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:

Using the read-across approach there is a single study available for butyl propionate and pentyl propionate.

In a GLP study conducted according to OECD TG 429 (LLNA), Pentyl Propionate did not demonstrate dermal sensitization potential in the mouse LLNA as the lymph nodes draining the area of topical application did not demonstrate a 3-fold increase in proliferation when compared to vehicle-treated mice.

The non-GLP study conducted according to OECD TG 406 (Skin sensitization), as no positive response was noted in any of the animals exposed to n-butyl propionate (50% in corn oil), hence based on the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures, n-butyl propionate will not be classified for skin sensitization


Migrated from Short description of key information:
Based on similar material Pentyl Propionate a GLP study was conducted according to OECD TG 429 (LLNA). Pentyl Propionate did not demonstrate dermal sensitization potential in the mouse LLNA as the lymph nodes draining the area of topical application did not demonstrate a 3-fold increase in proliferation when compared to vehicle-treated mice.

Justification for selection of skin sensitisation endpoint:
High reliability guideline study on registered substance

Respiratory sensitisation

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

There are no studies available for assessment of respiratory sensitization of pentyl propionate and since skin irritation was not noted in the GLP study conducted according to OECD TG 429, it is expected that pentyl propionate will not cause respiratory irritation.


Migrated from Short description of key information:
There are no studies available for assessment of respiratory sensitization of pentyl propionate and since skin irritation was not noted in the GLP study conducted according to OECD TG 429, it is expected that pentyl propionate will not cause respiratory irritation.

Justification for classification or non-classification

In a GLP study conducted according to OECD TG 429 (LLNA), Pentyl Propionate did not demonstrate dermal sensitization potential in the mouse LLNA as the lymph nodes draining the area of topical application did not demonstrate a 3-fold increase in proliferation when compared to vehicle-treated mice. There are no studies available for assessment of respiratory sensitization of pentyl propionate and since skin irritation was not noted in the GLP study conducted according to OECD TG 429, it is expected that pentyl propionate will not cause respiratory irritation.

On the basis of the available information and based on the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures, pentyl propionate will not be classified for skin and respiratory sensitization.