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Toxicological information

Acute Toxicity: oral

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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:
other: Study meets generally accepted scientific principles (non-GLP)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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
Name:
Unnamed
Type:
Constituent
Details on test material:
- 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 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:
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; fully reversible within 14 days.
5000 mg/kg bw and 6400 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: squatting posture, aggressiveness, contaminated fur, diarrhea, crusted muzzle and eyes; fully reversible within 13 days
8000 mg/kg bw dose group: directly after application accelerated respiration, squatting posture, red eyes, slight diarrhea, spastic gait, reduced movement; 1 day later: squatting posture, red eyes, diarrhea, contaminated fur, aggressiveness; 5 days later: aggressiveness, squatting posture, diarrhea, contaminated fur, crusted muzzle and eyes; fully reversible within 14 days in the surviving animal
10000 mg/kg bw dose group: directly after application accelerated respiration, squatting posture, red eyes, slight diarrhea, spastic gait, mortality within 90 min.
Body weight:
Body weights were not recorded during and at the end of the observation period.
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