Registration Dossier

Administrative data

Description of key information

Highly irritating to eyes (OECD 437)
Irritating to skin (OECD 404)

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (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 C4 alcohols and C4 alkenes obtained as by-products from the manufacturing of butan-2-ol by sulfuric acid esterification and hydrolysis of butene.

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 3.3 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

The test material was also classified as irritant according to EU labelling regulations. The hazard phrase H315 "Causes skin irritation" is therefore required.

The eye irritation potential of the test material was 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 54.6%. According to the protocol followed the test material was considered to be an irritant under the conditions of the test.

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 to be an ocular corrosive or severe irritant.

Data from the acute inhalation study that Reaction Products of C4 alcohols and C4 alkenes obtained as by-products from the manufacturing of butan-2-ol by sulfuric acid esterification and hydrolysis of butene is not a respiratory irritant.

Effects on skin irritation/corrosion: irritating  

Effects on eye irritation: highly irritating

Justification for classification or non-classification

Skin irritation

The substance does meet the criteria for classification and labelling for this endpoint, as set out in Regulation (EC) No. 1272/2008.

Eye irritation

According to CLP classification criteria, this substance does meet the criteria for classification and labelling for this endpoint, as set out in Regulation (EC) No. 1272/2008.

 

Respiratory tract

Some information regarding the respiratory tract irritation can be derived from the acute inhalation study as described in section 5.2.1 of the CSR. Very minimal respiratory effects were observed during the exposure and recovery periods. Based on these observations, and the fact that no abnormalities were detected in the lungs at necropsy it can be concluded that very minimal, if any, respiratory irritation was considered to have occurred during exposure to the test item.