Registration Dossier

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:

No definitive skin sensitization studies have been conducted for propionic acid.

Occupational sensitization has not been reported among workers (OECD SIDS for SIAM 25, 2007). There was no sensitization response to sodium propionate in trials with human subjects following topical use (Haseltine, 1952). However, positive pin-prick responses to propionic acid were obtained in 3/91 patients suffering from chronic uticaria: patients were presumed to have prior

exposure with propionic acid as a food preservative. There was no response observed among 247 normal control (non-uticaria) subjects (Malanin, and Kalimo, 1989)

In a dermal sensitization study with calcium propionate (CAS No. 4075-81-4) in water (intradermal induction) and Vaseline (topical induction and challenge), young guinea pigs were tested according to the method described by Magnusson and Kligmann (1970), a method comparable OECD TG 406. The control group contained 10 animals and 6 guinea pigs were used in the test group. Intradermal inductions were performed with 2% of calcium propionate in water while topical inductions were carried out with 20% calcium propionate in Vaseline, 1 week later and under occlusive conditions for 48 hours. 2 weeks after topical induction exposure, challenge was performed epicutaneously (open) with 20% calcium propionate in Vaseline. No positive control was tested. No skin irritations were noticed in all animals of the control or treated group after challenge experiments (TNO/CIVO 1978). In this study, calcium propionate is not a dermal sensitizer.

The same authors tested the sensitization potential of sodium propionate (CAS No.137-40-6) in young guinea pigs following an identical study design and concentrations described for calcium propionate (TNA/CIVO 1978). In this study, sodium propionate is not a dermal sensitizer


Migrated from Short description of key information:
Salts of propionic acid are not skin sensitizing in animal tests. Thus, propionic acid is not considered to be sensitizing to the skin.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

No data for the assessment of respiratory sensitization are available. As propionic acid is not supposed to be sensitizing to the skin it is also not supposed to be sensitizing to the respiratory tract.

Justification for classification or non-classification

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