Registration Dossier

Administrative data

Description of key information

 

Skin Irritation – Category 3 Mild Skin Irritant based on WOE approach

 

In vitro testing data (OECD 439) indicated that 1,2-Benzenedicarboxylic acid, isodecyl ester, manuf. of, by-products from (C10/11 Discard Alcohol) is an irritant. However, the in vitro skin corrosion test (OECD 431) was negative for corrosion and the in vivo murine Local Lymph Node Assay skin sensitisation data (OECD 429) for structural analogues 1,2-Benzenedicarboyxylic acid, isononyl ester, manuf. of, by-products from (C9 Discard Alcohol) and 1,2-Benzenedicarboyxylic acid, trideyl ester, manuf. of, by-products from (C13 Discard Alcohol) indicate that the substances were not skin sensitiserstisers (i.e., mean SI score of ≥1.5 and < 2.3 for erythema/eschar).  In addition, the oral acute toxicity test did not indicate toxicity up to the limit dose level >2000 mg/kg/day. Taken together, a classification of Category 3 Mild Skin Irritant is warranted based on EU GHS classification.

 

Eye Irritation – Category 2 Eye Irritant based on WOE approach

 

Due to inconclusive results for eye irritation in 2 endpoint studies (OECD 437 and 492) for the submission substance, QSAR modeling was performed to enhance confidence in classifying these substances as irritants or non-irritants. The QSAR analysis was performed using National Institute for Public Health and Environment (RIVM) BfR eye irritation/corrosion v.1.0 model, and the submission substance was predicted to be an eye irritant. The submission substance testing data indicated minimal irritation, but not sufficient for classification as Category 1. Based on the weight of evidence (WOE) these data suggest that the submission substance should be classified as a Category 2 eye irritant.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Justification for read across for skin irritation:The testing data for the submission substance indicated that the in vitro data was a false positive for a skin irritant. This was based on the in vivo LLNA data for C9 and C13 Discard Alcohol that showed that these were mild irritants. Discard Alcohols are a homologous series of UVCB substances produced by the same manufacturing process, differing primarily in the carbon number distribution of the constituents. The read-across hypothesis is based on structurally similar constituent pools and assumption of a similar mode of action based on constituent pools exchanging with cell membranes, resulting in cytotoxicity at high concentrations unless eliminated.

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 – Category 2 eye irritant according to the classification, labelling and packaging (CLP) regulation (EC) No 1272/2008.