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Administrative data

Description of key information

 

Skin Irritation – Category 3 Mild Skin Irritant

In vitro testing data (OECD 439) indicated that 1,2-Benzenedicarboxylic acid, tridecyl ester, manuf. of, by-products from (C13 Discard Alcohol) is an irritant. However, the in vitro skin corrosion test (OECD 431) was negative for corrosion, the in vivo murine Local Lymph Node Assay (OECD 429) resulted in a mean score of≥1.5 and < 2.3 for erythema/eschar and the acute dermal toxicity was >2000 mg/kg body weight. Together, these data indicate that the submission substance is a mild skin irritant. Therefore a classification of Category 3 is warranted.

 

Eye Irritation – Not Classified based on WOE approach

Both the Reconstructed Human Cornea-like Epithelium (OECD 492) and the Bovine Corneal Opacity Permeability (OECD 437) tests indicated that C13 does not need to be classified for eye irritation.

 


Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

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

Additional information

Justification for classification or non-classification

Skin Irritation – Category 3 mild skin irritant according to GHS classification. "No Classification" according to the classification, labelling and packaging (CLP) regulation (EC) No 1272/2008.

Eye Irritation – does not need to be classified

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