Note: Ingredients listed on restricted chemical lists
EC/CAS
238-455-4/14464-46-1
Name of the chemical
Cristobalit (s. u. TRGS 906)
Concentration
1≤x<8
EC/CAS
201-004-7/77-09-8
Name of the chemical
Phenolphthalein
Concentration
0≤x<0,2
EC/CAS
205-500-4/141-78-6
Name of the chemical
acetic acid, ethyl ester
Concentration
0≤x<0,2
General Information
Revision date
2019-04-30
Product name
HYDROCOLOR 5
Emergency telephone
For urgent inquiries refer to
Icons in SDS
Company Information
company name
Zhermack S.p.a
e-mail address of the competent person responsible for the Safety Data Sheet
msds@zhermack.com
GHS Information
Signal word
Warning
Hazard Codes
Hazard statements (CLP)
H373
Hazard statements
Code
Statements
H373
May cause damage to organs through prolonged or repeated exposure
Section 2
2.1 Classification of the substance or mixture
The product is classified as hazardous pursuant to the provisions set forth in (EC) Regulation 1272/2008 (CLP) (and subsequent amendments and supplements). The product thus requires a safety datasheet that complies with the provisions of (EU) Regulation 2015/830. Any additional information concerning the risks for health and/or the environment are given in sections 11 and 12 of this sheet. Hazard classification and indication: Specific target organ toxicity - repeated exposure, category 2 H373 May cause damage to organs through prolonged or repeated exposure.
2.2 Label elements
The Regulation EC 1272/2008, on classification, labelling and packaging of substances and mixtures (CLP), shall not apply to a medical device in the finished state used in direct physical contact with the human body according to art. 1.5, letter d). Therefore the product is exempted from the CLP labeling requirements. Hazard labelling pursuant to EC Regulation 1272/2008 (CLP) and subsequent amendments and supplements.
Signal word
Warning
Hazard statements
H373 May cause damage to organs through prolonged or repeated exposure. EUH208
Contains
4-HYDROXY-2,5-DIMETHYLFURAN-2(3H)-ONE. May produce an allergic reaction CRISTOBALITE
Precautionary statements
P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P260 Do not breathe dust / fume / gas / mist / vapours / spray. P314 Get medical advice / attention if you feel unwell.
2.3 Other hazards
Classification of the mixture is based on the results of an in vitro assay conducted in accordance with the guidelines provided by OCSE (OECD Test Guideline 437 resp. EU Method B.47 – Bovine Corneal Opacity and Permeability (BCOP) Test Method) and GLP certified - Good Laboratory Practices. For more information refer to section 11. On the basis of available data, the product does not contain any PBT or vPvB in percentage greater than 0,1%.
