Registration Dossier
Registration Dossier
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EC number: 240-383-3 | CAS number: 16291-96-6 An amorphous form of carbon produced by partially burning or oxidizing wood or other organic matter.
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion
- Remarks:
- other: in vitro test
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-07-5 to 2010-08-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was performed according to EU-Method B.46 " In vitro Skin Irritation: Reconstructed human epidermis model test" (23. July 2009)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: According to Human Skin Model Test EU-Method B.46 adopted 23. July 2009
- Deviations:
- no
- Principles of method if other than guideline:
- The in vitro skin irritation test is used to determine the skin irritancy of chemicals by measuring the cell viability in a reconstructed human epidermis (RhE) model after applying the test substance. The RhE model consists of human-derived epidermal keratinocytes, which have been cultured to form a multilayered model of the human epidermis. Irritant chemicals are identified by their ability to decrease cell viability by quantitatively measuring the enzymatic conversion of the vital dye MTT (3-[4,5-dimethyl thiazole 2-yl] 2,5-diphenyl-tetrazoliumbromide) to a blue formazan salt. Skin irritation potential of the test substance is assessed by reducing the formazan production to less than 50% of the negative control.
- GLP compliance:
- no
Test material
- Reference substance name:
- Charcoal
- EC Number:
- 240-383-3
- EC Name:
- Charcoal
- Cas Number:
- 16291-96-6
- IUPAC Name:
- Carbón vegetal
- Details on test material:
- Name: Charcoal (Probe 3: C-Fix = 88.7%)
Batch No.: DP07.2008/1
Appearance: Charcoal typic
CAS-No.: 16291-96-6
EINECS-No.: 240-838-3
Purity: C-Fix = 88.7%
Date of expiry: Dec. 2030
Storage conditions: Room temperature 20 ± 5°C
Constituent 1
Test animals
- Species:
- other: test in vitro
- Strain:
- other: no aplica
- Details on test animals or test system and environmental conditions:
- no aplica por ser test in vitro
Test system
- Type of coverage:
- other: no aplica
- Preparation of test site:
- other: no aplica al ser test in vitro
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- Amount of approximately 25 mg
- Duration of treatment / exposure:
- 60 min
- Observation period:
- not applicable (cell viability was determined after the end of treatment period)
- Number of animals:
- not applicable (this is an in vitro test)
Results and discussion
In vivo
Results
- Irritation parameter:
- other: percentage values of formazan production in comparison to the negative control
- Basis:
- other: provided on the above section 'any other information on materials and methods incl. tables'
- Time point:
- other: 60 min
- Reversibility:
- other: no aplicable
- Remarks on result:
- other: No irritante
- Irritant / corrosive response data:
- The relative absorbance values were reduced to 89.4% after the treatment with charcoal (Probe 3: C-Fix = 88.7%). This value is above the threshold for irritation (50%). Therefore, the test item is considered not irritant. The reduction of the relative absorbance of the positive control was 7.8%.
- Other effects:
- not applicable
Any other information on results incl. tables
Comparison of formazan production:
For the test item and the positive control the following percentage values of formazan production were calculated in comparison to the negative control:
% Formazan Production
Designation |
Charcoal |
Positive control |
% Formazan production (Tissue 1) |
87.3% |
7.6% |
% Formazan production (Tissue 2) |
93.1% |
8.1% |
% Formazan production (Tissue 3) |
87.7% |
7.9% |
% Formazan production Mean |
89.4% |
7.8% |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- It can be stated that under the experimental conditions reported, charcoal did not exhibit any skin irritating potential.
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