Charcoal

Eye irritation

Administrative data

Endpoint:

eye irritation

Remarks:

other: in vitro

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: del estudio se realizó de acuerdo a ICCVAM protocolo recomendado por el método HET-CAM (noviembre de 2006)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: According to ICCVAM recommended HET-CAM Method Protocol (Nov. 2006)

Deviations:

no

Principles of method if other than guideline:

El método de HET-CAM es una alternativa en el procedimiento in vitro que permite predecir el potencial irritativo o corrosivo ocular de una sustancia mediante la observación del desarrollo de los efectos de irritación en la membrana del huevo de pollo corioalantoidea (CAM).
La CAM es una parte vital de la membrana vascular fetal, con un sistema cerrado de los vasos sanguíneos. Dada la alta vascularización de esta membrana, este método se propone proporcionar información sobre los efectos que pueden ocurrir en la conjuntiva (una estructura ocular altamente vascularizada) tras la exposición a una sustancia de ensayo.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Charcoal

EC Number:

240-383-3

EC Name:

Charcoal

Cas Number:

16291-96-6

Molecular formula:

C

IUPAC Name:

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

Species:

other: test in vitro, sin animales

Strain:

other: no aplica

Details on test animals or tissues and environmental conditions:

no aplica al ser ensayo in vitro

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

50 mg aprox.

Duration of treatment / exposure:

300 sec

Observation period (in vivo):

300 sec

Number of animals or in vitro replicates:

no aplica al ser test 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

Results

Irritation parameter:

overall irritation score

Basis:

other: Provided on the above section 'any information on materials and methods incl. tables

Time point:

other: 300 sec

Score:

ca. 0

Max. score:

21

Reversibility:

not specified

Remarks on result:

other: resultado de 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 aplica

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

el carbón vegetal no exhibe poder irritante ocular