Diphosphoric acid, zinc salt, compd. with 1,3,5-triazine-2,4,6-triamine (1:1:2)

Acute Toxicity: oral

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:

other: Study conducted to OECD guidelines and GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of 1,3,5-triazine-2,4,6-triamine and zinc bis(dihydrogen phosphate)

EC Number:

690-512-6

Cas Number:

1271172-98-5

Molecular formula:

Zn(C3H7N6)2(P2O7)

IUPAC Name:

Reaction products of 1,3,5-triazine-2,4,6-triamine and zinc bis(dihydrogen phosphate)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage JANVIER, France
- Age at study initiation: 8 weeks old
- Weight at study initiation: Between 185 and 201g.
- Fasting period before study: Fasted from the day prior to treatment to 4 hours after test substance administration
- Housing: Housed by groups of 3 in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid
- Diet (e.g. ad libitum): Freely supplied (except during fasting period)
- Water (e.g. ad libitum): Freely supplied
- Acclimation period: At least 5 days under test conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): Approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark cycle

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Oral gavage using a dose volume of 10 mL/Kg bodyweight using a suitable graduated syringe fitted with an oesophageal metal canula.

Preparation: An amount of test substance (2 g) was weighed and distilled water added in a 10 mL volumetric flask. The preparation was magnetically stirred until dosing.

Doses:

2000 mg/Kg bw

No. of animals per sex per dose:

6

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs were measured daily with weights being taken on Days 0 (before dosing), 2, 7 and 14.
- Necropsy of survivors performed: yes (macroscopic pathology)

Results and discussion

Preliminary study:

No mortality occured, no clinical signs observed, normal body weight evolution, no macroscopical change observed at the end of the study

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No unscheduled mortality occured

Clinical signs:

No clinical signs related to administration of the test substance were observed

Body weight:

The bodyweight gain of the animals remained normal throughout the study

Gross pathology:

The macroscopic examination of the animals at the end of study did not reveal any treatment related changes

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of the test item is higher than 2000 mg/kg bw and in accordance with the OECD guideline N° 423, the LD50 cut-off may be considered to exceed 5000 mg/kg bw by oral route.