Registration Dossier

Administrative data

Description of key information

1,6 Hexanediol is neither irritating to the skin nor irritating to the eye. From the available information it is concluded that 1,6 hexanediol is not irritating to the respiratory tract.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not 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

Irritation to skin was analyzed in a study, where ca. 1 ml of 80% 1,6-hexanediol was applied to the intact back skin of two Vienna

White rabbits for 1, 5, 15 minutes and 20 hours (BASF, 1961). After the exposure period, the application site was washed with Lutrol and Lutrol/water followed by an observation period of 72 hours. Since the evaluation of the application sites resulted in

erythema and edema scores of 0, no signs of skin irritation was found.

The results of the key study are confirmed by other studies. Since an overall irritation score of two out of ten was found after an open application of 1,6-hexanediol to rabbit skin (Carpenter, 1974).

In a study with pigs, three animals received application of 0.2 ml 1,6-hexanediol at a concentration of 45% to the shaved skin for 24

hours (Kurihara, 1996). When sites were evaluated using the criteria of the International Contact Dermatitis Research Group, no primary skin irritation was observed.

The potential of 1,6-Hexanediol to cause damage to the conjunctiva, iris or cornea was assessed in a study according to OECD 405 (BASF 2016) by a single ocular application of 0.1 mL of the undiluted heated and then cooled down test item to one eye of three New Zealand White rabbits (stepwise procedure starting with one animal and supplementing two additional animals). About, and not less than 24 hours after application the eye was rinsed with tap water. The following test item-related clinical observations were recorded during the course of the study: no corneal lesions detectable; moderate iritis (grade 1); slight to obvious conjunctival redness (grade 1-2); slight to moderate conjunctival chemosis (grade 1-2); slight to obvious discharge (grade 1-2). Additional findings like desquamation of corneal epithelium and injected scleral vessels in a circumscribed or circular area were noted in the animals within 48 or 72 hours after application. The ocular reactions were reversible in all animals within 7 days after application. Considering the described ocular reactions as well as the average score for irritation, 1,6 -hexandiol does not show an eye irritating potential under the test conditions chosen.

Irritation to eyes was evaluated in a study, where 50 mg 1,6-hexanediol was instilled into the eyes of Vienna White rabbits (BASF, 1961). As result, some minor effects were noted, but they disappeared within the five day observation period, so that the scores for corneal opacity, conjunctival chemosis and erythema were 1, 0.2 and 1, respectively. Thus, 1,6-hexanediol was found to be not irritant to eyes.

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.