Octamethylenediamine

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: comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: BASF-Test

Principles of method if other than guideline:

In priciple the BASF Test used the method described in OECD Guideline 423.
3 rats per sex and dose were treated simultaneously by gavage (single administration) with preparations of the test substance in water. Two doses were tested. Group-wise documentation of clinical signs was performed over the 14 days study period. The clinical signs and findings were reported in summary form. On the basis of the observed lethality, the LD50 value was estimated as dose range (LD50 < that dose which killed more than 50% of the animals, LD50 > that dose which killed less than 50% of the animals).

GLP compliance:

no

Remarks:

internal standards comparable to GLP

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Octamethylenediamine

EC Number:

206-764-3

EC Name:

Octamethylenediamine

Cas Number:

373-44-4

Molecular formula:

C8H20N2

IUPAC Name:

octane-1,8-diamine

Details on test material:

- Name of test material (as cited in study report): 1,8-Oktandiamin

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomas GmbH, D-Biberach
- Weight at study initiation: males, 2000 mg/kg: 232 g / males, 200 mg/kg: 221 g / females, 2000 mg/kg: 197 g / females, 200 mg/kg: 198 g
- Fasting period before study: about 16 h before administration
- Housing: Stainless steel wire mesh cages, Type DK-III, 3 animals per cage
- Diet (ad libitum): Kliba-Labordiät 343, Klingentalmühle AG, Kaiseraugst, Switzerland
- Water (ad libitum): tap water
- Acclimation period: at least 1 week

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

aqua dest.

Details on oral exposure:

FORM OF ADMINISTRATION: Solution

AMOUNTS ADMINISTERED
- 2000 mg/kg: Concentration: 20 % w/v, administred volume: 10 mL/kg
- 200 mg/kg: Concentration: 2 % w/v, administred volume: 10 mL/kg

Doses:

200 and 2000 mg/kg

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: several times on the day of administration, at least once per workday.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross-pathological observation

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 200 - < 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: All animals (male and female) dosed with 2000mg/Kg died after 1 day. All animals dosed with 200mg/kg survived until the end of the study.

Mortality:

After a single application of 2000 mg/kg test substance all animals (males and females) died within the first day. No mortality was observed after the administration of 200mg/Kg.

Clinical signs:

other: Symptoms only occured at a dosage of 2000 mg/kg of the test substance for male and female animals partially 30 min after application. Symptoms included: dyspnea, apathy, abnormal body positions, staggering, paresis, piloerection, exsiccosis and a poor gen

Gross pathology:

Animals died during the study (2000 mg/kg dose group) showed a general congestion. Additionally, a moderate emphysema of the lungs, an intense red fore-/glandular stomach was observed with a thickened wall as well as the small intestine possessed a reddened mucosa and bloody contents.
For sacrified animals (200 mg/kg dose group) no pathological findings were noted.

Applicant's summary and conclusion

Interpretation of results:

other: The result range (> 200 < 2000 mg/kg) may belong to Toxicity Category 3 as well as to Toxicity Category 4

Executive summary:

The acute oral toxicity of Octamethylenediamine was investigated in male and female rats (Kirsch and Hildebrand, 1989). Doses of 200 mg/kg bw and 2000 mg/kw bw were applied to 3 animals per sex per dose. The substance were administered by oral gavage. The symptoms of intoxication were only observed at the dose level of 2000 mg/kg bw and included dyspnea, apathy, abnormal body positions, staggering, paresis, piloerection, exsiccosis and a general bad condition of the animals, starting partially already 30 min after application. All animals (male and female) died in the dose group of 2000 mg/kg bw within the first day after application. No animal died in the lower dose group. Animals died during the study (2000 mg/kg dose group) were examined as soon as possible and showed a general congestion. Additionally, a moderate emphysema (of the lungs), an intense red fore-/glandular stomach was observed with a thickened wall as well as the small intestine possessed a reddened mucosa and bloody contents.

For sacrified animals (14 days after application) no pathological findings were noted. Due to these results, the oral toxicity is characterised by a LD50 range more than 200 mg/kg bw but less than 2000 mg/kg bw for both male and female rats together.