4-morpholinopropanesulphonic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2005-09-06 to 2005-10-20

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-morpholinopropanesulphonic acid

EC Number:

214-478-5

EC Name:

4-morpholinopropanesulphonic acid

Cas Number:

1132-61-2

Molecular formula:

C7H15NO4S

IUPAC Name:

3-morpholin-4-ylpropane-1-sulfonic acid

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage JANVIER (53490 Le Genest St Isle, France)
- Females nulliparous and non-pregnant: yes
- Age at study initiation: not available
- Weight at study initiation: 184 - 208 g
- Fasting period before study: not available
- Housing: not available
- Diet: ad libitum: rats and mice maintenance diets
- Water: not available
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22
- Humidity (%): 37 - 56
- Air changes (per hr): not available
- Photoperiod (hrs dark / hrs light): not available

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

distilled

Details on oral exposure:

VEHICLE
- Justification for choice of vehicle: good solubility in water

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

3

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 4 times (day 0, 2, 7, 14)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Statistics:

not applicable

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortaliy occured during the study.

Clinical signs:

other: No clinical signs related to the administration of the test item were observed.

Gross pathology:

no findings

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of the test item is higher than 2000 mg/kg bw in rats.

Executive summary:

A study according OECD TG 423 was performed. The test item was administered to a group of 6 females Sprague Dawley rats at the single dose of 2000 mg/kg body weight.

No mortality occurred during the study. No clinical signs related to the administration of the test item were observed. The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals. The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes. In conclusion, the LD50 of the test item is higher than 2000 mg/kg body weight by oral route in the rat.