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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 October 2010 - 03 May 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 402 (Acute Dermal Toxicity)
- 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:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- GLP according to German Chemikaliengesetz and Directive 2004/9/EC
- 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
- Colour: Grey
- 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:
- male/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: male and female - the female animals were non-pregnant and nulliparous
Number of animals: 5 male and 5 female
Age at the beginning of the study: males: 9 - 10 weeks old
females: 14 - 15 weeks old
Body weight on the day of administration: males: 256 – 291 g
females: 201 – 247 g
The animals were derived from a controlled full-barrier maintained breeding system.
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 approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- The animals were kept individually 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)
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- cotton seed oil
- Remarks:
- Sigma, lot no. MKBB7604, expiry date: 01/06/2011
- Details on dermal exposure:
- PREPARATION OF THE ANIMALS:
Approximately 23 hours before the test, the fur was removed from the dorsal area of the trunk by using an electric clipper. Care was taken to avoid abrading the skin, and only animals with healthy intact skin were used.
No less than 10 % of the body surface was cleared for the application. Prior to the application a detailed clinical observation was made of all animals.
APPLICATION:
The test item was applied at a single dose, uniformly over an area which was approximately 10 % of the total body surface.
The test item was held in contact with the skin by a dressing throughout a 24-hour period. The dressing consisted of a gauze-dressing and non-irritating tape and was fixed with an additional dressing in a suitable manner.
DOSE LEVEL:
The test item was applied at a single dose of cc to each animal.
EXPOSURE PERIOD:
The test item was held in contact with the skin throughout a 24-hour period. At the end of the exposure period the residual test item was removed by using aqua ad injectionem – sterile water (Berlin Chemie, lot no. 0195A191, expiry date: 04/2013). Nevertheless there was still residual test item, which could not be removed. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5 male and 5 female
- 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 application) and on days 8 and 15.
- Necropsy of survivors performed:
At the end of the observation period the animals were sacrificed with an overdosage of pentobarbital injected intraperitoneally (Narcoren®, Merial; lot no. 205100; expiry date: 10/2013) at the dosage of approximately 8 mL/kg bw. All animals were subjected to gross necropsy.
- 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. Attention was directed to observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. - Statistics:
- Not applicable since no clinical signs of irritation or mortality have been observed.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured.
- Clinical signs:
- other: With regard to signs of toxicity and effects on organs no treatment-related effects have been observed. Furthermore no erythema and no oedema were observed. Scratches were observed in 3 out of 5 female and 3 out of 5 male animals. Eschar was observed in 1
- Gross pathology:
- With the exception of acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection, no specific gross pathological changes were recorded for any animal.
Any other information on results incl. tables
Table 1: Clinical Signs of Systemic Toxicity – Individual Data - Males
Animal |
Time of |
Observations (for Signs of Dermal Irritation, see Table 3) |
21/ male / 2000 mg/kg bw |
during the whole observation period |
no signs of toxicity |
22/ male / 2000 mg/kg bw |
during the whole observation period |
no signs of toxicity |
23/ male / 2000 mg/kg bw |
during the whole observation period |
alopecia on both front legs |
24/ male / 2000 mg/kg bw |
during the whole observation period |
no signs of toxicity |
25/ male / 2000 mg/kg bw |
during the whole observation period |
no signs of toxicity |
Table 2: Clinical Signs of Systemic Toxicity – Individual Data – Females
Animal |
Time of |
Observations (for Signs of Dermal Irritation, see Table 5) |
26/ female / 2000 mg/kg bw |
during the whole observation period |
no signs of toxicity |
27/ female / 2000 mg/kg bw |
during the whole observation period |
no signs of toxicity |
28/ female / 2000 mg/kg bw |
during the whole observation period |
no signs of toxicity |
29/ female / 2000 mg/kg bw |
during the whole observation period |
no signs of toxicity |
30/ female / 2000 mg/kg bw |
during the whole observation period |
no signs of toxicity |
Table 3: Skin Irritation – Individual Data – Males
Day after Start of Application |
Animal No. 21 |
Animal No. 22 |
Animal No. 23 |
Animal No. 24 |
Animal No. 25 |
|||||
E/O |
Comments |
E/O |
Comments |
E/O |
Comments |
E/O |
Comments |
E/O |
Comments |
|
day 2 |
0/0 |
nsf* |
0/0 |
s* |
0/0 |
nsf* |
0/0 |
nsf* |
0/0 |
nsf* |
day 3 |
0/0 |
small s* |
0/0 |
s* |
0/0 |
nsf* |
0/0 |
nsf* |
