Registration Dossier

Administrative data

Description of key information

Four irritation studies were carried out on the test material H-CB Sodium salt, two in relation to skin irritation and two concerned with eye irritation.
All studies have been ranked 'reliability 1' according to the Klimisch et al scale as they were conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.
In both cases an in vitro study was carried out prior to an in vivo study. As in vivo studies are considered to provide a more accurate basis for classification the in vivo studies were designated as the key studies.

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:
adverse effect observed (irritating)

Additional information

Skin Irritation: Both the in vitro study ( Determination of skin irritation potential using the EPISKIN (TM) Reconstituted Human Epidermis Model) and the in vivo study (OECD Guideline 404 (Acute Dermal Irritation / Corrosion)) showed no effects to exposure to H-CB Sodium salt and as a result it was concluded that the test material was non irritating to the skin.

Eye Irritation: An in vitro study was conducted using the SkinEthic Reconstituted Human Corneal model (HCE, SkinEthic Laboratories, Nice, France), this gave a preliminary indication that the test material was non irritating.

A further study conducted according to OECD Guideline 405 (Acute Eye Irritation / Corrosion) however concluded that the test material should be considered to be an irritant.


Effects on eye irritation: irritating

Justification for classification or non-classification

Skin Irritation: No effects to the skin were noted either during the in vitro or in vivo study indicating that the test material can be considered to be non classified in relation to skin irritation.

Eye irritation: The in vitro study gave a preliminary result of non irritating whilst the in vivo study indicated that the test material was irritating. This was due to irreversible colouration and as such it has been concluded that the test material should be classified as an irritant to the eye.