Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Both in vitro and in vivo data were generated to assess the skin and eye irritating potential of Reaction products of C3 alcohols and C3 alkenes obtained as by-products from the manufacture of propan-2-ol by hydration of propylene.

The skin corrosivity potential of the test material was assessed in vitro using the EPISKINTM Reconstituted Human Epidermis (RHE) Model (according to OECD guideline 431).  Duplicate tissues were treated with the test material for exposure periods of 3, 60 and 240 minutes. Based on the relative mean viability of the test material treated tissues, the test material was considered to be non-corrosive to the skin.

In New Zealand white rabbits, the test material produced a primary irritation index of 3.5 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

The test material would be classified as Category 3 (mild irritant) according to GHS criteria. However according to CLP guidelines, this compound is not classified.

The eye corrosivity potential of the test material was assessed in vitro using the Bovine Corneal Opacity and Permeability Assay (according to OECD guideline 437). The test material was considered not to be an ocular corrosive or severe irritant.

The eye irritation potential of the test material was subsequently assessed in vitro using the Skin Ethic Reconstituted Human Corneal model. The test is based on the hypothesis that irritant chemicals are able to penetrate the corneal epithelial tissue and are sufficiently cytotoxic to cause cell death. The relative mean viability of the test material treated tissues after a 10 minute exposure was 45.8%. According to the protocol followed the test material was considered to be an irritant under the conditions of the test.

An in vivo study in New Zealand white rabbits showed that Reaction Products of C3 alcohols and C3 alkenes obtained as by-products from the manufacture of propan-2-ol by hydration of propylene is not an eye irritant.

Data from the acute inhalation study indicate that Reaction Products of C3 alcohols and C3 alkenes obtained as by-products from the manufacture of propan-2-ol by hydration of propylene is not a respiratory irritant.


Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

Skin irritation: The substance does not meet the criteria for classification and labelling for this endpoint, as set out in Regulation (EC) No. 1272/2008. However, this substance does meet the classification and labelling for this endpoint (Xi, R38: Irritating to skin), as set out in the EU Directive 67/548/EEC for dangerous substances. Eye irritation: According to CLP classification criteria, this substance does not meet the criteria for classification and labelling for this endpoint, as set out in Regulation (EC) No. 1272/2008.