Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
other: Publication
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1995

Materials and methods

Principles of method if other than guideline:
no further data available from the publication
GLP compliance:
not specified
Remarks:
no further data available from the publication
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
no further data available from the publication

Test animals

Species:
mouse
Strain:
not specified
Sex:
female
Details on test animals and environmental conditions:
2 month-old female mice (24 g average, three mice per group)

Administration / exposure

Route of administration:
other: intravenous and intraperitonial
Vehicle:
not specified
Details on exposure:
injected intravenously with increasing quantities of the charcoal suspension in a volume of 0.1 ml: 20/xg (0.83 mg/kg), 40/xg (1.66 mg/kg), 400/zg (16.6 mg/kg) and 4 mg (166 mg/kg)
Doses:
not further data available from the publication
No. of animals per sex per dose:
not further data available from the publication
Control animals:
not specified
Details on study design:
not further data available from the publication
Statistics:
no further data available from the publication

Results and discussion

Mortality:
micronized activated charcoal caused no death of mice tested
Clinical signs:
no further data available from the publication
Body weight:
no further data available from the publication
Gross pathology:
no further data available from the publication
Other findings:
Intravenous injection of 166 mg/kg b.w. of activated charcoal caused instantaneous death of animals tested.
Intraperitoneal administration of 166 mg/kg b.w. of micronized activated charcoal caused no death of mice tested.
Acute toxicity observed only if large amounts of charcoal are directly indroduced into the circulation.

Any other information on results incl. tables

no further data available from the publication

Applicant's summary and conclusion

Conclusions:
Intravenous injection of 166 mg/kg b.w. of activated charcoal caused instantaneous death of animals tested.
Intraperitoneal administration of 166 mg/kg b.w. of micronized activated charcoal caused no death of mice tested.
Acute toxicity observed only if large amounts of charcoal are directly indroduced into the circulation.
Executive summary:

In the study of Bonhomme-Falvre et al.(1996) to determine the in vivo lethal dose 50 (LD50) of a micronized peat charcoal (Norit) suspension, 2 month-old female mice (24 g average, three mice per group) were injected intravenously with increasing quantities of the charcoal suspension in a volume of 0.1 ml: 20/xg (0.83 mg/kg), 40/xg (1.66 mg/kg), 400/zg (16.6 mg/kg) and 4 mg (166 mg/kg). Surviving mice were killed at the following times: 3 hours, 24 hours, days 22 and 60 and autopsied. Intravenous injection of 166 mg/kg b.w. of activated charcoal caused instantaneous death of animals tested. Intraperitoneal administration of 166 mg/kg b.w. of micronized activated charcoal caused no death of mice tested. According to the study authors, acute toxicity is observed only if large amounts of charcoal are directly indroduced into the circulation.

It is noted that both routes of exposure studied by Bonhomme-Falvreet al.(1996) are not relevant for the examined charcoal and the intended use pattern. However, the significant difference noted following the intraperitoneal and intravenous exposure to activated charcoal supports the fact that the systematic absorption of charcoal (at least in terms of fix carbon content) is limited when administered via the dermal route.