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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:
March 1st- 31th, 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
, 1981
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): n-Butylchlorid
- Storage condition of test material: in well-closed containers at a well-ventilated place; protected from inflammable matter

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Lippische Versuchstierzucht HAGEMANN GmbH & Co., Exertal 1, Germany
- Age at study initiation: 51 - 54 days
- Weight at study initiation: 229 - 249 g (males); 212 - 250 g (females)
- Fasting period before study: 16 hours
- Housing: in groups of two or three in MAKROLON cages (type III)
- Diet: ad libitum standardized diet for rats ALTROMIN 1324 (ALTROMIN GmbH, Lage/Lippe, Germany); analysed for contaminants
- Water: ad libitum tap water; analysed regularly
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/-2
- Humidity (%): 50 +/- 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: Feb. 1990 To: March 15th, 1990

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: dynamic inhalation apparatus with a nose-only exposure according to Kimmerle & Trepper.
- Exposure chamber volume: 40 L
- Method of holding animals in test chamber: Apparatus consists of a cylindrical exposure chamber which holds a maximum of 20 animals in pyrex tubes at the edge of the chamber in a radial position
- Source and rate of air: 400 L/h
- System of generating particulates/aerosols: A mixture of test substance and air was obtained using a spray-jet. The spray-jet was fed with compressed air from a compressor and with the test article using an infusion pump and a 50 mL syringe.
- Temperature, humidity, pressure in air chamber: 22 +/- 3°C

TEST ATMOSPHERE
- Brief description of analytical method used: GC-analyses of two air samples
- Samples taken from breathing zone: yes

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: Test substance is of volatile nature at room temperture (vapour pressure 10700 Pa at 20°C). This resulted in an almost complete gas phase in the inhalation chamber after the test substance air mixture escaped from the spray-jet.


Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
1.49 and 7.74 mg/L air (actual concentrations)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Observations and clinical examiniations: on the day of exposure 5, 15, 30 and 60 min, 3 h and 24 h after end of exposure; during recovery period at least once a day until all symptoms had subsided, thereafter each working day.
Individual body weight: before the exposure and after exposure in weekly intervals; if animals died body weight at time-point of death was recorded.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight gain

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 7.74 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Mortality:
No mortality occured.
Clinical signs:
No substance-related intolerance reactions were observed.
Body weight:
No inhibition of body weight gain was examined.
Gross pathology:
Macroscopic inspection revealed no pathological findings.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information