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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:
other: Study meets generally accepted scientific principles, acceptable for assessment.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977
Reference Type:
publication
Title:
A new dust-feed mechanism
Author:
Wright BM
Year:
1950
Bibliographic source:
J.Sci.Instrum. 27 (1): 12-5
Reference Type:
publication
Title:
Über Vorkommen von Sulfoniumverbindungen in Metasystox (i) und Metasystox R und ihre physiologische Wirkung
Author:
Niessen H, Tietz H, Hecht G & Kimmerle G
Year:
1963
Bibliographic source:
Arch.Toxicol. 20, (1): 44-60

Materials and methods

Principles of method if other than guideline:
Male and female Sprague-Dawley rats were exposed to a dust/aerosol of 0.46 mg/l phenylbase for 6 h. Animals were observed for 7 or 14 days for mortality, clinical signs and body weight.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Phenylbase
- Physical state: White powder
- Analytical purity: 98%


Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Weight: male 235 g (195-275 g); female 175 g (157-200 g)
Diet: Altromin-R (Altrogge), tab water ad libitum.
Housing: 2/3 animals per cage.

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
Substance was pulverised and 5% talcum was added. Substance was nebulized by an equipment according to Wright (1950). Exposition of rats was performed according to Kimmerle (1963). Air stream 1000 l per hour.
Gravimetric determination of test substance concentration in exposure atmosphere: sampling using membrane filters (0.3µm pore diameter), determination of particle size distribution using a cascade impactor (Modell CS-6, Scientific Advances).
Analytical verification of test atmosphere concentrations:
yes
Remarks:
gravimetrically
Duration of exposure:
6 h
Concentrations:
0.46 mg/l
No. of animals per sex per dose:
10
Control animals:
yes
Details on study design:
Observations:
Body weight: twice a week
Clinical symptoms: daily
Mortality: daily
Clinical chemistry: total protein, total lipid, bilirubin, GOT (glutamate-oxalacetate-transaminase), GPT (glutamate-pyruvate-transaminase), AP (alkaline phosphatase), plasma-cholinesterase
Heamatology and urinalysis.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 0.46 mg/L air
Exp. duration:
6 h
Mortality:
no mortality occured
Clinical signs:
Animals were in a good physical state.
Body weight:
No influence of exposure on body weight was observed.
Gross pathology:
no data,
Other findings:
Total lipid, bilirubin, GOT and AP levels were increased. Total protein and plasma-cholinesterase leves were decreased. Additionally an increase of segmented leukocytes. Effects were observed 24-48h following application of the test substance in both sexes and were reversible within the 7-14 day observation period.

Result of test atmosphere analysis:
82% of particles were determined to be <8µm therefore respirable

Applicant's summary and conclusion