16.3. Key Literature References and Sources for Data

This section identifies the primary sources of information used to compile the Safety Data Sheet. It provides transparency about the origin of hazard, toxicological, ecological, and regulatory data, allowing users to verify information and consult original sources if needed.

Purpose and Importance

Citing key literature references and data sources in a Safety Data Sheet serves several important functions:

Transparency

Provides clarity about where information originated, allowing users to assess its reliability and credibility.

Traceability

Enables users to trace information back to its source for verification or to obtain additional details.

Compliance

Meets regulatory requirements for documenting the basis of hazard classifications and safety recommendations.

Scientific Integrity

Demonstrates that the SDS is based on credible scientific evidence and authoritative sources.

Regulatory Requirements

According to the Globally Harmonized System (GHS) and regulations such as REACH in the EU and HazCom in the US, Safety Data Sheets should include references to the key literature and sources of data used to compile the SDS. This information helps users understand the basis for hazard classifications and safety recommendations.

Types of References and Data Sources

Regulatory Sources

Source Type	Examples	Information Provided
Chemical Inventories	REACH Registration Dossiers ECHA C&L Inventory US EPA TSCA Inventory Canadian DSL/NDSL Australian AICS	Official regulatory status, harmonized classifications, registered uses, and restrictions
Regulatory Guidance	ECHA Guidance Documents OSHA Technical Manuals EPA Test Guidelines OECD Test Guidelines	Official interpretation of regulations, testing methodologies, and classification criteria
Exposure Limits	ACGIH TLV Documentation NIOSH Pocket Guide to Chemical Hazards EU SCOEL Recommendations German MAK Values	Occupational exposure limits, biological exposure indices, and their scientific basis
Transport Regulations	UN Recommendations on the Transport of Dangerous Goods IMDG Code IATA Dangerous Goods Regulations ADR/RID Regulations	Transport classifications, packaging requirements, and special provisions

Scientific Literature

Source Type	Examples	Information Provided
Toxicological Databases	TOXNET RTECS (Registry of Toxic Effects of Chemical Substances) HSDB (Hazardous Substances Data Bank) IRIS (Integrated Risk Information System)	Comprehensive toxicological data, health effects, and risk assessments
Peer-Reviewed Journals	Journal of Hazardous Materials Toxicology Letters Environmental Toxicology and Chemistry Chemical Research in Toxicology	Original research on toxicological properties, environmental fate, and exposure effects
Ecotoxicological Databases	ECOTOX Database OECD SIDS Initial Assessment Reports ECETOC Technical Reports GESAMP Reports and Studies	Environmental fate and behavior, aquatic toxicity, and bioaccumulation data
Reference Books	Patty's Toxicology Casarett and Doull's Toxicology Handbook of Chemistry and Physics Bretherick's Handbook of Reactive Chemical Hazards	Authoritative compilations of chemical properties, toxicological data, and safety information

Industry Sources

Source Type	Examples	Information Provided
Manufacturer Data	Technical Data Sheets Product Specifications Internal Testing Reports Chemical Safety Reports	Specific information about composition, properties, and recommended uses
Industry Associations	American Chemistry Council European Chemical Industry Council (CEFIC) International Council of Chemical Associations (ICCA) Sector-specific associations (e.g., petroleum, coatings)	Industry standards, best practices, and collective research
Supplier Information	Supplier Safety Data Sheets Raw Material Specifications Quality Control Data Technical Support Documentation	Information about components, impurities, and manufacturing processes
Testing Laboratories	GLP Study Reports Accredited Laboratory Test Results Physical Property Determinations Analytical Method Validations	Experimental data on physical, chemical, toxicological, and ecotoxicological properties

International Organizations

Source Type	Examples	Information Provided
United Nations	GHS (Globally Harmonized System) UN Model Regulations for Transport UNEP Publications IPCS (International Programme on Chemical Safety)	International standards for classification, labeling, and safe management of chemicals
World Health Organization	Environmental Health Criteria IARC Monographs on Carcinogenic Risks WHO Guidelines for Drinking-water Quality WHO Air Quality Guidelines	Health-based evaluations, cancer classifications, and exposure guidelines
OECD	OECD Guidelines for Testing of Chemicals OECD Screening Information Data Sets (SIDS) OECD Existing Chemicals Database OECD eChemPortal	Standardized test methods, chemical assessments, and data sharing
ILO	International Chemical Safety Cards ILO Encyclopaedia of Occupational Health and Safety Code of Practice on Safety in the Use of Chemicals at Work	Workplace safety information, chemical hazard summaries, and occupational health guidance

Example of Section 16.3 Content

16.3 Key Literature References and Sources for Data

Information in this Safety Data Sheet was obtained from the following sources:

Regulatory Information:

REACH Registration Dossier for the substance (Registration No. 01-2119456816-28-XXXX)
European Chemicals Agency (ECHA) C&L Inventory Database
EU CLP Regulation (EC) No 1272/2008, including all amendments
US OSHA Hazard Communication Standard (29 CFR 1910.1200)

Toxicological and Ecotoxicological Data:

ECHA Brief Profile for the substance
TOXNET Hazardous Substances Data Bank (HSDB)
RTECS (Registry of Toxic Effects of Chemical Substances)
OECD SIDS Initial Assessment Report (2008)
US EPA ECOTOX Database

Physical and Chemical Properties:

Manufacturer's technical data sheet (2023)
CRC Handbook of Chemistry and Physics, 103rd Edition
Internal laboratory test reports (Report No. 2023-PT-157)

Transport Information:

UN Recommendations on the Transport of Dangerous Goods, 22nd Revised Edition
International Maritime Dangerous Goods (IMDG) Code, 2022 Edition
IATA Dangerous Goods Regulations, 64th Edition

Exposure Controls and Personal Protection:

ACGIH Threshold Limit Values and Biological Exposure Indices, 2023 Edition
NIOSH Pocket Guide to Chemical Hazards
EU Scientific Committee on Occupational Exposure Limits (SCOEL) Recommendations

Methods and Evaluation:

GHS Classification according to the criteria of Regulation (EC) No 1272/2008
Calculation methods for mixture classification as per GHS Rev. 9 (2021)
Expert judgment and weight of evidence determination

Common Issues with Literature References in SDSs

When preparing or reviewing Section 16.3 of an SDS, be aware of these common issues:

Generic references without specific citations (e.g., "literature data" without details)
Outdated references that do not reflect current scientific knowledge
Inconsistency between cited sources and information presented in the SDS
Overreliance on secondary sources rather than primary literature
Failure to cite sources for critical hazard classifications or safety recommendations
Lack of transparency about data gaps or conflicting information
Missing references for key regulatory determinations

Best Practices for Section 16.3

Provide specific, traceable references rather than generic statements
Include publication dates or version numbers for cited sources
Organize references by category (regulatory, toxicological, physical properties, etc.)
Cite the most current and authoritative sources available
Include registration numbers or other identifiers for regulatory references
Specify which sections of the SDS are based on which sources
Update references when new information becomes available
Include both mandatory regulatory sources and supporting scientific literature
Provide sufficient detail to allow users to locate the original sources if needed

Important: The quality and reliability of a Safety Data Sheet depend significantly on the quality of the sources used to compile it. Using current, authoritative, and peer-reviewed sources helps ensure that the hazard information and safety recommendations are accurate and scientifically sound. Regular review and updating of references are essential as new information becomes available and regulations evolve.