reaction mass of disodium;3-[2-(2-carboxylatoethylamino)-ethylamino]propanoate and sodium 3-[(2-aminoethyl)amino]propanoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: according to BASF-internal standard

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

reaction mass of disodium;3-[2-(2-carboxylatoethylamino)-ethylamino]propanoate and sodium 3-[(2-aminoethyl)amino]propanoate

Molecular formula:

C5H11N2O2Na and C8H14N2O4Na2

IUPAC Name:

reaction mass of disodium;3-[2-(2-carboxylatoethylamino)-ethylamino]propanoate and sodium 3-[(2-aminoethyl)amino]propanoate

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 78/574

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: males: 210 g - 270 g, females: 150 g - 210 g
- Diet: The animals were offered a standardized animal laboratory diet (Harilan, MRH, H. Egersmann KG, Germany)
- Fasting period: 15 - 20 h before administration.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 21.5, 31.6, 38.3, 50, 68.1% (G/V)

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:

2150, 3160, 3830, 5000, 6810 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations. at 1 h and days 1, 2, 7, 14 after application, weighing: prior to administration, days 2 - 4, day 7, days 12 - 13
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs (dyspnoe, apathy, abnormal position, staggering, spastic gait, ruffled fur, diarrhea, cyanosis, paresis, poor general condition)

Statistics:

no

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

4 520 mg/kg bw

Based on:

test mat.

Mortality:

Male animals:
2150 and 3160 mg/kg: no deaths after 14 days;
3830 mg/kg: 2/5 after 14 days;
5000 mg/kg: 4/5 after 14 days;
6810 mg/kg: 5/5 after 14 days
Female animals:
2150 mg/kg: no deaths after 14 days;
3160 mg/kg: 1/5 after 14 days;
3830 mg/kg: 0/5 after 14 days;
5000 mg/kg: 2/5 after 14 days;
6810 mg/kg: 5/5 after 14 days

Clinical signs:

Dyspnea, apathy, abnormal position, staggering, spastic gait, ruffled fur, diarrhea, cyanosis, paresis, poor general state

Body weight:

Mean body weight male animals: 260 g - 270 g at study start, 309 g after 13 days
Mean body weight female animals: 150 g - 210 g at study start, 223 g after 13 days

Gross pathology:

Animals that died: heart: acute dilatation (right); acute congestive hyperemia; stomach: atonic, dilated, liquid content, mucosa diffuse reddened; intestine: atonic, diarrheic content, reddened mucosa; urine: orange-coloured up to red staining.
Sacrificed animals: nothing abnormal detected.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met