Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

The test item l-H-TETRAZOL-5-AMINE-, N-1H-TETRAZOL-5-YL-, MONOAMMONIUM SALT was applied, as supplied, at the dose of 0.5 g, under semi-occlusive dressing during 4 hours on an undamaged skin area of three rabbits according to OECD Guideline 404.
No cutaneous reactions (erythema and oedema) were observed whatever the examination time (1, 24, 48 and 72 hours).
The test item 1-H-TETRAZOL-5-AMINE-, N-1H-TETRAZOL-5-YL-, MONOAMMONIUM SALT was instilled as supplied, into the eye of three New Zealand rabbits at the dose of 0.1 g according to OECD Guideline 405.
The ocular reactions observed during the study have been slight to moderate, and totally reversible in the three animals. In accordance with the Globally Harmonized System, the test item needs to be classified in category 2 "irritating to eyes". The signal word "Warning" and hazard statement H319 "Causes serious eye irritation" are required in category 2.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Justification for selection of skin irritation / corrosion endpoint:
One reliable in vivo GLP-study is available.

Justification for selection of eye irritation endpoint:
One reliable in vivo GLP-study available.

Effects on eye irritation: irritating

Justification for classification or non-classification

In accordance with the Globally Harmonized System, the test item doesn't need to be classified in category 2 "irritant". No signal word and hazard statement are required.

In accordance with the Globally Harmonized System, the test item needs to be classified in category 2 "irritating to eyes".The signal word "Warning" and hazard statement H319 "Causes serious eye irritation" are required in category 2.