Registration Dossier

Diss Factsheets

Administrative data

Description of key information

SKIN IRRITATION


- 1,3-Dioxolane is classified as non-irritating


 


EYE IRRITATION


- 1,3-Dioxolane causes serious eye damage and is classified as Category 1 (irreversible effects on the eye)


 


REPEATED DOSE INHALATION


- no irritating effects 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 (irreversible damage)

Respiratory irritation

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

Additional information

In an eye irritation study (Auletta, 1980), 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 72 h. An in vitro study was performed according to the OECD TG 437. 1,3-Dioxolane was applied undiluted for 10 minutes and incubated for 120 minutes. The in vitro irritancy score determined in this study (115.7) indicates that 1,3-Dioxolane causes serious eye damage.


 


Based on the available data, the classification for 1,3-dioxolane is Eye Dam. 1, with the Hazard Statement H318: Causes serious eye damage (according to Regulation (EC) No 1272/2008).


 


In a skin irritation study, 1,3-dioxolane applied under occlusion (for 24 h) showed some irritation. Although the score at t = 48 h is missing, the mean overall irritation score is below the relevant score trigger for classification (score of 2.0 to be observed with 4 h application under semi-occlusion). An in vitro study was performed according to the OECD TG 439. 1,3-Dioxolane was applied undiluted for 15 minutes on reconstructed human epidermis tissue and incubated for 42 hours. The relative mean viability of the test item treated tissues was 78.8% after the 15-minute exposure period and 42-hour post-exposure incubation period. The test item was therefore classified as non-irritant


 


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

Justification for classification or non-classification

According to the studies submitted,1,3-dioxolane is not irritating to the skin and to the respiratory system, but causes serious eye damage (Category 1) with Hazard Statement H318: Causes serious eye damage (in compliance with Regulation (EC) No 1272/2008).