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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 guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: according to BASF-internal standard
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

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

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