Octadecylamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was performed according to OECD Guideline 401 in compliance with GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Octadecylamine

EC Number:

204-695-3

EC Name:

Octadecylamine

Cas Number:

124-30-1

Molecular formula:

C18H39N

IUPAC Name:

octadecan-1-amine

Test material form:

other: wax

Details on test material:

Chemical name: Octadecylamine
EC no.: 204-690-6

To the best of knowledge, the sample used is representative to the boundary composition shared and agreed by each registrant.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HOECHST AG, Kastengrund, SPF-Zucht
- Age at study initiation:
- male: ca. 7 weeks
- female: ca. 8 weeks
- Weight at study initiation:
- male:
- mean: 195 g
- min: 178 g
- max: 208 g
- sd: +- 11g
- n = 5
- female:
- mean: 189 g
- min: 186 g
- max: 192 g
- sd: +- 3g
- n = 5
- Housing: fully airconditioned rooms, makrolon cages on soft wood chips in groups of 5 animals
- Diet (e.g. ad libitum): Altromin 1324 ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: min. 5 days
- no feeding 16 hrs prior and 3-4 hours past application of the test-substance

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +-3 °C
- Humidity (%): 50 +- 20 %
- Photoperiod (hrs dark / hrs light): 12 / 12 hrs

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

- Concentration in vehicle: 20% (w/v)

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations once daily / Weighing once weekly
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

2000 mg/kg: 1 / 5

Clinical signs:

other: disequilibrium, dyspnoe, convulsions

Gross pathology:

Dissection of rats killed at the end of the observation period revealed no macroscopic findings

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

The median lethal dose of Octadecylamine (LD50) was greater 2000 mg per kg body weight in both male and female rats. Based on the result of this study Octadecylamine is not subject for labelling and classification requirements according to regulatory requirements

Executive summary:

The study of the acute oral toxicity of Genamin 18 R 100 D (octadecylamine) to 5 male and 5 female Wistar rats resulted in a median lethal dose (LD50) of greater 2000 mg/kg body weight. After the application of 2000 mg/kg body weight one male animal deceased on day four after application. Animals showed beside unspecific signs of poisoning impairment of breathing and in motion. For one male animal a swollen stomach was observed additionally. An impairment (interference) of the body-weight development was not observed. Macroscopic findings of toxicological significance were not observed during gross pathology at the end of the observation period.