The eSDScom Tool Chain
The following are the tasks, tools and resources we envision are useful with eSDScom today. Where standard solutions exist, we have listed the products.
- Use standard phrases: The eSDScom phrases are what this project recommends, but you can use any phrase catalogue for the SDS main body. (For EU exposure scenarios, industry agreed on an eSDScom phrase subset). The eSDScom phrase tool allows you to browse the standard phrase catalogue and request changes.
- Convert Safety Data Sheets from PDF into eSDScom: Several commercial solutions exist. Follow the workshops for more info.
- Edit/author eSDScom data: A simple editor is developed via GitHub, but currently stalled.
- Validate eSDScom: QualiVali or any standard XML software validates technically.
- Quality check eSDScom data: Also called content validation, this remains an expert task. To a certain degree, ECHA or ACEA requirements help with basic quality requirements. A content validation tool and its scope is under discussion.
- "Print" Safety Data Sheets: Currently, there is a stylesheet for version 4.4 and an SDBtransfer subset stylesheet for version 4.2. Stylesheets for 5.x are here.
- Create Operating Directives according to German law: The GisChem system allows to upload SDScom data to save effort in authoring of workplace specific directives.
Further tools are possible once XML exchange is widely used and downstream user exposure assessment methodology has developed, e.g. for scaling risk management measures when a substance becomes part of a mixture.
Further Resources and Glossary
The full wording of Abbreviations and Acronyms must be listed in section 16 of the SDS. Since this must cover all abbreviations/acronyms used in the specific SDS and still the SDs should be as concise as possible, this list of acronyms may not be complete (and contain too many entries at the same time). Also, a reference/link to this (or any other) list document is not sufficient for a compliant SDS.
List of Abbreviations and Acronyms (PDF, changed 2013)
REACH Annex II states for section 15.1: “Where relevant the national laws of the relevant Member States which implement these provisions and any other national measures that may be relevant shall be mentioned.”
The eSDScom project provides an overview file (XLSX, changed 11/2023) to cover these topics:
- Many safety data sheets of companies are not sufficiently complete in this section, as mostly only the relevant EU regulations are cited. The reason for this is probably that the information on national rules of the Member State concerned is not easy to find and understand for both SDS creators and content providers. Some Member States already provide specific information for national requirements (e.g. Germany in TRGS 220).
- In addition, problems with workplace limit values were identified in the SDS in section 8.1, as the SDS providers are unlikely to use the original sources, but often secondary databases that contain some errors or are not up-to-date at all.
- Section 1.4 requires an emergency telephone number. If an official advisory body exists in the Member State where the substance or mixture is placed on the market (this may be the body responsible for receiving health information in accordance with CLP Article 45), its telephone number shall be provided, which may be sufficient.
If you miss regulations and/or would like to give feedback on mistakes/change requests please send an email to info--at--esdscom.eu
The term „Exposure Frequency“ is not used in the test methods. Therefore, one should be careful when introducing an additional term, since the test methods already use several quite different terms to describe the situation:
A differentiation between exposure time (e.g. 6h/d) for inhalation and dermal tests compared to exposure duration (e.g. 2 years) makes sense in general.
Unlike in the past, 'Exposure duration' is now generally used in the test methods; Furthermore, descriptive terms such as subchronic duration (90 days), duration of the carcinogenicity phase, "duration of study," "12 month chronic toxicity study" and "period of dosing", "period of administration"...duration of the chronic phase, im German trial duration, duration of administration, then 'Dosing period and duration of chronic phase…'etc. used.
In reproductive studies, the term "exposure duration" is not used, instead:
- "Animals are dosed with the test chemical daily for 7 days a week", or "test chemicals are administered" (OECD 422), or "dosing is continued …during the mating period", or "animals are dosed with the chemical for 7days a week" (B.63 Reproduction…)
- "During the period of administration" (OECD 421), or "…the test substance is administered … from implantation to one day prior to the day of scheduled kill" (B.31-Prenatal DevelopmentalToxicity Study)
In summary, it can be said that the relevant designations are not used consistently in the OECD/EU test methods and also in the CLP Regulation and are also not defined in some cases.
Recommendation of usage in phrase catalogues
1. For carcinogenicity and other repeated dose studies:
Retain the previous text and add "n.a." (= not applicable) to the exposure time with regard to the oral route, while e.g. 6 h/d would be relevant for the inhalation and dermal route only.
Furthermore, e.g. daily or 5 times/w should be specified, in the case of inhalation or dermal exposure, also specify the time (e.g. 6 hours/day).
Alternatively, "Exposure time" could be omitted and only "Exposure duration/Frequency" or "Exposure duration/frequency" with the appropriate information on the duration (e.g. 18 m; lifetime) could be used. Furthermore, e.g. “daily” or “5 times per week” is to be specified, in the case of inhalation or dermal exposure also with time specification (e.g. 6 h/d).
This alternative structure was decided not be used in the eSDScom phrase catalogue.
2. For reproduction studies
The exposure duration and frequency of administration result from the test method, so this must be specified in any case, e.g. "Exposure/Administration according to B.123/OECD 123" or "Exposure/administration according to test method B.123/OECD 123", specifying any deviations from the standard; in the case of dermal and inhalation studies, however, there would also be an indication of the duration of the daily exposure (e.g. 6 hours/day) necessary.
Remarks
In many studies, the duration/frequency of administration/exposure results from the specifications of the test method (OECD or EU) and it is sufficient to indicate deviations from the standard.
It is correct that the current information in eSDScom on "Exposure time" and "Exposure duration" with time information of 1.2 year/s is not consistent and not generally applicable. (In the case of carcinogenicity, "a" (= annum) instead of "years" is used.)
The eSDScom Phrase Workgroup uses the following definitions:
- Product = can be an article, a mixture or a substance. Therefore this term should not be used in phrases. The appropriate specific term should be used.
- Material = can be an article, a mixture or a substance (in analogy to product). Therefore this term should not be used in phrases. The appropriate specific term should be used.
- Substance = used for any kind of a substance including UVCB, reaction mass and reaction products as well as for mono- and multi-constituent substances.
- Mixture = used for substances which are intentionally and physically mixed together without reacting.
- Article = used for objects which during production are given a special shape, function, surface or design which determines their functions to a greater degree than does their chemical composition. (For articles no SDS is required, but for borderline cases, the distinction between mixture and article might be difficult.)
Remark
eSDScom will be reworked to match those definitions consistently.
List of test methods (XLSX, changed 07/2019) applicable to CLP, including a reference to their mentioning