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:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: no GLP study; equivalent or similar to OECD 403

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
not specified
Principles of method if other than guideline:
Rats were exposed to a vapour atmosphere of the test item in an acute inhalation toxicity study.
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
tert-butyl peroxypivalate
EC Number:
213-147-2
EC Name:
tert-butyl peroxypivalate
Cas Number:
927-07-1
Molecular formula:
C9H18O3
IUPAC Name:
tert-butyl 2,2-dimethylpropaneperoxoate

Test animals

Species:
rat
Strain:
other: Charles River CD
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: male: 216 - 292 grams and female: 209 - 286 grams
- Housing: individually in compartmented wire-mesh exposure cages
- Diet: purina laboratory chow ad libitum
- Water: water ad libitum
- Acclimation period: at least week

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: a FMI Lab pump or a Harvard infusion pump
- Exposure chamber volume: 160 L
- Source and rate of air: 8 L/min


TEST ATMOSPHERE
- Brief description of analytical method used: The invidual concentratins of the compound in the chamber atmosphere were calculated from the ratio of the rate of liquid dissemination to the rate of total chamber airflow.



Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
2.0, 4.2, 8.3, 17.1 mg/L
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights were recorded prior to the 4 hour exposure and at 24 and 48 hours in order to detect any latent effects following the exposure.
- Necropsy of survivors performed: yes

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LC50
Effect level:
5.07 mg/L air (analytical)
Based on:
test mat.
95% CL:
3.81 - 6.75
Exp. duration:
4 h
Sex:
female
Dose descriptor:
LC50
Effect level:
> 8.3 - < 17.1 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: by inspection only as data were not suitable for calculation
Sex:
male/female
Dose descriptor:
LC50
Effect level:
7.79 mg/L air (analytical)
Based on:
test mat.
95% CL:
5.89 - 10.28
Exp. duration:
4 h
Mortality:
At the concentration of 2.0 mg/L, no mortality was observed. At the concentration of 4.2 mg/l, one male rat died. At the concentration of 8.3 mg/L, five male rats died. At the concentration of 17.1 mg/L, all animals died.
Clinical signs:
other: Slight to marked dyspnea was observed in all groups of rats at the concentrations above 2.0 mg/L.
Body weight:
All rats lost weight following the exposures.
Gross pathology:
Necropsy of the dead rats revealed reddened lungs with dark red patches and discoloration of the liver.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The 4 hours LC50 was calculated to be 7.79 mg/l with 95 % confidence limits of 5.89 and 10.28 mg/L (aerosol exposure).
Executive summary:

Tert-butyl peroxypivalate was tested in an acute inhalation toxicity study. Four groups of 5 male and 5 female rats were exposed to an aerosol atmosphere of tert-butyl peroxypivalate. The four "metered" concentrations were 17.1, 8.3, 4.2, 2.0 mg/L respectively. Slight to marked dyspnea and deaths were observed in all groups of rats at concentrations above 2.0 mg/L. All rats lost weight following the exposures. Necropsy of the dead rats revealed reddened lungs with dark red patches and discoloration of the liver. The 4 hours LC50 was calculated to be 7.79 mg/l with 95 % confidence limits of 5.89 and 10.28 mg/L.