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Diss Factsheets
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EC number: 304-661-9 | CAS number: 94277-77-7
- 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
The substance was found to be non-hazardous upon gavage dosing of rats and it was of low toxicity upon intraperitoneal injection of rats.
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
- Study period:
- 1972
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: non GLP, deviations from OECD guideline, reported with sufficient detail.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- 7 days observation period, doses much higher, higher number of animals per dose group
- Principles of method if other than guideline:
- according to BASF-internal standard
- GLP compliance:
- no
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Mean body weight: males 234 g, females 191 g
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- Aqueous suspension with CMC
Test concentration used: 30% (G/V) - Doses:
- 8000 and 10000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Mortality:
- None
- Clinical signs:
- other: Dyspnea
- Gross pathology:
- Sacrificed animals: nothing abnormal detected
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 10 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1972
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: only orientating information about the inhalation hazard. Poorly characterized test atmosphere.
- Principles of method if other than guideline:
- Whole body exposure to dust generated by blowing air through a layer of the test substance.
- GLP compliance:
- no
- Test type:
- other: inhalation hazard test
- Species:
- rat
- Sex:
- male/female
- Route of administration:
- inhalation: dust
- Analytical verification of test atmosphere concentrations:
- no
- Duration of exposure:
- ca. 8
- Concentrations:
- Mean concentration: 8.29 mg/l
- No. of animals per sex per dose:
- 12
- Control animals:
- yes
- Details on study design:
- Whole body exposure to dust generated by blowing air through a layer of the test substance.
Temperature 20°C
Air flow: 200L per hour
Strong dust generation observed. - Sex:
- male/female
- Dose descriptor:
- LC0
- Effect level:
- >= 8.29 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 8 h
- Remarks on result:
- other: Concentration determined by weight difference of test substance layer at the beginning and at the end of the exposure period.
- Mortality:
- None
- Clinical signs:
- other: Slight mucosal irritations; fur intense blue-coloured
- Gross pathology:
- Sacrificed animals: organs: nothing abnormal detected
- Interpretation of results:
- relatively harmless
- Remarks:
- Migrated information
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Insufficient characterization of test substance in the atmosphere.
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
In the acute oral toxicity study in rats, the substance was applied as an aqueous suspension at doses of up to 10000 mg/kg bw to each five male and female rats. The animals were observed for 7 days and then subjected to necropsy. This procedure deviates from the OECD testing guideline in the shorter observation period. Considering that the doses applied are up to five times higher than the limit dose in the OECD guideline and that no adverse effects were observed, the shorter observation period is acceptable.
Intraperitoneal injection of rats resulted in mortality at high doses. The LD50 for this route of application was determined at 2000 mg/kg bw.
According to ECHA guidance r7a (Aug 2014) testing for acute dermal toxicity is indicated if: systemic toxicity is observed in skin/eye irritation and/or skin sensitisation studies; if death is observed in an acute oral toxicity test and there is potential for dermal absorption, if
systemic toxicity is observed in an acute oral toxicity test and if there is potential for high dermal absorption.
None of these criteria is fulfilled in case of this substance. The substance did not cause mortalities after a single oral dose of 10000 mg/kg bw. Its molecular weight exceeds 500 g/mol and its water solubility is very low. Skin absorption is considered to be absent or very low. No skin sensitization potential was detected in the LLNA (BASF 2015). Overall, based on the acute toxicity data and the physico-chemical properties, it can be concluded that the substance is non-hazardous for acute dermal toxicity without further animal testing.
Justification for selection of acute toxicity – inhalation endpoint
Only study available
Justification for selection of acute toxicity – dermal endpoint
Absence of an acute dermal toxicity hazard can be determined without further testing.
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 not considered to be classified for acute oral or dermal or inhalation toxicity under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG.
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 not considered to be classified for acute oral or dermal or inhalation toxicity under Regulation (EC) No. 1272/2008, as amended for the fifth time in Directive EC 944/2013.
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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