Trimethyl-3-[(1-oxo-10-undecenyl)amino]propylammonium methyl sulphate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January 1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1981

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Trimethyl-3-[(1-oxo-10-undecenyl)amino]propylammonium methyl sulphate

EC Number:

304-990-8

EC Name:

Trimethyl-3-[(1-oxo-10-undecenyl)amino]propylammonium methyl sulphate

Cas Number:

94313-91-4

Molecular formula:

C17H35N2O.CH3O4S

IUPAC Name:

bis(2-ethylhexyl) adipate

Test material form:

other: Liquid

Details on test material:

The test material was a 47% aqueous solution of the substance

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: no data
- Weight at study initiation: m: 125 - 135g; f: 110 - 125g
- Fasting period before study: over night
- Housing: single caging, cage type: Macrolon type IlI./max. 5
- Diet: ad libitum; rat diet (R 4 Alleindiät für Ratten), Ssniff Spezialdiäten GmbH, 4770 Soest/Westfalen
- Water: ad libitum
- Acclimation period: 11 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23
- Humidity (%): 40 - 70
- Air changes (per hr): 10 per hour
- Photoperiod (hrs dark / hrs light): 12 hours daily

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 500 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg bw

The test substance was weighed out in a glass, then was filled with Aqua destillata up to the desired volume, was shaken well and afterwards labeled. The formulated test substance was a clear solution.

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

The group of 5 female and 5 male rats were were given a single oral dose 5000 mg/kg of the test substance by gavage.

- Duration of observation period following administration: 14 d
- Body weights were recorded before treatment (day -1), at the treatment day (day 0), and on days 7 and 14 after treatment
- Clinical observation: Animals were observed 1/4 h, 1/2 h, 1 h, 2 h, 4 h after dosing and thereafter once daily up to day 14.
- Necropsy of the survivors performed: yes

Statistics:

As none of the test animals died a calculation of the LD50 was not possible.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: based on product; mortality 0/10

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 350 mg/kg bw

Based on:

act. ingr.

Remarks on result:

other: based on a.i.; mortality 0/10

Mortality:

There were no mortalities

Clinical signs:

other: Except of ruffled fur on the day of treatment, the animals were free of clinical-/toxicological symptoms during the entire observation period of 14 days.

Gross pathology:

Necropsies were performed on all animals at the end of the 14-day observation period. In one animal a slight thickening of the stomach mucosa could be observed. Necropsies of all other animals showed no test compound-related macroscopic findings in the cranial-, thoracic- and abdominal cavity.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral toxicity of the test material was >5000 mg/kg bw (47% a.i.), equivalent to LD50 > 2350 mg/kg bw (100% a.i.)

Executive summary:

In an acute oral toxicity study similar to OECD Guideline 401 (1981) 5 male and 5 female Sprague-Dawley rats were given a single dose of the substance (a.i. 47 %) at a dose of 5000 mg/kg bw (limit test). The test item was formulated in water and applied in a volume of 10 mL/kg bw. Animals were subsequently observed for 14 consecutive days.There were no deaths following a single oral dose of the substance. Except of ruffled fur on the day of treatment, the animals were free of clinical/ toxicological signs during the entire observation period of 14 days. Necropsies were performed on all animals at the end of the 14-day observation period. In one animal a slight thickening of the stomach mucosa could be observed. Necropsies of all other animals showed no test compound-related macroscopic findings in the cranial-, thoracic- and abdominal cavity.

Oral LD₅₀Combined: > 2350 mg/kg bw (active ingredient)

LD₅₀ > 5000 mg/kg bw determined in the study report refers to the test substance as delivered by the sponsor. Amount of active ingredient in test substance is 47 % according to the sponsor information. Therefore the calculated oral LD₅₀ combined referring to 100 % active substance is 2350 mg/kg bw. The substance is practically nontoxic based on LD₅₀ in males and females.