Octylamine

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:

other: Meets generally accepted scientific standards, well documented and acceptable for assessment

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)

Principles of method if other than guideline:

Rats (10/sex/dose) were exposed to an aerosol (seven different doses) of the test substance (head/nose exposure) for 4 hours. The rats were then observed for 14 days and the LC50 was calculated.

GLP compliance:

no

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Octylamine

EC Number:

203-916-0

EC Name:

Octylamine

Cas Number:

111-86-4

Molecular formula:

C8H19N

IUPAC Name:

octan-1-amine

Details on test material:

- Name of test material (as cited in study report): n-Octylamin
- Physical state: liquid
- Analytical purity: 99 %
no further data

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: WIGA, Sulzfeld and MUS RATTUS, Brunnthal
- Weight at study initiation: 185 +- 15 g
- Diet: ad libitum
- Water: ad libitum
no further data

ENVIRONMENTAL CONDITIONS
no data

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose/head only

Vehicle:

other: air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
continuous infusion pump UNITA (B. Braun), two substance injector (Rhema Jato)
The test substance was fed in a constant amount using a continuous infusion pump into a two substance injector. Compressed air (up to 3 bar) was
used to generate ab aerosol which was then fed into the exposure chamber. The pressure in the inhalation system was adjusted to 3 Pa to generate
over pressure.


TEST ATMOSPHERE
- Brief description of analytical method used: the atmosphere in the exposure chamber was analyzed using gas chromatography
- Samples taken from breathing zone: yes

no further data

Analytical verification of test atmosphere concentrations:

yes

Remarks:

using gas chromatography

Duration of exposure:

4 h

Concentrations:

0.13, 0.76, 1.44, 1.57, 1.64, 2.58, 9.85 mg/l (analytical concentration)

No. of animals per sex per dose:

10

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations were performed daily, weighing on day 0, day 7 and day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross patholody

Statistics:

Probitanalysis according to D.J. Finney in the BASF computing center

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

1.6 mg/L air

Exp. duration:

4 h

Mortality:

4 hour exposure:
at 0.13 mg/l 0/10 male and 0/10 female rats died; at 0.76 mg/l 1/10 male and 0/10 female rats died; at 1.44 mg/l 4/10 male and 1/10 female animals died; at 1.57 mg/l 3/10 male and 1/10 female animals died; at 1.64 mg/l 5/10 male and 7/10 female animals died; at 2.58 mg/l 9/10 male and 10/10 female animals died; at 9.85 mg/l 10/10 male and 10/10 female animals died

Clinical signs:

other: 0.13 mg/l dose group: aqueous to reddish secretion from the eyes and nose, animals were free of signs of toxicity after 2 days 0.76-2.58 mg/l dose group: attempts to escape, aqueous to reddish secretion from the eyes and nose, eye lid closure, intermitten

Body weight:

There were no significant changes in weight gain in most dose groups, most animals gained weight normally.
Male rats of the 1.44 mg/l dose group showed a reduced weight gains compared to controls and the surviving male animal of the 2.58 mg/l dose group also showed a reduced weight gain.

Gross pathology:

animals that died:
heart: acute dilation of the antechambers, acute congestive hyperemia
lung: striking hyperemia, oedematous

sacrificed animals: organs without findings

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the test the LC50 in rats was 1.6 mg/L.

Executive summary:

Sprague-Dawley rats (10 animals per sex and dose) were exposed against 0, 0.13, 0.76, 1.44, 1.57, 1.64, 2.58, 9.85 mg substance/l (analytical concentration) for 4 h (nose only exposure). The animals were observed for 14 days.

at 0.13 mg/l 0/10 male and 0/10 female rats died; at 0.76 mg/l 1/10 male and 0/10 female rats died; at 1.44 mg/l 4/10 male and 1/10 female animals died; at 1.57 mg/l 3/10 male and 1/10 female animals died; at 1.64 mg/l 5/10 male and 7/10 female animals died; at 2.58 mg/l 9/10 male and 10/10 female animals died; at 9.85 mg/l 10/10 male and 10/10 female animals died. The LC50 in rats was dertermined with 1.6 mg/L.