Alcohols, C16-18

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

Justification for type of information:

Alcohols, C16-18 is a member and is from Long Chain Alcohols (C6-22 primary aliphatic alcohols) category.
The Long Chain Alcohols (C6-22 primary aliphatic alcohols) category is considered suitable as a source of data for Alcohols, C16-18.
Considered valid for read-across for purposes of classification.
No further vertebrate testing can be justified.

Long Chain Alcohols (C6-22 primary aliphatic alcohols) category covers a family of 30 primary aliphatic alcohols within a carbon chain length range of C6-C22. Commercial products generally include several aliphatic alcohol components, with a range of carbon chain lengths present. The family consists of alcohols with varying compositions and structures. Composition depends on the route to manufacture and the related feedstocks. Most of the alcohols have linear carbon chains but certain manufacturing processes create branched structures. Data are also available for eleven other similar substances, which support the category. Non-sponsored alcohols may not be HPV or may not be produced by members of the consortium, but have structures similar to sponsored linear alcohols.

Key points are that the members share:
• The same structural features
• Similar metabolic pathways
• Common mode of ecotoxicological action
• Common levels and mode of human health related effects.

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Data source

Reference

Reference 1

Reference Type:

review article or handbook

Title:

Unnamed

Year:

2022

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

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:

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

GLP compliance:

not specified

Test type:

acute toxic class method

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

Details on test material:

Name of test material (as cited in study report): ALFOL 6

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

Effect levels 1

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 21 mg/L air

Based on:

test mat.

Exp. duration:

1 h

Remarks on result:

other: To convert mg/l into mg/m³ 1 mg/m³=mg/l x 1000, 21mg/lx1000=21000 mg/m³

Effect levels 2

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5 025 ppm

Based on:

test mat.

Exp. duration:

1 h

Remarks on result:

other: To convert mg/m3 into ppm at 25°C and 760 mm Hg (101.32 kPa) ppm = mg/m3 x (24.45/molecular weight) 21000 x (24.45/102.18)=5025 ppm

Effect levels 3

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 21 000 mg/m³ air

Based on:

test mat.

Exp. duration:

1 h

Remarks on result:

other: To convert ppm into mg/m3 at 25°C and 760 mm Hg (101.32 kPa) mg/m3 =ppm x molecular weight /24.45. mg/m3  =5025x 102.18/24.45=21000 mg/m3                          

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

Other findings:

No potential target organs were identified.

Any other information on results incl. tables

To convert mg/l into mg/m³

1 mg/m³=mg/l x 1000,

21mg/lx1000=21000 mg/m³

To convert mg/m3 into ppm at 25°C and 760 mm Hg (101.32 kPa)

ppm = mg/m³ x 24.45

molecular weight

21000 x (24.45/102.18)=5025 ppm

To convert ppm into mg/m3 at 25°C and 760 mm Hg (101.32 kPa)

mg/m³ =ppm x molecular weight

                           24.45

mg/m³  =5025x 102.18 =21000

                           24.45

Applicant's summary and conclusion

Interpretation of results:

other: practically nontoxic

Remarks:

Criteria used for interpretation of results: other: Federal Hazardous Substances Act

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, Alfol 6 Alcohol was found not to be a toxic substance.