Diphosphoric acid, compound with 1,3,5-triazine-2,4,6-triamine (1:2)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2017-01-17 to 2017-04-06

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

December 17, 2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

May 30, 2008

GLP compliance:

yes (incl. QA statement)

Remarks:

Behörde für Gesundheit und Verbraucherschutz, Hamburg

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Diphosphoric acid, compound with 1,3,5-triazine-2,4,6-triamine (1:2)

EC Number:

236-860-0

EC Name:

Diphosphoric acid, compound with 1,3,5-triazine-2,4,6-triamine (1:2)

Cas Number:

13518-93-9

Molecular formula:

C3H6N6.1/2H4O7P2

IUPAC Name:

diphosphoric acid, compound with 1,3,5-triazine-2,4,6-triamine (1:2)

Test material form:

solid

Test animals

Species:

rat

Strain:

other: CD / Crl: CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH
- Females nulliparous and non-pregnant: yes
- Age at study initiation: Approx. 8 weeks
- Weight at study initiation: 171 - 193 g
- Fasting period before study: yes, 16 hours prior administration
- Housing: During the 14-day observation period the animals were kept in groups of 3 animals in MAKROLON cages (type III plus)
- Diet: Commercial diet, ssniff® R/M-H V1534; ad libitum
- Water: drinking water provided ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hours each

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: Corn oil was chosen as vehicle as it is known not to produce toxic effects.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

CLASS METHOD
- Rationale for the selection of the starting dose: Three animals of one sex (preferably females) were first treated at 2000 mg/kg bw. If two to three animals died, testing at 300 mg/kg bw would be performed. If no to one animal dies, the test item was retested with 2000 mg/kg bw, using three animals of the same sex. If, in this second step, two to three animals died, testing at 300 mg/kg bw was performed. If, in this second step, no to one animal dies, no further testing was necessary.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 female rats

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours after administration. All animals were observed for a period of 14 days. Individual body weights were recorded before administration of the test item and thereafter in weekly intervals up to the end of the study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs (changes of skin and fur, eyes and mucous membranes, respiratory and circulatory function, autonomic and central nervous system and somatomotor activity as well as behaviour pattern)

Statistics:

No statistical analysis could be performed (the method used is not intended to allow a calculation of a precise LD50 value).

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50 cut-off

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Mortality:

No animal died prematurely.

Clinical signs:

other: No signs of toxicity were observed in any of the treated female rats.

Gross pathology:

No pathological changes were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria are not met, no classification is required according to Regulations (EC) No 1272/2008.

Conclusions:

In an acute oral toxicity study conducted according to OECD 423, no mortality was observed in all treated female rats and the LD50 cut-off was established at 5000 mg/kg bw.