Octylamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

The test substance was administered orally at a dose level of 200 mg/kg bw to 5 male and 5 female rats. The animals were then observed for 21 days.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

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
no further data

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GmbH
- Age at study initiation: young adults
- Weight at study initiation: mean males: 191 g; mean females: 179 g
- Fasting period before study: the animals were given no feed about 16 hours before administration
- Housing: 5 animals/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 0.26 ml/kg

Doses:

200 mg/kg

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 21 days
- Frequency of observations and weighing: recording of signs and symptoms several times on the day of administration and at least once each workday; Check for moribund and dead animals twice each workday and once on holidays. Weighing was performed on day 0, day 6, day 13, day 20.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

< 200 mg/kg bw

Mortality:

2/5 male animals and 5/5 female animals died

Clinical signs:

other: male animals: poor general state, dyspnoea, apathy, staggering, piloerection, exsiccosis, salivation, weight reduction, discoloured urine (red) female animals: poor general state, dyspnoea, apathy, staggering, piloerection, smeared fur, exsiccosis, weight

Gross pathology:

animals that died: general congestion
lungs: intensified emphysema in one animal, emaciation in two animals; these two animals died after 10 and 20 days.
sacrificed animals:
no pathologic findings noted

Any other information on results incl. tables

Mortality

Dose (mg/kg)	No. of animals	Died within1h	1 day	2 days	7 days	14 days	21 days
200	5 male	0	1	1	1	1	2
200	5 female	2	4	4	4	4	5

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category III

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 of n-octylamine was determined to be below 200 mg/kg.

Executive summary:

In a non-GLP study that was conducted similar to OECD TG 401, n-octylamine was administered at 200 mg/kg bw by oral gavage to male and female rats (5 animals per sex and dose) that were fasted 16 h before administration. Signs of toxicity included poor general state, dyspnoea, apathy, staggering, piloerection, exsiccosis, salivation, weight reduction, discoloured urine (red), smeared fur, and snout red crusted. At 200 mg/kg bw, 2/5 male animals and 5/5 female animals died. Gross lesions of the animals that died included general congestion, intensified emphysema (one animal), and emaciation (two animals) of the lungs. The acute oral LD50 in rats was below 200 mg/kg bw (BASF, 1990).