Ammonium carbamate

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Ammonium carbamate was tested for its potential to cause skin sensitization in a GLP-compliant local lymph node assay performed according to OECD guideline 429, which was also used as the key study in this dossier. 3 experimental groups of 5 female CBA/J mice were treated with test substance concentrations of 10, 25 and 50% on 3 consecutive days by open application on the ears. Five vehicle control animals were similarly treated, but with vehicle alone (propylene glycol) and another group of five animals received a positive control substance (DNCB). Three days after the last exposure, all animals were injected with 3H-methyl thymidine and after five hours the draining (auricular) lymph nodes were excised and pooled for each animal. No irritation of the ears was observed, and the determined SI values gave no indication that the test substance is a skin sensitizer.

In a supporting study, data from a Guinea Pig Maximisation Test with ammonium chloride (CAS# 12125-02-9) were evaluated in a read-across approach. The study was performed according to the guideline EPA 540/9-82-025. Twenty Pirbright-Hartley Guinea pigs were injected intradermally with 5% ammonium chloride (99.1% pure) in saline. 9 days later, 25% ammonium chloride was epicutaneously applied for the duration of 48 hours. On day 22 of the test, the animals were challenged with 10% ammonium chloride epicutaneously applied under occlusive dressing on the flank for 24 hours. Twenty-four and 48 hours after removal of the dressing, a total of 2 animals (of 20) in the treatment group showed very slight, hardly perceptible erythema (Hoechst, 1987). Since only 10% of the animals showed a positive reaction, the experimental call is negative as 30 % positive reactions are requisite for positive result. In conclusion, ammonium carbamate is considered to be not sensitising.

Migrated from Short description of key information:
The assessment is performed using data of the test substance itself and supporting data of ammonium chloride. A GLP-compliant LLNA with ammonium carbamate gave no indication of a skin sensitising potential. The results of an EPA 540/9-82-025 compliant GPMT animal study with ammonium chloride indicated no skin sensitising potential.

Respiratory sensitisation

Endpoint conclusion

Additional information:

No data available for assessment.

Justification for classification or non-classification

Based on the available data for the test substance and , there is no need for classification according to EU Directive 67/548/EEC and the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.