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EC number: 244-063-4 | CAS number: 20824-56-0
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:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- Body weight was only determined at the beginning of the study (OECD: weekly); Observation period: 7 days (OECD:14 days)
- Principles of method if other than guideline:
- BASF-TEST: In principle, the methods described in the OECD Guideline 401 were used. Young adult laboratory rats were purchased from breeder. Usually the source and strain of animals were not documented. Several groups of 5 rats per sex and dose were treated simultaneously by gavage with preparations of the test substance in suitable vehicle. The concentrations of these preparations were used to achieve comparable volumes per kg body weight. Group-wise documentation of clinical signs was performed over the 7 day study period. Body weight was determined before the start of the study only, as it was needed for determination of dose.
- GLP compliance:
- no
- Test type:
- standard acute method
Test material
- Reference substance name:
- Disodium dihydrogen ethylenediaminetetraacetate
- EC Number:
- 205-358-3
- EC Name:
- Disodium dihydrogen ethylenediaminetetraacetate
- Cas Number:
- 139-33-3
- Molecular formula:
- C10H14N2Na2O8
- IUPAC Name:
- disodium dihydrogen 2,2',2'',2'''-(ethane-1,2-diyldinitrilo)tetraacetate
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Mean body weight at study initiation:
259 g males/ 211 g females
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- DOSAGE PREPARATION:
- Stock solutions prepared: 30%
- Dose volume applied:
2500 mg/kg bw dose group: 8.33 mL/kg bw
3200 mg/kg bw dose group: 10.66 mL/kg bw
4000 mg/kg bw dose group: 13.33 mL/kg bw
5000 mg/kg bw dose group: 16.66 mL/kg bw
6400 mg/kg bw dose group: 21.4 mLkg bw - Doses:
- 2500; 3200; 4000; 5000; 6400 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days;
- The animals were observed for mortality and clinical signs of toxicity;
- Frequency of observations: Several times on the application day, thereafter once each working day;
- Body weights were only recorded at the beginning of the study;
- Necropsy of survivors and animals which died performed: yes
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 800 mg/kg bw
- Mortality:
- - One female died in the 2500 mg/kg bw dose group; 9/10 animals died in the 3200 mg/kg bw dose group and all animals of the higher dose groups (see table 1).
- Clinical signs:
- other: - 2500, 3200 and 4000 mg/kg bw: directly after application: accelerated respiration, squatting posture, twitching, ataxia, red eyes, some animals showed light secretion, reluctance to move; the next day: squatting posture, contaminated fur, intermittened
- Gross pathology:
- Animals which died:
- heart: acute dilatation, venous hyperemia
- liver: congestion
- gut: diarrhea like content
- stomach: dilatation
- kidneys: degeneration
Animals which were sacrificed:
- nothing abnormal detected
Any other information on results incl. tables
Table 1: Mortalities of rats after oral application
| 2500 mg/kg bw | 3200 mg/kg bw | 4000 mg/kg bw | 5000 mg/kg bw | 6400 mg/kg bw | ||
| 1 h | male | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 |
| female | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 | |
| 24 h | male | 0/5 | 3/5 | 5/5 | 5/5 | 5/5 |
| female | 1/5 | 5/5 | 5/5 | 5/5 | 5/5 | |
| 48 h | male | 0/5 | 3/5 | 5/5 | 5/5 | 5/5 |
| female | 1/5 | 5/5 | 5/5 | 5/5 | 5/5 | |
| 7 d | male | 0/5 | 4/5 | 5/5 | 5/5 | 5/5 |
| female | 1/5 | 5/5 | 5/5 | 5/5 | 5/5 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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