2H-Tetrazol-5-amine, potassium salt (1:1)

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

potassium 5-amino-1H-1,2,3,4-tetrazol-1-ide

Cas Number:

136369-04-5

Molecular formula:

CH2KN5

IUPAC Name:

potassium 5-amino-1H-1,2,3,4-tetrazol-1-ide

Test material form:

solid: particulate/powder

Details on test material:

Batch no.: 08KI030

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

Healthy female rats were housed by group of three in solid-bottomed clear polycarbonate cages with a stainless steel mesh Iid. 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 temperature and relative humidity of the main test were controlled to remain within target ranges of 19 to 25°C and 30 to 70%, respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity ofthe study. The rate of air exchange was approximately fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (07.00 to 19.00) and twelvehours darkness. 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 Europeen 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 the treated group, received an effective dose of 2000 mglkg body weight of the test item 5-Aminotetrazol Potassium, 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 per body weight

No. of animals per sex per dose:

2 x 3

Control animals:

no

Details on study design:

Systematic examinations were carried out to identify any behavioural or toxic effects on the major physiological functions 14 days after administration of the test item. This examination focuses particularly on a Iist of symptoms, recorded as "present" or "absent" on the observation sheet. These observations were compared to control data. Observations and a mortality repmt were then carried out every day for 14 days. The animals were weighed on day D0 (just before administering the test item) then on D2, D7, and D14. Weight changes were calculated and recorded. On D14, the animals were anaesthetised with sodium pentobarbital and administration continued to fatallevels. Macroscopic observations were entered on individual autopsy sheets. Only those organs likely to be modified in cases of acute toxicity were examined. Those presenting macroscopic anomalies can be removed and preserved in view to microscopic examinations.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

No mortality occurred during the study.

Clinical signs:

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

Gross pathology:

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

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LDso of the test item 5-Aminotetrazol Potassium is high er than 2000 mglkg body weight by oral raute in the rat. In accordance with the OECD guideline n°423, the LD50 of the test item may be considered higher than 5000 mglkg body weigbt by oral raute in the rat. According to the criteria for classification, packaging and labelling of dangeraus substances and preparations in accordance with the E.E.C. Directives 67/548, 2001/59 and 99/45, the test item 5-Aminotetrazol Potassium doesn't need tobe classified. No symbol and risk phrase are required. In accordance with the Globally Ha1monized System (Regulation (EC) No 1272/2008), the lest item doesn't need to be classified in category 4. No signal work and hazard statement are required.

Executive summary:

The test item 5-Aminotetrazol Potassium was admiuistered by oral route to a group of 6 female Sprague Dawley rats at the siugle dose of 2000 mg/kg body weight. The experimental protocol was established on the basis of the official method as defined iu the O.E.C.D. guideliue N° 423 dated December 17th, 2001 and the test method B.lter ofthe Council regulation No 440/2008. No mortality occurred duriug the study. No clinical sigus related to the administration ofthe test item were observed. The body weight evolution of the animals remairred normal throughout the study, similar between treated and control animals. The macroscopical examination ofthe animals at the end ofthe study did not reveal treatment-related changes. In conclusion, the LD50 of the test item 5-Aminotetrazol Potassium is higher than 2000 mg/kg body weight by oral route iu the rat. In accordance with the OECD goideiirre n°423, the LD50 of the test item may be considered higher than 5000 mg/kg body weight by oral raute in the rat. Accordiug to the criteria for classification, packagiug and labeHing of dangerous substances and preparations in accordance with the E.E.C. Directives 67/548, 2001/59 and 99/45, the test item 5-Aminotetrazol Potassium doesn't need to be classified. No symbol and risk phrase are required. In accordance with the Globally Harmonized System (Regulation (EC) No 1272/2008), the test item doesn't need tobe classified in category 4. No sigual word and hazard statement are required.