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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Principles of method if other than guideline:
Rats (10 males and 10 females per dose) were exposed for 4 hours to 6.58 or 17.76 mg/l of the test substance. A dynamic inhalation method with whole-body exposure and with analytical and nominal determination of the concentration was used. The animals were observed for 14 days.
GLP compliance:
no
Test type:
standard acute method

Test material

Constituent 1
Chemical structure
Reference substance name:
Butan-1-ol
EC Number:
200-751-6
EC Name:
Butan-1-ol
Cas Number:
71-36-3
Molecular formula:
C4H10O
IUPAC Name:
butan-1-ol
Test material form:
liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: WIGA, Germany
- Weight at study initiation: 185 +- 15 g
- Housing: during exposure: 5 animals/cage
- Diet: ad libitum (food was withdrawn during the exposure)
- Water: ad libitum (water was withdrawn during the exposure)

ENVIRONMENTAL CONDITIONS
no data

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Whole body inhalation system
- Exposure chamber volume: 200 L
- Method of holding animals in test chamber: animals are kept in wire mesh cages within the exposure chamber (5 animals/cage)


TEST ATMOSPHERE
- Brief description of analytical method used: samples were taken from the exposure chamber and analyzed via gaschromatography
- Samples taken from breathing zone: yes
Analytical verification of test atmosphere concentrations:
yes
Remarks:
via gaschromatography
Duration of exposure:
4 h
Concentrations:
6.58, 17.76 mg/L
No. of animals per sex per dose:
10
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the animal weight was determined before the start of the exposure, after 7 days and at the end of the observation period. The animals were checked daily for clinical signs and mortality
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
no data

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LC0
Effect level:
> 17.76 mg/L air (analytical)
Exp. duration:
4 h
Remarks on result:
other: highest concentration that could be generated
Mortality:
no deaths occured
Clinical signs:
other: none observed
Body weight:
Only marginal differences (slightly reduced weight gain) were observed between the treated groups and the control group. No dose dependency was observed.
Gross pathology:
no abnormalities detected

Applicant's summary and conclusion