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Registration Dossier
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EC number: 435-740-7 | CAS number: 94317-64-3
Acute Toxicity: inhalation
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:
- 2 016
- 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
- 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
Constituent 1
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.
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