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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

In order to study a possible contact allergenic potential of Charcoal, three charcoal test items -Charcoal (Probe 1: C-Fix = 73.3%), Charcoal (Probe 2: C-Fix = 80.5%), and Charcoal (Probe 3: C-Fix = 88.7%) were tested in LLNA. Three groups each of four female mice were treated daily with each of charcoal test item at concentrations of 2.5, 5, and 10% (w/w) in propylene glycol by topical application to the dorsum of each ear (left and right) for three consecutive days. Control group of four mice was treated with the vehicle (propylene glycol) only. Five days after the first topical application the mice were injected intravenously into a tail vein with radio-labelled thymidine (3H Methyl thymidine, 3HTdR). Approximately five hours after intravenous injection, the mice were sacrificed, the draining auricular lymph nodes excised and pooled per group. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes, which were subsequently washed and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by the incorporation of 3HTdR measured in a beta-scintillation counter.

All treated animals survived the scheduled study period and no signs of toxicity were observed.

 

A test item is regarded as a sensitiser in the LLNA if the exposure to one or more test concentration resulted in 3-fold or greater increase in incorporation of 3HTdR compared with concurrent controls, as indicated by the Stimulation Index (S.I.). The estimated concentration of test item required to produce a S.I. of 3 is referred to as the EC3 value. The EC3 value could not be calculated, since none of the tested concentrations of each of charcoal test item induced an S.I. greater than 3.

The charcoal test items were not a skin sensitiser under the test conditions of this study.


Migrated from Short description of key information:
Three LLNA tests were performed on mice with the following three charcoal test items - Charcoal (Probe 1: C-Fix = 73.3%), Charcoal (Probe 2: C-Fix = 80.5%), and Charcoal (Probe 3: C-Fix = 88.7%). Tests were carried out according to OECD 429 and EU test method B.42 guidelines under the GLP compliance. Three test concentrations 2.5, 5 and 10% (w/w) of each test charcoal were used in the assay. No sensitization reaction was observed with any concentrations of all three charcoal items tested in the study.

Respiratory sensitisation

Endpoint conclusion
Additional information:

No studies on the respiratory sensitisation potential of charcoal were conducted.


Migrated from Short description of key information:
No studies on the respiratory sensitisation potential of charcoal were conducted.

Justification for classification or non-classification

Based on the results obtained in the local lymph node assay, charcoal is considered not to exert any sensitising activitty on the skin of mice. Hence, charcoal is not classified as a skin sensitizer according to the current EU-CLP Regulation.