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EC number: 701-026-1 | 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
Endpoint summary
Administrative data
Description of key information
The acute oral toxicity in rats was determined according to the method as recommended in the OECD Guideline No. 423. The study was accomplished on two groups, each consisting of three female animals. A starting dose level of 2000 mg/kg bw and a dose volume of 10 mL/kg bw were applied.
All animals survived the administration of the dosing level of 2000 mg/kg bw and showed only mild signs of toxicity. The oral LD50 value of the test substance in rats was found to be above 2000 mg/kg bw under the experimental conditions. The test substance does therefore not meet the classification criteria according to regulation (EC) No. 1272/2008.
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:
- 2012-11-20 to 2013-03-12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-97633 Sulzfeld, Germany
- Age at study initiation: not reported
- Weight at study initiation: 146-163 g
- Housing: transparent macrolon cages (type 3-180, floor area 810 cm2), three rats per cage and separated regarding sex if applicable
- Diet (e.g. ad libitum): ad libitum, pelleted diet "Altromin 1324" supplied by Altromin, D-32791 Lage, Germany
- Water (e.g. ad libitum): ad libitum, domestic qualitiy drinking water which is acidified with hydrochloric acid to pH 2.5 to prevent microbial growth
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 30-70%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20% (w/v)
- Amount of vehicle (if gavage): 1x 10 mL/kg bw
- Justification for choice of vehicle: non-toxic vehicle, the test item could despite its big volume be suspended in the vehicle and still passed the cannula in a concentration of 20% (w/v)
MAXIMUM DOSE VOLUME APPLIED:
- 1x 10 mL of vehicle with suspended test item at a concentration of 20% (w/v)
CLASS METHOD (if applicable):
- Rationale for the selection of the starting dose: because the bioavailability of the milled carbonised PAN based fibre is negligible no toxicity is expected after oral exposure. Hence, the limit dose of 2000 mg/kg bw was chosen as the starting dose. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 females per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: body weight is recorded before administration (day 0) as well as on day 7 and day 14; animals died during the study are weighed as well
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
- Clinical observations are made at 30 min, 2 hrs, 4 hrs and 6 hrs after dosing as well as daily thereafter for a total of 14 consecutive days.
- All signs of illness and behaviour changes are recorded. - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No observed mortality
- Clinical signs:
- other: Piloerection was observed in three animals at 30 minutes, 2 hrs and 4 hrs after application. After 6 hrs as well as from day 1 until the end of the observation period on day 14, no animal showed any abnormalities.
- Gross pathology:
- Necropsy done, but no signs of pathological signs were found.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- As there are no deviations from the test protocol and GLP criteria are met the study is regarded as valid. The oral LD50 value of the test substance (milled carbonised PAN based fibre) in rats was found to be above 2000 mg/kg bw under the experimental conditions. The test substance does therefore not meet the classification criteria according to regulation (EC) No. 1272/2008.
- Executive summary:
The acute oral toxicity in rats was determined according to the method recommended in the OECD Guideline No. 423 and in the Council Regulation (EC) No. 440/2008 part B.1.tris.
The study was accomplished on two groups, each consisting of three female animals. A starting dose level of 2000 mg/kg bw and a dose volume of 10 mL/kg bw were applied. Animals were observed for a total of 14 days.
All animals survived the administration of the dosing level of 2000 mg/kg bw and only showed slight signs of toxicosis.
The oral LD50 value of the test substance in rats was found to be above 2000 mg/kg bw under the experimental conditions. The test substance does therefore not meet the classification criteria according to regulation (EC) No. 1272/2008.
Reference
Table 1: Results of the daily observation of the animals according to the assessment key (see below)
Group |
Animal No. |
Dose mg/kg bw |
Sex |
After administration |
Day after administration |
||||||||||||||||
30 min |
2 hrs |
4 hrs |
6 hrs |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||||
1 |
1 |
2000 |
female |
B |
B |
B |
A |
A |
A |
A |
A |
A |
A |
A |
A |
A |
A |
A |
A |
A |
A |
2 |
2000 |
female |
B |
B |
B |
A |
A |
A |
A |
A |
A |
A |
A |
A |
A |
A |
A |
A |
A |
A |
|
3 |
2000 |
female |
B |
B |
B |
A |
A |
A |
A |
A |
A |
A |
A |
A |
A |
A |
A |
A |
A |
A |
|
2 |
1 |
2000 |
female |
B |
B |
A |
A |
A |
A |
A |
A |
A |
A |
A |
A |
A |
A |
A |
A |
A |
A |
2 |
2000 |
female |
B |
B |
A |
A |
A |
A |
A |
A |
A |
A |
A |
A |
A |
A |
A |
A |
A |
A |
|
3 |
2000 |
female |
B |
B |
A |
A |
A |
A |
A |
A |
A |
A |
A |
A |
A |
A |
A |
A |
A |
A |
A |
Normal behaviour |
B |
Piloerection |
Table 2: Individual values of the body weight [in g] of the animals on day 0, 7 and 14
Group |
Animal No. |
Dose mg/kg bw |
Sex |
Day 0 |
Day 7 |
Day 14 |
1 |
1 |
2000 |
female |
153 |
172 |
204 |
2 |
2000 |
female |
163 |
197 |
224 |
|
3 |
2000 |
female |
158 |
194 |
221 |
|
2 |
1 |
2000 |
female |
146 |
191 |
219 |
2 |
2000 |
female |
148 |
216 |
226 |
|
3 |
2000 |
female |
154 |
195 |
223 |
Table 3: Average body weight [in g] of the groups on day 0, 7 and 14
Group |
Dose mg/kg bw |
Sex |
Day |
Ø |
σ |
n |
1 |
2000 |
female |
0 |
158 |
5 |
3 |
7 |
188 |
14 |
3 |
|||
14 |
216 |
11 |
3 |
|||
2 |
2000 |
female |
0 |
149 |
4 |
3 |
7 |
201 |
13 |
3 |
|||
14 |
223 |
4 |
3 |
Ø: Mean value
σ: Standard deviation
n: Number of animals
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- GLP guideline study
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The test substance (milled carbonised PAN based fibre) falls within the typical range of the substance definition including the impurities (in total < 0.3%) which in principle consist of metal and mixed metal oxides (mainly Al, Ca, Fe, Na, Si oxides). These substances are of negligible concern regarding human health and the environment.
The different manufacturing processes and precursor materials for non-graphitic carbon fibres within the scope of this registration lead to slightly different compositions. Accordingly, the choice of the test material is based on the substance with the highest nitrogen content. The obtained test results are therefore regarded to also cover all other qualities of the substance non-graphitic carbon fibre within the scope of this registration.
The acute oral toxicity in rats was determined according to the method as recommended in the OECD Guideline No. 423 and in the Council Regulation (EC) No. 440/2008 part B.1.tris.
The study was accomplished on two groups, each consisting of three female animals. A starting dose level of 2000 mg/kg bw and a dose volume of 10 mL/kg bw were applied.
All animals survived the administration of the dosing level of 2000 mg/kg bw and showed only mild signs of toxicity.
The oral LD50 value of the test substance in rats was found to be above 2000 mg/kg bw under the experimental conditions. The test substance does therefore not meet the classification criteria according to regulation (EC) No. 1272/2008.
Justification for classification or non-classification
The oral LD50 value of the test substance (milled carbonised PAN based fibre) in rats was found to be above 2000 mg/kg bw under the experimental conditions. The test substance does therefore not meet the classification criteria for acute toxicity according to regulation (EC) No. 1272/2008.
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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