田寮港漫遊

縮寫／名詞

解釋／定義

來　源

AE

評估要件

Assessment element. A critical scientific aspect of a read-across to be assessed. It is assessed through a number of questions to be answered. These AEs are described in data sheets that are compiled in the annex to this document.

指在一個交叉參照過程中，須透過一系列問題予以評估的關鍵科學面向。評估要件須以本文件附錄中的標準文件格式編寫。

Analogue approach

近似物交叉參照法

The term analogue approach is used when read-across is employed between a few, very structurally similar substances for which it is not possible to establish a trend or a regular pattern. As a result of the structural similarity, a given (toxicological or other) property of one substance (the source) is used to predict the same property for another substance (the target), for which this property is not available but is needed to fulfil a REACH information requirement. The outcome of a study conducted with the source substance is read-across for all investigated parameters to the target substance. A worst-case approach may also be used.

「近似物交叉參照法」這個名詞運用在當利用交叉參照法對一小群具有高度結構相似度的化學物質，而這群物質彼此間又難以釐清出明顯趨勢或是規律模式時。基於這些物質間的結構相似性，當為滿足REACH資訊需求而必須填寫某項化學物質（化學物質B）的某項特性，但實務上卻無法取得相關資料時，可利用群組中一個化學物質A（源頭物質）的一個給定特性（毒性或其他特性），來預測推估群組中另一個化學物質B（目標物質）也具有相同特性。此時對源頭物質的研究結果可以交叉參照法應用至目標物質的各個參數上，同時也可利用「最糟情境法」（Worst-case Approach）進行推估。

AO

評估選項

Assessment option. A verbal descriptor reflecting the opinion of the assessor on the information provided to cover the aspect addressed by an assessment element.

評估選項。反應評估者對所提供的資訊是否滿足評估要件中各個面向的口頭描述。

Applicability domain

適用領域

The set of inclusion/exclusion rules that identify the ranges of values within which a reliable prediction can be made for category members.

一組用以鑑別數據範圍是否可被接受或排除的規則，用以對同一群組中的多個化學物質產出可信賴的預測推估。

Bias

偏差

Three types of bias are addressed in the RAAF:

1. Analogue substance selection. Information from (an)other suitable analogue substance(s) which is significantly different for relevant property(ies), and thereby reduce confidence in the proposed prediction.

2. Study selection. Information from other studies than the one proposed to be used as source study, which give rise to a higher concern.

3. Independent variable. The results of the measurement or estimation for the independent variable used to describe a regular pattern are systematically and inappropriately altered in category members with certain structural features. This may have an influence on the prediction.

化學物質交叉參照評定架構（RAAF）中提出了三項重要的偏差來源：

1. 近似物選擇偏差：來自其他適當近似物的資訊，在相對應的特性上有顯著的差異，因此降低了目前所提出的推估預測的可信度。
2. 研究選擇：來自其他研究的結果，比現有研究資料來源顯示出更高的關注性。
3. 獨立變項：對具有相當結構特徵的一個群組中化學物質，其中用以描述一個規律模式之獨立變項的測量或估計結果，發生系統性且不適當的改變，將對預測推估結果產生影響。

(Bio)transformation

（生物）轉型

A series of chemical changes in a compound as a result of enzymatic or other activity in a living organism. The term “transformation” used for environmental endpoints refers to abiotic and biotic degradation.

化合物因酵素或其他生物活動所導致的一系列化學變化，而當在「轉型」這個詞彙使用在環境測試終點時，可指非生物性或生物性的降解。

Category approach

群組比對法

The term category approach is used when read-across is employed between several substances that have structural similarity. These substances are grouped together based on defined structural similarity and differences between the substances. As a result of the structural similarity, one or more (toxicological or other) properties are proposed to be similar or to follow a regular pattern. The predictions are made within the group for the target substance(s) based on the observed regular pattern. Alternatively, the prediction is based on a read-across from a category member in a conservative manner (worst case).

「群組比對法」這個詞彙用於描述在數個具有結構相似性的化學物質之間進行交叉參照。這些化學物質先透過特定的結構相似性與差異性特徵，分類為一個群組。由於結構上的相似性，可以推測這個群組中的化學物質，彼此間的一個或多個特性（例如：毒性）會相同或是遵循某一個固定的模式。此外，預測推估結果是基於同一個群組多個化學物質間以較保守的態度進行（最糟情境）。

Category definition

群組定義

The category definition includes a category hypothesis, description of the applicability domain of the category (category description) and details on the identity and purity/impurity profiles of the category members.

「群組定義」包括一個有關該群組的假說、對該群組定義適用性領域的描述（群組描述），以及有關該群組成員化學物質的鑑定、純化物／不純物的詳細說明。

Category description

群組描述

The category description describes the applicability domain (or boundaries) of the category and clearly identifies which substances can be part of the category and which not.

「群組描述」係描述該群組的適用領域（或適用界線），同時可以清楚界定那些化學物質可被歸入該群組而那些不能。

Category hypothesis

群組假說

Explanation as to why property(ies) of category members may be predicted from reference substances within the category. This explanation must be based on a relationship between structural similarity and the predicted property(ies).

解釋為何某一群組中的成員可以由該群組中的某化學物質預測推估具有一個或多個特性，此解釋必須基於結構相似性及所預測推估的一個或多個特性間的連結性。

Category justification

群組鑑定

Reasoning and associated supporting evidence that are provided to verify the scientific validity and robustness of the category hypothesis.

對所提供用以驗證科學上合法性以及群組假說強固性的支持性證據，進行推理與連結。

Data matrix

資料陣列

A table that summarises all available study results of the source and target substances per REACH information requirement/endpoint and including planned studies. The data should be arranged to reflect the regular pattern identified and used in the prediction. The IUCLID dossier should contain (robust) study summaries of each study referred to in the data matrix to allow an independent assessment of the data.

針對每一項REACH資訊需求或測試終點彙整一張總結表，該表需彙整當下所有針對源頭與目標化學物質可取得的研究結果，同時包含計畫中的研究。資料須經整理以有效呈現已被辨認出、且被運用於預測推估的規律模式。IUCLID紀錄應包含資料陣列中每項研究的（堅實的）研究結果，以利對資料進行獨立評估。

Fate

化學物質環境生命週期

Distribution of a chemical in various environmental compartments (e.g. soil or sediment, water, air, biota) as a result of transport, partitioning, transformation, and degradation. In the RAAF, fate properties are used to indicate REACH standard information requirements related to fate (e.g. bioaccumulation, hydrolysis, biodegradation)

化學物質因運輸、分割、轉型、降解等作用，在不同環境成分（例如：土壤、底泥、水、空氣、生物體）中的流佈。在化學物質交叉參照評定架構（RAAF）中，化學物質環境生命週期特性被運用於表明REACH標準資訊需求與化學物質環境生命週期間（生物聚積、水解、生物降解）的關聯。

Group

組

Under REACH, substances that are structurally similar with physicochemical, toxicological, ecotoxicological and/or environmental fate properties that are likely to be similar or to follow a regular pattern may be considered as a group of substances. Within a group of substances, a data gap might be filled by read-across, as described below.

在REACH架構下，結構相似的化學物質若其物理化學性質、毒理性質、生態毒性、及／或環境生命週期等特性相似或彼此間遵循某一規律模式者，可被視為一組化學物質。在同一組化學物質中，可利用交叉參照法補足資訊缺口。

Mono-constituent substance

單一成分物質

A mono-constituent substance is a substance, defined by its quantitative composition, in which one main constituent is present to at least 80 % (w/w).

「單一成分物質」是由其內含成分比例定義，當物質中單一主要成分其重量百分比在80%以上時，可定義為單一成分物質。

Non-common compound

非相同化合物

This term encompasses the structurally different compounds formed through (bio)transformation of the source and target substances, including intermediates formed during the (bio)transformation.

此名詞包含自源頭物質至目標物質間（生物）轉型過程中結構相異的各個化合物形式，並包含（生物）轉型過程中的中間體。

Order within the category

群組內級數

To predict a property within a category of substances, an order has to be established among the category members. As structural similarity is the basis for read-across under REACH this order has to be based on a variable directly linked to the allowed structural differences in the group (e.g. the number of carbon atoms in a side chain or a suitable physical chemical property).

為預測推估某一群組內物質之特性，應建立該群組各成員間的群組內級數。結構相似性是REACH架構下交叉參照的基礎，群組內級數必須基於直接連結至該群組化學物質間已被確認的結構差異而建立的變數上（例如：支鏈上的碳原子數目或一適當的物理化學特性）。

Prediction

預測推估

In the context of read-across, the property of target substance(s) is estimated from the property of source substance(s). The prediction may be made by means of read-across or by observation of a regular pattern.

