Registration Dossier

Administrative data

Description of key information

The in vivo tests of Skin irritation and Eye irritation were performed according to the following methods: 
1/ Method B.4 - Acute Toxicity: Dermal Irritation/Corrosion, Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.
1/ Method B.5 - Acute Toxicity: Eye Irritation/Corrosion, Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.
The in vitro tests of Skin irritation, Skin Corrosion and Eye irritation were performed according to the following methods:
1/ Method B.46 - In vitro skin irritation: Reconstructed human epidermis model test and Standard Operating Procedure for EpiDermTM published by ZEBET.
2/ Method B.40 - Skin corrosion (in vitro), Council Regulation (EC) No.440/2008. Published in O.J. L 142, 2008
3/ Method according to MatTek Ocular Irritation Protocol: Neat Method (MTT ET-50), Rev. 1/1/01 (1): in vitro eye irritation in human corneal model EpiOcularTM.
All five tests were performed in accordance with GLP principles.

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)

Additional information

Skin irritation /corrosion:

The test substance was not corrosive in EpiDermal (TM) in test "In vitro Skin Corrosion". For no corrosive effects found, the irritating potential was determined. The test substance was not irritating in EpiDermal (TM) in test "In vitro Skin Irritation".

In vivo test "Acute Toxicity: Dermal Corrosion/Irritation" no evidence of a corrosive effect or symptoms of irritation were observed on skin.

 

Eye irritation:

The test substance was moderately irritating in EpiOcular(TM) Model.

Examination of eye irritation (in vivo) after single application to rabbits demonstrated, that the test substances does not irritate of rabbit eye.

Justification for classification or non-classification

Based on the results and according to the EC criteria for classification and labelling (Council Directive 67/548/EEC, Annex VI), the test substance does not have to be classified for skin irritation/corrosion.

Based on the test results and according to the EC criteria for classification and labelling the test substances does not have to be classified for eye irritation.