Registration Dossier

Administrative data

Description of key information

Skin irritation: Mild irritation effects were noted which cleared and were not sufficient for classification.
Eye irritation: Minor irritation effects were noted which cleared and were not sufficient for classification.

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:

Introduction. 

The study was performed to assess the irritancy potential of the test item to the skin of the New Zealand White rabbit. The method was designed to be compatible with the following:

- OECD Guidelines for the Testing of Chemicals No. 404 “Acute Dermal Irritation/Corrosion” (adopted 24 April 2002)

- Method B4 Acute Toxicity (Skin Irritation) of Commission Regulation (EC) No. 440/2008

- United States Environmental Protection Agency Health Effects Test Guidelines OPPTS 870.2500 Acute Dermal Irritation August 1998

- Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), Testing Guidelines for Toxicology Studies, 12 NohSan No. 8147, amended 10 December 2002

- Japanese Ministry of Health and Welfare, 1992

Results. 

3-minute and 1-hour semi-occluded applications of the test item to the intact skin of one rabbit produced no corrosive effects.

A single 4-hour, semi-occluded application of the test item to the intact skin of three rabbits produced very slight to well-defined erythema at two treated skin sites. Very slight oedema, light brown discolouration of the epidermis and loss of skin elasticity were

also noted at one treated skin site. No evidence of skin irritation was noted at one treated skin site during the study. One treated skin site appeared normal at the 48-Hour observation and the remaining treated skin site appeared normal at the 7-Day

observation.

Conclusion. 

The test item produced a maximum individual mean score of 1.7 and therefore did not meet the criteria for classification according to the Globally Harmonised System of Classification and Labelling of Chemicals.

Eye Irritation:

Introduction. 

The study was performed to assess the irritancy potential of the test item to the eye of the New Zealand White rabbit. The method was designed to be compatible with the following:

- OECD Guidelines for the Testing of Chemicals No. 405 “Acute Eye Irritation/Corrosion” (adopted 24 April 2002)

- Method B5 Acute Toxicity (Eye Irritation) of CommissionRegulation (EC) No. 440/2008

- United States Environmental Protection Agency Health Effects Test Guidelines OPPTS 870.2400 Acute Eye Irritation August 1998

- Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), Testing Guidelines for Toxicology Studies, 12 NohSan No. 8147, amended 10 December 2002

- Japanese Ministry of Health and Welfare, 1992

Result. 

A single application of the test item to the non-irrigated eye of three rabbits produced moderate conjunctival irritation. All treated eyes appeared normal at the 72‑Hour observation.

Conclusion. 

The test item does not meet the criteria for classification according to the Classification, Labelling and Packaging Regulation (CLP) or the Globally Harmonised Classification System.

Justification for classification or non-classification

The results from skin irritation and eye irritation studies were evaluated according to the Classification, Labelling and Packaging Regulation (CLP).

Skin irritation: The test item produced a maximum individual mean score of 1.7 and therefore did not meet the criteria for classification according to the Classification, Labelling and Packaging Regulation (CLP).

Eye irritation:

The test item does not meet the criteria for classification according to the Classification, Labelling and Packaging Regulation (CLP).