhalation exposure of humans to vapour or a droplet aerosol unlikely.
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