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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non GLP, not according to current standart test protocols

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Inhalation risk test; equivalent to H.F. Smyth et al; 1962; Am. Ind. Hyg. Ass. J. 23, 95-107
GLP compliance:
no
Test type:
other: Inhalation risk test
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Butanone
EC Number:
201-159-0
EC Name:
Butanone
Cas Number:
78-93-3
Molecular formula:
C4H8O
IUPAC Name:
butan-2-one
Details on test material:
- Name of test material (as cited in study report): Methylethylketone

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation:
10 minutes exposure group: 228g (males); 199g (females)
30 minutes exposure group: 218g (males); 189g (females)
1 hour exposure group: 238g (males); 174g (females)
1.2 hour exposure group: 233g (males); 179g (females)

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- A saturated atmosphere was generated by bubbling 200l/h air at 20 ° C through a substance column of about 5 cm above a fritted glass disc in a glass cylinder for 10 min, 30 min, 1h or 1.2h.

TEST ATMOSPHERE
- No analytical determination of the atmosphere concentration was performed. The nominal concentration was calculated as the quotient of the amount of test substance weight loss during the exposure and the amount of air used during the exposure.

Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
<= 1.2 h
Remarks on duration:
10 min, 30 min, 1h, 1.2h tested
Concentrations:
10 minutes exposure group: appr. 330 mg/l
30 minutes exposure group: appr. 230 mg/l
1 hour exposure group: appr. 250 mg/l
1.2 hour exposure group: appr. 220 mg/l
No. of animals per sex per dose:
10 minutes exposure group: 6
30 minutes exposure group: 9
1 hour exposure group: appr. 3
1.2 hour exposure group: appr. 3
Control animals:
other: not applicable
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Mortality:
10 minutes exposure group: 0/12
30 minutes exposure group: 2/18
1 hour exposure group: 1/6
1.2 hour exposure group: 3/6
Clinical signs:
other: Attempts to escape; accelerated to intermittent respiration; eyelid closure, salivation, eye secretion with slight chromodacryorrhea; loss of pain reflex; lateral position; narcotic state, slow gait, ataxia, apathy, ruffled fur.
Body weight:
No data
Gross pathology:
Found dead:
Heart (acute dilatation, acute congestion hyperemia);
Lung (partial slight to medium acute exhalation; partly single cranial parts were carnified);
Liver (single bright parts, clay coloured discoloration)
sacrificed scheduled:
organs without findings

Applicant's summary and conclusion