2-phosphonobutane-1,2,4-tricarboxylic acid

Acute Toxicity: oral

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

Test material information

Constituent 1

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 levels

Effect levels 1

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)

Effect levels 2

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).