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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

eye irritation
other: in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010-06-17 to 2010-08-17
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was performed according to ICCVAM recommended HET-CAM Method Protocol (Nov. 2006)

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
other: According to ICCVAM recommended HET-CAM Method Protocol (Nov. 2006)
Principles of method if other than guideline:
The HET-CAM method is an alternative in vitro procedure that predicts the ocular irritative or corrosive potential of a test substance by observing the development of irritancy effects in the chicken egg chorioallantoic membrane (CAM). The CAM is a vital vascular fetal membrane with a closed blood vessel system. Given the high vascularity of this membrane, this method is proposed to provide information on the effects that may occur in the conjunctiva (a highly vascularised ocular structure) following exposure to a test substance.
GLP compliance:

Test material

Constituent 1
Reference substance name:
EC Number:
EC Name:
Cas Number:
Carbón vegetal
Details on test material:
Name: Charcoal (Probe 1: C-Fix = 73.3%)
Batch No.: 19062009 1PP
Appearance: Charcoal typic
CAS No.: 16291-96-6
EINECS No.: 240-383-3
Purity: C-Fix: 73.3%
Date of expiry: December 2030
Storage conditions: Room temperature 20 ± 5 °C, keep away from humidity

Test animals / tissue source

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

Test system

unchanged (no vehicle)
not required
Amount / concentration applied:
50 mg aprox
Duration of treatment / exposure:
300 sec (5 min)
Observation period (in vivo):
300 sec (5 min)
Number of animals or in vitro replicates:
no aplicable (ensayo in vitro)
Details on study design:
Test system:
The HET-CAM was carried out with Lohmann Selected Leghorn chicken's eggs. The eggs were obtained 9 days before the start of the test. Eggs were incubated at 38.5 °C, 58.8% humidity for nine days, periodically rotated. On day eight the eggs were candled and non-viable eggs were discarded. The rest of the eggs were placed upwards in the incubator for another day.

Test groups:
Negative control: 0.9% NaCl, on 3 eggs; 300 μL each
Positive control: 1% SDS solution in deionized water, on 3 eggs; 300 μL each
Positive control: 0.1 N NaOH, on 3 eggs; 300 μL each
Test item: Neat charcoal about 50 mg of <100 µm size

Experimental performance:
After application of test item, negative and positive control, the eggs were observed for a period of 300 sec. Three endpoints were observed. The time when that particular endpoint was observed was noted. The three endpoints were:
• hemorrhage
• blood vessel lysis
• coagulation

Results and discussion

In vivo

Irritation parameter:
overall irritation score
other: Provided on the above section 'any information on materials and methods incl. tables'
Time point:
other: 300 sec
ca. 0
Max. score:
not specified
Remarks on result:
other: no irritante
Irritant / corrosive response data:
The irritation score (IS) for charcoal (IS:0.0) was not different from the negative control (IS: 0). The positive controls (0.1N NaOH, and 1% SDS) caused values (IS: 19.99 and 11.25, respectively) that fell within the classification of severely irritating to the eye.
Other effects:
no aplicable

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 ocular irritating potential in vitro.