Cyclohexanaminium, N,N,N-trimethyl-, sulfate (2:1)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Trimethylcyclohexylammonium sulfate , aqueous solution 50 wt.%

IUPAC Name:

Trimethylcyclohexylammonium sulfate , aqueous solution 50 wt.%

Constituent 2

Reference substance name:

bis(N,N,N-trimethylcyclohexanaminium) sulfate

EC Number:

807-085-0

Cas Number:

1004297-30-6

Molecular formula:

2 C9 H20 N .O 4S

IUPAC Name:

bis(N,N,N-trimethylcyclohexanaminium) sulfate

Details on test material:

- Name of test material (as cited in study report): Trimethylcyclohexylammonium sulfate , aqueous solution 50 wt.%
- Physical state: Liquid / colorless, clear
- Analytical purity: 51.8 g/100 g,
- Lot/batch No.: DENECKE00120

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Age at study initiation: Young adult animals (female animals approx. 10 weeks)
- Weight at study initiation: Animals of comparable weight (± 20% of the mean weight)
- Housing: Single housing, Makrolon cage, type III
- Diet (e.g. ad libitum): VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: at least 5 days before the beginning of the experimental phase

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%): 30 – 70%
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
For the high dose, the liquid test item was administered undiluted. For the lower dose, an administration volume of 2 mL/kg bw of suitable test item preparations was used to facilitate application. 600 and 300 mg/kg bw: The test item was prepared in deionized water and homogenized for each dose group shortly before and during administration by stirring with a magnetic stirrer.

Doses:

300, 600 and 2000 mg/kg bw (150, 300 and 1000 mg/kg bw acutal dose; to ensure the actual dose, the content of active ingredient (approx. 50%) was taken into account.)

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: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology: yes

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 600 - < 2 000 mg/kg bw

Remarks on result:

other: acutal dose of greater than 300 mg/kg bw and less than 1000 mg/kg bw.

Mortality:

All animals of the 2000 mg/kg bw test group were found dead within 2 or 3 hours after administration. No mortality occurred in both 600 and 300 mg/kg bw test groups.

Clinical signs:

other: In all animals of the 2000 mg/kg bw test group impaired general state was observed at hour 0 and persisted in two of these animals until hour 1 after administration. Thereafter, poor general state was noted in two out of three animals at hour 1 or 2. In t

Gross pathology:

The following macroscopic pathologic findings were observed in the three animals that were found dead in the 2000 mg/kg bw test group: Red discoloration of the glandular stomach and small intestine, swollen glandular stomach and swollen small intestine
There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period (600 mg/kg bw: 6 females, 300 mg/kg bw: 6 females).

Any other information on results incl. tables

Under the conditions of this study the median lethal dose of Trimethylcyclohexylammonium sulfate , aqueous solution 50 wt.% after oral administration was found to be greater than 600 mg/kg bw and less than 2000 mg/kg bw in rats (actual dose of greater than 300 mg/kg bw and less than 1000 mg/kg bw).