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Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Since no study on skin irritation testing of ammonium hydrogen carbonate was available, a study with the structural analogue ammonium chloride (CAS 12125 -02 -9) was used for assessment. This test substance was investigated in a guinea pig maximization test using 20 guinea pigs in the test group. The result of the test were as follows:

1) The treated animals did not show any signs of toxicity throughout the study period.
2) Induction: Very slight to slight edema were observed in the treatment group.
3) Challenge: 24 and 48 hours after removal of the occlusive dressing, a total of 2 animals (in 20) of the treatment group showed very slight, hardly perceptible erythema.
Ten percent of the animals of treatment group demonstrated a positive reaction after the challenge exposure (the criteria: the limit value of 30 percent).

It was therefore conluded that ammonium chloride like ammonium hydrogencarbonate is not a skin sensitizer.

Read across justification:

Ammonium bicarbonate rapidly dissociates in biological fluids to yield ammonium ion (NH4+) and bicarbonate ion (HCO3-). Ammonium ion then reaches equilibrium with ammonia (NH3) in a pH-dependent fashion and both are integral components of normal metabolic processes and play an essential role in the physiology of man and other species. Bicarbonate ion reaches equilibrium with CO2and H2O in aqueous solution and this equilibrium reaction acts as the major extracellular buffer system in blood and interstitial fluids of vertebrates.

Inorganic salts which are releasing either ammonium or bicarbonate ions are therefore in general suitable as read across substances for ammonium bicarbonate. These substances include: Sodium hydrogencarbonate, ammonium sulphate, ammonium carbamate, ammonium chloride etc.

Migrated from Short description of key information:
Sensitization:
- skin: not sensitising (EPA 540/9-82-025; Analogy CAS 12125-02-9, ammonium chloride)

Justification for classification or non-classification

Classification is not warranted according to the criteria of EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.