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To meet product safety, environmental protection, and health requirements, materials and products using pigments must comply with regulatory requirements in countries and regions around the world. The most important and concerning of these are requirements for chemical substance control, particularly the chemical requirements for colorants, which are important additives in product materials. These requirements cover a wide range of consumer products, including toys, textile materials and accessories (such as zippers and buttons), cosmetics (such as nail polish and lipstick), electronic and electrical products, food containers and food contact materials or products, and automotive materials.
Toksisitas Akut Bahan Kimia
The most commonly used metric for measuring acute toxicity is the LD50 (lethal dose). LD50 stands for the median lethal dose. A simple definition is the dose required to cause death in 50% of a group of test animals, such as rats. The LD50 is expressed in mg/kg body weight. Lower LD50 values ​​indicate a more potent poison; higher LD50 values ​​indicate a less toxic poison. The European Union defines three acute toxicity categories (rat oral) for substances.
LD50 ≤ 25 mg/kg; extremely toxic
LD50 = 25-200 mg/kg; toxic
LD50 = 200-2000 mg/kg; harmful
Regarding the acute toxicity of colorants, a monograph reviewed 194 pigments and found that the majority had oral LD50 values ​​greater than 5000 mg/kg, with no reported values below 2000 mg/kg. Considering that the oral LD50 value of table salt (NaCl) is 3000 mg/kg, this would be equivalent to an average-weight person ingesting 350g of pigment, which is unlikely. Therefore, the conclusion is that colorants generally have low acute toxicity. Pigments are typically excreted through the gastrointestinal tract, not through the urine.
Kotoran dalam Pigmen Organik
Organic pigments are widely used as colorants in plastic consumer products, cosmetics, toys, and food packaging. Therefore, in addition to the toxicological and ecological properties of the pure pigments, the potential for trace impurities generated during production must be considered, potentially impacting their use in these consumer products. Possible impurities are listed below.
(1) Certain heavy metal compounds Some organic pigments (C.I. Pigment Red 48:1) use heavy metal salts (barium) as pigments and are therefore not recommended for use in food packaging materials and toys.
(2) Aromatic amines Aromatic amines are only allowed to appear in very low amounts as components of pigment synthesis in organic pigments. For use in food contact packaging materials, the upper limit has been clearly defined: Aromatic primary amines: <500ppm (mg/kg, total amount); 4-aminobiphenyl, benzidine, 2-naphthylamine, 2-methyl-4-chloroaniline: <10ppm (mg/kg, total amount).
(3) Polychlorinated biphenyls Polychlorinated biphenyls (PCBs) are mainly harmful because their persistent residues in the environment are more harmful than to humans. In the EU, chemicals containing 50ppm or more of polychlorinated biphenyls (PCBs) or PCTs are classified as polychlorinated biphenyls.
(4) Dioxins Pigment Violet 23 is prepared by condensing tetrachlorobenzoquinone with N-ethylcarbazole. During the synthesis process, a small amount of dioxins is inevitably formed.
Keamanan Pigmen Bischlorobiphenyl
Yellow-orange organic pigments synthesized from 3,3-bischlorobenzidine (DCB) are important azo pigments. DCB pigments are a key component of plastic coloring due to their vibrant color, high tinting strength, and affordability. Examples include Pigment Yellow 13, 14, 17, 81, and 83, and Pigment Orange 13 and 34.
Concerns persist about whether DCB series pigments used in chemical fiber non-woven textile materials, clothing zippers and button accessories, and food packaging materials meet the safety requirements of domestic and international ecological and environmental regulations.
Bischlorobenzidine is a probable carcinogen. The International Agency for Research on Cancer (IARC) classifies compounds into three categories based on their carcinogenicity: 1 – Carcinogenic to humans; 2A – Probably carcinogenic to humans; and 2B – Possibly carcinogenic to humans.
Bischlorobenzidine is a Category 2B carcinogen, and its carcinogenicity primarily occurs through the formation of adducts with nucleotides (DNA), leading to DNA mutagenesis. Polychlorinated biphenyls (PCBs) are highly bioaccumulative and difficult to biodegrade, significantly damaging the human endocrine system. Consequently, strict international regulations exist. The European Union prohibits the use of products containing PCBs exceeding 10 mg/kg; the United States prohibits the production, processing, sale, and use of products containing PCBs exceeding 25 mg/kg. The International Association for Research and Testing of Textile Ecology (Oske-Tex Standard 100 Special Technical Conditions for General Machines) stipulates that the content of 24 aromatic amines shall not exceed 20 mg/kg, and DCB is listed among them, see Table 1.
Tabel 1. Oeko-Tex Standard 100 mencantumkan 24 amina aromatik
Nomor seri
nama
Nomor CAS
Nomor seri
nama
Nomor CAS
1
4-Aminoaniline
92-67-1
13
3,3-Dimetil-4,4-diaminodifenilmetana
838-88-0
2
Benzidine
92-87-5
14
2-Metoksi-5-metilanilin
120-71-8
3
2-Methyl-4-benzidine
95-69-2
15
4,4-Methylenebis (o-chloroaniline)
101-14-4
4
2-Naphthylamine
91-59-8
16
4,4-Diaminodifenil eter
101-80-4
5
o-Aminoazotoluene
97-56-3
17
4,4-Diaminodifenil sulfida
139-65-1
6
2-Amino-4-nitrotoluidine
99-55-8
18
o-Benzylamine
95-53-4
7
p-Chloroaniline
106-47-8
19
2,4-Diaminotoluena
95-80-7
8
2,4-Diaminoanisole
615-05-4
20
2,4,5-Trimethylaniline
137-17-7
9
4,4-Diaminodifenilmetana
101-77-9
21
o-Anisidin
90-04-0
10
3,3-Dikloroanilin
91-94-1
22
2,4-Dimetilanilin
95-68-1
11
3,3-Dimethoxybenzidine
119-90-4
23
2,6-Dimetilanilin
87-62-7
12
3,3-Dimethylbenzidine
119-93-7
24
p-Aminoazobenzene
1960-9-3
Catatan: Kategori 1:Â Amina aromatik yang bersifat karsinogenik bagi manusia (4 jenis, 1 hingga 4);
 Kategori 2: Amina aromatik yang bersifat karsinogenik pada hewan dan mungkin bersifat karsinogenik pada manusia (20 jenis, 5 hingga 24).
Logam Berat dalam Pigmen Anorganik
Kecuali titanium dioksida, karbon hitam, dan biru laut, semua pigmen anorganik mengandung logam berat. Seperti zat lainnya, logam berat dianggap berbahaya bagi manusia dan lingkungan apabila berada di atas konsentrasi tertentu. Keberadaan logam berat lainnya tergantung pada jenis dan bentuk logam berat.
4.1 Logam Berat Kromium
Kromium oksida mengandung kromium trivalen atau heksavalen, dan efeknya sangat bervariasi. Senyawa kromium heksavalen (kromat) memiliki kecenderungan kuat untuk berubah menjadi senyawa kromium trivalen, melepaskan oksigen, sehingga menghasilkan efek pengoksidasi dan toksik yang kuat pada organisme. Senyawa ini 1.000 kali lebih beracun bagi manusia, hewan, dan tumbuhan daripada senyawa kromium trivalen.
Pigmen timbal kromat: Pigmen timbal kromat mengandung timbal dan kromium heksavalen, yang keduanya memiliki bahaya kronis. Timbal kromat adalah senyawa timbal dengan tingkat kelarutan rendah. Timbal terlarut ditemukan dalam asam klorida dan asam lambung pada konsentrasi yang menyebabkan akumulasi timbal dalam tubuh. Menelan timbal dalam jumlah besar dapat mengganggu sintesis hemoglobin. Sebagai tindakan pencegahan, Uni Eropa telah mengklasifikasikan timbal kromat sebagai karsinogen Kategori 3 (diduga berpotensi karsinogenik).
Hijau Pigmen Kromium Oksida Pigmen kromium oksida hijau hanya mengandung kromium trivalen. Dalam kondisi alami, tidak ada partikel kromium bebas yang dilepaskan dari pigmen kromium oksida hijau. Bahkan, dalam kondisi asam kuat (pH = 1-2), hanya sejumlah kecil (mg/kg) kromium (III) yang dilepaskan. Kromium (III) oksida hanya dapat dioksidasi menjadi kromium (VI) ketika dipanaskan, terutama dalam kondisi basa.
4.2 Logam Berat Kadmium
Cadmium pigments are compounds with low solubility, but are soluble in dilute acid (at concentrations equivalent to gastric acid). Long-term oral ingestion of cadmium pigments can cause accumulation in the body. The European Commission has classified cadmium sulfide as a Class III carcinogen, but cadmium pigments are not included.
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