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:

Sensitization to skin was analyzed in a Guinea pig Maximization test performed under GLP according to guideline EU method B.6 (BASF, 1992). In this study, ten female Pirbright-Hartley guinea pigs received six intradermal injections of 5% in 0.9% aqueous

NaCl-solution resp. in Freunds adjuvant/0.9 % aqueous NaCl-solution (1:1), resp. 0.9 % aqueous NaCl-solution in groups of two

per animal. An epicutanous application of 1,6-hexanediol followed one week later. For the challenge three weeks later, a

concentration of 25% was applied via soaked filter stripes to the clipped flank of the animals under occlusive conditions for 24 hours. The readings 24 and 48 hours after patch removal did not reveal any signs of sensitizing effects.

The same result was found in another Guinea pig Maximization test where two female Dunkin-Hartley guinea pigs received an

intradermal injection of 50 µl 1,6-hexanediol at a concentration of 0.2% in equal parts of distilled water and Freund's complete adjuvant (Kurihara, 1996). One week later, the second induction application followed with a filter paper soaked with 0.2 ml of a

100% solution given to the shaved back. For the challenge, 0.1 ml of a pure 1,6-hexanediol was applied to two sites using a filter paper under sealed dressing for 24 hours. The readings made 24 and 48 hours after challenge did not reveal any signs of sensitizing

effects (Kurihara, 1996).


Migrated from Short description of key information:
1,6 Hexanediol is not a skin sensitizer.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Migrated from Short description of key information:
1,6 Hexanediol is not a skin sensitizer. Therefore the compound is supposed to be not a respiratory sensitizer. Beyond this, no cases of respiratory sensitization in humans are known up to know.

Justification for classification or non-classification

Due to the negative results in a guinea pig maximization study performed according to EU guideline, no classification is required.