Registration Dossier

Administrative data

Description of key information

Skin irritation: Not irritating (in vitro), OECD 439, EU Method B.46, Dreher 2013e
Skin corrosion: Not corrosive (in vitro), OECD 431 and EU Method B.40 bis, Dreher 2013d
Eye irritation = Not irritating, bovine corneal opacity and permeability assay (BCOP) and OECD 405, EU method B.5, Dreher 2013c

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:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin

The potential of the test material to be corrosive to skin was investigated in vitro, in a GLP study which was conducted in accordance with the standardised guidelines OECD 431 and EU Method B.40 bis. During the study, duplicate EpiDerm™inserts were treated with test material, distilled water (negative control) and 8N potassium hydroxide (positive control) for 3 minutes and 1 hour. At the end of the treatment period, the tissues were washed with phosphate buffered saline and cell viability was assessed using the MTT assay. The skin corrosivity potential was classified according to the remaining cell viability obtained after test material treatment with either of the two treatment times. Skin viability after a three minute or one hour exposure to the test material was 93 % and 89 %, respectively. Skin viability after a three minute or one hour exposure to the positive control article was 18 % and 11 %, respectively, demonstrating appropriate performance of the assay. Under the conditions of the study, the test material was considered not to be corrosive to the skin in the in vitro skin model EpiDerm™.

 

Subsequently, the skin irritation potential of the test material was investigated in vitro, in a GLP study which was conducted in accordance with the standardised guidelines OECD 439 and EU Method B.46. During the study EpiSkin™ inserts were treated with test material, negative control (phosphate buffered saline (PBS)) and positive control (5% w/v sodium dodecyl sulphate (SDS)) for 15 minutes. At the end of the treatment period, the tissues were washed with PBS and cell viability was assessed using the MTT assay. The skin irritation potential was classified according to the remaining cell viability obtained after test article treatment. The group mean viability for the test article was 110.0 %, for the negative control was 100.0 % and for the positive control was 4.3 %. Under the conditions of the study the test material was considered to be a 'non-irritant' to the skin.

An in vivo skin irritation study is not required as the existing in vitro data is adequate to address this endpoint.

Eye

The eye irritation potential of the test material was determined in a GLP study which was conducted in accordance with standardised guidelines OECD 437, OECD 405 and EU Method B.5.

A bovine corneal opacity and permeability assay (BCOP) was initially conducted. This demonstrated that the test material did not have the potential to cause corrosion or severe irritation to the eye. An in vivo test was therefore conducted. The undiluted test material (0.1 mL) was instilled into one conjunctival sac of each of three New Zealand White rabbits on Day 1. Ocular reactions were assessed for up to three days after treatment. Ocular instillation of the test article provoked no initial sting reaction. Instillation of the test material produced scattered or diffuse areas of corneal opacity and minimal conjunctival irritation. There were no iridial effects. The eyes of all rabbits were overtly normal by the 72-hour examination. Under the conditions of the test, the test material only elicited slight reactions in any of the animals during the course of the study that meant the test material does not require classification as an eye irritant.


Justification for selection of skin irritation / corrosion endpoint:
Two key studies are available to address skin irritation and corrosion.

Justification for selection of eye irritation endpoint:
Two key studies are available to address eye irritation.

Justification for classification or non-classification

Skin

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

Eye

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