Amines, tri-C8-10-alkyl

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to OECD guideline study, with acceptable restrictions (no data on test substance purity, limited documentation)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

(adopted 1987)

Deviations:

yes

Remarks:

(limited documentation)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Trioctylamine

EC Number:

214-242-1

EC Name:

Trioctylamine

Cas Number:

1116-76-3

Molecular formula:

C24H51N

IUPAC Name:

N,N-dioctyloctan-1-amine

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Tri-N-Octylamine
- Analytical purity: no data
- Impurities (identity and concentrations): no 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, D-7950 Biberach, Germany
- Age at study initiation: no data
- Weight at study initiation: anmals of comparable weight ( ± 20% of the mean weight)
mean weight: males 191 g; females 181 g
- Fasting period before study: 16 hrs before administration of the test substance
- Housing: 5 animals per cage, in stainless steel wire mesh cages, Type DK-III
- Diet (ad libitum): Kliba-Labordiaet 343, Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland
- Water (ad libitum): tap water
- Acclimation period: at least one 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:

olive oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 40 g/100 mL
- Amount of vehicle (if gavage): 5 mL/kg bw
- Justification for choice of vehicle: The test substance is insoluble in water.

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 animals/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

- Frequency of observations and weighing:
Recording of signs and symptoms were performed several times on the day of administration, then at least once each workday. A check for moribund and dead animals was performed twice each workday and once on holidays.
Body weights of individual animals were recorded before test start. After 7 and 13 days, group-wise documentation of body weights was performed.

- Necropsy of survivors performed: yes
Food was withdrawn about 16 hrs before sacrifice with CO2. Then, necropsy with gross-pathological examination was performed. Necropsy of all animals that died during the study, was conducted as early as possible.

- Other examinations performed: clinical signs, body weight: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

On day 7 one male rat out of five and one female rat out of five rats treated with 2000 mg/kg bw of the test substance died. The remaining animals survived until the end of the observation period (14 days after administration). 20 % mortality was observed during the present study.

Clinical signs:

other: Male animals: - no abnormalities Female animals: - from day 5 until day 6: dyspnoea, apathy and poor general state - from day 5 until day 7: spastic gait and piloerection - on day 7: impaired general state

Gross pathology:

Deceased animals: general congestion.

Sacrificed animals: no pathologic findings noted.

Any other information on results incl. tables

Mean body weights:

	Mean body weights [g]
After x days [d]	males	females
0	191	181
7	249	179
13	283	199