Tetracosanol

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Only one dose level, short exposure period, no indication of droplet size.

GLP compliance:

not specified

Test type:

other:

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Hexan-1-ol

EC Number:

203-852-3

EC Name:

Hexan-1-ol

Cas Number:

111-27-3

Molecular formula:

C6H14O

IUPAC Name:

hexan-1-ol

Test animals

Species:

rat

Strain:

other: T23-48:COX-SD

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS

- Weight at study initiation: 245-356g

- Housing: 57 litre capacity glass chamber

- Diet: Purina laboratoy chow (ad libitum)

- Water: yes (ad libitum)


IN-LIFE DATES: Not specified.

Administration / exposure

Route of administration:

other: mist

Type of inhalation exposure:

whole body

Vehicle:

other: atmosphere generated as a mist

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION

- Exposure apparatus: Devilbiss Nebulizer

- Exposure chamber volume: 57 litres

- Method of holding animals in test chamber: Free to move in the glass chamber

- Source and rate of air: Delivery flow concentration of approximately 21 mg per litre of air, at a flow rate of six litres per minute.



TEST ATMOSPHERE

- Brief description of analytical method used: Prior to the actual exposure period, the test material was introduced into the chambre for ten minutes in order to make sure the test atmospheric concetration could reach theoretical equilibrium.

- Samples taken from breathing zone: no


TEST ATMOSPHERE (if not tabulated)

- Particle size distribution: Droplet size not reported

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

1 h

Concentrations:

21 mg/l

No. of animals per sex per dose:

5 male, 5 female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: The animals were observed frequently for gross effects during the exposure and daily thereafter for 14 days.

- Necropsy of survivors performed: yes

Statistics:

No statistical analysis was carried out on the test results.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 21 mg/L air

Exp. duration:

1 h

Mortality:

All animals survived the 14 day observation period.

Clinical signs:

other: During exposure all animals showed hypoactivity and/or ataxia, lethargy and prostration. However within 2 hours of removal from the exposure chamber the animals all appeared and continued to appear normal throughout the observation period.

Body weight:

Final bodyweights showed a  slight weight loss in one animal however the others all exhibited weight gains within expected limits.

Gross pathology:

Gross necropsy revealed moderate pulmonary, adrenal and hepatic congestion in one animal only. The findings in the remaining 9 test animals were unremarkable.

Other findings:

No potential target organs were identified.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The rat inhalational LC50 following a 1 hour exposure to a mist of Alfol 6 was >21 mg/l. Since the test atmospheric concentration would in all probablility exceed that to be encountered by humans when the substance is used, hexan-1-ol was found not to be a toxic substance.