於交叉參照之文本中，目標物質之特性係自源頭物質特性推估而得。此預測推估結果可藉由交叉參照而得，或透過觀察規律模式獲致。

Prediction of absence of effect(s)

效應缺失預測推估

This term refers to the situation where no effects have been observed in a source study and this result, i.e. absence of effect(s), is read-across to a target substance. This situation is also often referred to as “negative read-across”.

此名詞意指當自來源研究中無法觀察到效果，而相關結果（例如：效應缺失）是透過交叉參照法得到目標物質相關資訊。此情況也被歸至於「負向交叉參照」。

Property

特性

In the context of this document, property is considered to refer to inherent characteristics of the substance, which can be studied in a defined experimental study type. These characteristics may relate to physico-chemical, environmental fate or (exo)toxicological aspects. The properties of a substance can be determined from the results of experimental studies.

於本文件中，「特性」是化學物質本質上的特徵，可藉由特定的實驗方式獲得。這些特徵可與物理化學物質、環境生命週期或（環境）毒性等面向相關。化學物質的特性是由實驗結果決定。

REACH

Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals

Read-across

交叉參照

Under REACH, read-across is a technique for predicting endpoint information for one substance (target substance), by using data from the same endpoint from (an)other substance(s), (source substance(s)). Consequently, the read-across approach has to be considered as property-specific.

在REACH架構下，交叉參照是一種利用其他化學物質（源頭物質）測試終點資訊，推估預測化學物質（目標物質）測試終點資訊的技術。必須非常清楚認識到，交叉參照法依化學物質特性具有高度專一性。

Read-across approach

交叉參照法

A read-across approach, either analogue or category approaches, is composed of elements addressing the structural similarity, a read-across hypothesis, a read-across justification and the prediction of property(ies) of the target substance(s).

交叉參照法，無論是近似物交叉參照或群組比對，都是由結構相似性、交叉參照假說、交叉參照鑑定以及目標物質特性預測推估等四個基礎要件構成。

Read-across hypothesis

交叉參照假說

Hypothesis on the basis of which property(ies) of target substance(s) may be predicted from source substance(s). This hypothesis must be based on a relationship between structural similarity and the predicted property(ies) and needs to be supported by read-across justification.

有關可藉由源頭物質特性預測推估目標物質之假說。假說必須基於化學物質之結構相似性與待預測推估之特性等二者間的關係，同時交叉參照鑑定結果必須能支持此假說。

Read-across justification

交叉參照鑑定

The reasoning and associated supporting evidence that are provided to verify the scientific validity and robustness of the read-across hypothesis.

對用以驗證交叉參照假說的科學支持證據，進行推理與連結。

Regular pattern

規律模式

A regular pattern refers to the observation of regular behavior in a property among the category members. This can consist of no observed differences in a property across the category or in a regular change in that property across the category.

規律模式指同一類組成員間在某特性上表現出固定行為，這種固定行為可以是群組成員間在某個特性上沒有可被觀察到的差異，或在某個特性上表現出固定的變化。

Supporting evidence

支持性證據

Any scientific evidence provided to support the read-across hypothesis. Such supporting evidence may be, for example, information on the toxicokinetic properties of the substances, information from valid (Q)SARs, in vitro or in vivo experimental data addressing specific aspects of the read-across hypothesis.

任何供作支持交叉參照假說的科學證據。這些證據可為化學物質的毒理動力學特性、來自有效(Q)SARs資訊或生物體內外實驗結果等可支持交叉參照假說特殊面向者。

Test material

測試物質

The substance actually tested in the source study(ies). The identity and composition (including impurities) of this test substance should be representative of the source substance described in the read-across hypothesis.

來源研究中確實測試過的物質，此測試物質的鑑定結果與組成（含不純物）確實可代表交叉參照假說中描述的源頭物質。

Transformation

轉型

A series of chemical changes in a compound as a result of biotic or abiotic degradation.

化合物經生物或非生物性降解過程中的一系列化學變化。

UVCB

Substances of Unknown or Variable composition, Complex reaction products or Biological materials.

未知物質、變動組成物質、複雜反應產物或生物性材料

Worst-case approach

最糟情境法

The strength of effect(s) in the target substance is actually expected to be lower than the strength of effect(s) observed for the source substance; therefore, using the value obtained from the source substance, the prediction constitutes a worst case that will not lead to an underestimation of the effects that would be observed in a study with the target substance if it were to be conducted.

目標物質之效果可預期較源頭物質效果更糟，是故以「最糟情境法」利用源頭物質觀測數據進行預測推估時，目標物質的預測推估結果須較實際對目標物質實施研究後可能得到的結果更糟。