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Diss Factsheets
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EC number: 936-414-1 | CAS number: -
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- - test substance was not administered by gavage but by feeding in a single dose for up to 6 hours and only 5 of six animals received the complete dose
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- - test substance was not administered by gavage but by feeding in a single dose for up to 6 hours and only 5 of six animals received the complete dose
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- deviation: stability of the test substance in the formulation for administration was not determined. However, the test substance was formulated directly before administration.
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- carbon
- EC Number:
- 936-414-1
- Molecular formula:
- C
- IUPAC Name:
- carbon
- Test material form:
- solid: nanoform, no surface treatment
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan-Winkelmann GmbH, Borchen, Germany
- Strain: HsdCpb:Wu
- Age at study initiation: approx. 10-12 weeks
- Weight at study initiation: 164-180 g
- Fasting period before study: 16-24 hours
- Housing: individual (for the period of administration); in groups (for 14-day observation period)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 5
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: feed
- Details on oral exposure:
- The individual dose for each animal was calculated on the base of the body weight at time of administration. To make the test compound flavorsome for the animals, the individual dose for each animal was carefully mixed with approximately 2 g chocolate hazelnut spread (Nutella®, Ferrero, 60624 Frankfurt, Germany).
For administration, food was withheld from the animals for approximately 16 - 24 h before administration of the test compound. The animals were feed again
approximately 2 h after the end of the period of administration. For the period of administration the animals were housed individually. The mixture was offered to the animals in stainless steel containers. Over the period of administration in 2 of 6 cases (animal no. 4 and 7) residuals of the test compound were mixed with additional chocolate hazelnut spread (approximately 1 g) and were offered to the animals again.
The period of administration did not exceed 6 hours. Residues were documented and judged: Only one animal (animal no. 8) did not consume the complete amount of test compound within the period of administration (Residue: 1 g oft he mixture). - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 6 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at least once daily (clinical signs, mortality) or once weekly (weight gain)
- Necropsy of survivors performed: yes - Statistics:
- Not specified.
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LDLo
- Effect level:
- >= 2 000 mg/kg bw
- Sex:
- female
- Dose descriptor:
- other: LD50 cut-off
- Effect level:
- >= 5 000 mg/kg bw
- Mortality:
- All 6 animals survived the treatment.
- Clinical signs:
- other: No clinical signs were observed.
- Gross pathology:
- No gross pathological findings were observed.
- Other findings:
- none
Applicant's summary and conclusion
- Executive summary:
A single oral dose of 2000 mg /kg body weight was tolerated by female rats without mortalities, clinical signs, effects on weight gain and gross pathological findings. According to OECD guideline 423 the LD50 cut-off of the test material meeting the form described in Section 4.5 of the IUCLID dossier is > 5000 mg/kg bw for rats (Category 5 / unclassified of the Globally Harmonized Classification System).
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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