Tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate

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:

other: short report

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

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:

Ten male rats each received a single dose of 10 - 30 ml of the test substance per gavage. The animals were observed for mortality and clinical signs through day 14. A gross pathological examination was performed on animals which died during the observation period or were killed after termination of the study.

GLP compliance:

no

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate

EC Number:

266-442-3

EC Name:

Tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate

Cas Number:

66669-53-2

Molecular formula:

C7H7Na4O9P

IUPAC Name:

tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate

Details on test material:

41.8 % solution in water

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

10, 16, 18, 20, 22, 25, or 30 ml/kg bw of a 41.8 % solution in water
= ca. 4129, 6607, 7433, 8259, 9085, 10232, 12388 mg/kg bw

No. of animals per sex per dose:

10 animals/dose

Control animals:

no

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 8 300 mg/kg bw

Based on:

act. ingr.

Mortality:

Beginning with an application volume of 16 ml/kg (= ca.4129 mg/kg bw) the animals showed after treatment a ruffle fur, decreased motility, prone position, accelerated and irregular breathing, cyanosis and after 24 hours diarrhoea. The animals died within 1 hour until 24 hours, but also up to 6 days after treatment.

Clinical signs:

other: Beginning with an application volume of 16 ml/kg (= ca.4129 mg/kg bw) the animals showed after treatment a ruffle fur, decreased motility, prone position, accelerated and irregular breathing, cyanosis and after 24 hours diarrhoea. The animals died within

Gross pathology:

The section of the animals which died revealed a diffuse reddening of the mucosa of the stomach and intestine.

Any other information on results incl. tables

Sublethal range: No findings.

Lethal range: Beginning with an application volume of 16 ml/kg the animals showed after treatment a ruffle fur, decreased motility, prone position, accelerated and irregular breathing, cyanosis and after 24 hours diarrhoea. The animals died within 1 hour until 24 hours, but also up to 6 days after treatment. No cinical findings were evident 7 days after treatment in the surviving animals.

The section of the animals which died revealed a diffuse reddening of the mucosa of the stomach and intestine. The section of the surviving animals killed 14 days after treatment were without findings.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Executive summary:

Ten male rats each received a single dose of 10 - 30 ml of the test substance per gavage. The animals were observed for mortality and clinical signs through day 14. A gross pathological examination was performed on animals which died during the observation period or were killed after termination of the study. Signs of intoxication were ruffle fur, decreased motility, prone position, accelerated and irregular breathing, cyanosis and after 24 hours diarrhoea. The section of the animals which died revealed a diffuse reddening of the mucosa of the stomach and intestine. For male and female rats a LD50 = 20.1 ml/kg bw (ca. 8300 mg/kg bw) was found.