Registration Dossier

Administrative data

Description of key information

The in vivo Acute Eye Irritation/Corrosion test (OECD 405) and the Acute Dermal Irritation/Corrosion test (OECD 404) showed no significant signs of irritation, therefore there is no need 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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Two in vivo irritation/corrosion tests were performed, one for eyes and one for skin, both according to the respective OECD standards and according to GLP principles.

For the Acute eye irritation/corrosion test:

Under the conditions of the study, a single ocular application of the test item ALUFLUX or Aluminium dross or gray Aluminium dross to rabbits at a dose of 0.1 g produced irritant effects, which were fully reversed within 48 hours in animals no. 1 and 2 and within 72 hours in animal no. 3. Neither mortalities nor significant clinical signs of toxicity were observed. In conformity with the EC criteria for classification and labelling requirements for dangerous substances and preparations according to Annex VI of Commission Directive 2001/59/EC and Annex I of Regulation (EC) 1272/2008, the test item ALUFLUX or Aluminium dross or gray Aluminium dross does not have to be classified and has no obligatory labelling requirement for eye irritation (for details of the classification criteria see Evaluation of Results).

For the Acute dermal irritation/corrosion test:

Under the conditions of the present study, the single dermal application of the test item ALUFLUX or Aluminium dross or gray Aluminium dross to rabbits at a dose of 0.5 g showed slightly irritant effects, which were fully reversible within 48 hours.

Neither mortalities nor significant clinical signs of toxicity were observed.

In conformity with the EC criteria for classification and labelling requirements for dangerous substances and preparations according to Annex VI of Commission Directive 2001/59/EC [6] and Annex I of Regulation (EC) 1272/2008 [7], the test item ALUFLUX or Aluminium dross or gray Aluminium dross does not have to be classified and has no obligatory labelling requirement for skin irritation.

Justification for classification or non-classification

Two in vivo irritation/corrosion tests were performed, one for eyes and one for skin, both according to the respective OECD standards and according to GLP principles.

For the Acute eye irritation/corrosion test:

Under the conditions of the study, a single ocular application of the test item ALUFLUX or Aluminium dross or gray Aluminium dross to rabbits at a dose of 0.1 g produced irritant effects, which were fully reversed within 48 hours in animals no. 1 and 2 and within 72 hours in animal no. 3. Neither mortalities nor significant clinical signs of toxicity were observed. In conformity with the EC criteria for classification and labelling requirements for dangerous substances and preparations according to Annex VI of Commission Directive 2001/59/EC and Annex I of Regulation (EC) 1272/2008, the test item ALUFLUX or Aluminium dross or gray Aluminium dross does not have to be classified and has no obligatory labelling requirement for eye irritation (for details of the classification criteria see Evaluation of Results).

For the Acute dermal irritation/corrosion test:

Under the conditions of the present study, the single dermal application of the test item ALUFLUX or Aluminium dross or gray Aluminium dross to rabbits at a dose of 0.5 g showed slightly irritant effects, which were fully reversible within 48 hours.

Neither mortalities nor significant clinical signs of toxicity were observed.

In conformity with the EC criteria for classification and labelling requirements for dangerous substances and preparations according to Annex VI of Commission Directive 2001/59/EC [6] and Annex I of Regulation (EC) 1272/2008 [7], the test item ALUFLUX or Aluminium dross or gray Aluminium dross does not have to be classified and has no obligatory labelling requirement for skin irritation.