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

Justification for grouping of substances and read-across

There are no data available on the acute toxicity of "Reaction mixture of glycerol-1,3-di(acetate), glycerol acetate and triacetin".

In order to fulfil the standard information requirements set out in Annex VIII, 8.1 and 8.2, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from a structurally related substance is conducted.

In accordance with Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.” In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across).

Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No 1907/2006 whereby substances may be predicted as similar provided that their physicochemical and toxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity.

Overview of Irritation / Corrosion data

#

EC 905-964-4

CAS 102-76-1

Chemical name

"Reaction mixture of glycerol-1,3-di(acetate), glycerol acetate and triacetin"

Triacetin

Molecular weight

134.13 - 218.20 g/mol

218.20 g/mol

Skin irritation

RA: CAS 102-76-1

Not irritating

Eye irritation

RA: CAS 102-76-1

Not irritating

The above mentioned substances are considered to be similar on the basis of the structural similarity resulting in similar properties and/or activities. The available endpoint information is used to predict the same endpoints for "Reaction mixture of glycerol-1,3-di(acetate), glycerol acetate and triacetin".

A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).

No studies are available investigating the skin irritation properties of "Reaction mixture of glycerol-1,3-di(acetate), glycerol acetate and triacetin"

In order to fulfil the standard information requirements set out in Annex VIII, 8.1, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006 read-across from the structurally related analogue substance Triacetin (CAS 102-76-1) is conducted.

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 out of all four animals over 24, 48 and 72 h = 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.

No studies investigating the eye irritation properties of "Reaction mixture of glycerol-1,3-di(acetate), glycerol acetate and triacetin"

are available. In order to fulfil the standard information requirements set out in Annex VIII, 8.2, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006 read-across from the structurally related analogue substance Triacetin (CAS 102-76-1) is conducted.

An acute eye irritation study was performed with Triacetin (CAS 102-76-1) similarly to OECD Guideline 405 and under GLP conditions (Kästner, 1988). 0.1 mL of the undiluted test substance 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 exsudation 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 Triacetin.

Conclusion for skin and eye irritation

In conclusion, the tested structurally related source substance Triacetin (CAS 102-76-1) showed no skin and eye irritation potential. Therefore, based on this result, no skin or eye irritation potential for "Reaction mixture of glycerol-1,3-di(acetate), glycerol acetate and triacetin" was identified.


Justification for selection of skin irritation / corrosion endpoint:
Hazard assessment is conducted by means of read-across from a structural analogue. The selected study is the most adequate and reliable study based on the identified similarities in structure and intrinsic properties between source and target substance and overall assessment of quality, duration and dose descriptor level (refer to the endpoint discussion for further details).

Justification for selection of eye irritation endpoint:
Hazard assessment is conducted by means of read-across from a structural analogue. The selected study is the most adequate and reliable study based on the identified similarities in structure and intrinsic properties between source and target substance and overall assessment of quality, duration and dose descriptor level (refer to the endpoint discussion for further details).

Justification for classification or non-classification

Based on read-across from the source substance Triacetin following an analogue approach, the available data on skin and eye irritation properties of "Reaction mixture of glycerol-1,3-di(acetate), glycerol acetate and triacetin" do not meet the criteria for

classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and the data are therefore conclusive but not sufficient for classification.