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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1968
Report date:
1968

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Principles of method if other than guideline:
After the approximate Minimum Lethal Dose was determined, groups of male and female rats were fed in increasing doses at increments of 0.1 fractional log intervals at four levels designed to blanket the toxicity range thereby supplying data for calculation of the LD50. The length of the observation period was not specified.
GLP compliance:
no
Test type:
other:
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
[ethane-1,2-diylbis[nitrilobis(methylene)]]tetrakisphosphonic acid
EC Number:
215-851-5
EC Name:
[ethane-1,2-diylbis[nitrilobis(methylene)]]tetrakisphosphonic acid
Cas Number:
1429-50-1
Molecular formula:
C6H20N2O12P4
IUPAC Name:
[ethane-1,2-diylbis[nitrilobis(methylene)]]tetrakisphosphonic acid
Test material form:
not specified

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
No data.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: Sample fed as a 25% solution-suspension in corn oil


Doses:
5010, 6310, 7940, 10000 mg/kg
No. of animals per sex per dose:
3+2 M/F per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: not specified

- Frequency of observations and weighing: no data

- Necropsy of survivors performed: not specified
.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 6 900 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 6070-7865 mg/kg
Mortality:
See table 1. Survival time was 4 hours to approximately 24 hours.
Clinical signs:
other: Toxic symptoms included diarrhea, loss of appetite and increasing weakness.
Gross pathology:
At autopsy, there was inflammation of the gastric mucosa in addition to liver hyperemia.
Other findings:
None reported.

Any other information on results incl. tables

Table 1: Number of animals dead and time range within which mortality occurred

Dose
(mg/kg
bw)

Mortality (# dead/total)

Time range of deaths (hours)

Male

Female

Combined

5010

0/2

0/3

0/5

6310

1/3

1/2

3/5

4-24h

7940

2/3

2/2

4/5

4-24h

10000

3/3

2/2

5/5

4-24h

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
An acute oral toxicity LD50 of 6900 mg/kg is reported in a report which was carried out according to a protocol similar to guideline but not in compliance with GLP.