Registration Dossier

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientifically sound survey study, but no individual animal data, no information on necropsy data.

Data source

Reference
Reference Type:
publication
Title:
Determination of the median lethal concentration of the main chlorinated aliphatic hydrocarbons in the rat.
Author:
Bonnet, P.; Francin, J.-M.; Gradinski, D.; Raoult, G.; Zissu, D.
Year:
1980
Bibliographic source:
Arch Mal Prof Med Trav, vol. 41, No. 6 -7, s. 317-321

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): tétrachlorure de carbone (french for carbon tetrachloride)
- Physical state: not stated
- Analytical purity: 99.5 %
- Lot/batch No.: not reported, supplier: Merck, Darmstadt, Germany
- Stability under test conditions: not reported
- Storage condition of test material: not reported

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Sprague Dawley, O.F.A., Iffa-Credo
- Age at study initiation: not reported
- Weight at study end: 130 - 200 g
- Fasting period before study: not reported
- Housing: not reported
- Diet (e.g. ad libitum): not reported
- Water (e.g. ad libitum): not reported
- Acclimation period: not reported


ENVIRONMENTAL CONDITIONS
- Temperature (°C): not reported
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: cubic cages made of stainless steel, glass and teflon
- Exposure chamber volume: 170 L in total separated in 28 independent cages
- Method of holding animals in test chamber: whole-body in the cage
- Source and rate of air: 0 - 50 m³/h
- Method of conditioning air: dry sterile air at 10 °C is provided by a central device and is conditioned in seperate pneumatic regulation devices for each chamber to give a defined temperature, humidity and air rate
- System of generating vapour: the volatile test substance is vaporised by a thermostated injector
- Method of particle size determination: not applicable (vapour of volatile solvent)
- Treatment of exhaust air: the test substance is eliminated from the exhaust air by an undefined method
- Temperature, humidity, pressure in air chamber: 24 °C ± 1, 50 ± 1 %, - 0.294 mbar
- air changes in the exposure chamber: 60/h

TEST ATMOSPHERE
- Brief description of analytical method used: gas chromatography + measurement of volume loss of vaporized solvent
- Samples taken from breathing zone: yes, every 3 minutes by automatic sampling and analysis by gas chromatography

VEHICLE
- no vehicle used
Analytical verification of test atmosphere concentrations:
yes
Remarks:
gas chromatography analysis method of the gas chromatography not mentioned)
Duration of exposure:
6 h
Concentrations:
Not reported in detail, only visible as data point in a figure: 6000- 7000 ppm (38.4 -44.8 mg/l)
No. of animals per sex per dose:
12
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: frequently
- Frequency of weighing: once before treatment and on days 7 and 14 post treatment
- Necropsy of survivors performed: yes
Statistics:
- the LD50 calculations were done by the Bliss method

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LC50
Effect level:
7 228 ppm
95% CL:
7 072 - 7 378
Exp. duration:
6 h
Mortality:
- not reported
Clinical signs:
- hypnotic and somnolence
Body weight:
- retarded growth stated but no values presented
Gross pathology:
- analysed, but no findings, especially not in the liver the lung or the kidneys

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: According to EU directive 67/548/EEC and EU Regulation (EC) N0. 1272/2008 (CLP)
Conclusions:
The present study (Bonnet, 1980) states a LC50(rat) of 7228 ppm (= 46.260 mg/L air) after single exposure to CTC for 6 h.
Executive summary:

The potential of the test substance CTC (named carbon tetrachloride in the report) to induce toxicity upon exposure via the inhalation route was evaluated in a study following, along general lines, the OECD guideline No. 403.

Male Sprague Dawley rats were treated with vapors of the test substance for 6 hours by whole body mode. The animals were observed for 14 days post exposure for mortality, body weight development and clinical signs of toxicity, but neither the clinical signs nor the body weight results or the mortality were detailed in the report.

Mortality data of these animals were analysed by Bliss' probit method, which gave an acute inhalation toxicity (LC50) value of CTC in rats of 7228 ppm air (95 % confidence level: 7072 - 7378) after an exposure for 6h.

The LC50 in rat was found to be 7228 ppm (= 46.260 mg/L air) after single exposure to CTC for 6 h.