Registration Dossier

Administrative data

Description of key information

Skin - Slightly irritating

Eye - Highly irritating

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin:

Findings using non-standard methods with HEDTA-Na3 and in vitro studies with HEDTA-H3 indicate that prolonged or repeated contact, particularly on abraded skin, may result in moderate irritation and burn. Short-term contact of a few minutes to hours may cause little or no apparent effects. Three studies describe corrosivity testing to US DOT standards with a 4 hour exposure, the same exposure period as used by OECD/EU test methods. HEDTA-Na3 was mixed with varying concentrations of NaOH and, at low NaOH concentration, no corrosion was noted. EDTA-Na4, a structural analogue of HEDTA-Na3, was not significantly irritating to the skin when assessed using standard methods. The same is expected of HEDTA.

 

Eye:

Eye irritation has been carried out with HEDTA-Na3 and HEDTA-H3 ex-vivo with the results indicating the potential for the undiluted substance to cause severe eye irritation, as was also seen with EDTA-Na4. This is supported by a number of in-vivo studies with HEDTA-Na3 for the assessment of eye irritation, most of which are poorly documented. The best documented (Dow, 1982) describes a single exposure of one animal to HEDTA + 1.9% NaOH. Results indicated marked discomfort, moderate conjunctival redness and swelling, reddening of the iris and moderate corneal cloudiness. Signs of irritation were present at 21 days if not washed. The effects were considered fully reversible on washing out within 30 seconds. The extent of the influence of NaOH on the observed irritation is not clear. Five additional, poorly documented, studies on exposure to HEDTA-Na3 products are available and indicate that exposure may cause slight to moderate eye irritation in rabbits. The information from these studies is regarded as sufficient to be able to draw conclusions regarding the need for classification and labeling.

Justification for classification or non-classification

Skin:

Based on the results of the available data the substance does not require to be classified and labelled according to Regulation 1272/2008/EC (CLP).

Eyes:

The information available is regarded as sufficient to be able to draw conclusions regarding the need for classification.

Classification of the undiluted substance as “causes serious eye damage” Category 1 - H318 according to CLP (1272/2008/EC) is indicated.

In solution at a concentration of 40% or less, a reduced classification of “causes serious eye irritation” – Category 2 - H319 according to CLP (1272/2008/EC) is indicated.