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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

In an acute dermal irritation study with C-4000 in rabbits the substance produced no mortalities and minimal erythema and edema.  The Modified Primary Irritation Index [PII] was 0.42.
In an acute ocular irritation study with C-4000 in rabbits the substance produced no mortalities, no corneal opacity or iritis, and minimal conjunctival irritation.  The Primary Eye Irritation Score [Draize score] was <8 in all cases and returned to zero within 48 hours after exposure. 
The potential for respiratory irritation from C-4000 under reasonable conditions of use, or even inadvertent misuse, is low.

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 classification or non-classification

C-4000 is not corrosive to eyes or skin, produced only minimal irritation in either organ, and has low probability of inhalation exposure due to its physical properties, therefore, the potential for respiratory irritation attributable to C-4000 is low under reasonably anticipated conditions of use.

The substance, C-4000, does not require a risk phrase for this endpoint in the EU and should also be not classified for irritation according to both Directive 67/548/EEC and Regulation (EC) 1272/2008. No signal word or hazard statement is necessary.