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Diss Factsheets
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EC number: 220-518-2 | CAS number: 2788-26-3
- 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: discriminating dose = 3942 mg/kg bw
Acute dermal toxicity: no study available
Acute inhalation toxicity: no study available
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:
- comparable to guideline study with acceptable restrictions
- Principles of method if other than guideline:
- One group of five male and five female Wistar rats were dosed at 5.0 ml/kg. The animals were observed for mortality and clinical signs through day 14. The surviving animals were randomly dissected.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- At the start of the study the rats were approx. 9 respective 14 weeks old. The average weight of the male rats was 151 g, and the average weight of the female rats was 159 g.
The rats were kept in Macrolon typ III cages at a temperature of 22 +/- 1.5°C. Air humidity was 60 +/- 5% at artifical light for 12 hours daily. Water was ad libitum. - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- About 16 hours before the application and 4 hours afterwards feed was restricted.
- Doses:
- 5 ml/kg bw = 3942 mg/kg bw.
- No. of animals per sex per dose:
- 5 male and 5 female rats per dose
- Control animals:
- no
- Details on study design:
- The animals killed at the end of the study were randomly dissected.
- Key result
- Sex:
- male/female
- Dose descriptor:
- discriminating dose
- Effect level:
- 5 mL/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 5 ml/kg bw = 3942 mg/kg bw.
- Mortality:
- No mortality occured.
- Clinical signs:
- other: No clinical signs were observed.
- Gross pathology:
- No adverse findings.
- Other findings:
- No data.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A single dose of 5 ml/kg bw = 3942 mg/kg bw was tolerated without symptoms.
- Executive summary:
One group of five male and five female Wistar rats were dosed at 5.0 ml/kg. The animals were observed for mortality, and clinical signs through day 14. The surviving animals were randomly dissected. A single dose of 5 ml/kg bw = 3942 mg/kg bw was tolerated without symptoms. No mortality occured.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 3 942 mg/kg bw
- Quality of whole database:
- Scientifically acceptable and well documented.
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
According to Commission Regulation (EU) 2016/863 of May 2016 acute toxicity testing by the dermal route (Annex VII, point 8.5.3., column 2) ‘does not need to be conducted if the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure’. The registered substance conforms with the requirements given above. Therefore, it can be concluded for acute dermal toxicity that the available information is conclusive for non-classification.
Justification for classification or non-classification
In the acute oral toxicity study a single dose of 5 ml/kg bw = 3942 mg/kg bw was tolerated without symptoms. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is therefore not justified.
No studies were available for acute dermal and acute inhalation toxicity. According to Commission Regulation (EU) 2016/863 of May 2016 acute toxicity testing by the dermal route (Annex VII, point 8.5.3., column 2) ‘does not need to be conducted if the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure’. The registered substance conforms to the requirements given above. Therefore, it can be concluded for acute dermal toxicity that the available information is conclusive for non-classification.
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.