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Diss Factsheets
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EC number: 254-372-6 | CAS number: 39236-46-9
- 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 LD50 in the rat 5200 mg/kg and dermal toxicity with LD0 of 8000 mg/kg.
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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Brief report of a study using a standard test method: no information on adverse reactions other than death, but sufficient to conclude an LD50 value.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Classical acute oral LD50 test using groups of 3 males, 2 females.
- GLP compliance:
- no
- Remarks:
- Pre-GLP study
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Sherman - Wistar
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Single oral dose after 24h starvation period.
- Doses:
- Volumes of 25% solution equivalent to 3.15, 4.0, 5.0, 6.25 and 7.9 g test substance/kg.
- No. of animals per sex per dose:
- 3 males, 2 females.
- Control animals:
- no
- Details on study design:
- Animals observed for 14 days post-dose.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 5 200 mg/kg bw
- Based on:
- act. ingr.
- 95% CL:
- >= 4 200 - <= 6 400
- Remarks on result:
- other: Dosages expressed in terms of active ingredient in the 25% solution tested.
- Mortality:
- All rats dosed at 7900 mg/kg died; no other deaths occurred.
- Clinical signs:
- other: No information given
- Gross pathology:
- Not evaluated
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- An oral LD50 value of 5200 mg/kg was determined in this study.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 200 mg/kg bw
- Quality of whole database:
- Together the 4 studies provide sufficient evidence to come to a reliable conclusion.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Low quality of available studies.
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Brief report of a study performed using a standard test method: contains sufficient information to conclude an LC0 value.
- Qualifier:
- according to guideline
- Guideline:
- other: US Federal Register 26 (1961) Section 191.10
- GLP compliance:
- no
- Remarks:
- Pre-GLP study
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rabbit
- Strain:
- other: described as albino rabbits
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No further data available.
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Dry powder test material moistened with saline and applied to clipped skin (intact for 2 rabbits/group, abraded to penetrate stratum corneum for 2 rabbits/group) under occlusive dressing.
- Duration of exposure:
- Up to 24h
- Doses:
- 0.5, 1.5, 2.0, 4.0, 8.0 g/kg.
- No. of animals per sex per dose:
- 2 rabbits, skin intact + 2 rabbits, skin abraded per dose. Sex not specified.
- Control animals:
- not required
- Details on study design:
- Animals observed for 14 days after dressing removal.
- Sex:
- not specified
- Dose descriptor:
- LD0
- Effect level:
- 8 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No deaths occurred.
- Mortality:
- No deaths occurred.
- Clinical signs:
- other: Not reported.
- Gross pathology:
- Not evaluated.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Application of test substance at up to 8000 mg/kg caused no deaths in this study, even when the possibilities for skin penetration were increased by abrasion of the test sites.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Value:
- 8 000 mg/kg bw
- Quality of whole database:
- The available studies (Klimisch 2) include sufficient information to conclude a reliable LC0 value.
Additional information
Low toxicity of the test substance following acute exposure by all three routes has been demonstrated in reliable studies
Justification for selection of acute toxicity – oral endpoint
Among 4 studies which together support a weight of evidence conclusion of low toxicity, the lowest defined LD50 value was that reported in the selected study: 5200 mg/kg.
Justification for selection of acute toxicity – inhalation endpoint
A rat 1h LC0 value of 5.5 mg/l (whole body exposure to a dust atmosphere) has been determined for the registered substance. However, the short duration of the test and observation of increasing respiratory distress during the last 20 minutes of the test period make it impossible to extrapolate to a 4h LC50 value
Justification for selection of acute toxicity – dermal endpoint
No mortality occurred after dermal application of test substance to rabbits at up to 8000 mg/kg, even when the possibilities for skin penetration were increased by abrasion of test sites.
Justification for classification or non-classification
Acute toxicity via oral and dermal routes is low; while no 4h inhalation LC50 value is available, the1h inhalation LC0 value (>5.5 mg/l) suggests low acute toxicity by this route also. Accordingly, no classification in respect of acute toxicity is warranted.
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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