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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

Constituent 1
Chemical structure
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:
No clinical signs related to the administration of the test item were observed.
Body weight:
The body weight evolution of the animals remained normal throughout the study.
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 17th, 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.