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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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-06-18 to 2010-08-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted as per OECD 429 and EU B.42 test method guidelines
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:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Principles of method if other than guideline:
- NA
- GLP compliance:
- no
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- 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:
- Identity: Charcoal (Probe 1: C-Fix = 73.3%)
CAS No.: 16291-96-6
Batch No.: 19062009 1PP
Purity: C-Fix: 73.3%; dose calculation not adjusted to purity
Storage: At room temperature, moisture protected
Expiration Date: December 2030
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsd
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Remarks:
- 99% purity
- Concentration:
- 3 groups of 4 female mice were treated on the dorsal surface of both ears once per day for 3 days with the test article, charcoal (Probe 1: C-Fix = 73.3%) at 2.5, 5, and 10% (w/w) in the vehicle propylene glycol.
- No. of animals per dose:
- 4 female mice
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: SI: Vehicle control = 1.00; Charcoal (2.5% w/v) = 0.65; Charcoal (5% w/v) = 0.72; and Charcoal (10% w/v) = 1.11
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: DPM per lymph node: Vehicle control = 295.6; Charcoal (2.5% w/v) = 192.7; Charcoal (5% w/v) = 211.4; and Charcoal (10% w/v) = 329.3
Any other information on results incl. tables
% Concentración elemento de prueba la (w/w) |
Grupo |
Medición DPM |
Cálculo |
Resultado |
||
DPM-Guna) |
Nº de ganglios linfáticos |
DPM por los ganglios linfáticos b) |
SI |
|||
--- |
BG I |
20 |
--- |
--- |
--- |
--- |
--- |
BG II |
17 |
--- |
--- |
--- |
--- |
0 |
1 |
2383 |
2365 |
8 |
295,6 |
1,00 |
2.5 |
2 |
1560 |
1542 |
8 |
192,7 |
0,65 |
5 |
3 |
1710 |
1692 |
8 |
211,4 |
0,72 |
10 |
4 |
2653 |
2635 |
8 |
329,3 |
1,11 |
Bg = Antecedentes (1 ml 5% de ácido tricloroacético) por duplicado
1 = Grupo de Control
2-4 = Grupos de prueba
IE = Índice de Estimulación
a) = El valor medio fue tomado de la I y II cifras BG
b) = Dado que los ganglios linfáticos de los animales de un grupo de dosis se combinaron, se determinaDPM / nododividiendo el valor medido por el número de nodos linfáticos agrupados.
Nota: La concentración estimada del producto de ensayo requerida para producir un aumento de 3 veces en la actividad de un ganglio linfático de drenaje proliferativa (denominado el valor EC3) se puede calcular de acuerdo con la ecuación.
[EC3 =(ac) [(3-d) / (bd )] + c]
Aquí, (a, b) y (c, d) son respectivamente las coordenadas de los dos pares de datos situadas inmediatamente por encima y por debajo del valor SI de 3 en el nodo local linfático gráfico de la respuesta ensayo dosis.
El valor EC3 no puede ser calculado, ya que todos los SI están por debajo de 3.
No ocurrieron muertes durante el período de estudio; y no hay síntomas de toxicidad local en las orejas de los animales y no hay hallazgos sistémicos durante el período de estudio.
El peso corporal de los animales, registrado antes de la primera aplicación y antes del tratamiento con 3HTdR, estaba dentro del rango comúnmente registrado en animales de esta cepa y edad.
El resultado obtenido se interpreta comono sensibilizante hasta el 10% (w/w) de carbón vegetal.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information para concentraciones superiores al 10%
- Conclusions:
- The test item, charcoal was not a skin sensitiser under the test conditions of this study.
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