Registration Dossier

Diss Factsheets

Administrative data

Description of key information

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.
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.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Reliable without restrictions

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Reliable without restrictions

Additional information

Justification for selection of acute toxicity – oral endpoint
One reliable GLP-study is available.

Justification for selection of acute toxicity – dermal endpoint
One reliable GLP-study is available.

Justification for classification or non-classification

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.

Categories Display