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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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: 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

Constituent 1
Chemical structure
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.