2H-Tetrazol-5-amine, N-2H-tetrazol-5-yl-, ammonium salt (1:1)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2008-03-04 - 2008-04-03

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to an internationally accepted guideline. All study parameters are based on the specific guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

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:

-

EC Number:

485-280-6

EC Name:

-

Cas Number:

303749-96-4

Molecular formula:

Hill formula: C2H6N10 CAS formula: C2H3N9.H3N

IUPAC Name:

N-(1H-1,2,3,4-tetrazol-5-yl)-1H-1,2,3,4-tetrazol-5-amine amine

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

• Form : powder
• Colour : white
• Expiry date: unlimited stability
•CAS No: 303749-96-4
• Purity: >99%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

Animals
Six Sprague Dawley rats (SPF Caw) originated from Elevage JANVIER (53940 Le Genest St Isle - France), were used after an acclimatisation period of at least five days. At the beginning of the study, the animals of the treated group weighed between 186 g and 206 g and were 8 weeks old.

Housing
Three healthy female rats were kept in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid. Each cage contains sawdust bedding which was changed at least 2 times a week. Each cage was installed in conventional air conditioned animal husbandry; the environmental conditions were:
- temperature : between 19 °C and 24 °C
- relative humidity : between 36% and 62%
- lighting time: 12 hours daily
- rate of air exchange: at least ten changes per hour
Food and drink
Drinking water (tap-water from public distribution system) and foodstuff were supplied freely. Food was removed at D-1 and then redistributed 4 hours after the test item administration. Microbiological and chemical analyses of the water were carried out once every six months by the Institut Européen de l'Environnement de Bordeaux (I.E.E.B.).

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

The animals of treated group, received an effective dose of 2000 mg/kg body weight of the test item 1H-TETRAZOL-5AMINE-,N-1H-TETRAZOL-5-YL-, MONOAMMONIUM SALT, diluted in distilled water and administered by gavage under a volume of 10 mL/kg body weight using a suitable syringe graduated fitted with an oesophageal metal canula.

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

6

Control animals:

no

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study.

Clinical signs:

other: No clinical signs related to the administration of the test item were observed.

Gross pathology:

The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item 1H-TETRAZOL-5-AMINE-,N-1H-TETRAZOL-5-YL-, MONOAMMONIUMSALT was administered by oral route to a group of 6 female Sprague Dawley rats at the single dose of 2000 mg/kg body weight according to OECD Guideline 423.The results obtained, under these experimental conditions, enable to conclude that the LD50of the test item 1H-TETRAZOL-5AMINE-,N-1H-TETRAZOL-5-YL-, MONOAMMONIUM SALT is higher than 2000 mg/kg body weight by oral route in the rat.

Executive summary:

The test item 1H-TETRAZOL-5-AMINE-,N-1H-TETRAZOL-5-YL-, MONOAMMONIUMSALT was administered by oral route to a group of 6 female Sprague Dawley rats at the single dose of 2000 mg/kg body weight. The experimental protocol was established on the basis of the official method as defined in the O.E.C.D. guideline N° 423 dated December 17^th, 2001 and the test method B.1tris of the Directive N° 2004/73/EC.

No mortality occurred during the study.

No clinical signs related to the administration of the test item were observed.

The body weight evolution of the animals remained normal throughout the study.

The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.

The results obtained, under these experimental conditions, enable to conclude that the LD₅₀of the test item 1H-TETRAZOL-5AMINE-,N-1H-TETRAZOL-5-YL-, MONOAMMONIUM SALT is higher than 2000 mg/kg body weight by oral route in the rat.

In accordance with the OECD guideline n°423, the LD₅₀of the test item may be considered higher than 5000 mg/kg body weight by oral route in the rat.

According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with the E.E.C. Directives 67/548, 2001/59 and 99/45, the test item 1H- TETRAZOL-5AMINE-,N-1H-TETRAZOL-5-YL-, MONOAMMONIUM SALT needs not to be classified. No symbol and risk phrase are required.