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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: scientifically acceptable and sufficient documented

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
Remarks:
10 rats were used instead of 3 rats.
Principles of method if other than guideline:
10 rats were used instead of 3 rats.
GLP compliance:
not specified
Test type:
standard acute 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

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)
Doses:
One time dosage of undiluted test substance in amount of 5 mL/kg
= 6500 mg/kg (calculation based on density = 1.3 kg/L)
A ca. 50 % solution of Bayhibit AM was used, therefore an amount of ca. 3250 mg/kg of active ingredient was applied.
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

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 mL/kg bw
Based on:
dissolved
Remarks:
test substance
Remarks on result:
other: A ca. 50% aqueous solution of 2-phosphonobutane-1,2,4-tricarboxylic acid was used (density = 1.3 kg/l)
Sex:
male
Dose descriptor:
LD50
Effect level:
> 3 250 mg/kg bw
Based on:
act. ingr.
Mortality:
No mortality occurred during the study time.
Clinical signs:
other: No clinical signs were observed during the study time.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
LD50 > 5,0 mL/kg bw (equivalent to LD50 > 3250 mg/kg bw active ingredient)
Executive summary:

2-Phosphonobutane-1,2,4-tricarboxylic acid was tested for acute oral toxicity in 10 male rats. A single dosage of 5 mL/kg bw (equivalent to about >3250 mg/kg bw) of active ingredient 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 > 3250 mg/kg bw (active ingredient (5 mL/kg bw of an aqueous 50% solution).