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Toxicological information

Acute Toxicity: inhalation

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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:
test procedure in accordance with national standard methods with acceptable restrictions

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:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
May 1981
Deviations:
yes
Remarks:
only limited data about analytics
Principles of method if other than guideline:
NA
GLP compliance:
no
Test type:
other: standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Purity batch
> 99.0 % 7.32% active oxygenBatch 247408973
99.27 % 9407226339; 247408999
99.6 % 0410105225413
> 97 % 4289070300; 0419101226056
99.1 % 11600 0010-108
99.3 % 247413988
99.4 % 7.35 % active oxygen Batch 247409800
98.9 % 0707518256
> 99.1 % 247412384
98.5 % 0707603153
99.0 % 1703465433
99.5 % 150726; 247413309
99.3 % 000055055

Test animals

Species:
rat
Strain:
other: Charles River CD
Sex:
male/female
Details on test animals and environmental conditions:
- Weight: male 216 to 300 g; females 200 to 299 g
- Housing: wire-mesh cages
- Diet and water (e.g. ad libitum): Purina Laboratory Chow and water (ad libitum)
- Acclimation period: 4 hour


Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
- Exposure apparatus: FMI LAB pump
- Exposure chamber volume: 160-liter cubical
- Rate of air: 8 L/min
- Pressure in air chamber: 10 psig


Analytical verification of test atmosphere concentrations:
no
Remarks:
The individual concentrations 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.
Duration of exposure:
4 h
Concentrations:
"metered" conc.: 9.2, 20.8, 46.5 and 103.4 mg/L
No. of animals per sex per dose:
5 animals per sex per dose (total: 20 animals)
Control animals:
not specified
Details on study design:
95 % confidence limits

Results and discussion

Preliminary study:
No preliminary study
Effect levelsopen allclose all
Key result
Sex:
male
Dose descriptor:
LC50
Effect level:
42.2 mg/L air
95% CL:
28.4 - 62.9
Exp. duration:
4 h
Key result
Sex:
female
Dose descriptor:
LC50
Effect level:
42.2 mg/L air
95% CL:
25.2 - 70.7
Exp. duration:
4 h
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
42.2 mg/L air
95% CL:
30.8 - 58
Exp. duration:
4 h
Mortality:
All animals (5 male, 5 females) died during the 14 day study period at the chamber concentration of 103.4 mg/L.
Further animals (6 animals) died at the chamber concentrations of 20.8 (1 female) and 46.5 mg/L (2 females, 3 male).
Clinical signs:
other: Exposure concentration (103.4 mg/L): By 30 minutes of exposure, a nasal discharge was observed in all rats. Slight dyspnoea was observed in 4 rats by 3 hours of exposure and in all rats by 4 hours of exposure. Redness was observed in the ears and the paws
Body weight:
Exposure concentration (103.4 mg/L): A slight body weight loss was observed for day 1 postexposure.
Exposure concentration (46.5 mg/L): A slight body weight loss was observed for day 1 postexposure. This condition persisted for 7 days in the surviving rats.
Exposure concentration (20.8 mg/L): A slight body weight loss was observed in all rats for day 1 postexposure.
Exposure concentration (9.2 mg/L): A slight body weight loss was observed for day 1 postexposure which persisted for 5 days for 3 male rats and 14 days for 1 female rat.
Gross pathology:
Exposure concentration (103.4 mg/L): Necropsy of the rats revealed red patches in the lungs.
Exposure concentration (46.5 mg/L): Necropsy of the rats which died revealed pink lungs with dark red patches.
Exposure concentration (20.8 mg/L): Necropsy of the 1 female rat revealed 2 large red patches on the left lung.
Other findings:
NA

Any other information on results incl. tables

No remarks

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LC50 was calculated to be 42.2 mg/L with 95% confidence limits of 30.8 and 58.0 mg/L.
Executive summary:

Four groups of male and female rats were exposed to the aerosol and vapour atmospheres of tert.-Butylperoxy- 2-ethylhexanoat. The four "metered" concentrations were 103.4, 46.5, 20.8 and 9.2 mg/L, respectively. During the 4 -hour exposures, nasal discharge and slight dyspnoea were observed in all groups of rats. Redness of ears and paws developed shortly after exposure in all rats exposed to 103.4 and 46.5 mg/L. Death occurred in all groups on 1 or 2 days postexposure at concentrations above 9.2 mg/L.

The LC50 was calculated to be 42.2 mg/L with 95% confidence limits of 30.8 and 58.0 mg/L.

Necropsy of the rats that died during the observation period revealed red patches in the lungs.