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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

An Ames test gave positive results: NO induced gene mutations in bacteria at non cytotoxic concentrations, with and without metabolic activation. The exposure concentrations were maximised: 5000 ppm. The reliability of this GLP-compliant guideline test is Klimisch 1.

 

A chromosome aberration assay on CHO cells indicated a clastogenic effect at highly cytotoxic concentrations without metabolic activation. The exposure concentrations were maximised: 1800 ppm. Metabolic activation has not been tested. Due to this deviation, the reliability of this GLP-compliant test has been established as Klimisch 2.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (positive)

Genetic toxicity in vivo

Description of key information

An in vivo rat micronucleus test was negative after inhalation up to the maximum tolerated dose (150 ppm leading to mortality). The reliability of this GLP-compliant guideline test is Klimisch 1.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Mode of Action Analysis / Human Relevance Framework

Besides these studies with forced exposure, the relevance of in vivo exposure to NO should also be discussed. First, it is a highly toxic chemical where actual exposures are well controlled due to acute toxicity and induction of methemoglobinemia. Secondly, NO is a highly reactive chemical: in actual exposure conditions it would undergo transformation into NO2 and other NOx/HNO3 species due to humidity or oxygen in air, well before reaching any target tissue. Due to this degradation, any leak becomes clearly visible as NO2 is an orange-colour gas. Last, NO it is an endogenous compound acting as an important cellular signalling molecule in many physiological and pathological processes, with a half-life of ca. 5 seconds.

Additional information

Justification for classification or non-classification

Not classified based on an in vivo genotoxicity study with maximized exposure.

Actual exposure potential is negligible due to high toxicity, high instability of this chemical, and easiness to spot any leak based on orange-color.