Reaction mass of 3-[(2-aminoethyl)ammonio]propane-1-sulfonate and 3,3'-(ethane-1,2-diyldiammonio)dipropane-1-sulfonate and ethane-1,2-diamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

May 12, 1981

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-[(2-aminoethyl)amino]propane-1-sulfonic acid

Cas Number:

14235-54-2

Molecular formula:

C5H14N2O3S

IUPAC Name:

3-[(2-aminoethyl)amino]propane-1-sulfonic acid

Details on test material:

- Name of test material (as cited in study report): EPS-8602
- Physical state: liquid
- Analytical purity: approximately 47 %
- Lot/batch No.: 8602
- Stability under test conditions: stable for at least 2 hours

Test animals

Species:

rat

Strain:

other: KFM-Han. Wistar (outbred, SPF-Quality)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH 4414 Fuellinsdorf / Switzerland
- Age at study initiation: 9-11 weeks
- Weight at study initiation: Males: 196-208 g; females: 173-198 g
- Fasting period before study: 12-18 hours
- Housing: groups of five in Makrolon type-3 cages with standard softwood bedding. The cages were cleaned twice weekly.
- Diet: ad libitum; pelleted standard Kliba 343, Batch 36/85 and 39/86 rat maintenance diet
- Water: ad libitum; community tap water from Itingen.
- Acclimation period: one week under laboratory conditions, after veterinary examination.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 40-70 %
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light / 12 hours dark.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 4 % solution of CMC in distilled water

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg body weight

Doses:

5000 mg/kg

No. of animals per sex per dose:

5 male and 5 female

Control animals:

other: not relevant

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: body weight: test day 1 (pre-administration), 8 and 15. Mortality/viability: four times during test day 1, and daily during days 2-15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, other: behavior

Statistics:

The LOGIT-Model could not be applied to the observed rates of death. The toxicity was estimated without use of a statistical model.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

0 % at 5000 mg/kg

Clinical signs:

other: sedation, dyspnoea, curved body position, ruffled fur. All rats had recovered within 2 days after test article application.

Gross pathology:

No macroscopic organ changes were observed.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information

Executive summary:

The test article EPS-8602 was administered to rats of both sexes by oral gavage, at a dose of 5000 mg/kg. The death rate that was observed was 0 % at 5000 mg/kg.

The LOGIT-Model could not be applied to these data.

The acute oral toxicity of EPS-8602 in rats of both sexes, observed over a period of 15 days, was estimated to

be greater than 5000 mg/kg.