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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
repeated dose toxicity: oral
Remarks:
other: literature assessment
Type of information:
other: Assessment
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Reliability score 2 on the basis of the weight of evidence found during review of public documents relating to toxicity of charcoal and activated charcoal

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Literature assessment
GLP compliance:
not specified

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

Test animals

Species:
other: human - medical use studies

Results and discussion

Effect levels

Dose descriptor:
other: effect level
Effect level:
> 0.5 - < 5 other: g/day
Based on:
act. ingr.
Sex:
male/female
Basis for effect level:
other: A dosage of up to 5g per day is recommended for adults taking activated charcoal as a prevention cure for gastric disorders.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Charcoal is not toxic with respect to repeated dose oral administration
Executive summary:

There is no evidence that charcoal or activated charcoal is orally toxic. In fact all evidence suggests that it is beneficial in certain circumstances as a treatment for removing toxins from the stomach and gastric tract.

The use of charcoal in medicine is varied. Charcoal was consumed in the past as dietary supplement for gastric problems in the form of charcoal biscuits. Activated charcoal is used today to treat poisonings, reduce intestinal gas (flatulence), lower cholesterol levels, prevent hangover, and treat bile flow problems (cholestasis) during pregnancy. 

For activated charcoal used in human and animal medical applications there are numerous medical papers widely available, which extol the virtues of using this substance in certain circumstances.

Dosing would normally be for acute treatment rather than for repeat dose treatment, especially in cases of poisoning and is usually 1 gram/kg of body mass usually given only once, but depending on the drug taken, it may be given more than once.

There are a numerous medical articles relating to the use of charcoal in human and veterinary medicine. Activated charcoal has been used for such conditions as diarrhoea or flatulence where the recommended dosage for treatment of in adults is 520-975 mg after each meal and up to 5 g per day.

It can be used for treating reduced bile flow (cholestasis) during pregnancy and also for administration in paediatrics.

It is highly unlikely that the world of medicine would have adopted activated charcoal to such an extensive way if there was the slightest doubt that the substance was itself orally toxic, especially for children and pregnant women.

Activated charcoal can be bought over the counter as a non-prescription medicine

There is no evidence that charcoal or activated charcoal is orally toxic under repeat dose circumstances. In fact all evidence suggests that it is beneficial in certain circumstances as a treatment for removing toxins from the stomach and gastric tract. On this basis, the testing required for this end point has been waived and it is suggested that charcoal is non-toxic orally both in acute circumstances and also for repeat dose administration.

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