Registration Dossier

Administrative data

Description of key information

Two reliable studies were identified on skin irritation and one reliable study was identified on eye irritation, all performed in rabbits. In the repeated dose inhalation studies no irritating effects of 1,3-Dioxolane to the respiratory tract were observed.

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)

Respiratory irritation

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

Additional information

In a skin irritation study, 1,3-Dioxolane applied under occlusion (during 24h) showed some irritation. Although the score at t=48h is missing, the mean overall irritation score is below the relevant trigger for classification of 2.0 (to be observed with 4h application under semi-occlusion ). Also in a supporting study treatment during 24h with 1,3-Dioxolane did not result in skin irritation. Repeated treatment showed skin irritation after 10 days of treatment, but effects were reversible after 5 days.

In an eye irritation study, 1,3-Dioxolane showed irritating effects on the cornea, iris and conjunctivae. Irritating effects on cornea and conjunctivae were not fully reversible at termination of the study at 72h, and therefore 1,3-Dioxolane is considered to be irritating to eyes.

In repeated dose inhalation studies with 1,3-Dioxolane no irritating effects were observed.


Effects on eye irritation: irritating

Justification for classification or non-classification

1,3-Dioxolane is not irritating to the skin and to the respiratory system. 1,3-Dioxolane is irritating for eyes, leading to classification with R36 and H319 according to DSD and CLP, respectively.