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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 425-450-9 | CAS number: 294-90-6
- 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
Acute oral toxicity. Key study (001). Test method according to OECD 423. GLP study.
Acute oral toxicity. Key study (002). Test method according to 92/69/EWG, B.1. GLP study.
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:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 1996
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl: (WI) BR
- Sex:
- male/female
- Vehicle:
- other: NaCl/Polyoxyl-50-stearate (Myrj53)
- No. of animals per sex per dose:
- Preliminary sighting study: 3 (male)Preliminary sighting study: 3 (female)Main study: 3 (male)Main study: 3 (female)
- Details on study design:
- Preliminary sighting study:At 2000 mg/kg 6 of 6 animals died.Main study:200 mg/kg: no abnormal findings occurred
- Preliminary study:
- Species/strain: rat, Wistar2000 mg/kg bw: Evident toxicity: Y; Mortality: Y500 mg/kg bw: not administered50 mg/kg bw: not administered5 mg/kg bw: not administered<5 mg/kg bw: not administered200 mg/kg bw: Evident toxicity: N; Mortality: NObservations:2000 mg/kg: reddish rhinorrhea and silorrhea in one maleafter 30 min of treatment, additionally slight apathy,incomplete eylid closure, ruffled fur, and abnormalbreathing from ca. 6h after treatment in all males, femaleswithout clinical findings.
- Key result
- Sex:
- male/female
- Dose descriptor:
- discriminating dose
- Effect level:
- >= 200 mg/kg bw
- Effect level:
- 200 mg/kg bw
- Remarks on result:
- other: No. with evident toxicity: 0; No. of deaths: 3; No of animals used:3
- Effect level:
- 200 mg/kg bw
- Remarks on result:
- other: No. with evident toxicity: 3; No. of deaths: 3; No. of animals used: 3
- Effect level:
- 2 000 mg/kg bw
- Remarks on result:
- other: No. with evident toxicity: 0; No. of deaths: 0; No. of animals used: 3
- Clinical signs:
- other: 2000 mg/kg: males: reddish rhinorrhea and silorrhea in one animal after 30 min of treatment, additionally slight apathy, incomplete eylid closure, ruffled fur, and abnormalbreathing from ca. 6 h after treatment in all animals, all animals dead after 24 h
- Gross pathology:
- 2000 mg/kg (males and females): necropsy revealed multifocal reddening in stomach, paleness of spleen, discoloration in lung lobes200 mg/kg (males and females): no abnormal findings
- Interpretation of results:
- other: Harmful
- Remarks:
- Migrated information criteria interpretation of results: EU
- Conclusions:
- Test substance in Wistar rats has a discriminating dose of >=200 mg/kg bw.
- Executive summary:
The acute toxicity of test substance was performed according to the OECD 423 (1996) Guideline under GLP conditions.
For this limit test type, an initial concentration of 200 mg/kg bw of tst substance in vehicle ( NaCl/Polyoxyl-50 -stearate (Myrj53)) were administered orally to 3 male and 3 female Wistar rats. Due to the 100% mortality of the initial dose, for the main test a concentration of 200 mg/kg bw concentration was used. The effects of test substance on animals were evaluated using the clinical signs, gross pathology, body weight and necropsy.
