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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.