General Information
Revision date
2014-03-17
Product name
Angeliq (Drospirenone + Estradiol coated Tablets)
1.2.1 Relevant identified uses
unfinished drug mixture
Emergency telephone
+49 (0) 214 30 99300 (Sicherheitszentrale Bayer
Icons in SDS
Company Information
company name
Bayer Pharma AG
e-mail address of the competent person responsible for the Safety Data Sheet
msds@bayerhealthcare.com
GHS Information
Signal word
Danger
Hazard Codes
Hazard statements (CLP)
H351, H360FD, H362, H412
Hazard statements
Code
Statements
H351
Suspected of causing cancer
Section 2
2.1 Classification of the substance or mixture
GHS-Classification (according to EC 1272/2008): Carcinogenicity, Category 2 (H351) Reproductive toxicity, Category 1A (H360FD) Effects on or via lactation (H362) Hazardous to the aquatic environment, Category 3 (H412) (67/548/EEC, 1999/45/EC) Carcinogenic Category 3 Toxic to Reproduction Category 1 Toxic to Reproduction Category 2 Dangerous for the environment Limited evidence of a carcinogenic effect. May impair fertility. May cause harm to the unborn child. May cause harm to breastfed babies. Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment.
2.2 Label elements
GHS-Labelling (according to EC 1272/2008): Danger
Hazard statements
H351 Suspected of causing cancer. H360FD May damage fertility. May damage the unborn child. H362 May cause harm to breast-fed children. H412 Harmful to aquatic life with long lasting effects.
Prevention
P260 Do not breathe dust or mist. P263 Avoid contact during pregnancy/ while nursing. P273 Avoid release to the environment. P281 Use personal protective equipment as required.
Response
P308 + P313 IF exposed or concerned: Get medical advice/ attention.
Hazardous Ingredients
67392-87-4 Drospirenon 35380-71-3 Estradiol-Hemihydrate Labelling according to EC Directives: Labelling in accordance with directive 1999/45/EC (preparations) and its amendments and adaptations 67392-87-4 Drospirenon 35380-71-3 Estradiol-Hemihydrate
R-phrase(s)
R60 May impair fertility. R61 May cause harm to the unborn child. R40 Limited evidence of a carcinogenic effect. R52/53 Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment. R64 May cause harm to breastfed babies.
S-phrase(s)
S53 Avoid exposure - obtain special instructions before use. S22 Do not breathe dust. S35 This material and its container must be disposed of in a safe way. S36/37 Wear suitable protective clothing and gloves. S61 Avoid release to the environment. Refer to special instructions/ Safety data sheets.
Other hazards which do not result in classification
None known.
