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:

The skin sensitizing potential of Neopentylglycol was assessed using the radioactive Murine Local Lymph Node Assay (OECD 429). Groups of 5 female CBA/J mice each were treated with a 60% w/w preparation of the test substance in propylene glycol or with the vehicle alone. The test substance showed no increase in the 3H-thymidine incorporation, auricular lymph node cell counts or lymph node weights and did not cause any increase in ear weights. Thus it is concluded that Neopentylglycol does not show a skin sensitizing effect in the Murine Local Lymph Node Assay under the test conditions chosen.

Furthermore, there are studies available for structural similar compounds as 1,2 -propanediol (57-55-6) or isopropanol (67-63-5).

In a epicutaneous sensitization study no skin reaction was seen in 20 guinea pigs exposed to 1,2-propanediol (57-55-6) in the challenge application. The study was conducted similar to OECD 406. Acclimatization of the animals was 1 week followed by intradermal induction (first week) , dermal induction (3 applications per week for 2 weeks) and one week rest. Challenge application was on day 28. Challenge readings of the treated area are made 1, 6, 24 and 48 h after removing the patch.

Neopentylglycol was also predicted to be non-sensitizing by the OECD Toolbox on the basis of data available for isopropanol (67-63-5).


Migrated from Short description of key information:
Neopentylglycol does not show a skin sensitizing effect in the Murine Local Lymph Node Assay (OECD 429). In a short communication of a product information sheet (no details available) it is mentioned that repeated application to the guinea pig skin did not result in skin sensitization. Beyond this, there is no hint for any sensitizing property for animal studies available for structural related substances (isopropyl alcohol see QSAR; 1,2 propandiol see read across substance).Consequently Neopentylglykol is considered non sensitizing to the skin.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Migrated from Short description of key information:
As Neopentylglycol was found to be non-sensitizing to the skin it is supposed to be non sensitizing to the respiratory tract as well.

Justification for classification or non-classification

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