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Toxicological information

Acute Toxicity: inhalation

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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 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

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: COX-SD
Sex:
male/female
Details on test animals 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:
GHS criteria not met
Conclusions:
The rat 1 hour inhalational LC50 for tetradecan-1-ol is >1.5 mg/l. There were no signs of toxicity and findings at gross necropsy were unremarkable.