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Diss Factsheets
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EC number: 252-667-4 | CAS number: 35674-65-8
- 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
In the acute oral toxicity study no death occurred up to the highest dose administered which amounted to 10000 mg/kg body weight.
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 in a contract research organization according to internationally accepted technical guidelines then at force, but without QA-statement. The study is scientifically valid and, despite limited documentation, fully adequate for assessment.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- 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
- Source: Strain Winkelmann, Paderborn
- Age at study initiation: no data
- Weight at study initiation: 180 - 190 g
- Fasting period before study: 16 hours
- Housing: in groups of 5 males or 5 females
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 1°C
- Humidity (%): 45% - 55%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 h / 1 2h - Route of administration:
- oral: gavage
- Vehicle:
- other: 1% Tylose (cellulose ether)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: low dose: 25%, mid dose and high dose : 30%
- Amount of vehicle (if gavage):low dose: 10 ml/kg, mid dose: 17 ml/kg, high dose : 33 m l/kg - Doses:
- 2500, 5000, and 10000 mg/kg body weight
- 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 and weighing: observations 1, 2, 7, and 14 days after application, weighing at start and on day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs: appearance, behaviour, hair coat, mucosae, faeces, food and water intake - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no death occurred
- Clinical signs:
- there were no clinical signs in any animal
- Body weight:
- no differences in body weight gain between animals of the three dose groups
- Gross pathology:
- no findings in any animal in lungs, heart, stomach, small and large intestine, liver, spleen, kidneys, blood vessels, lymphatic vessels, reproductive glands
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
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 WS400505 is higher than the limit dose of 2000 mg/kg b.w. The conduct of an acute dermal or inhalation toxicity study would not have added relevant toxicological hazard information
Justification for classification or non-classification
In the acute oral toxicity study, all animals survived a single dose of up to 10000 mg WS400505 per kg body weight. Therefore, classification of WS400505 for acute oral toxicity is not required [REGULATION (EC) 1272/2008].
Non-classification of WS400505 by the dermal route was reasonable, because of the absence of effects indicative of relevant systemic toxicity and/or local irritation and the absence of any relevant adverse effects in all available toxicity studies with WS400505.
Non-classification of WS400505 by the inhalation route was justified by its low vapour pressure making inhalation exposure of humans to any vapour phase unlikely.
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.
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