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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-10-09 to 2013-01-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- Commission Regulation (EC) No 761/2009, Annex III, B.46
- Deviations:
- no
- 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
- Species:
- other: reconstructed human epidermal skin model
- Details on test animals or test system and environmental conditions:
- not applicable
Test system
- Type of coverage:
- other: not applicable
- Preparation of test site:
- other: not applicable
- Amount / concentration applied:
- approx. 25 mg of test item per well
- Duration of treatment / exposure:
- 60 +/- 1 min
- Observation period:
- MTT assay performed 42 hrs (in total) after incubation
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 106.4
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1: Individual measured values of the optical density (OD) and percentages of the viability derived from these during the MTT assay of the main investigation as well as the additional investigation
Test substance |
Tissue n |
Measured OD values |
Blank-corrected OD |
Ø of the aliquots |
Viability [%] |
||
Aliquot 1 |
Aliquot 2 |
Aliquot 1 |
Aliquot 2 |
||||
Negative control |
1 |
2,612 |
2,600 |
2,581 |
2,569 |
2,575 |
97,9 |
2 |
2,642 |
2,616 |
2,611 |
2,585 |
2,598 |
98,8 |
|
3 |
2,700 |
2,796 |
2,669 |
2,765 |
2,717 |
103,3 |
|
Positive control |
1 |
0,101 |
0,100 |
0,070 |
0,069 |
0,070 |
2,6 |
2 |
0,095 |
0,094 |
0,064 |
0,063 |
0,064 |
2,4 |
|
3 |
0,104 |
0,103 |
0,073 |
0,072 |
0,073 |
2,8 |
|
MILLED CARBONISED PAN BASED FIBRE; SIGRAFIL C30 M150 UNS |
1 |
2,735 |
2,695 |
2,704 |
2,664 |
2,684 |
102,1 |
2 |
2,953 |
2,873 |
2,922 |
2,842 |
2,882 |
109,6 |
|
3 |
2,895 |
2,825 |
2,864 |
2,794 |
2,829 |
107,6 |
|
MILLED CARBONISED PAN BASED FIBRE; SIGRAFIL C30 M150 UNS |
1step2 |
0,035 |
0,034 |
0,004 |
0,003 |
0,004 |
|
2step2 |
0,033 |
0,033 |
0,002 |
0,002 |
0,002 |
|
|
3step2 |
0,033 |
0,033 |
0,002 |
0,002 |
0,002 |
|
OD = optical density, Ø = mean,step2 without MTT and incubated in medium only (step 2)
Table 2: Means of the optical density (OD) and viabilities during the MTT assay of the main investigation as well as the additional investigation (step 2)
Test substance |
Ø of the OD |
σ of the OD |
Ø of the viability [%] |
σ of the viability |
CV % [%] |
Negative control |
2,630 |
0,076 |
100,0 |
2,90 |
2,90 |
Positive control |
0,069 |
0,005 |
2,6 |
0,17 |
6,69 |
MILLED CARBONISED PAN BASED FIBRE; SIGRAFIL C30 M150 UNS |
2,798 |
0,103 |
106,4 |
3,90 |
3,66 |
MILLED CARBONISED PAN BASED FIBRE; SIGRAFIL C30 M150 UNSstep2 |
0,003 |
0,001 |
0,1 % ≈ relative ODTI= 100 % x 0,003/2,630 |
OD = optical density, Ø = mean, σ = standard deviation, CV = coefficient of variation, step2 without MTT and incubated in medium only (step 2), TI = test item
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No deviations from the test protocols are reported and GLP criteria are fullfilled. Therefore, the study and the results are regarded as valid.
Based on the results described and according to the criteria of the Comission Regulation (EC) No.761/2009 the test item (milled carbonised PAN based fibre) shall not be classified into one of the GHS categories. - Executive summary:
The skin irritating potential of the test item (milled carbonised PAN based fibre) was investigated in accordance with the methods of the Commission Regulation (EC) No. 761/2009 Annex III B.46., the MatTek protocol EPI-200-SIT, the OECD guideline 439 as well as the draft updated guideline 439.
An amount of approx. 25 mg of the test item was applied on reconstructed human epidermis EpiDerm moistened with 25 µL DBPS. The reference items [negative control = Dulbecco's phosphate buffered saline (DPBS), positive control = 5 % Sodium Dodecyl Sulfate (SDS)] were applied on non-moistened EpiDerm tissues in an amount of 30 µL. After the termination of the 60 minute exposure time the test substances were removed from the skin surface by washing with DPBS. Subsequently, the treated tissue models were post-incubated in medium for 42 hours. Afterwards, the viability of the treated EpiDerm tissues was determined using the MTT assay (MTT = 3 -(4,5 -dimethylthiazol-2 -yl)-2,5 -diphenyltetrazolium bromide).
A MTT viabilty of 106,4% was determined for the test item.
In an additional investigation, the coloured test item was tested on three more viable EpiDerm tissues which were not incubated in MTT solution but in medium only. Thereby, it was revealed that the test item was alomst completely removable from the tissues after the 60 minute exposure time and had no appreciable influence of the MTT endpoint determination. The relative optical density caused by the coloured test item was approx. 0.1% only and a correction calculation of the MTT viability not necessary.
Based on the results described and according to the criteria of the Comission Regulation (EC) No.761/2009 the test item shall not be classified into one of the GHS categories.
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