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EC number: 291-367-8 | CAS number: 90387-90-9
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 October 2010 - 18 April 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was generated according to internationally accepted guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Regulation (EC) No. 440/2008, L 142, Annex Part B, 30 May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EPA Health Effects Test Guidelines, OPPTS 870.1000 “Acute toxicity testing background”, EPA 712-C-02-189, December 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- GLP according to German Chemikaliengesetz and Directive 2004/9/EC
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Graphite, acid-treated
- EC Number:
- 291-367-8
- EC Name:
- Graphite, acid-treated
- Cas Number:
- 90387-90-9
- Molecular formula:
- C(Carbon) + acid + oxidant Not available by EC, (CnX mHX)
- IUPAC Name:
- carbon
- Details on test material:
- - Name of test material (as cited in study report): Graphite, acid treated
- Substance type: Inorganic
- Physical state: Solid
- Lot/batch No.: 1706
- Storage condition of test material: Room temperature
- Density: 2.2 g/cm³
- Particle size range: 80 % < 50 mesh
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Species/strain: healthy rats, WISTAR rats Crl: WI(Han) (full barrier)
- Source: Charles River, 97633 Sulzfeld, Germany
- Sex: female, non-pregnant, nulliparous
- Age at study initiation: 9 - 10 weeks old
- Weight at study initiation:
Step 1 / animals no. 1 - 3: 148 – 168 g
Step 2 / animals no. 4 - 6: 151 – 157 g
- Fasting period before study: 16 to 19 hours (access to water was permitted)
HOUSING AND FEEDING CONDITIONS
- Full barrier in an air-conditioned room
- Temperature: 22 +/- 3 °C
- Relative humidity: 55 +/- 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: 10 x / hour
- Free access to Altromin 1324 maintenance diet for rats and mice (lot no. 1307)
- Free access to tap water, sulphur acidified to a pH value of approx. 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- The animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot no. 081110)
- Certificates of food, water and bedding are filed at BSL BIOSERVICE
- Adequate acclimatisation period (at least five days, for details see Schedule)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- cotton seed oil
- Remarks:
- Sigma, lot no. MKBB7604, expiry date: 01/06/2011
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2000 mg/kg body weight at a dose volume of 10 mL/kg body weight
- Amount of vehicle (if gavage): 10 mL/kg body weight
- Justification for choice of vehicle: The vehicle was chosen due to its non-toxic characteristics
- Lot/batch no. (if required): MKBB7604
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight
CLASS METHOD
For animals no. 1 and no. 2 of the first step, 1 g of the test item was suspended in the vehicle to gain a final volume of 5 mL and to achieve a dose of 2000 mg/kg body weight at a dose volume of 10 mL/kg body weight.
For animal no. 3 of the first step and the three animals of the second step, 2 g of the test item were suspended in the vehicle to gain a final volume of 10 mL and to achieve a dose of 2000 mg/kg body weight at a dose volume of 10 mL/kg body weight. - Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 3 per step - 2 steps performed
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration:
14 days
- Frequency of observations and weighing:
A careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose). As soon as symptoms were noticed they were recorded. Thereafter, the animals were observed for clinical signs once daily until the end of the observation period.
The animals were weighed on day 1 (prior to the administration) and on days 8 and 15.
- Necropsy of survivors performed:
yes
- Other examinations performed:
Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma. - Statistics:
- Not relevant due to no toxic effects observed in Limit test
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured.
- Clinical signs:
- other: No signs of toxicity have been observed.
- Gross pathology:
- No specific gross pathological changes were recorded for any animal (for individual data see Table 5).
- Other findings:
- No abnormalities or treatment related effects have been observed.
