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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02 March 2010 - 25 March 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
performed under GLP

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Remarks:
Statement of Compliance
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Activated Carbon - Low Density Skeleton
EC Number:
931-334-3
Molecular formula:
C
IUPAC Name:
Activated Carbon - Low Density Skeleton
Details on test material:
- Name of test material (as cited in study report): Chemically Activated Carbon
- Physical state: Black powder
- Analytical purity: confidential
- Lot/batch No.: confidential
- Expiration date of the lot/batch: confidential
- Stability under test conditions: Stable under storage conditions; Stable in water
- Storage condition of test material: At room temperature (range of 20 ± 5 °C, provided by Harlan Laboratories Ltd.), light protected.

Test animals

Species:
rat
Strain:
other: RccHan: WIST(SPF)
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories B.V., Kreuzelweg 53, 5961 NM Horst / The Netherlands
- Age at study initiation: 10 weeks
- Weight at study initiation: 169.1 g – 178.7 g
- Fasting period before study: approximately 18 to 19 hours
- Housing: In groups of three in Makrolon type-4 cages with wire mesh tops and standard softwood bedding
- Diet: Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet
- Water: Community tap water from Füllinsdorf ad libitum
- Acclimation period: 02 March 2010 to 08 March 2010 (Group 1); 02-March 2010 to 10 March 2010 (Group 2)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 02 March 2010 To: 23/25 March 2010

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
purified
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.2 g/mL
- Justification for choice of vehicle: The vehicle was chosen after a non-GLP solubility trial which was performed before the study initiation date. The test item was prepared at 20 % in purified water (w/w), which resulted in a black dispersion that was considered orally applicable.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: not specified
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
2 groups of 3 female animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs 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 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.
- Necropsy of survivors performed: yes, on day 15
- Other examinations performed: clinical signs, body weight, mortality, viability, macroscopic findings.
Statistics:
No statistical analysis was performed.

Results and discussion

Preliminary study:
Not relevant
Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: No treatment related effects were observed.
Mortality:
No mortality occurred.
Clinical signs:
Clinical signs of slight to moderate degree were observed in the animals of group 1, including sedation, hunched posture and ruffled fur and laborated breathing. All symptoms were completely reversed by test day 2 or 3. No clinical signs were observed in the animals of group 2. For all animals, black feces were noted on test day 2 or 3, which was most likely a consequence of the black test item.
Body weight:
The body weight of the animals was within the range commonly recorded for this strain and age.
Gross pathology:
No macroscopic findings were recorded at necropsy.

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
based on CLP criteria
Conclusions:
No treatment related effects were found under the conditions of this study. The median lethal dose of Chemically Activated Carbon after single oral administration to female rats, observed over a period of 14 days, is: LD50 (female rat): greater than 2000 mg/kg body weight. The substance does not have to be classified according to the EU classification criteria outlined in 1272/2008/EC.
Executive summary:

The acute oral toxicity of Chemically Activated Carbon in the rat was assessed by using the acute toxic class method. The study was carried out based on OECD guideline 423. Two groups, each consisting of three female RccHan:WIST (SPF) rats, were treated with Chemically Activated Carbon by single oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was formulated in purified water at a concentration of 0.2 g/mL and administered at a dosing volume of 10 mL/kg.

No intercurrent deaths occurred during the course of the study.

Clinical signs of slight to moderate degree were observed in the animals of group 1, including sedation, hunched posture and ruffled fur and laborated breathing. All symptoms were completely reversed by test day 2 or 3. No clinical signs were observed in the animals of group 2. For all animals, black feces were noted on test day 2 or 3, which was most likely a consequence of the black test item.

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 Chemically Activated Carbon after single oral administration to female rats, observed over a period of 14 days, is: LD50 (female rat): greater than 2000 mg/kg body weight. The substance does not have to be classified according to the EU classification criteria outlined in 1272/2008.