Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Skin irritation: not irritating
Eye irritation: not irritating

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 reliable data available for the irritating properties ofDiPE triisononanoate triethylhexanoate(CAS 68443-84-5). In order to fulfil the standard information requirements set out in Annex IX, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substances was 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, 1.5, of Regulation (EC) No 1907/2006, whereby substances may be predicted as similar provided that their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity.

Irritation/Corrosion

CAS

68443-84-5

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Chemical name

DiPE triisononanoate triethylhexanoate

Pentaerythritol C7-C10 Tetraester

MW

1053.6 – 1081.59 g/mol

584.8 – 753.1 g/mol

Skin irritation

RA: Pentaerythritol C7-C10 Tetraester

Experimental result: not irritating

Eye irritation

RA: Pentaerythritol C7-C10 Tetraester

Experimental result: not irritating

 

The above mentioned substances are considered to be similar on the basis of the structural similar properties and/or activities. The available endpoint information is used to predict the same endpoint forDiPE triisononanoate triethylhexanoate(CAS 68443-84-5).

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

Discussion

Skin irritation

Irritation to skin is assessed using data from a study with the structural analoguePentaerythritol C7-C10 Tetraester, which was performed similar to OECD guideline 404 (Robinson, 1991). 0.5 mL of the substance was applied to the shaved skin of three female New Zealand White rabbits for 4 h. Upon removal of the semi-occlusive dressing the treated skin sites were washed with warm water and assessed for erythema and edema according to the Draize scoring system 30 - 60 min, 24, 48, 72 and 96 h later, respectively. The mean score for erythema was 1.3 in two animals and 1.7 in the third animal. Erythema reactions were fully reversible within 4 days. The edema score was 0.3 in all animals and the effects were fully reversible within 48 h. In conclusion, based on the mean scores and the reversibility of the effects,Pentaerythritol C7-C10 Tetraester is not irritating to the skin.

Eye irritation

Eye irritation is assessed using data from a study with the structural analoguePentaerythritol C7-C10 Tetraester, which was performed similar to OECD guideline 405 (Robinson, 1991). 0.1 mL of pure substance was instilled into the eyes of three female New Zealand White rabbits followed by observations for three days. Since the scores for cornea, iris, conjunctivae and chemosis were 0 for all time points and in all animals, respectively,Pentaerythritol C7-C10 Tetraester is not irritating to the eyes.

In conclusion, the available data on the analogue substances indicate that DiPE triisononanoate triethylhexanoate is also not irritating to skin and eyes.

 


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 quality assessment (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 quality assessment (refer to the endpoint discussion for further details).

Justification for classification or non-classification

The available data on skin and eye irritation of the test 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.