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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
Study period:
NA
Reliability:
1 (reliable without restriction)
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
yes
Principles of method if other than guideline:
10 rats were used instead of 3 rats.
GLP compliance:
not specified
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-phosphonobutane-1,2,4-tricarboxylic acid
EC Number:
253-733-5
EC Name:
2-phosphonobutane-1,2,4-tricarboxylic acid
Cas Number:
37971-36-1
Molecular formula:
C7H11O9P
IUPAC Name:
2-phosphonobutane-1,2,4-tricarboxylic acid
Details on test material:
Lot Nr. 2851
Name of the test item: Bayhibit AM

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 160-180 g.






Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
NA
Doses:
One time dosage of undiluted test substance in amount of 5 mL/kg
= 6.500 mg/kg (calculation based on density = 1.3 kg/L)
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs, body weight.
Statistics:
NA

Results and discussion

Preliminary study:
NA
Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 mL/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
> 6 500 mg/kg bw
Mortality:
No mortality occurred during the study time.
Clinical signs:
No clinical signs were observed during the study time.
Body weight:
Mean body weight was changed from 176 g to 219 g.
Gross pathology:
NA
Other findings:
NA

Any other information on results incl. tables

NA

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
LD50 > 5,0 mL/kg bw (equivalent to LD50 > 6.500 mg/kg bw)
Executive summary:

Bayhibit AM was tested for acute oral toxicity in 10 male rats. A single dosage of 5 mL/kg bw (equivalent to about > 6500 mg/kg bw) of test substance was administrated by gavage to 10 rats. During 14 days of observation, no mortality and no toxication symptoms were observed. The LD50 was therefore estimated to be > 6500 mg/kg bw (5 mL/kg bw). Due to the high dosage given in the study which resulted with no clinical effects and for animal welfare reasons, there seem to be no need in repeating the test of 1979.