Any other information on results incl. tables
Table 1: LD50 Cut-Off
Dose |
Number of Animals |
Number of Intercurrent Deaths |
LD50 Cut-Off |
2000 mg/kg bw |
6 |
0 |
unclassified |
Table 2: Results per Step
Step |
Sex/No. |
Dose (mg/kg) |
Number of Animals |
Number of Intercurrent Deaths |
1 |
female (1 -3) |
2000 |
3 |
0 |
2 |
female (4 -6) |
2000 |
3 |
0 |
Table 3: Clinical Signs - Individual Data
Animal |
Time of Observation |
Observations
|
Step 1 (2000 mg/kg Body Weight) |
||
1 / female |
during the whole observation period |
no signs of toxicity |
2 / female |
during the whole observation period |
no signs of toxicity |
3 / female |
during the whole observation period |
no signs of toxicity |
Step 2 (2000 mg/kg Body Weight) |
||
4 / female |
during the whole observation period |
no signs of toxicity |
5 / female |
during the whole observation period |
no signs of toxicity |
6 / female |
during the whole observation period |
no signs of toxicity |
Table 4: Absolute Body Weights in g and Body Weight Gain in %
Animal No. / |
g |
g |
g |
% |
Step 1 (2000 mg/kg Body Weight) |
||||
1 / female |
168 |
200 |
215 |
28 |
2 / female |
148 |
167 |
177 |
20 |
3 / female |
149 |
179 |
198 |
33 |
Step 2 (2000 mg/kg Body Weight) |
||||
4 / female |
157 |
180 |
199 |
27 |
5 / female |
151 |
175 |
182 |
21 |
6 / female |
151 |
178 |
196 |
30 |
Table 5: Findings of the Necropsy - Individual Data
Animal No./ |
Organ |
Macroscopic Findings |
Step 1 (2000 mg/kg Body Weight) |
||
1 / female |
- |
nsf |
2 / female |
- |
nsf |
3 / female |
- |
nsf |
Step 2 (2000 mg/kg Body Weight) |
||
4 / female |
- |
nsf |
5 / female |
- |
nsf |
6 /female |
- |
nsf |
nsf = no specific findings
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the present study, a single oral application of the test item Graphite, acid treated to rats at a dose of 2000 mg/kg body weight was associated with no signs of toxicity or mortality.
The median lethal dose of Graphite, acid treated after a single oral administration to female rats, observed over a period of 14 days is:
LD50 cut-off (rat): unclassified
In conformity with the criteria given in Annex VI to Commission Directive 2001/59/EC the test item Graphite, acid treated has no obligatory labelling requirement for toxicity.
According to Annex I of Regulation (EC) 1272/2008 the test item Graphite, acid treated has no obligatory labelling requirement for toxicity and is unclassified.
According to OECD-GHS (Globally Harmonised Classification System) the test item Graphite, acid treated has no obligatory labelling requirement for toxicity. - Executive summary:
Two groups, each of three female WISTAR Crl: WI (Han) rats, were treated with the test item by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was suspended in the vehicle cottonseed oil at a concentration of 0.2 g/mL and administered at a dose volume of 10 mL/kg.
All animals used in the study after their entrance at BSL were allowed to acclimatise to the laboratory conditions for at least 5 days. The animals were observed on delivery, on inclusion in the study and before administration for mortality/morbidity and other clinical signs. All animals were examined for clinical signs several times on the day of dosing and once daily until the end of the observation period. Their body weights were recorded on day 1 (prior to the administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.
Table1: Results per Step
Step
Sex/No.
Dose (mg/kg)
Number of Animals
Number of Intercurrent Deaths
1
female/1-3
2000
3
0
2
female/4-6
2000
3
0
All animals survived until the end of the study without showing any signs of toxicity.
Throughout the 14-day observation period, the body weight gain of the test animals was within the normal range of variation for this strain.
At necropsy, no macroscopic findings were observed in any animal of any step.
On the basis of the test results given below and in conformity with the criteria given in Annex VI to Commission Directive 2001/59/EC[7]as well as in Annex I of Regulation (EC) 1272/2008[8], the substance should be not classified.
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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