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Administrative data

Endpoint:
eye irritation
Remarks:
other: in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
06/17/2010 al 08/17/2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: el 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:
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:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Charcoal
EC Number:
240-383-3
EC Name:
Charcoal
Cas Number:
16291-96-6
Molecular formula:
C
IUPAC Name:
Charcoal
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: analisis in vitro, no se usan animales
Strain:
other: análisis in vitro

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
5 min (300 sec)
Observation period (in vivo):
5 min (300 sec)
Number of animals or in vitro replicates:
no aplicable en ensayos in vitro

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: result: no irritante
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:
In vitro el carbón vegetal no tiene poder irritante por via ocular

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