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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
Study period:
29/10/2013 - 29/11/2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 436 (Acute Inhalation Toxicity: Acute Toxic Class Method)
Deviations:
no
Principles of method if other than guideline:
(1): Ventilation of the animal room was shut down in the following period during the scheduled maintenance of the power source of the test facility. 19:00-22:38 on November 9, 2013 Since it was confirmed temperature and relative humidity were within the permissible range and the body weights of animals increased, it was concluded that this deviation did not affect the study results.

(2): The test substance concentrations in the test atmosphere were made unscheduled measurements before the animal exposures. Since the exposure concentrations were maintained to the target concentrations based on these operations, it was concluded that these deviations did not affect the study reliability.
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
gas
Specific details on test material used for the study:
Lot number: 130130
Storage: Room temperature (actual range: from 19.4°C to 21.0°C, permissible range: 10°C to 30°C), light shielding, and air tight (metal pressure proof air tight container)
Expiry: March 5th, 2014

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: gas
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
The test substance gas at intended concentration was generated by passing through specified pressurized air into the test substance in a stainless-steel cylinder held into a constant temperature water bath set at 10°C. The generated gas was passing through a heat exchanger set at 10°C after mixing it with pressurized air at 10 L/min. Then the test atmosphere was prepared by mixing the diluted gas with pressurized air at 6 L/min. The test atmosphere was continuously supplied to the chamber to expose it to the rats. The air from the chamber was exhausted to outside air after passing through an activated carbon filter. The rats held in the restraint tubes were connected to the chamber to start exposure after concentration of hydrocarbon of the test atmosphere (relative concentration) reached temporally equilibrium. The rats were disconnected from the chamber to terminate exposure 4 hours after the start of exposure.
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
>= 4 - <= 4 h
Concentrations:
15,182 mg/m3 (2,500 ppm) and 121,456 mg/3 (20,000 ppm)
No. of animals per sex per dose:
3
Control animals:
no

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 122 549 mg/m³ air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 20 180 ppm
Based on:
test mat.
Exp. duration:
4 h
Mortality:
No mortality was observed.
Clinical signs:
No clinical abnormalities were observed.
Body weight:
No changes in body weight were observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material did not show any adverse effects in any of the test animals. Therefore the LC50 concentration can be considered to be greater than 122,549 mg/m3 (20,180 ppm), which was the highest concentration of test material measured.
Executive summary:

The test material did not show any adverse effects in any of the test animals. Therefore the LC50 concentration can be considered to be greater than 122,549 mg/m3 (20,180 ppm), which was the highest concentration of test material measured.