Registration Dossier

Administrative data

Description of key information

- Skin/Eye: Corrosive

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No irritation/corrosion studies have been carried out on the registered THPC-urea-amine. The studies submitted are for a closely related substance ITC 826. Read-across is considered justified since the only differences between ITC 826 and the current product are in amine carbon chain length (C16 -18for ITC 826 and C14for the registered THPC-urea-amine).

1- Skin irritation/ corrosion:

One study was available for this endpoint and considered as the key study (Lees, 1996). This study was conducted according to OECD guideline 404 and in compliance with GLP (Rel. 2). The test substance was ITC 826 Concentrate. Following an in vitro pre-screen, the test sites were covered with an occlusive dressing for 3 minutes or 1 hour. No irritation was seen at the 3-minute application site.

On the basis of an in vitro pre-screen, a single New Zealand White rabbit was exposed to 0.5 mL of a water dilution of ITC 826 (around 69% Active Ingredient – AI) for a three minute and one hour exposure. The animal was assessed for up to three days for any signs of irritation/corrosivity.

No irritation was seen at the three minute application site. At the one hour application site, very slight to severe erythema and slight to severe oedema was observed. Additional observations included blanching, suspected necrosis, application sites raised and wrinkling of the application site. As a result of suspected necrosis at day three, confirmed by a histopathological examination, the test was terminated. Based on these results, ITC 826 is considered as corrosive following a one hour exposure.

By analogy with ITC 826, THPC-urea-amine is considered as corrosive to skin.

 

2- Eye irritation/ corrosion:

ITC 826 was assessed for corrosive properties to the eye using the rabbit isolated eye assay. The test substance caused significant corneal swelling following a 10 second exposure. A maximal swelling of 29.4% was observed at 5 hours post dosing. Minimal opacity was seen in both eyes at 2, 3, 4 and 5 hours post dosing. ITC 826 was considered likely to be a severe ocular irritantin vivo.

No in vivo study is available for this end-point. However, the study is scientifically unjustified considering animal welfare as THPC-urea-amine is classified as skin corrosive (column 2 of REACH Annex VIII). Based on the results of the skin irritation study (Lees, 1996) performed on ITC 826, THPC-urea-amine is classified as "causes severe skin burns and eye damage" according to EU criteria.


Justification for selection of skin irritation / corrosion endpoint:
No study performed on THPC-urea-amine was available. However, one study performed on ITC 826 (analogous) with good reliability was available (Kr. 2).

Justification for selection of eye irritation endpoint:
No study performed on THPC-urea-amine was available. However, one in vitro study performed on ITC 826 (analogous) with good reliability was available (Kr. 2). No in vivo study conducted due to skin corrosivity.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Skin/ Eye corrosion:

Following a 1 hour dermal exposure of the skin of one rabbit to ITC 826, evidence of necrosis was noted after 3 days and the experiment terminated (Lees 1996, Rel. 1). By analogy with ITC 826, THPC-urea-amine is classified into Category1B, H314 (causes severe skin burns and eye damage) and into category 1, H318 (Causes serious eye damage) according to the CLP regulation (1272/2008) and as corrosive (C, R34) according to the Directive 67/548/EEC.