Reaction mass of 7-azatridecane-1,13-diamine and hexamethylenediamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given: comparable to guidelines/standards

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

bis(6-aminohexyl)amine; hexane-1,6-diamine

EC Number:

907-605-7

Cas Number:

68815-47-4

Molecular formula:

C6H16N2 (HMD) C12H29N3 (BHT)

IUPAC Name:

bis(6-aminohexyl)amine; hexane-1,6-diamine

Details on test material:

- Name of test material (as cited in study report): HEXAMETHYLENDIAMIN-RUECKSTAND, SAMBAY-RUECKSTAND

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. Thomae, Bibrach, D
- Mean weight at study initiation: males 185 g, females 174 g (+- 20%)
- Fasting period before study: 16 h
- Housing: 5 per cage in stainless steel wire mesh cages, Typ DK-III
- Diet (e.g. ad libitum): Kliba-Labordiet, Klingenthalmuehle AG, Kaiseraugst, CH; ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 1 week

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 3.83 - 8.25 % (w/v)

MAXIMUM DOSE VOLUME APPLIED: 10 mL

Doses:

383, 562 and 825 mg/kg bw

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: observations: 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 on day 0, 2, 7 and 13
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 562 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Within the 14 days observation period no animals died at a dose level of 383 mg/kg bw. At 562 mg/kg bw 2/5 males and 2/5 females died. Application of 825 mg/kg bw resulted in death of all animals. All deaths occurred within 1-2 days after administration

Mortality:

383 mg/kg bw: 0 males and 0 females died
562 mg/kg bw: 2 males and 2 females died
825 mg/kg bw: all animals died
All animals that died were dead within 1-2 days after administration

Clinical signs:

other: 383 mg/kg bw: no clinical signs observed 562 mg/kg bw: dyspnea, apathy, abnormal position (only males), staggering, atonia, paresis, spastic gait (only females), piloerection, exsiccosis and poor general state; reversible in surviving animals within at le

Gross pathology:

Animals-that died (male and female):
General congestive hyperemia
Stomach: severe redness of the glandular stomach
Small intestines, cecum: severe redness, filled with hematinised contents.

Sacrificed animals (male and female):
no abnormalities detected.

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Acute toxicity category 4 Criteria used for interpretation of results: EU

Conclusions:

After single application of either 383, 562 or 825 mg test substance per kg into male and female lethality could be observed during the 14 day observation period, resulting in a LD50 of approx. 562 mg/kg bw.

Executive summary:

Acute oral toxicity was investigated using male and female Wistar rats in a test similar to acute standard method (i.e. OECD TG 401). The test substance was administered by gavage at doses of 383, 562 and 825 mg/kg bw to 3 groups of 10 animals (5animals/sex). Clinical signs, e.g. dyspnea, apathy, atonia etc., were observed starting from the mid-dose group. Within the 14 days observation period 2 males and 2 females died from the mid-dose group, whereas all animals died from the high-dose group. Having this results a median lethal dose (LD50) of approximately 562 mg/kg bw was identified.