Registration Dossier
Registration Dossier
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EC number: 200-449-4 | CAS number: 60-00-4
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
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)
- Principles of method if other than guideline:
- BASF-TEST: In principle, the methods described in the OECD Guideline 401 were used. 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 14 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
- Limit test:
- no
Test material
- Reference substance name:
- Edetic acid
- EC Number:
- 200-449-4
- EC Name:
- Edetic acid
- Cas Number:
- 60-00-4
- Molecular formula:
- C10 H16 N2 O8
- IUPAC Name:
- 2,2',2'',2'''-(ethane-1,2-diyldinitrilo)tetraacetic acid
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- OTHER SPECIFICS:
- Name of test material (as cited in study report): Trilon BS
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: males: 264 g; females: 274 g
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- DOSAGE PREPARATION
- Stock solution prepared: 30 %
- Dose volume applied: 10.66 mL/kg bw for the 3200 mg/kg bw dose group; 13.33 mL/kg bw for the 4000 mg/kg bw dose group; 16.66 mL/kg bw for the 5000 mg/kg bw dose group; 21.4 mL/kg bw for the 6400 mg/kg bw dose group; 26.6 mL/kg bw for the 8000 mg/kg bw dose group; 33.3 mL/kg bw for the 10000 mg/kg bw dose group. - Doses:
- 3200; 4000; 5000; 6400; 8000; 10000 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;
- 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
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 4 500 mg/kg bw
- Mortality:
- 1/10 died in the 3200 mg/kg bw dose group, 3/10 died in the 4000 mg/kg bw dose group, 6/10 died in the 5000 mg/kg bw dose group, 8/10 died in the 6400 mg/kg bw dose group, 9/10 died in the 8000 mg/kg bw dose group, 10/ 10 died in the 10000 mg/kg bw dose group (See table 1).
- Clinical signs:
- other: 3200 mg/kg bw and 4000 mg/kg bw dose group: directly after application accelerated respiration, squatting posture, red eyes; 1 day later: squatting posture, aggressiveness, contaminated fur, slight diarrhea; 5 days later: aggressiveness, contaminated fur;
- Gross pathology:
- Animals which died:
10000 mg/kg bw dose group: heart: acute dilatation, venous hyperemia; kidneys: muddy gray
Remaining dose groups: heart: acute dilatation particularly right, venous hyperemia; stomach: dilatated, dry hard content, bloody ulceration in the corpus; gut: diarrhea,
Animals sacrificed:
-nothing abnormal detected
Any other information on results incl. tables
Table 1: Mortalities of rats after oral application of EDTA
| 3200 mg/kg bw | 4000 mg/kg bw | 5000 mg/kg bw | 6400 mg/kg bw | 8000 mg/kg bw | 10000 mg/kg bw | ||
| 1 h | male | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 |
| female | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 | |
| 24 h | male | 0/5 | 0/5 | 0/5 | 0/5 | 1/5 | 5/5 |
| female | 0/5 | 0/5 | 0/5 | 0/5 | 1/5 | 5/5 | |
| 48 h | male | 0/5 | 0/5 | 0/5 | 1/5 | 1/5 | 5/5 |
| female | 0/5 | 0/5 | 0/5 | 1/5 | 1/5 | 5/5 | |
| 7 d | male | 1/5 | 3/5 | 5/5 | 5/5 | 5/5 | 5/5 |
| female | 0/5 | 0/5 | 0/5 | 3/5 | 4/5 | 5/5 | |
| 14 d | male | 1/5 | 3/5 | 5/5 | 5/5 | 5/5 | 5/5 |
| female | 0/5 | 0/5 | 1/5 | 3/5 | 4/5 | 5/5 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Classification criteria of Regulation (EC) No 1272/2008 not met
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