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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2008-03-11 - 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 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

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:

male/female

Details on test animals or test system and environmental conditions:

Animals
Ten 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 214 g and 222 g (males) and between 197 g and 215 g (females) and were 7-8 weeks old.
Treated group : 5 male rats Rm0455 to Rm0459
and 5 female rats Rf0460 to Rf0464
Housing
During the treatment, the animals were kept in individual cage. At D3, the animals were put into their cage by 2 or 3. The 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. 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

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

Animals from treated group received by topical application, under porous gauze dressing, an effective dose of 2000 mg/kg body weight of 1H-TETRAZOL-5AMINE-,N-1H-TETRAZOL-5-YL-, MONOAMMONIUM SALT, diluted in distilled water and administered under a volume of 10 mL/kg body weight, during 24 hours. After 24-hour exposure period, the gauze dressings were removed and the treated areas were rinsed with distilled water.

Duration of exposure:

24 hours

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

5

Control animals:

no

Results and discussion

Effect levels

Sex:

male/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: Neither cutaneous reactions nor systemic 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-, MONOAMMONIUM SALT was applied onto the intact skin of 10 Sprague Dawley rats (5 males and 5 females) at the single dose of 2000 mg/kg body weight according to OECD Guideline 402.
The LD50 of the test item 1H-TETRAZOL-5-AMINE-,N-1H-TETRAZOL-5-YL-, MONOAMMONIUM SALT is higher than 2000 mg/kg body weight by dermal route in the rat.

Executive summary:

The test item 1H-TETRAZOL-5AMINE-,N-1H-TETRAZOL-5-YL-, MONOAMMONIUMSALT was applied onto the intact skin of 10 Sprague Dawley rats (5 males and 5 females) 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° 402 dated February 24^th, 1987 and the test method B.3 of the directive. n° 92/69/EEC.

No mortality occurred during the study.

Neither cutaneous reactions nor systemic 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.

In conclusion, the LD50 of the test item 1H-TETRAZOL-5AMINE-,N-1H-TETRAZOL-5-YL-,MONOAMMONIUMSALT is higher than 2000 mg/kg body weight by dermal route in the rat.

According tothe 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-, MONOAMMONIUMSALT needs not to be classified.No symbol and risk phrase are required.

In accordance with the Globally Harmonized System (C0M(2007)355 final), the test item needs not to be classified in category 4. No signal word and hazard statement are required.