Pentadecanol, branched and linear

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

Study period:

1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study was well documented and meets generally accepted scientific principles, acceptable for assessment but was not conducted in compliance with GLP. The study is a read across from tetradecanol (CAS 112-72-1).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Method: other: In house protocol

GLP compliance:

not specified

Test type:

fixed concentration procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Tetradecanol

EC Number:

204-000-3

EC Name:

Tetradecanol

Cas Number:

112-72-1

IUPAC Name:

112-72-1

Constituent 2

Reference substance name:

tetradecanol

IUPAC Name:

tetradecanol

Details on test material:

- Name of test material (as cited in study report): ALFOL 14 alcohol

- Lot/batch No.: 8714J

Test animals

Species:

rat

Strain:

other: COX-SD

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS


- Weight at study initiation: 238-338g

- Housing: A 57 litre capacity glass chamber


ENVIRONMENTAL CONDITIONS

- Air changes (per hr): Air flow rate of 600 litres per hour



IN-LIFE DATES: Not stated

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

other: produced as a heated vapour

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION


- Exposure chamber volume: 57 litres

- Method of holding animals in test chamber: Animals were contained in a glass chamber.

- Source and rate of air: ALFOL 14 alcohol was introduced by passing an air flow over the test material as it was heated in a 60C at an ambient chambre concentration of approximately 1.5mg per litre of air at a flow rate of ten litres per minute for a period of one hour.


TEST ATMOSPHERE


- Samples taken from breathing zone: Prior to the actual test period, the test material was introduced into the chambre for six minutes, in order that the test atmospheric concentration could reach theoretical equilibrium.


VEHICLE

- Lot/batch no. (if required): 8714J



CLASS METHOD (if applicable)

- Rationale for the selection of the starting concentration: The 1.5mg/litre test concentration was chosen since the level does not exceed any to which man could be subjected to in any foreseeable use of the material.

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

1 h

Concentrations:

1.5 mg/l

No. of animals per sex per dose:

5 female, 5 male

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Final body weight records of the ten animals at termination (14 days) showed weight gains within expected limits of that expected in all ten animals. The animals were observed frequently on the day of exposure and daily thereafter. Survivors were weighed and necropsied at the end of  the exposure period.

Statistics:

No statistical test was performed.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

other: Inhalation

Effect level:

> 1.5 mg/L air

Exp. duration:

1 h

Mortality:

There were no mortalities during the exposure itself or in the 14 day observation period.

Clinical signs:

other: There were no clinical signs of toxicity present at any point of the study.

Body weight:

Body weight gain remained within expected limits for all ten animals.

Gross pathology:

Gross necropsy of the animals sacrificed at termination (14 days) showed no remarkable findings.

Other findings:

There were no other observations.

Any other information on results incl. tables

Table 1: Concentrations, exposure conditions and number of evident toxicity per animals treated

Nominal Conc. (mg/L)	MMAD µm	GSD	Number with evident toxicity (#/total)
			Males	Females	Combined
1.5mg/L			0 /5	0/5	0/10

 

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

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

Conclusions:

The rat 1 hour inhalational LC50 for Alfol 14 is >1.5 mg/l. There were no signs of toxicity and findings at gross necropsy were unremarkable. The result is a read across from tetradecanol (CAS 112-72-1).