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EC number: 271-974-4
CAS number: 68647-86-9
The acute inhalative toxicity of the Read-Across substance charcoal (Probe 2: C-Fix=80.5%) was investigated in a study in rats that was performed according to OECD guideline no. 403, EU method B.2 and the US EPA Health Effects Test guideline OPPTS 870.1300, Acute Inhalation Toxicity, as per August 1998.The acute oral toxicity of coconut shell charcoal was investigated in a study in rats that was performed according to OECD guideline no. 423.
Acute toxicity: Inhalative route
This test was not conducted with coconut
shell charcoal but due to the Read-Across approach the test results for
“Charcoal” can be used:
In this study, a group of 10 Wistar Crl: (WI)
BR rats (5 males and 5 females) was exposed to an aerosol atmosphere.
The animals were exposed for 4 h using a nose-only exposure system,
followed by a 14-d observation period.The
mean achieved concentration of charcoal in the exposure was 4.968 mg/L
(standard deviation: 3.624 mg/L; nominal concentration: 18.2 mg/L).The
characteristics of the test atmosphere were as follows: Mean mass median
aerodynamic diameter (MMAD) (mm): 3.52 µm; geometric standard deviation:
2.46; inhalable fraction (< 4 µm): 52.3%
No death occurred in the test animals.In
males, test item related clinical signs were found between the third
hour of inhalation exposure and first hour of observation period. All
animals were symptom –free on first day of observation period.In
females animals, test item related clinical signs were found between the
third hour of inhalation exposure and first hour of observation period.
All female animals were symptom–free from first day of observation
period.The clinical signs represented
the decreased activity and general reaction and dyspnoea.In
both genders, body weight loss was observable on the day of inhalation
exposure. In both sexes, a compensation of body weight loss was found
from third day of observation period.On
basis of body weight and body weight gain data, there was no notable
test item effect observable in the exposed animals.
In conclusion, a single 4-h nose-only
exposure to charcoal sample Probe 2 to CRL: (WI) BR rat followed by a
14-day observation period at a dose level 5 mg/L was not associated with
mortality or any test item-related toxicological findings on the male
and female animals.
Accordingly, the acute inhalation median
lethal concentration (4-h LC50) of charcoal rats was
therefore considered to be greater than 4.97 mg/L.
Acute toxicity: Oral route
According to REACH Regulation (EC) No.
1907/2006, Annex IX, 7.1.5, column 2, a study on the acute toxicity
after oral administration is not required as acute toxicity upon
inhalation has been investigated.As the study on acute
toxicity upon inhalation was only performed with the Read-Across
substance charcoal the testing of the acute toxicity after oral
administration was performed.
In this study two groups, each consisting of three female
RccHan:WIST (SPF) rats, were treated with coconut shell charcoal by
single oral gavage administration at a dosage of 2000 mg/kg body weight.
The test item was formulated in PEG 300 at a concentration of 0.2 g/ml
and administered at a dosing volume of 10 ml/kg.
The animals were examined daily during the acclimatization period
and mortality, viability and clinical sign were recorded. All animals
were examined for clinical signs before treatment, within the first 30
minutes and approximately 1, 2, 3 and 5 hours after treatment on day 1
and once daily during test days 2-15. Mortality/viability was recorded
before treatment, within the first 30 minutes and approximately 1, 2, 3
and 5 hours after administration on test day 1 (with the clinical signs)
and twice daily during days 2-15. Body weights were recorded on day 1
(prior to administration) and on days 8 and 15. All animals were
necropsied and examined macroscopically.
No intercurrent deaths occurred during the course of the study.
All animals excreted feces stained in black one day after the
administration (test day 2). No other clinical signs were observed
during the course of the study.
One animal showed a slight loss of body weight (-1,7%) from test
day 8 to day 15. Otherwise, the body weight of the animals was within
the range commonly recorded for this strain and age.
No macroscopic findings were recorded at necropsy.
The median lethal dose of coconut shell charcoal after single oral
administration to female rats, observed over a period of 14 days, is:
LD50(female rat): >2000 mg/kg body weight.
Acute toxicity: Dermal route
Based on the results of the acute inhalative
toxicity studies in rats (for the Read-Across substance carcoal),
coconut shell charcoal is not classified for acute inhalation toxicity
as specified in the current EU-CLP regulation.
Based upon the referred classification
criteria (Regulation (EC) No 1272/2008 of the European Parliament and of
the Council of 16 December 2008), coconut shell charcoal is not
classified with respect due acute oral toxicity in the rat.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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