Registration Dossier

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

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: basic data given, comparable to guideline/standards

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Principles of method if other than guideline:
dynamic inhalation method with analytical and nominal determination of the concentration.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity: 99.9%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Weight of the animals: 185 +/- 15 g. Standard diet and tap water ad libitum during the observation period.

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
ANALYTICAL EXAMINATIONS:
1. Apparatus, chemicals and solutions:
- gaschromatograph HP 5840 A
- dimethylformamid
2. Sampling:
- apparatus: 2 consecutive connected absorption vessels and a downstream fritted bottle
- sorption agent: dimethylformamide
- sampling rate: 1 liter/min
- sampling amount: 3 liter
- sampling place: near the animals' nose
- sampling probe: diameter 4 mm
3. Analytical determination method:
- gaschromatographically
- principle of the method: n-butylenoxide was determined in dimethylformamide

Supplying of the test substance with a prolonged infusion pump in a constant volume on a 93°C heated evaporator; the refined vapours were mixed with a fresh air flow and were conducted through an inhalation chamber with a chamber content of about 200 liters.
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
6.3 mg/l
No. of animals per sex per dose:
10
Control animals:
yes
Details on study design:
Dynamic inhalation test with analytical monitoring; post exposure observation period: 14 days
As a first orientating dose, a concentration was used which allow a classification in a toxic class. A dose level ought to allow an no effect level (no mortality).
The inhalation mixture was offered for 4 hours.
The body weight of the animals were checked before starting of the study, after 7 days and at the end of the observation period. Clincal signs and mortality were checked daily.
After the 14-day observation period the animals were killed and a pathological-anatomical evaluation was done.
Statistics:
none

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 6.3 mg/L air (analytical)
Exp. duration:
4 h
Remarks on result:
other: No mortalities.
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 25 mg/L air (analytical)
Exp. duration:
1 h
Remarks on result:
other: No mortalities.
Mortality:
none
Clinical signs:
no symptoms
Gross pathology:
nothing abnormal detected

Any other information on results incl. tables

Absolute body weight growth:

 Mean body weight  before starting     after 7 days     after 14 days   
   males  females  males  females  males  females

 Group 1

           
 Body weight in g  185  178  219  190  258  206
 No. of animals  10  10  10  10  10  10
 Control            
 Body weight in g  178  180  219  190  254  210
 No. of animals  10  10  10  10  10  10

Relative body weight growth:

 Mean body weight  before starting     after 7 days     after 14 days   
   males  females  males  females  males  females

 Group 1

           
 Body weight in g  0  0  34  12  73  28
 No. of animals  10  10  10  10  10  10
 Control            
 Body weight in g  0  0  41  10  76  30
 No. of animals  10  10  10  10  10  10

No significant differences regarding body weight growth in comparison to the air control group.

Applicant's summary and conclusion