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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:
supporting study
Study period:
During November 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
Conducted prior to adoption of OECD 401.
Deviations:
yes
Remarks:
Short acclimatisation period, wide variation in starting body weights, only 5 animals/sex.
Principles of method if other than guideline:
Method: other: Hazleton protocol (number P631/22/4/-/553/d/rev.1). The first four doses were in effect a dose-range finding study (only deaths recorded for 48 hours) and the highest dose a limit test.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
[[(phosphonomethyl)imino]bis[(ethylenenitrilo)bis(methylene)]]tetrakisphosphonic acid, sodium salt
EC Number:
244-751-4
EC Name:
[[(phosphonomethyl)imino]bis[(ethylenenitrilo)bis(methylene)]]tetrakisphosphonic acid, sodium salt
Cas Number:
22042-96-2
Molecular formula:
C9H28N3O15P5.xNa
IUPAC Name:
sodium hydrogen [10,10-dihydroxy-10-oxido-2,5,8-tris(phosphonomethyl)-2,5,8-triaza-10-phosphadec-1-yl]phosphonate
Constituent 2
Reference substance name:
[[(phosphonomethyl)imino]bis[(ethylenenitrilo)bis(methylene)]]tetrakisphos phonic acid, sodium salt
IUPAC Name:
[[(phosphonomethyl)imino]bis[(ethylenenitrilo)bis(methylene)]]tetrakisphos phonic acid, sodium salt
Test material form:
liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Bantin and Kingman Ltd
- Age at study initiation: No data
- Weight at study initiation: 150 to 250 g
- Fasting period before study: Overnight (18-20 hours)
- Housing: Groups of 2 or 5 in solid-bottomed plastic cages.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least three days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 40-60
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): Natural light supplemented with fluorescent lighting during working hours (08.45-17.00)


IN-LIFE DATES: No data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25, 50, 100, 200, 500 mg/ml
- Justification for choice of vehicle: None given


MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg
Doses:
250, 500, 1000, 2000 and 5000 mg/kg bw. Doses presumed to be given in terms of DTPMP-xNa (not diluted solution), but not to have been corrected for purity, therefore presumed equivalent to 82.5, 165, 330, 660, and 1650 mg active salt/kg bw respectively.
No. of animals per sex per dose:
Two (except five at 500 mg/kg bw)
Control animals:
no
Details on study design:
- Duration of observation period following administration: High dose group only: 14 days
- Frequency of observations and weighing: High dose group only: All animals were observed for overt signs of toxicity or behavioural change at 15 minutes, 1, 2, and 4 hours after treatment and subsequently once daily for 14 days. Individual body weights were recorded on the day before treatment, on the day of treatment and 14 days after treatment.
- Necropsy of survivors performed: yes, in high dose group only.
- Other examinations performed: gross pathology.
Statistics:
None

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 5 000 mg/kg bw
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 1 650 mg/kg bw
Based on:
act. ingr.
Remarks:
active salt
Remarks on result:
other: equivalent to 1303 mg active acid/kg bw
Mortality:
No animals died during the observation period.
Clinical signs:
No clinical signs.
Body weight:
All animals showed normal body weight gains at the end of the observation period.
Gross pathology:
No animals died so no necropsies were performed.
Other findings:
None reported.

Any other information on results incl. tables

Calculation of equivalent dose: Based on DTPMP-xNa composed of 33% active salt including minor components, remainder water (MSDS).

For purposes of comparison with other Group 3 results, 
1650 mg active salt/kg bw is equivalent to 1303 mg parent acid (DTPMP, CAS 15827-60-8)/kg bw.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
No mortality or clinical signs of toxicity occurred in any of the test animals.
Conclusions:
In an acute oral toxicity study, conducted prior to the adoption of OECD Test Guidelines and GLP, the LD50 for DTPMP-xNa was ≥5000 mg/kg bw (equivalent to ≥1650 mg active salt/kg bw and ≥1303 mg active acid/kg bw) in the rat.