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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010-09-24 to 2010-10-09
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.2 (Acute Toxicity (Inhalation))
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1300 (Acute inhalation toxicity)
Deviations:
no
Principles of method if other than guideline:
No aplica
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

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:
Carbón vegetal
Details on test material:
Batch no.: 29004
Appearance: charcoal typic
Purity: C-Fix: 80.5%; dose calculation not adjusted to purity
Expiry: December 2030
Storage condition: At room temperature, moisture protected
Safety precautions: Routine hygienic procedures

The test atmosphere was generated from the micronized powder of test item as supplied by the Sponsor. No vehicle was used.

The original test item was micronized by mill (Fritsch, Laborette, Lot. 09.203.381) to around 150 µm. This particle size was used in the test. The actual particle size distribution in the breathing zone was determined by the parameters of the aerosol generation system employed.

Test animals

Species:
rat
Strain:
other: CRL (WI) BR of Wistar origin
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
nose only
Vehicle:
air
Analytical verification of test atmosphere concentrations:
yes
Remarks:
The actual concentration of generated atmosphere was measured gravimetrically at regular intervals (about 50-60 min) during exposure by pulling a volume of 4 L of test atmosphere from the exposure chamber through glass fibre filters Fiberfilm T60A20
Duration of exposure:
ca. 4 h
Concentrations:
4.968 mg/L
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 4.97 mg/L air
Exp. duration:
4 h

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Bajo las condiciones experimentales de este estudio, no se produjeron muertes en un grupo de diez ratas expuestas a un ambiente medio alcanzado de 4,97 mg / L durante cuatro horas.
La inhalación aguda mediana de la concentración letal (4-h CL50) de carbón vegetal de ensayo elemento en Wistar Crl: (WI) BR ratas, se considera por lo tanto a ser mayor que 4,97 mg / l.
No hubo mortalidad en los animales de prueba.
En consecuencia, la inhalación aguda mediana de la concentración letal (4-h LC 50) de las ratas de carbón tanto, se consideró que ser mayor que 4,97 mg / l.

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