0/0 |
nsf* |
day 4 |
0/0 |
small s* |
0/0 |
s* |
0/0 |
nsf |
0/0 |
nsf* |
0/0 |
nsf* |
day 5 |
0/0 |
small s* |
0/0 |
nsf* |
0/0 |
nsf |
0/0 |
nsf* |
0/0 |
nsf* |
day 6 |
0/0 |
nsf* |
0/0 |
nsf* |
0/0 |
nsf |
0/0 |
nsf* |
0/0 |
nsf* |
day 7 |
0/0 |
nsf* |
0/0 |
nsf* |
0/0 |
nsf |
0/0 |
nsf* |
0/0 |
nsf |
day 8 |
0/0 |
small s* |
0/0 |
nsf* |
0/0 |
nsf |
0/0 |
nsf* |
0/0 |
nsf |
day 9 |
0/0 |
small s |
0/0 |
nsf* |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
day 10 |
0/0 |
small s |
0/0 |
nsf* |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
day 11 |
0/0 |
small s |
0/0 |
nsf* |
0/0 |
nsf |
0/0 |
nsf* |
0/0 |
nsf |
day 12 |
0/0 |
s |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf* |
0/0 |
small s |
day 13 |
0/0 |
s |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf* |
0/0 |
small s |
day 14 |
0/0 |
es |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
es |
day 15 |
0/0 |
es |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
es |
Comments: E = erythema; O = oedema; 1, 2, 3, 4 = scoring system laid down in OECD Guideline 404 (Table 2) es = eschar; s = scratches; nsf = no specific findings, * = residual test item
|
Table 4: Skin Irritation – Individual Data – Females
Day after Start of Application |
Animal No. 26 |
Animal No. 27 |
Animal No. 28 |
Animal No. 29 |
Animal No. 30 |
|||||
E/O |
Comments |
E/O |
Comments |
E/O |
Comments |
E/O |
Comments |
E/O |
Comments |
|
day 2 |
0/0 |
nsf* |
0/0 |
s* |
0/0 |
nsf* |
0/0 |
nsf* |
0/0 |
nsf* |
day 3 |
0/0 |
nsf* |
0/0 |
nsf* |
0/0 |
nsf* |
0/0 |
nsf* |
0/0 |
nsf* |
day 4 |
0/0 |
nsf* |
0/0 |
nsf* |
0/0 |
nsf* |
0/0 |
nsf* |
0/0 |
nsf |
day 5 |
0/0 |
small s* |
0/0 |
nsf* |
0/0 |
nsf |
0/0 |
small s* |
0/0 |
nsf |
day 6 |
0/0 |
s* |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
s* |
0/0 |
nsf |
day 7 |
0/0 |
s* |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
s* |
0/0 |
nsf |
day 8 |
0/0 |
s* |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
s* |
0/0 |
nsf |
day 9 |
0/0 |
s, es |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
day 10 |
0/0 |
s, es |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
day 11 |
0/0 |
s* |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
day 12 |
0/0 |
s, es |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
day 13 |
0/0 |
s, es |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
day 14 |
0/0 |
s, es |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
day 15 |
0/0 |
s, es |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
Comments: E = erythema; O = oedema; 1, 2, 3, 4 = scoring system laid down in OECD Guideline 404 (Table 2) es = eschar; s = scratches; nsf = no specific findings, * = residual test item
|
Table 5: Absolute Body Weights in g and Body Weight Gain in %
Animal No. / |
g |
g |
g |
% |
Dose: 2000 mg/kg bw |
||||
21 / male |
285 |
300 |
330 |
16 |
22 / male |
291 |
292 |
320 |
10 |
23 / male |
279 |
284 |
300 |
8 |
24 / male |
256 |
255 |
277 |
8 |
25 / male |
281 |
290 |
319 |
14 |
26 / female |
247 |
242 |
246 |
0 |
27 / female |
201 |
205 |
209 |
4 |
28 / female |
209 |
215 |
218 |
4 |
29 / female |
238 |
238 |
243 |
2 |
30 / female |
220 |
219 |
230 |
5 |
Table 6: Macroscopic Findings - Individual Data – Males and Females
Animal No. / |
Organ |
Macroscopic Findings |
Dose: 2000 mg/kg bw |
||
21 / male |
- |
nsf |
22 / male |
- |
nsf |
23 / male |
- |
nsf |
24 / male |
- |
nsf |
25 / male |
- |
nsf |
26 / female |
- |
nsf |
27 / female |
- |
nsf |
28 / female |
- |
nsf |
29 / female |
- |
nsf |
30 / 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, single dermal application of the test item Graphite, acid treated to rats at a dose of 2000 mg/kg body weight was associated with neither mortality nor signs of toxicity and did not cause erythema or oedema.
The minor findings (eschar, scratches) observed are not considered to be clearly treatment-related.
The dermal LD50 was determined to be > 2000 mg Graphite, acid treated / kg body weight.
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 percutaneous toxicity. According to Annex I of Regulation (EC) 1272/2008 the test item Graphite, acid treated has no obligatory labelling requirement for percutaneous toxicity and is unclassified. According to OECD-GHS (Globally Harmonised Classification System) the test item Graphite, acid treated has no obligatory labelling requirement for percutaneous toxicity. - Executive summary:
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 as well as in Annex I of Regulation (EC) 1272/2008, the substance should be not classified.
LD50: > 2000 mg /kg bw
Species/strain: WISTAR Crl: WI(Han) rats
Vehicle (moistening): cottonseed oil
Number of animals: 5 male and 5 female
Duration of exposure: 24 hours
Method: OECD 402, EC 440/2008, OPPTS 870.1200
Table1: Results per Step
Sex
Dose
(mg/kg bw)Number
of AnimalsNumber
of Intercurrent Deathsmale
2000
5
0
female
2000
5
0
Signs of toxicity related to dose level used, time of onset and duration:
No treatment-related effects were observed.
Effect on organs (related to dose level):
No treatment-related effects were observed.
Signs of irritation:
No erythema and no oedema were observed. Scratches were observed in 3 out of 5 female and 3 out of 5 male animals. Eschar was observed in 1 out of 5 female and 2 out of 5 male animals.
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