Pentane-1,2-diol

Endpoint summary

Description of key information

Irritation:
- skin: not irritating (OECD 404)
- eye: severe damage to the eye (OECD 405)

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:

adverse effect observed (irritating)

Additional information

Irritation to skin was assed in a study performed in compliance according to OECD 404 (BASF, 1992). Three Vienna White rabbits received application of 0.5 ml pure pentane-1,2-diol under semiocclusive condition for 24 h. Since no reactions were observed, the edema and erythema scores were all 0, showing that pentane-1,2-diol was not irritant to skin.

In another study conducted according to guideline EPA OPP 81-5 (Acute Dermal Irritation), three male and three female New Zealand White rabbits received application of 0,5 ml to intact or abraded on their backs under occlusion for 24 hours (Ciba-Geigy, 1982). The readings 24 and 72 hours after patch removal led to erythema and edema scores of 1.1 und 0.75, respectively. Thus, pentane-1,2-diol was found to be not irritant in this test.

In addition to the studies with animals, a 48 h closed epicutaneous test with human volunteers was available for assessment (Tronnier, 1997). pentane-1,2-diol was applied as 10% aqueous solution an the backs of 50 volunteers, of which 14 had some history of allergy or were skin sensitive and were therefore considered to be more sensitive. When the test sites were assessed immediately and 24 hours after patch removal, no irritation was observed in all cases.

Irritation to eyes was evaluated in a study performed in compliance with OECD guideline 405 and EU method B.5 (BASF, 1992). Three Vienna White rabbits received application of 0.1 ml of pure pentane-1,2-diol and reactions were evaluated for 21 days. As result, the scores for corneal opacity, iris, conjuctival erythema and edema were 1.0, 0.8, 2.6 and 1.8, respectively. In addition, all reaction, except for iris, were not reversible within the 21 day observation period.

In another study, irritation to eyes were analyzed in nine New Zealand White rabbits according to guideline EPA OPP 81-4 (Ciba-Geigy LTD., 1982). 0.1 ml of pentane-1,2-diol was instilled in to the left eyes of the animals, while in three of the animals the substance was washed out after 30 seconds. As results, the primary irritation indices calculated from observed reactions were 31.7 and 25.5 for unrinsed and rinsed eyes, respectively.

Taken together the results of both studies, pentane-1,2-diol was irritant to eyes.

Effects on eye irritation: corrosive

Justification for classification or non-classification

1,2 pentanediol is non irritating to the skin and causes servere damage to the eyes in animal testing. According to the criteria of EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 the following classification is warranted:

CLP: Eye irritation cat 1

DSD: R41 serious damage to the eyes