Cyclohexanol

Acute Toxicity: inhalation

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)

GLP compliance:

no

Test type:

traditional method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Cyclohexanol

EC Number:

203-630-6

EC Name:

Cyclohexanol

Cas Number:

108-93-0

Molecular formula:

C6H12O

IUPAC Name:

cyclohexanol

Test material form:

not specified

Details on test material:

Supplier: BASF
Highest purity, purity not specified.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Source: MUS RATTUS Brunnthal
- average weight at study initiation: 178g (male), 176 g (female)
- Feeding: Herilan MRH der Firma H. ECGERSMANN, Rinteln/Weser; ad libitum
- Water: tap water; ad libitum

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose/head only

Vehicle:

air

Details on inhalation exposure:

Aerosol was generated using "Dauerinfusionspumpe" UNITA (B, Braun), and "Zweistoffdüse" (Rhema)

Analytical verification of test atmosphere concentrations:

yes

Remarks:

method: gas chromatography

Duration of exposure:

4 h

Concentrations:

Nominal/target concentration: 7.5 mg/L
Analytical concentration: 3.63 mg/L

No. of animals per sex per dose:

10

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14d
- Control animals: air
- Frequency of observations : daily
- Frequency of weighing: before begin, on day 7 and at termination
- Necropsy of survivors performed: yes

Statistics:

A modification of the Wittig Binomial test (Wittig H: Matematische Statistik 1974, S 32-35)

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 3.6 mg/L air (analytical)

Exp. duration:

4 h

Mortality:

no deaths occured

Clinical signs:

other: Ruffled fur coat was noticed after exposure. Symptoms dissappeared after 1 day.

Body weight:

TREATED ANIMALS
- In comparison to the air controls, body weight gain was not influenced. Mean body weight on day 7 was 221g (male) and 198g (female). On day 14, body weights were 250 g (male), and 209g (females). CONTROLS: Day 0: 180g (male); 173g (female)
Day 7: 224 g (male); 194 (female)
Day 14: 261g (male); 207g (female)

Gross pathology:

No adverse gross pathological findings

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The LC50 under the conditions of the test was >3.6 mg/L leading to a classification into class Acute Tox. 4.

Executive summary:

This acute inhalation toxicity test was performed similar to OECD Guideline 403. GLP compliance was not reported. A group of 20 Sprague-Dawley rats (10 male and 10 female) was subjected to a nominal vapour concentrated airstream of the test material for four hours. Animals were observed for 14 days. No mortalities were observed. Clinical signs included ruffled fur coat, which disappeared after one day. No abnormalities were detected in the organs of survivors. Under the conditions of the study the LC50 for rats was reported to be >3.6 mg/L.