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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:
Study initiation: 22 Jan 2015, experimental completion: 17 Feb 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
fixed concentration procedure
Limit test:
yes

Test material

Constituent 1
Details on test material:
Sponsor's identification : NBPT
Description : White powder
Batch number : 100111
Purity : >97%
Date received : 04 August 2010
Expiry Date : 01 July 2011
Storage conditions : Stored cold at approximately 4°C, in the dark

Test animals

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

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
nose only
Vehicle:
air
Mass median aerodynamic diameter (MMAD):
3.3 µm
Geometric standard deviation (GSD):
2.62
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
>= 4 h
Remarks on duration:
Exposure was paused and the system cleaned after approximately 1, 2 & 3 hours due to test material blocking the delivery apparatus. Cleaning time was 11 minutes, resulting in an exposure period of 4 h 11 min.
Concentrations:
2.2 mg/l
No. of animals per sex per dose:
5/sex/dose
Control animals:
no

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 2.2 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Mortality:
None
Clinical signs:
other: Increased respiration for 1 male and 2 females, 1 - 2 hours post exposure. Vocalisation upon handling for 1 female. White material around the nose immediately following exposure was attributed to the test substance; red material around eyes and nose. Yel
Body weight:
Males lost 3-7 grams and 4 females lost 1-14 grams. All animals surpassed initial bodyweight by study day 14 and were considered normal.
Gross pathology:
1 male had misshapen spleen.

There were no other findings.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LC50 of NBPT was >2.2 mg/L when male and female Crl:CD(SD) albino rats were exposed to a dust aerosol as a single 4 hour nose-only exposure.
Executive summary:

The LC50 of NBPT was >2.2 mg/L when male and female Crl:CD(SD) albino rats were exposed to a dust aerosol as a single 4 hour nose-only exposure.