Fusel oil

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Scientifically acceptable study (inhalation hazard test; 7-hour exposure period)

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)

Version / remarks:

(1981)

Principles of method if other than guideline:

Internal BASF method was used (Inhalation Hazard Test) which was in large part equivalent to method stated in OECD guideline 403 (1981).

GLP compliance:

no

Test type:

other: inhalation hazard test

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-methylbutan-1-ol

EC Number:

205-289-9

EC Name:

2-methylbutan-1-ol

Cas Number:

137-32-6

Molecular formula:

C5H12O

IUPAC Name:

2-methylbutan-1-ol

Details on test material:

- Name of test material (as cited in study report): 2-methylbutanol-1
- Physical state: liquid
- Analytical purity: ca. 99%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 184 g for males, 177 g for females
- Diet: Herilan MRH-Haltung; H Eggersmann KG; ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- System of generating particulates/aerosols: vapour generated by bubbling 200 L/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder

Analytical verification of test atmosphere concentrations:

no

Remarks:

The nominal concentration was calculated as quotient of the amount of test substance weight loss during exposure, and the amount of air used during exposure.

Duration of exposure:

7 h

Concentrations:

No verification of the concentration was performed. The test atmosphere is supposed to be saturated with test substance vapour at approximately 12.80 mg/l (3556.5 ppm; first experiment) or 16.61 mg/l (second experiment).

No. of animals per sex per dose:

6 (3 per experiment)

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: group wise documentation on working days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC0

Effect level:

12.8 - 16.61 mg/L air (nominal)

Based on:

test mat.

Exp. duration:

7 h

Remarks on result:

other: Inhalation hazard test

Mortality:

No deaths observed when animals were exposed to an atmosphere saturated with the test substance in 2 successive experiments.

Clinical signs:

other: Intermittent respiration and attempts to escape were observed during the first 10 minutes of exposure. No further adverse effects observed.

Body weight:

No adverse effects were apparent (no data).

Gross pathology:

No adverse effects observed.

Any other information on results incl. tables

The exposure of test animals to an atmosphere supposedly saturated with test substance for 7 hours caused no death and no remarkable adverse effects after 14-day observation period.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU