Ivomec GOLD solution for injection

Hazard statements (CLP)

H302, H317, H361, H362, H373, H400, H410

Code

Statements

H302

Harmful if swallowed

SECTION 2: Hazards identification

Regulation (EC) No. 1272/2008 Classification of the substance or mixture

Signal word

Warning

Hazard statements

H302 Harmful if swallowed. H317 May cause an allergic skin reaction. H361 Suspected of damaging fertility or the unborn child. H362 May cause harm to breast-fed children. H373 May cause damage to organs (Central nervous system) through prolonged or repeated exposure if swallowed. H410 Very toxic to aquatic life with long lasting effects.

Prevention

P201 Obtain special instructions before use. P202 Do not handle until all safety precautions have been read and understood. P260 Do not breathe mist or vapours. P263 Avoid contact during pregnancy and while nursing. P273 Avoid release to the environment. P280 Wear protective gloves/ protective clothing/ eye protection/ face protection/ hearing protection.

Response

P391 Collect spillage.

Hazardous Ingredients

Ivermectin

2.3 Other hazards

This substance/mixture contains no components considered to be either persistent, bioaccumula- tive and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of 0.1% or higher.

ECOLOGICAL INFORMATION

The substance/mixture does not contain components considered to have endocrine disrupting properties according to REACH Article 57(f) or Commission Delegated regu- lation (EU) 2017/2100 or Commission Regulation (EU) 2018/605 at levels of 0.1% or higher.

TOXICOLOGICAL INFORMATION

The substance/mixture does not contain components considered to have endocrine disrupting properties according to REACH Article 57(f) or Commission Delegated regulation (EU) 2017/2100 or Commission Regulation (EU) 2018/605 at levels of 0.1% or higher. This drug is not subject to the labelling requirements under the Globally Harmonized System (GHS) The pharmacological effect of the medicament has to be considered (see package leaflet).

2.1 Classification of the substance or mixture

Classification (REGULATION (EC) No 1272/2008) Acute toxicity, Category 4 H302: Harmful if swallowed. Skin sensitisation, Category 1 H317: May cause an allergic skin reaction. Reproductive toxicity, Category 2 H361: Suspected of damaging fertility or the un- born child. Effects on or via lactation H362: May cause harm to breast-fed children. Specific target organ toxicity - repeated H373: May cause damage to organs through pro- exposure, Category 2, Central nervous longed or repeated exposure if swallowed. system Short-term (acute) aquatic hazard, Cate- H400: Very toxic to aquatic life. gory 1 Long-term (chronic) aquatic hazard, Cat- H410: Very toxic to aquatic life with long lasting egory 1 effects.