Il-Forma tal-prodott

Dikjarazzjonijiet ta' periklu (CLP)

H360D, H362, H373, H411

Kodiċi

Dikjarazzjonijiet

H360D

May damage the unborn child

Taqsima 2: identifikazzjoni tar-riskji

Skont ir-Regolament (KE) Nru 1272/2008 (CLP) Klassifikazzjoni tas-sustanza jew tat-taħlita

Pittogrammi ta 'periklu (CLP)

GHS08 GHS09 Kelma sinjal (CLP) Periklu GHS08 Sustanzi dannużi Telmisartan; 4-methyl-6-(1-methyl-1H-benzimidazol-2-yl)-2-propyl-1H-benzimidazole; 4'-[[7- methyl-5-(1-methyl-1H-benzimidazol-2-yl)-2-propyl-1H-benzimidazol-1-yl]methyl][1,1'- biphenyl]-2-carboxylic acid; Tert-butyl 4'-[[4-methyl-6-(1-methyl-1H-benzimidazol-2-yl)-2- propyl-1Hbenzimidazol-1-yl]methyl][1,1'-biphenyl]-2-carboxylate; 1-[(2'-carboxy[1,1'- biphenyl]-4-yl)methyl]-4-methyl-2-propyl-1H-benzimidazole-6-carboxylic acid; 4'-[[4-methyl- 6-(1-methyl-1H-benzimidazol-2-yl)-2-propyl-1H-benzimidazol-1-yl]methyl][1,1'-biphenyl]-2- carboxamide

Fih

Telmisartan; 4-methyl-6-(1-methyl-1H-benzimidazol-2-yl)-2-propyl-1H-benzimidazole; 4'-[[7- methyl-5-(1-methyl-1H-benzimidazol-2-yl)-2-propyl-1H-benzimidazol-1-yl]methyl][1,1'- biphenyl]-2-carboxylic acid; Tert-butyl 4'-[[4-methyl-6-(1-methyl-1H-benzimidazol-2-yl)-2- propyl-1Hbenzimidazol-1-yl]methyl][1,1'-biphenyl]-2-carboxylate; 1-[(2'-carboxy[1,1'- biphenyl]-4-yl)methyl]-4-methyl-2-propyl-1H-benzimidazole-6-carboxylic acid; 4'-[[4-methyl- 6-(1-methyl-1H-benzimidazol-2-yl)-2-propyl-1H-benzimidazol-1-yl]methyl][1,1'-biphenyl]-2- carboxamide

Dikjarazzjonijiet ta 'Periklu (CLP)

EUH380 - Jistgħu jikkawżaw tfixkil fis-sistema endokrinali fil-bnedmin. H360D - Jista' jagħmel ħsara lit-tarbija li għadha ma twelditx. H362 - Jista’ jagħmel ħsara lit-tfal imreddgħa. H373 - Jista’ jikkawża ħsara lill-organi (sistema kardjovaskulari, sistema endokrinali, kliewi) minħabba espożizzjoni fit-tul jew ripetuta. H411 - Tossiku għall-organiżmi akwatiċi b'mod li jħalli effetti dejjiema.

Dikjarazzjonijiet ta 'prekawzjoni (CLP)

P201 - Ikseb struzzjonijiet speċjali qabel l-użu. P202 - Tmissux qabel ma tkun qrajt u fhimt l-istruzzjonijiet kollha ta' prekawzjoni. P260 - Tiblax bin-nifs trabijiet/dħaħen/gass/raxx/fwar/sprej. P263 - Evita l-kuntatt waqt it-tqala u t-treddigħ. P264 - Aħsel idejn, dirgħajn u wiċċ sew wara li timmaniġġjah. P270 - Tikolx, tixrobx u tpejjipx waqt li tuża’ dan il-prodott. P273 - Evita r-rilaxx fl-ambjent. P280 - Ilbes ingwanti protettivi/ilbies protettiv/protezzjoni għall-għajnejn/protezzjoni għall- wiċċ/protezzjoni għas-smigħ. P314 - Ikkonsulta tabib jekk tħossok ma tiflaħx. P391 - Iġbor it-tixrid. P405 - Aħżen f'post imsakkar. P501 - Armi l-kontenut / il- kontenitur fi punt ta’ ġbir ta’ skart perikoluż jew speċjali, skont ir- regolamenti lokali, reġjonali, nazzjonali u/jew internazzjonali. Tikkettar b'mod konformi ma': Eżenzjoni tal-imballaġġ fuq ġewwa fejn il-kontenut ma jaqbiżx 10 ml.

Perikli oħra

Ma fihx sustanzi PBT u/jew vPvB ≥ 0.1% ivvalutati skont l-Anness XIII tar-REACH Komponent Sustanza/i li ma tissodisfax/jissodisfawx il-kriterji tal- Telmisartan (144701-48-4), 4-methyl-6-(1-methyl-1H-benzimidazol-2-yl)-2-propyl-1H- PBT tar-regolament tar-REACH, skont l-Anness XIII benzimidazole (152628-02-9), 4'-[[7-methyl-5-(1-methyl-1H-benzimidazol-2-yl)-2-propyl- 1H-benzimidazol-1-yl]methyl][1,1'-biphenyl]-2-carboxylic acid (1026353-20-7), Tert-butyl 4'-[[4-methyl-6-(1-methyl-1H-benzimidazol-2-yl)-2-propyl-1Hbenzimidazol-1-yl]methyl][1,1'- biphenyl]-2-carboxylate (144702-26-1), 1-[(2'-carboxy[1,1'-biphenyl]-4-yl)methyl]-4-methyl- 2-propyl-1H-benzimidazole-6-carboxylic acid (884330-12-5), 4'-[[4-methyl-6-(1-methyl-1H- benzimidazol-2-yl)-2-propyl-1H-benzimidazol-1-yl]methyl][1,1'-biphenyl]-2-carboxamide (915124-86-6) Komponent Sustanza(i) li ma tissodisfax/jissodisfawx il-kriterju tal- Telmisartan (144701-48-4), 4-methyl-6-(1-methyl-1H-benzimidazol-2-yl)-2-propyl-1H- vPvB tar-regolament REACH, skont l-Anness XIII benzimidazole (152628-02-9), 4'-[[7-methyl-5-(1-methyl-1H-benzimidazol-2-yl)-2-propyl- 1H-benzimidazol-1-yl]methyl][1,1'-biphenyl]-2-carboxylic acid (1026353-20-7), Tert-butyl 4'-[[4-methyl-6-(1-methyl-1H-benzimidazol-2-yl)-2-propyl-1Hbenzimidazol-1-yl]methyl][1,1'- biphenyl]-2-carboxylate (144702-26-1), 1-[(2'-carboxy[1,1'-biphenyl]-4-yl)methyl]-4-methyl- 2-propyl-1H-benzimidazole-6-carboxylic acid (884330-12-5), 4'-[[4-methyl-6-(1-methyl-1H- benzimidazol-2-yl)-2-propyl-1H-benzimidazol-1-yl]methyl][1,1'-biphenyl]-2-carboxamide (915124-86-6) It-taħlita fiha sustanza(i) inkluża(i) fil-lista stabbilita skont Artikolu 59(1) tar-REACH għax fiha(hom) proprjetajiet ta' tfixkil tas-sistema endokrinali, jew sustanza(i) identifikata(i) għandha(hom) proprjetajiet ta' tfixkil tas-sistema endokrinali skont il-kriterju stabbilit fir-Regolament Delegat tal- Kummissjoni (UE) 2017/2100 jew ir-Regolament tal-Kummissjoni (UE) 2018/605 Komponent Sustanza/i inkluża/i fil-lista stabbilita skont Artiklu Telmisartan (144701-48-4), 4-methyl-6-(1-methyl-1H-benzimidazol-2-yl)-2-propyl-1H- 59(1) tar-REACH għax għandha/hom proprjetajiet li benzimidazole (152628-02-9), 4'-[[7-methyl-5-(1-methyl-1H-benzimidazol-2-yl)-2-propyl- tfixkel/jfixklu s-sistema endokrinali, jew għax 1H-benzimidazol-1-yl]methyl][1,1'-biphenyl]-2-carboxylic acid (1026353-20-7), Tert-butyl identifikata/i bħala li għandha/hom proprjetajiet li 4'-[[4-methyl-6-(1-methyl-1H-benzimidazol-2-yl)-2-propyl-1Hbenzimidazol-1-yl]methyl][1,1'- tfixkel/jfixklu s-sistema endokrinali skont il-kriterji biphenyl]-2-carboxylate (144702-26-1), 4'-[[4-methyl-6-(1-methyl-1H-benzimidazol-2-yl)-2- stabbiliti fir-Regolament Delegat tal-Kummissjoni (UE) propyl-1H-benzimidazol-1-yl]methyl][1,1'-biphenyl]-2-carboxamide (915124-86-6), 1-[(2'- 2017/2100 jew fir-Regolament tal-Kummissjoni (UE) carboxy[1,1'-biphenyl]-4-yl)methyl]-4-methyl-2-propyl-1H-benzimidazole-6-carboxylic acid 2018/605 (884330-12-5)

#2_3_13_FURTHER_INFO

Allert - Il-prodott ma' ġiex ittestjat b'mod sħiħ.

2.1. Il-klassifikazzjoni tas-sustanza jew it-taħlita

Klassifikazzjoni skont ir-Regolament (KE) Nru 1272/2008 [CLP] Interferent endokrinali għas-saħħa tal-bniedem, Kategorija 1 EUH380 Tossiċità riproduttiva, Kategorija 1A H360D Tossiċità riproduttiva, Kategorija addizzjonali, Effetti fuq jew H362 permezz tat-treddigħ Tossiċità għal organu wieħed immirat - Esponiment ripetut, H373 Kategorija 2 Perikoluż għall–ambjent akwatiku – Periklu Kroniku, Kategorija H411 2 It-test sħiħ tar-rendikonti H- u EUH: ara sezzjoni 16 Effetti negattivi fsikokimiċi, għas-saħħa tal-bniedem u għall-ambjentali Tossiku għall-organiżmi akwatiċi b'mod li jħalli effetti dejjiema. Jista' jagħmel ħsara lit-tarbija li għadha ma twelditx. Jista’ jagħmel ħsara lit-tfal imreddgħa. Jista' jikkawża ħsara lill-organi minħabba espożizzjoni fit-tul jew ripetuta.