4-(2-hydroxyethyl)-1-piperazinepropanesulphonic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Jul 17 - Aug 28, 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

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:

March 22, 1996

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

September 30, 1996

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-(2-hydroxyethyl)piperazin-1-ylethanesulphonic acid

EC Number:

230-907-9

EC Name:

4-(2-hydroxyethyl)piperazin-1-ylethanesulphonic acid

Cas Number:

7365-45-9

Molecular formula:

C8H18N2O4S

IUPAC Name:

2-[4-(2-hydroxyethyl)piperazin-1-yl]ethanesulfonic acid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: F. Winkelmann, 33178 Borchen
- Age at study initiation: 6 - 8 weeks
- Weight at study initiation: 172 (range from 159 to 184) g
- Fasting period before study: 17 hours before dosing
- Housing: separately in Makrolon cages type III with a shelter, placed on mobile racks.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 54 to 71
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: day 1 To: day 14

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 g/L
- Amount of vehicle: 10 mL/kg
- Justification for choice of vehicle: low toxicity, good solubility
- Purity: Aqua pro injectione

CLASS METHOD
- Rationale for the selection of the starting dose: limit dose

Doses:

2000 mg/kg bw

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: days 2, 4, 6, 8, 11, 13, and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Statistics:

Standard statistical methods have been applied for data processing.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

All rats survived the observation period.

Clinical signs:

other: No signs of toxicity were detected in the 3 male and 3 female rats after treatment.

Gross pathology:

No alterations were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to the results of this study the test material is not acute toxic, i.e. the LD50 value is expected to exceed 2000 mg/kg bw.

Executive summary:

The GLP study was performed according to OECD TG 423. The test material was tested for acute toxicity in Wistar rats (3/sex/dose) after oral administration of. A limit dose of 2000 mg/kg body weight was applied. Directly before the administration the test material was prepared with aqua pro injectione as vehicle. The animals were observed for 14 days.

All rats survived the observation period. No signs of toxicity were detected in the 3 male and 3 female rats after treatment with 2000 mg/kg bw. The body weight development was normal. Gross pathology showed no alterations.

According to the results of this study the test material is not acute toxic, i.e. the LD50 value is expected to exceed 2000 mg/kg bw.