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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 403-920-4 | CAS number: 107551-67-7 G 19-675 ZP
- 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
A single dose of 2000 mg/kg bw of the test substance was administrated dermal to groups of male and female rats (5/sex, OECD guideline 402). Application of the test substance did not induce any sings of toxicity. None of the animals died, viability and bodyweight gain were unaffected by the test article. However, single oral administration of the test item (OECD 401) to rats leads to dyspnoe, reduced spontaneous activity and hunched posture. All female animals of the high dose group (2000 mg/kg bw) died until day 3 of the post observation period. LD50 after single dermal administration is 2000 mg/kg bw, after single oral administration 1000 mg/kg bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 1 000 mg/kg bw
Acute toxicity: via dermal route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Procedure and observations
To evaluate the acute oral toxicity, a single dose of the test article was administrated to a group of 5 male (500 and 1000 mg/kg bw) or 5 female (1000 and 2000 mg/kg bw) rats by oral gavage. Following dosing, the animals were observed for 14d. Examination of clinical signs and viability were performed daily, weighing once a week.
Ruffled fur, dyspnoea, and abnormal body positions were seen. Additionally, reduced spontaneous activity was observed during the application day and day 1 after application. All female animals of the high dose group (2000 mg/kg bw) died until day 3 of the post observation period. Oedematous lungs were found in one female and a liquid-filled thoracic cavity in three females of the high dose group, respectively.
Dermal toxicity of the test substance was evaluated on a group of five male and 5 female RAI f (SPF) rats which were treated with the test article at 2000 mg/kg by dermal application. The substance was suspended in peanut oil and administered at a volume of 4 ml/kg. Four times during day 1 and once daily during days 2-15 the animals were examined for clinical signs and viability. Body weights were recorded on day 1 before administration and on days 8 and 15. All animals were necropsied and examined macroscopically.
No deaths occurred during the study period. Neither clinical signs of systemic toxicity nor local effects of the test article on the skin at the application site were observed during the observation period. Ruffled fur and dyspnoea were seen during post observation period. Macroscopic organ findings were not observed at necropsy.
Discussion
Oral application of the test item at concentrations of 2000 mg/kg bw leads to death of all animals. Macroscopic examination revealed oedematous lungs and liquid filled thorax. Other clinical signs were dyspnoea, exophthalmia and a decrease in spontaneous activity. These data indicate that the test substance is well absorbed and metabolized into products which might inhibit biochemical processes, liver function or regulation of blood pressure. LD50 is considered to be 1000 mg/kg bw.
Dermal application of the test article did not cause unscheduled mortalities or any sings of toxicity. Thus, LD50 is considered to be 2000 mg/kg bw.
Acute toxicity after inhalation of the test substance was not estimated. The substance is a solid and has a particle size of approximately 153 µm. Therefore the test article is not inhalable.
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is considered to be classified for acute oral toxicity under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is considered to be classified for acute oral toxicity under Regulation (EC) No. 1272/2008.
The substance is classified as harmfull if swallowed and labeled with R 22 or H302, respectively.
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.