Test substance in Wistar rats has a discriminating dose of >=200 mg/kg bw.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: 92/69/EWG, B.1 "ENGLISH"
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl: (WI) Br
- Sex:
- male/female
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 1 % wässerige Carboxymethyl Cellulose
- Doses:
- 200, 500, 1000, 2000 mg/kg bdw
- No. of animals per sex per dose:
- 5 male and 5 female per dose
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 000 mg/kg bw
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 022 mg/kg bw
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 978 mg/kg bw
- Mortality:
- Male: 200 mg/kg bw; Number of animals: 5; Number of deaths: 0Male: 500 mg/kg bw; Number of animals: 5; Number of deaths: 0Male: 1000 mg/kg bw; Number of animals: 5; Number of deaths: 232Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 5Female: 200 mg/kg bw; Number of animals: 5; Number of deaths: 0Female: 500 mg/kg bw; Number of animals: 5; Number of deaths: 0Female: 1000 mg/kg bw; Number of animals: 5; Number of deaths: 3Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 5
- Clinical signs:
- other: "DEUSTCH"Signs of toxicity related to dose levels: Folgende klinische Symptome wurden beobachtet:500 mg/kg: bucklige Haltung, nicht koordinierte Bewegungen.1000 mg/kg: Lethargie, buckliche Haltung, nicht koordinierteBewegungen, struppiges Fell.Die überleb
- Gross pathology:
- "DEUSTCH"Effects on organs:Makroskopisch post mortem Examinierung der toten Tieren ergab:1000 mg/kg: dunkelrote Verfärbung oder Rötung glandulare Mucosa, Blutungen in der Grenzriefe und Drüsenmagen.2000 mg/kg: Blutungen in dem Thymus, Epithelium vom Vormagen, verdickte Grenzriefe, unregelmäßige Oberfläche von dem Drüsenmagen, Erweiterung von dem Colon."ENGLISH"In the animals which died during the study:1000 mg/kg: dark red discolouration or redness of glandular mucosa, blleding in the glandular stomach.2000 mg/kg: bleeding in the thymus, epithelium of the prestomach, unregularsurface of the glandular stomach, extension of the Colon
- Interpretation of results:
- other: Harmful
- Remarks:
- Migrated information criteria interpretation of results: EU
- Conclusions:
- Test substance in Wistar rats (male/female) had a LD50 of 1000 mg/kg bdw.
- Executive summary:
The acute toxicity of test substance was performed according to the 92/69/EWG, B.1 "English" Guideline under GLP conditions.
Several concentrations of test substance (200, 500, 1000 and 2000 mg/kg bw) in vehicle (CMC) were administered orally to 5 male and 5 female Wistar rats per concentration. The effects of test substance on animals were evaluated using the clinical signs, gross pathology, body weight and necropsy.
Test substance in Wistar rats (male/female) had a LD50 of 1000 mg/kg bdw (1022 m/kg fpr mañes and 978 mg/kg fpr females).
Referenceopen allclose all
LD50 males: 1022 mg/kg
LD50 females: 978 mg/kg
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 200 mg/kg bw
- Quality of whole database:
- Both studies scored Klimisch I
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
Acute oral toxicity. Key study (001).Test method according to OECD 423. GLP study. Limit test type, an initial concentration of 200 mg/kg bw of test substance in vehicle ( NaCl/Polyoxyl-50 -stearate (Myrj53)) was administered orally to 3 male and 3 female Wistar rats. Due to the 100% mortality of the initial dose, for the main test a concentration a 200 mg/kg bw concentration was used. The effects of test substance on animals were evaluated using the clinical signs, gross pathology, body weight and necropsy.
Test substance in Wistar rats has a discriminating dose of >=200 mg/kg bw.
Acute oral toxicity. Key study (002). Test method according to 92/69/EWG, B.1. GLP study.The acute toxicity of test substance was performed according to the 92/69/EWG, B.1 "English" Guideline under GLP conditions. Several concentrations of test substance (200, 500, 1000 and 2000 mg/kg bw) in vehicle (CMC) were administered orally to 5 male and 5 female Wistar rats per concentration. The effects of test substance on animals were evaluated using the clinical signs, gross pathology, body weight and necropsy.
Test substance in Wistar rats (male/female) has a LD50 of 1000 mg/kg bdw.
Justification for selection of acute toxicity oral endpoint:
Both studies provides supplementary data about LD50 and discriminating dose of test substance in Wistar rats.
Justification for classification or non-classification
Based on the available information, test substance, in the acute oral toxicity test, is classified as Category 4.
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.