Registration Dossier

Administrative data

Description of key information

Skin irritation/corrosion: not irritating (OECD 404, GLP)
Eye irritation: not irritating (OECD 405, GLP)

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:
no study available

Additional information

Skin irritation:

In a primary dermal irritation study, the skin irritation/corrosion potential of Triacetin (CAS 102-76-1) was tested similarly to OECD Guideline 404 and under GLP conditions (Kästner, 1988). The shaved dorsal skin of four adult rabbits (Kleinrusse) was exposed to 0.5 mL of the undiluted test material for 4 h under occlusive conditions. The rabbits were observed for 72 h after application. Skin reactions were assessed using the Draize scoring system. One hour after application, mild erythema was observed in 1/4 tested animals (mean erythema and edema scores of all four animals after 24, 48 and 72 h was 0). No other skin reaction was observed in any animal at any observation time point. Thus, under the experimental conditions described, no evidence of skin irritation properties were seen after treatment with Triacetin.

Eye irritation:

An acute eye irritation study was performed with Triacetin (CAS 102-76-1) similarly to OECD Guideline 405 and under GLP conditions (Kästner, 1988). The undiluted test substance (0.1 mL) was instilled into the conjunctival sac of one eye of four adult male Kleinrusse rabbits. The animals were observed for 72 h. Eye irritation was scored according to the method of Draize 1, 6, 24, 48 and 72 h after application. Only 1 out of 4 animals showed slight redness of the conjunctivae at 1 and 6 h after application which was fully reversible within 24 h. In 3 out of 4 animals exudation was observed at the 1 h reading time point. No other eye irritation effects were observed at any time point in any tested animal. Thus the resulting mean cornea, iris, conjunctivae and chemosis scores out of all four animals over 24, 48 and 72 h were zero. Under the experimental conditions described no evidence of eye irritation properties were seen after treatment with substance.

Respiratory tract

This information is not available.

 

 


Justification for selection of skin irritation / corrosion endpoint:
There is only one study available.

Justification for selection of eye irritation endpoint:
There is only one study available.

Justification for classification or non-classification

The available data on skin and eye irritation properties of the substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.