Registration Dossier

Administrative data

Description of key information

Skin irritation study (GLP, OECD 404): not irritating
Eye irritation study (GLP, OECD 405): not irritating
As a consequence, no distinct chemical safety assessment, including exposure determination and risk characterisation, has to be performed in accordance with article 14(4) of the REACH regulation.

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

Irritation parameter Basis Time point Score Max. score Reversibility Remarks
erythema score mean 24, 48 and 72h 0 0
edema score mean 24, 48 and 72h 0 0
erythema score animal #1 (mean score 1) overall at 24, 48 and 72 h 0
erythema score animal #2 (mean score 2) overall at 24, 48 and 72 h 0
erythema score animal #3 (mean score 3) overall at 24, 48 and 72 h 0
edema score animal #1 (mean score 1) overall at 24, 48 and 72 h 0
edema score animal #2 (mean score 2) overall at 24, 48 and 72 h 0
edema score animal #3 (mean score 3) overall at 24, 48 and 72 h 0

EYE IRRITATION

Irritation parameter Basis Time point Score Max. score Reversibility Remarks
cornea score mean 24, 48 and 72 h 0 0
iris score mean 24, 48 and 72 h 0 0
conjunctivae score mean 24, 48 and 72 h 0 0
chemosis score mean 24, 48 and 72 h 0 0

CONCLUSION

As no skin reaction was induced over a period of 7 days in a GLP study acc. to OECD guideline no. 404, and no eye reaction were observed in a GLP study acc. to OECD guideline no. 405 at 24, 48 and 72 h, the test item is considered as neither skin nor eye irritating. This conclusion is furter supported by the fact that there are no indications of corrosion/irritation derived from both acute as well as repeated dose toxicity studies.

Justification for classification or non-classification

Since neither any classification criteria according to GHS/CLP (Regulation (EC) No. 1272/2008) nor any criteria according to DSD (Directive 67/548/EEC) are fulfilled, the substance is not classified for skin and/or eye irritation/corrosion.