GB30000.25-2013

Rules for classification and labelling of chemicals - Part 25: Specific target organ toxicity - Single exposure

化学品分类和标签规范第25部分: 特异性靶器官毒性一次接触

GB 30000.25-2013 は現行の中国強制国家規格です：Rules for classification and labelling of chemicals - Part 25: Specific target organ toxicity - Single exposure。業界：電子。テーマ：表示・分類。施行日：2014年11月1日。

適用可否は製品範囲、認証ルート、所管当局の通知、移行規定によって異なります。コンプライアンス判断に使う前に、翻訳をご依頼いただくか公式情報源をご確認ください。

コンプライアンス概要

この概要は現在英語のみで提供しています。

適用範囲

This standard applies to the classification and labeling of chemicals exhibiting specific target organ toxicity (single exposure) in accordance with the UN Globally Harmonized System (GHS). It is relevant for chemical manufacturers, importers, and downstream users dealing with substances and mixtures that may cause non-lethal target organ toxicity upon a single exposure. It does not cover repeated exposure toxicity or other specific toxic effects like acute toxicity or carcinogenicity, which are addressed in separate parts of the GB 30000 series.

技術要求

GB 30000.25-2013 establishes the mandatory classification criteria and labeling requirements for chemicals causing specific target organ toxicity from a single exposure. The standard classifies substances into three categories based on the weight of evidence from human and animal data. Category 1 and Category 2 cover substances that have produced significant toxic effects in humans or are presumed to do so based on animal studies, utilizing specific guidance values for dose/concentration assessment. Manufacturers must determine the specific affected organs and the route of exposure for accurate classification. A notable addition in this version is Category 3, which addresses transient target organ effects, specifically respiratory tract irritation and narcotic effects. For mixtures, the standard provides classification rules using test data for the mixture itself, or through the application of bridging principles (such as dilution, batch concentration, and substantially similar mixtures) when whole mixture data is lacking. When bridging principles cannot be applied, mixtures are classified based on the concentration limits of their classified components. The standard specifies threshold values (e.g., ≥1.0% or ≥10%) for Category 1 and Category 2 components to determine if the mixture itself requires classification. Suppliers must ensure that Safety Data Sheets (SDS) and labels reflect these classifications accurately. Labeling requirements mandate the use of specific hazard pictograms, signal words (Danger or Warning), and hazard statements. For instance, Category 1 requires the signal word 'Danger' and the health hazard pictogram, while Categories 2 and 3 require 'Warning'. The standard also details precautionary statements covering general, prevention, response, storage, and disposal measures.

試験方法

The standard does not prescribe specific new animal test methods but relies on evaluating existing data. Classification is primarily based on human experience (e.g., epidemiological studies, case reports) and experimental animal studies (typically acute toxicity studies in rats or mice). The evaluation involves clinical observations, macroscopic and microscopic pathology, and biochemical/hematological parameter changes. Expert judgment and weight-of-evidence assessments are critical when interpreting these data.

よくある質問

What products are regulated under GB 30000.25-2013?

It regulates chemical substances and mixtures that may cause specific, non-lethal target organ toxicity following a single exposure via oral, dermal, or inhalation routes.

What is the difference between Category 1/2 and Category 3 in this standard?

Categories 1 and 2 cover significant or presumed significant toxic effects based on human/animal data. Category 3 is a newer addition covering transient effects, specifically respiratory tract irritation and narcotic effects, which do not meet the criteria for Categories 1 or 2.

Is GB 30000.25-2013 mandatory?

Yes, Chapters 5 and 7 regarding classification criteria and labeling are mandatory, while the rest of the standard is recommended.

The summary above provides a high-level overview of GB 30000.25-2013. To ensure complete compliance for your chemical products entering the Chinese market, a precise and professional translation of the full technical specifications is essential. Purchase our high-quality English translation of GB 30000.25-2013 today to access all detailed parameters, classification tables, and labeling procedures.

適用のヒント

種別: 基礎
CCS: A80
所管部門: Ministry of Industry and Information Technology
技術委員会: Ministry of Industry and Information Technology