Registration Dossier

Administrative data

Description of key information

SKIN IRRITATION
In an in vitro study, the test material was determined to be non-irritating
EYE IRRITATION
The test material was determined to be irritating to the eyes of New Zealand White rabbits

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation

The skin irritation potential of the test material was evaluated in vitro using the EPISKIN reconstructed human epidermis model in accordance with the standardised guidelines OECD 439 and EU Method B.46.

Triplicate tissues were treated with the test material for an exposure period of 15 minutes. At the end of the exposure period, each tissue was rinsed before incubating for 42 hours after which each tissue was taken for MTT loading. After MTT loading, a total biopsy of each epidermis was made and formazan crystals were extracted out of the MTT-loaded tissues. Duplicate tissues treated with Dulbecco’s Phosphate Buffered Saline with Ca++ and Mg++ served as the negative control and duplicate tissues treated with 5 % w/v aqueous Sodium Dodecyl Sulphate served as the positive control. The optical density of all treated tissues was measured at 540 nm.

The relative mean viability of the test material treated tissues was 112.6 % after the 15 minute exposure period.

Under the conditions of this study, the test material was determined to be non-irritating and requires no classification in accordance with EU criteria.

In accordance with the principles set out in Section 1.4 of Annex XI of Regulation (EC) 1907/2006 (REACH), it is considered scientifically justified to omit any in vivo testing to confirm the substance's irritation or corrosive potential as these endpoints are adequately addressed by the in vitro testing summarised in this dossier.

 

Eye Irritation

In the key study, the irritancy potential of the test material was assessed in vivo in accordance with the standardised guidelines OECD 405 and EU Method B.5.

A single application of the test material was sequentially administered to the right eye of two New Zealand White rabbits. The treated eyes were not irrigated; the left eye remained untreated and served as the control. The animals were observed for 21 days.

Administration of the test material produced scattered or diffuse corneal opacity (vascularisation was noted in one eye at the 14 day observation), iridial inflammation and moderate conjunctival irritation (petechial haemorrhage on the nictitating membrane were noted in one eye at the 7 day observation). One treated eye appeared normal at the 14 day observation; the other treated eye appeared normal at the 21 day observation.

Under the conditions of this study, the test material causes irritation to the eye and requires classification as Category 2 in accordance with EU criteria.

 

In the supporting study, the corrosion and irritancy potential of the test material was investigated in vitro using the Bovine Corneal Opacity and Permeability Assay (BCOP) in accordance with the standardised guideline OECD 437.

The undiluted test material was applied for 10 minutes, followed by an incubation period of 120 minutes. Negative (0.9 % w/v sodium chloride solution) and positive controls (ethanol) were tested concurrently. The two endpoints, decreased light transmission through the cornea (opacity) and increased passage of sodium fluorescein dye through the cornea (permeability) were combined in an empirically derived formula to generate an In Vitro Irritancy Score (IVIS).

The IVIS for the test material was found to be 43.0.

Under the conditions of this study, the test material was considered not to be an ocular corrosive or severe irritant and as such requires no classification in accordance with EU criteria.


Justification for selection of skin irritation / corrosion endpoint:
Only one study available.

Justification for selection of eye irritation endpoint:
Two studies are provided to address irritation effects in the eye, one conducted in vitro and the other conducted in vivo. The in vivo study is selected as key for the purposes of risk assessment on the basis that the animal model provides a positive result.

Effects on eye irritation: irritating

Justification for classification or non-classification

Skin Irritation

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) 1272/2008, the test material does not require classification for skin irritation.

Eye Irritation

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) 1272/2008, the test material requires classification for eye irritation as Category 2.