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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-10-18 to 2012-11-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: method by Stern et al.
- Version / remarks:
- M. Stern, M. Klausner, R. Alvarado, K. Renskers, M. Dickens (1998). Evaluation of the EpiOcular Tissue Model as an Alternative to the Draize Eye Irritation Test. Toxicology In Vitro 12, 455-461.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: protocol of the supplier of the tissue models
- Version / remarks:
- MatTek Corporation, 200 Homer Avenue, Ashland MA 01721 (2001). Ocular Irritation Protocol: Neat Method (MTT ET-50) For Use with EpiOcular Tissue Model (OCL-200). Rev. 1/1/01, 1-6.
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- carbon
- EC Number:
- 701-026-1
- Cas Number:
- 7440-44-0
- Molecular formula:
- C up to (C80N5H16O)n
- IUPAC Name:
- carbon
- Test material form:
- solid: fibres
- Details on test material:
- - milled carbonised PAN based fibre (Sigrafil C30 M150 UNS)
- for further details on the test material, see section 1.4, endpoint "Non-graphitic carbon fibre (carbonised PAN based fibre, milled)", attached document "Analytics_milled_carbonised_PAN_based_fibre.pdf"
Constituent 1
Test animals / tissue source
- Species:
- other: corneal model consisting of human-derived epidermal keratinocytes
- Strain:
- other: not applicable
Test system
- Vehicle:
- water
- Amount / concentration applied:
- approximately 200 mg of the test substance in a 1:1 mixture with water
- Duration of treatment / exposure:
- test item: 3 min, 30 min, 60 min
negative control: 60 min
positive control: 4 min, 15 min, 45 min - Number of animals or in vitro replicates:
- not applicable
- Details on study design:
- see description in "any other information on materials and methods inc. tables"
Results and discussion
In vitro
Results
- Irritation parameter:
- other: irritation class according to Stern et al.
- Remarks:
- - irritation class is derived from the ET50 value (effective time of exposure to reduce tissue viability to 50%) of the test item - the ET50 is determined in human-derived EpiOcularTM corneal tissue models via a colorimetric viability test (MTT assay)
- Run / experiment:
- - the ET50 is calculated from the optical density (OD) as the percentage of viability referred to the negative control (= 100%) - the OD is measured during the MTT viability test (MTT = 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide)
- Value:
- > 60
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Remarks:
- - the ET50 value of > 60 min corresponds to a classification as non/minimally irritant according to Stern et al.
Any other information on results incl. tables
Table 2: Individual values of the optical density (OD) being corrected about the blank as well as the means and percentages of the tissue viability calculated from these and derived ET50 values.
test substance |
exposure time [min] |
tissue n |
optical density minus Ø Blank = 0,031 |
viability [% NC] |
ET50 [min] |
||||
aliquot 1 |
aliquot 2 |
aliquot 3 |
Ø |
Ø tissue |
|||||
negative control |
60 |
1 2 3 |
1,688 1,725 1,739 |
1,642 1,735 1,650 |
1,708 1,730 1,698 |
1,680 1,730 1,696 |
1,702 |
100 |
|
MILLED CARBONISED PAN BASED FIBRE; SIGRAFIL C30 M150 UNS |
3
30
60 |
1 2 1 2 1 2 |
1,624 1,580 1,596 1,377 1,696 1,650 |
1,667 1,542 1,609 1,347 1,628 1,584 |
1,678 1,628 1,648 1,364 1,689 1,614 |
1,657 1,584 1,618 1,363 1,671 1,616 |
1,620
1,491
1,644 |
95
88
97 |
> 60 |
positive control |
4 15 45 |
1 1 1 |
1,799 1,017 0,314 |
1,791 1,006 0,304 |
1,788 1,018 0,315 |
1,793 1,014 0,311 |
|
105 60 18 |
approx. 19 |
NC = negative control, OD = optical density, Ø = mean
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Because no deviations from the study protocol are reported and the study was performed according to the Principles of Good Laboratory Practice it is regarded as valid. The only slight decrease in tissue viability after exposition to the test item (milled carbonised PAN based fibre) and the determined ET50 value of > 60 minutes indicates at most a minimal irritation potential of the test item. Based on these results the test item shall be categorised as non/minimally irritant.
- Executive summary:
The eye irritant potential of the test item (milled carbonised PAN based fibre) was investigated according to the methods by STERN et al. (1998)1 and the protocol2 of the tissue models supplier, the MatTek Corporation. Approximately 200 mg of a 1:1 mixture of the test item and water was applied to human, three-dimensional corneal models EpiOcularTM. The reference items (negative control = water; positive control = 0,3% Triton X-100) were applied in amounts of 100 µL each. After the termination of the 3, 30, and 60-minute exposure period the test item was removed from the tissue surface by rinsing with phosphate buffer saline (DPBS), the tissues were submerged into medium for 10 minutes and then the cell viability was determined using the MTT assay. The exposition periods for the reference items were 4, 14 and 45 minutes for the positive control as well as 60 minutes for the negative control. Based on the obtained exposure time-related viability curve the time of exposure needed for the test item to reduce the viability of the treated tissue to 50% of control tissues (ET50) was determined. Based on the exposure time-related viability curve as result of the MTT assay the ET50 value of the test item was determined to be above 60 minutes. The positive control responded with a decrease of the tissue viability depending on the exposure time and meeting the expectations. The determined ET50 value was approx. 19 minutes and showed a moderate irritant effect of the positive control.
Under the experimental conditions described and based on the obtained results the test item shall be categorised as non/minimally irritant.
References
1) M. Stern, M. Klausner, R. Alvarado. K. Renskers, M. Dickens (1998). Evaluation of the EpiOcular(TM) Tissue Model as an Alternative to the Draize Eye Irritation Test. Toxicology In Vitro 12, 455 -461.
2) MatTek Corporation, 200 Homer Avenue, Ashland MA 01721 (2001). Ocular Irritation Protocol: Neat Method (MTT ET-50) For Use with EpiOcular Tissue Model (OCL-200). Rev. 1/1/01, 1-6.
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