5-nitro-2,4,6-triaminopyrimidine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2014-2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and OECD guideline compliant study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

(December 17, 2001)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

(Bioassay, Labor für biologische Analytik GmbH, Heidelberg)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

5-nitro-2,4,6-triaminopyrimidine

EC Number:

213-742-7

EC Name:

5-nitro-2,4,6-triaminopyrimidine

Cas Number:

1006-23-1

Molecular formula:

C4 H6 N6 O

IUPAC Name:

5-nitropyrimidine-2,4,6-triamine

Details on test material:

- Name of test material (as cited in study report): 5-Nitroso-2,4,6-triaminopyrimidine
- Analytical purity: 99.1 g/100 g by titration
- Physical state: Solid / pink to red
- Homogeneity: homogeneous by visual inspection
- Storage conditions: Room temperature
- Lot/batch No.: 1101-1217
- Expiration date of the lot/batch: October 10, 2023
- Stability: The stability of the test item under storage conditions over the study period was guaranteed by the sponsor.

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: about 8-12 weeks
- Weight at study initiation:
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Housing: single housing in Makrolon cages, type III
- Diet: VRF1(P); SDS Special Diets Services, Altrip, Germany
- Water: tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 30 – 70%
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

-In-life phase: First oral dosing Dec 9 2014

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.5% Carboxymethylcellulose in water

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The structure does not specifically indicate a hazard.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation. Additionally, at day of death in animals that died or were sacrificed moribund starting with study day 1. Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals. A check for any dead or moribund animals was made at least once each workday.
- Necropsy of survivors performed: yes

Statistics:

Calculations were performed using Microsoft Excel 2003 and checked with a calculator.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality occurred.

Mortality:

None

Clinical signs:

other: 2000 mg/kg (first test group):  Piloerection in all animals  Exsiccosis in all animals  Reddish discolored urine in all animals 2000 mg/kg (second test group):  Piloerection in all animals  Dyspnea in one animal  Reduced defecation in one animal 

Gross pathology:

There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU