Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 286-304-6 | CAS number: 85204-10-0
- 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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented and reported study fully adequate for assessment. The study was conducted according to internationally accepted technical guidelines and in compliance with GLP in a recognized contract research organization.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS: CRL:(WI) rats
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, D-97633 Sulzfeld
- Age at study initiation: 8 - 9 weeks
- Weight at study initiation: 188 – 207 g
- Fasting period before study: overnight prior administration
- Housing: 3 animals/cage (Type II polypropylene/polycarbonate)
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30-70
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- distilled water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 and 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg b.w.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: As the chemical type of test material tested in the present study was not expected to cause any mortality, 2000 mg/kg bw was selected to be the starting dose. - Doses:
- 2000 and 300 mg/kg b.w.
- No. of animals per sex per dose:
- 3 female rats/2000 mg/kg b.w. and 2 x 3 female rats/300mg/kg b.w. (incl. the confirmatory group)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
Frequency of observations (clinical signs, see below): at 15 and/or 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter.
Frequency of weighing: on the day before treatment (Day -1), on the day of treatment (Day 0, prior to dosing) and weekly thereafter.
- Necropsy of survivors performed: yes
Clinical signs observed: skin, fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 2/3 animals died at 2000 mg/kg. 0/6 animals died at 300 mg/kg.
- Mortality:
- WS400402 caused mortality at a single dose of 2000 mg/kg bw in two of three animals (2/3), but did not cause mortality at the dose of 300 mg/kg bw (0/6).
- Clinical signs:
- other: Treatment with WS400402 at the dose of 2000 mg/kg bw caused decreased activity (3/3), hunched back (3/3), incoordination (3/3), continuous tremors (3/3), tonic convulsion (1/3) and death (2/3). Treatment with 300 mg/kg bw did not cause any clinical signs
- Gross pathology:
- Found dead animals:
Dark/red discoloration/focus of the non-collapsed lungs was found at necropsy.
Terminal animals:
There were no macroscopic findings noted in the surviving animals - Conclusions:
- Under the conditions of this study, the acute oral LD50 value of the test material WS400402 was found to be between 300 and 2000 mg/kg bw in female CRL:(WI) rats.
According to Regulation (EC) No 1272/2008 WS400402 should be classified as "harmful" and “Category 4” for acute oral exposure, respectively.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
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
Justification for selection of acute toxicity – oral endpoint
LD50: between 300 and 2000 mg/kg body weight
Justification for classification or non-classification
In the acute oral toxicity study, the LD50 after a single dose of WS400402 was determined to range between 300 mg/kg (0/6 animals died) and 2000 mg/kg body weight (2/3 animals died). Therefore, WS400402 has to be classified for acute oral toxicity as acute tox 4 according to REGULATION (EC) 1272/2008.
Non-classification of WS400402 by the dermal route was reasonable, because it is not to be expected that systemic availability of WS400402 would be higher by the dermal than by the oral route.
Non-classification of WS400402 by the inhalation route was justified, because the substance has a very low vapour pressure making the inhalation exposure of humans 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.
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.