Registration Dossier

Administrative data

Description of key information

Skin irritation study:
The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method was designed to meet the requirements of the following:
§        OECD Guidelines for the Testing of Chemicals No. 404 “Acute Dermal Irritation/Corrosion” (adopted)
§        Method B4 Acute Toxicity (Skin Irritation) of Commission Directive 2004/73/EC
The test material did not meet the criteria for classification as an irritant to the skin according to EU labelling regulations Commission Directive 2001/59/EC
Eye irritation study:
The eye ittitation method was designed to meet the requirements of 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 Commission Directive 2004/73/EC
The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/59/EC.

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 material to the skin of the New Zealand White rabbit. The method was designed to meet the requirements of the following:

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

§        Method B4 Acute Toxicity (Skin Irritation) of Commission Directive 2004/73/EC

Results:

A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced very slight erythema. All treated skin sites appeared normal at the 48-hour observation.

Conclusion: 

The test material produced a primary irritation index of 0.5 no corrosive effects were noted.

The test material did not meet the criteria for classification as irritant or corrosive to the skin, according to the EU labelling regulations Commission Directive 2001/59/EC.

Eye Irritation:

Introduction:

The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the following:

  • OECD Guidelines for the Testing of Chemicals No. 405 “Acute Eye Irritation/Corrosion” (adopted)
  • Method B5 Acute Toxicity (Eye Irritation) of Commission Directive 2004/73/EC

Result:

A single application of the test material to the non-irrigated eye of three rabbits produced moderate conjunctival irritation. All treated eyes appeared normal at the 48-hour observation.

Conclusion:

The test material did not meet the criteria for classification as an irritant to the eye according to EU labelling regulations Commission Directive 2001/59/EC.

Justification for classification or non-classification

The substance Enordet 0241 does not meet the classification criteria according to DSD or the CLP regulations and is therefore not classified.