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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

skin irritation / corrosion
other: in vitro
Type of information:
experimental study
Adequacy of study:
key study
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 Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
other: According to Human Skin Model Test EU-Method B.46 adopted 23. July 2009
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:

Test material

Constituent 1
Reference substance name:
EC Number:
EC Name:
Cas Number:
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

Test animals

other: ensayo in vitro
other: ensayo in vitro
Details on test animals or test system and environmental conditions:
no aplica al ser ensayo in vitro

Test system

Type of coverage:
other: ensayo in vitro
Preparation of test site:
other: ensayo in vitro
unchanged (no vehicle)
not required
Amount / concentration applied:
25 mg aprox
Duration of treatment / exposure:
60 min
Observation period:
no aplicable
Number of animals:
no aplicable al ser in vitro
Details on study design:
The human skin model test was performed with commercially available Epi-200-SIT-Kit. The EpiDermTM tissues were produced from MatTek Corporation in Ashland, USA. The day of delivery was the 01. July 2010 batch: 13657

Negative control: Dulbecco’s Phosphate Buffered Saline (DPBS) without CaCl2 and MgCl2
One plate (three tissues) was used as negative control; each tissue was treated with 30 µL DPBS buffer
Positive control: Sodium dodecyl sulphate (SDS), CAS No. 151-21-3, solution in deionised H2O, concentration 50 g/L
One plate (three tissues) was used as positive control; each tissue was treated with 30 µL SDS-solution
Test item: ground charcoal comprised of particles < 100 µm about 25 mg
One plate (three tissues) was used for treatment with the test item

Experimental performance:
After dosing the tissues with negative control, positive control and test item, they were incubated at 37 °C for 35 min. After 60 min a rinsing step and two incubation periods at 37°C over a total period of 42 h followed.
After incubation, a MTT assay was performed and formazan production was measured by a spectral photometer at 570 nm.

Results and discussion

In vivo

Irritation parameter:
other: percentage values of formazan production in comparison to the negative control
other: provided on the above section 'any other information on materials and methods incl. tables'
Time point:
other: 60 min
other: no aplicable
Remarks on result:
other: resultado de 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:
no aplicable

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


(Probe 1: C-Fix = 73.3%)

Positive control

% Formazan production (Tissue 1)



% Formazan production (Tissue 2)



% Formazan production (Tissue 3)



% Formazan production Mean




Applicant's summary and conclusion

Interpretation of results:
not irritating
Migrated information Criteria used for interpretation of results: EU
It can be stated that under the experimental conditions reported, charcoal did not exhibit any skin irritating potential.