[No public or meaningful name is available]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 20 Dec 2016 to 11 Jan 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

up-and-down procedure

Limit test:

yes

Test material

Test material information

1

Reference substance name:

trans-(4-(methylamino)cyclohexyl)methanesulfonic acid

Cas Number:

2124221-12-9

Molecular formula:

C8H17NO3S

IUPAC Name:

trans-(4-(methylamino)cyclohexyl)methanesulfonic acid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Rationale for alternative/additional species to rat (if applicable)
- Source: Covance Research Products, Inc., Denver, PA
- Females (if applicable) nulliparous and non-pregnant: yes
- Rationale for use of males (if applicable)
- Age at study initiation: The animals were born on 04 Oct 2016.
- Weight at study initiation: The pretest body weight range was 234 - 259 grams.
- Fasting period before study:
- Housing: The animals were identified by cage notation and indelible body marks, and individually housed in suspended wire-bottom cages.
- Historical data:
- Diet (e.g. ad libitum): Fresh PMI Rat Chow (Diet No. 5012) was freely available except for 16 to
20 hours prior to dosing.
- Water (e.g. ad libitum): Water was available ad libitum.
- Acclimation period: at least five days
- Microbiological status when known
- Method of randomisation in assigning animals to test and control groups

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2 mL

DOSAGE PREPARATION (if unusual): 1.25 g were mixed with distilled water to a total volume of 5 ml.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Initially, a single female Sprague Dawley rat was dosed orally by syringe and dosing needle at a dose level of 2000 mg/kg. Since the animal survived, four additional females were dosed at 2000 mg/kg.

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed at 15 minutes, 1, 2 and 4 hours post-dosing and once daily thereafter for 14 days for toxicity and pharmacological effects. Observations included, but were not limited to, evaluation of skin and fur, eyes and mucous membranes, respiratory and circulatory effects, autonomic effects such as salivation, central nervous system effects including tremors and convulsions, changes in the level of activity, gait and posture, reactivity to handling or sensory stimuli, altered strength, and stereotypies or bizarre behavior (e.g., self-mutilation, walking backwards). All animals were observed twice daily for mortality on Day 1 to Day 14.
- Necropsy of survivors performed: yes, All animals were humanely euthanized using CO2 following study termination and examined for gross pathology.
- Clinical signs including body weight: Body weights were recorded pre-test, weekly, and at termination.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All five female rats survived following a single 2000 mg/kg oral dose.

Clinical signs:

other: No abnormal physical signs were observed among three out of five animals. Diarrhea was observed in two out of five animals on Day 1.

Gross pathology:

The gross necropsy revealed no observable abnormalities.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 of test item is greater than 2000 mg/kg of body weight in female rats.

Executive summary:

The study is performed according to OECD Guideline 425. Initially, a single female Sprague Dawley rat was dosed orally with test item at dose level of 2000 mg/kg. Since the animal survived, four additional females were dosed at 2000 mg/kg. The oral LD50 of test item is greater than 2000 mg/kg of body weight in female rats.