Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1986-12-03 to 1986-12-18
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP but Guideline not reported

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
yes
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): Chloracetone
- Analytical purity: 96.7%
- Impurities (identity and concentrations): 1,1-dichloracetone (2.3%)
- Composition of test material, percentage of components:
- Date of delivery: 1986-10-03

Test animals

Species:
rat
Strain:
other: Bor:WISW
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, GmbH&Co KG, Borchen
- Weight at study initiation: males 155g; females 133g
- Housing: five per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12

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: self desing of TNO
- Exposure chamber volume: 0.015 m3
- Method of holding animals in test chamber: tube
- Source and rate of air: 1.2 m3/h
- Temperature, humidity, pressure in air chamber: 22+/-2°C 30-70 % relative humidity (in the highest concentration 83%

TEST ATMOSPHERE
- Brief description of analytical method used: no data
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
1 h
Concentrations:
7.9, 4.2, 2.1, 3.1, 1.0, 0.5
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: prior to exposure and 1,2,4,7 and 14 days after.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
1.9 mg/L air
95% CL:
1.6 - 2.2
Exp. duration:
1 h
Mortality:
yes
Clinical signs:
kept eyes closed, salivation, nasal discharge, red skin, laboured respiration dyspnea
Body weight:
Some males and females showed decreased body weights the first day after exposure, which is a normal observation in this experiment.
Gross pathology:
The animals which died during the exposure or during the first two days of the observation period showed oedema in the lungs, in most cases accompnied by a hydro-thorax. Frequently the stomachs of these rats were observed to be filled with air, and lesser extent also caecum and intestine were filled with air. In some animals which were killed at the end of the observation period only greyly discoloured lungs and small bleedings were found.

Applicant's summary and conclusion

Interpretation of results:
Category 2 based on GHS criteria
Remarks:
Migrated information
Conclusions:
Monochloroacetone was found to be toxic to rats when inhaled as vapor. The calculated LC50 was 1.9 mg/L.
Executive summary:

Monochloraceton was examined for acute inhalative toxicity in a GLP study. The concentraitons were 7.9, 4.2, 2.1, 3.1, 1.0, 0.5 mg/L. Monochloroacetone was found to be toxic to rats when inhaled as vapor. The calculated LC50 was 1.9 mg/L. Both the presence of a hydro-thorax and the observed increased colouring of the skin of the extremeties could be explained by an induced hypertension. These finding toghether with oedema in lungs pointed at an impairment of lung functioning. Mouth breathing caused stomach, caecum as well as intestine to be filled with air.