Grandio Seal

Hazard statements (CLP)

H317

Code

Statements

H317

May cause an allergic skin reaction

SECTION 2: Hazards identification

Regulation (EC) No. 1272/2008 Classification of the substance or mixture This product is a medical device in accordance with Directive 93/42/EEC on medical devices or Regulation EU) 2017/745 (MDR), which is used invasively or in contact with the body. It is therefore exempt from the

Hazard pictograms

GHS07

Hazard statements

May cause an allergic skin reaction.

Precautionary statements

Wear protective gloves / eye protection / face protection. If on skin: Wash with plenty of water. If skin irritation or rash occurs: Get medical advice/attention. Dispose of contents/container in accordance with local/regional/national/international regulations.

Other hazards

Use only for intended scope of application

PBT Substances

Not applicable

vPvB Substances

Not applicable

2.1 Classification of the substance or mixture

This product is a medical device in accordance with Directive 93/42/EEC on medical devices or Regulation (EU) 2017/745 (MDR), which is used invasively or in contact with the body. It is therefore exempt from the classification and labelling requirements of Regulations (EC) 1907/2006 (REACH, Art. 2 (6) c)) and (EC) 1272/2008 ((UK) CLP, Article 1 (5) d). The classification criteria of Regulation (EC) No 1272/2008 are not directly applicable to this product, but are considered by us as an orienting basis for assessment.The health and environmental hazards have been assessed and classified on the basis of the information known to us on the components and their reaction processes.The following hazards based on the classification criteria of Regulation (EC) No 1272/2008 for humans and the environment cannot be excluded: GHS07 Sensitization - Skin 1 H317 May cause an allergic skin reaction. ꞏ Additional information: This product is a medical device within the meaning of the US Federal Food, Drug and Cosmetic Act, the Canadian Medical Devices Regulations (CMDR) SOR/98-282 and the Canadian Food and Drugs Act R.S.S., 1985, c. F-27, which is used invasively or in contact with the body. It is therefore exempt from the classification and labeling requirements of the US Hazard Communication Standard (HCS), WHMIS, the Canadian Hazardous Products Act (HPA) and the Canadian Hazardous Products Regulations Act (HPR). Health effects are based on the unmixed/uncured material. Under FDA regulations this product is classified as a medical device. Medical devices are exempt from the labelling provisions of GHS according to the Hazard Communication Standard (HCS). (Contd. of page 1)