Registration Dossier

Administrative data

Description of key information

No signs of skin irritation in a OECD 404 GLP study on rabbits. 
No signs of eye irritation in a OECD 405 GLP study with rabbits.
Transient signs of local respiratory tract irritation following repeated dose inhalation applications.

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:
adverse effect observed (irritating)

Additional information

Skin irritation

In an OECD 404 GLP study the semioccclusive application of trioxane to the skin of rabbits for 4h did not result in signs indicative for skin irritation (Hoechst, 1989). Erythema and edema scores were reported as 0, however no data regarding individual Draize scores are available. 

In a further incompletely reported skin irritation study with rabbits, no apparent irritation was reported following occlusive application of trioxane for 24h (IHFA, 1962). According to this study no classification for skin irritation is indicated, although the only result reported is a primary irritation score of 0.

Additionally data from a guinea pig maximization test indicated no skin irritation within 96h following 2 x 24h occlusive applications of a 75% trioxane solution (BASF AG, 1989).

Based on the Hoechst-study (1989) trioxane was not legally classified for skin irritation (reported erythema and edema scores of 0) (C&L 2002).

 

Eye irritation:

In an OECD 405 GLP study trioxane was reported to be not irritating to the eyes of rabbits (Hoechst, 1989). Instillation of trioxane in the eyes for 24 h did only result in mild reversible irritation of the conjunctivae and slight reversible chemosis (mean values: conjunctivae 1.7, chemosis 0.7, cornea 0, iris 0.1, fully reversible after 72 h).

In an incompletely reported eye irritation study with rabbits, reversible signs of mild eye irritation were observed (mild iritis, corneal opacity, conjunctivitits). According to the results of this study no classification according to Directive 67/548/EEC would be required but classification as a mild eye irritant (Cat.2B) according to GHS.

Additional data indicates only mild eye irritant properties of trioxane in rabbit eyes (BASF AG, 1968). No classification would be required according to this study. In this study a smaller amount of test substance was instilled into the eyes of 2 animals only and no rinsing was performed.

Based on the Hoechst (1989) study trioxane was not legally classified for eye irritation (C&L 2002).

Respiratory irritation:

Due to transient signs of local respiratory tract irritation observed in repeated dose inhalation studies, trioxane was classified as a respiratory tract irritant.

EU: R37, GHS: STOTsinglecategory 3 (H335, may cause respiratory irritation).

 

 


Effects on respiratory irritation: irritating

Justification for classification or non-classification

No classification for skin and eye irritation according to Directive 67/548/EEC and Directive 1272/2008.

Trioxane was classifid as a respiratory tract irritant. EU: R37, GHS: STOTsingle category 3 (H335, may cause respiratory irritation).