Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1969
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study is comparable with the inhalation hazard test described in the Annex of OECD Guideline 403 (adopted 1981) with acceptable restrictions.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1969
Report date:
1969
Reference Type:
other company data
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
not applicable
GLP compliance:
no
Remarks:
prior to GLP
Test type:
other: Inhalation Hazard Test (IHT)
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Pentan-3-one
EC Number:
202-490-3
EC Name:
Pentan-3-one
Cas Number:
96-22-0
Molecular formula:
C5H10O
IUPAC Name:
pentan-3-one
Details on test material:
- Name of test material (as cited in study report): Diaethylenketon
- Physical state: liquid
- Analytical purity: 99.8%

Test animals

Species:
rat
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Mean weight at study initiation: 202 g

ENVIRONMENTAL CONDITIONS
not reported

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
Rats exposed for 10 min and 35 min, respectively, to a vapour saturated atmosphere.
Vapour was generated by bubbling 200 l/h dry air (no CO2) through the liquid substance column (volume ca. 50 ml) of about 5 cm above a fritted glass disc in a glass cylinder. The glass cylinder was heated in a water bath. Temperature in the exposure chamber was 20°C. Nominal concentration was stated in the raw data to be 34967.8 ppm (corresponding to ca. 123.1 mg/L) in the case of the 10 min exposure and 31978.4 ppm (corresponding to ca. 112.6 mg/L) in case of the 35 min exposure.
The vapour saturation treshold was calculated to be 122.2 mg/L. Therefore, the test atmospheres should be considered as vapours.
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
35 min
Remarks on duration:
and 10 min
Concentrations:
34967.8 ppm (corresponding to ca. 123.1 mg/L) in the case of the 10 min exposure;
31978.4 ppm (corresponding to ca. 112.6 mg/L) in case of the 35 min exposure
No. of animals per sex per dose:
10 min: 6 (in two trials)
35 min: 3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Groupwise weighing was done on the day of application and on day 7. Observation was several times at the day of exposure and presumably daily exception of weekends and holidays afterwards.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
other: mortality
Exp. duration:
10 min
Remarks on result:
other: mortality 0/12 animals after treatment with a vapour saturated atmosphere (nominal 123.1 mg/L)
Sex:
male/female
Dose descriptor:
other: mortality
Exp. duration:
35 min
Remarks on result:
other: mortality 2/6 animals after treatment with a vapour saturated atmosphere (nominal 112.6 mg/L)
Mortality:
10 min: 0/12 animals
35 min: 1/6 animals during exposure ( after 34 min); 1/5 animals 6 min after the end of exposure
Clinical signs:
other: 10 min: during exposure tries to escape, intermittent respiration; after 5 min no pain reflex, irritation of the mucosa; after the exposure staggering; reversible within 40 min 35 min: during exposure tries to escape; after 3 min accelerated respiration;
Body weight:
10 min: slight body weight gain (+8g)
35 min: survivors with slight body weight reduction (-2g)
(only groupwise data were available)
Gross pathology:
Sacificed animals: nothing abnormal found
Animals that died (35 min): reduced lung dilatation; little arterialized, cyanotic blood

Applicant's summary and conclusion

Executive summary:

In an acute inhalation toxicity study (BASF AG, Department of Toxicology, 1969), groups of young adult rats (male/female) were exposed by inhalation route to Diethyl ketone [Diaethylenketon] (99.8% a.i.) for 10 min or 35 min (whole body inhalation exposure). Tested concentrations were 123.1 mg/L (10 min exposure) and 112.6 mg/L (35 min exposure). Animals then were observed for 7 days. No mortality was observed in rats exposed to Diethyl ketone for 10 min (0/12 animals died). Slight body weight gain was observed. After 35 min exposure, one animal died during exposure and one animal immediately after exposure (2/6 animals died). Both animals showed reduced lung dilatation, little arterialized, and cyanotic blood. Slight body weight reduction was noticed for survivors of this group. All surviving animals were sacrificed; gross necropsy revealed nothing anomalous. The inhalation hazard test (IHT) - study was performed similar to OECD Guideline 403 (Acute Inhalation Toxicity) overall and is classified as key study.

Categories Display