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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

skin irritation (OECD 439): not-irritating
eye irritation (OECD 437): 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)

Additional information

Skin irritation

The in vitro skin irritation properties of Amides, C18, branched and linear were tested in a study according to OECD TG 439 under GLP conditions using the EpiSkinTM, reconstructed three-dimensional human epidermis (Warren, 2014a). In the study, the tissues were treated with the neat test material for an exposure period of 15 min and further incubated for 42 h. Positive and negative controls were included in the study. The irritation potential of the test material was predicted from the relative mean tissue viabilities compared to the mean viability of the negative control tissues. The positive and negative control substances gave the expected results. The relative mean tissue viabilities for the test compound were 97.8% compared to controls after 42 h. Thus, in the described test Amides, C18, branched and linear is considered to be non-irritating.

 

Eye irritation

The eye irritation properties of Amides, C18, branched and linear have been investigated in accordance with OECD TG 437 under GLP conditions using the bovine corneal opacity and permeability test (BCOP, Warren, 2014b). For the assessment of the eye irritation properties 0.3 g of the test substance was used to cover the corneal surface of the eyes for 4 h. Positive and negative controls were included in the study and gave the expected results. Four hours after application mean values of cornea opacity (0.0), permeability (0.019) and In Vitro Irritancy Score (0.3) were calculated from three independent experiments. Based on the results of the study the test item should be considered as non-irritant.


Justification for selection of skin irritation / corrosion endpoint:
The reliable GLP compliant OECD Guideline study was chosen.

Justification for selection of eye irritation endpoint:
The reliable GLP compliant OECD Guideline study was chosen.

Justification for classification or non-classification

The available data on skin and eye irritation of Amides, C18, branched and linear do not meet the criteria for classification according to Regulation (EC) No 1272/2008 or Directive 67/548/EEC and are therefore conclusive but not sufficient for classification.