Registration Dossier

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given and the study (IRT test = inhalation risk test) is comparable to guideline, OECD 403. However with respect to this endpoint, the study has some deficiencies : the test substance concentration and the LC50 value were not indicated.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Principles of method if other than guideline:
BASF-Test (IRT = inhalation risk test):
The test was performed in principle as described in OECD test guideline 403. It demonstrates the toxicity of an atmosphere saturated with vapors of the volatile components of the test substance at the temperature chosen for vapor generation (20°C). Rats were exposed to the test substance vapors for maximal 8 hours. Observations for mortality and clinical signs were performed for 14 days, followed by gross pathological examination.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Firm Wiga, Sulzfeld
- Weight at study initiation: average weight of 222 g
- Diet: Altromin-R, ad libitum
- Water: water with ad libitum



Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: evaporator (continuous infusion); static exposure chamber
- rate of air: 200 L/h


TEST ATMOSPHERE
- Brief description of analytical method used: no analytics performed
- Samples taken from breathing zone: no
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
8 h
Remarks on duration:
The exposure durations were 3, 10, 30 minutes and 1, 3, 8 hours.
Concentrations:
not indicated
No. of animals per sex per dose:
12
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
other: IRT
Remarks on result:
other: no mortality, irritant to mucous membranes
Mortality:
no mortality observed
Clinical signs:
strong irritation of mucosal tissue
Gross pathology:
organs without abnormalities

Applicant's summary and conclusion