Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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 primary irritation index for similar substance 07 and for substance 02 as the measure of the acute irritation to the skin of rabbits was found to be 0.

Results on similar substance 07 was used to assess the irritation properties of Direct Red 16:1.

Therefore the tested item is to be considered as non-irritant to the skin of rabbits.

Eye irritation:

The irritation index for similar substance 07 and for substance 02 was found to be 0 for the cornea, 0 for the iris and 0.7 for the conjunctivae.

The result show minimal irritation on rabbit eye following the indicated guideline but the tested item is to be considered as non-irritant to eye based on CLP criteria, table 3.2.2.7.1.

Results on similar substance 02 and similar substance 07 was used as support to assess the non - irritation of Direct Red 16:1.


Justification for selection of skin irritation / corrosion endpoint:
Study well conducted, according to recognized method; the substance was tested at an adequate concentration to evaluate skin irritation.

Justification for selection of eye irritation endpoint:
Study well conducted, according to recognized method; the substance was tested at an adequate concentration to evaluate eye irritation.

Justification for classification or non-classification

No classification for irritation is warranted under Regulation CE 1272/2008.