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Part II: Referencing Requirements for Toxicology Information from Publicly Available Sources to be Included in ADs and TPSs

1. LD₅₀/LC₅₀ and Skin/Eye Irritation/Corrosion Studies

1. Data resulting in a change in WHMIS classification
   
   When the LD₅₀/LC₅₀ values or eye/skin irritation results obtained from the literature will result in a change in WHMIS classification (e.g., from unclassified to D1B, D1B to D1A, or to Class E from Class D2B due to eye/skin corrosion), the following approach should be followed:
   
   
   • Use and reference the primary source if it is available on the CAS file; if it is not on the CAS file request primary source for the CAS file.
   • When the primary source is not available on the CAS file and cannot be obtained, reference at least two reliable secondary sources (i.e. those sources which reference the primary source for the data—see Appendix I for details). Add an italicized note explaining why the primary source is not available.
   
   If other applicable but unverifiable LD₅₀/LC₅₀ values or eye/skin irritation data exist for the chemical, and have not been used in preparing the AD, the rationale for the advice provided in the AD should be included in a brief note to the screening officer.



2. Data resulting in no change in WHMIS classification
   
   When the LD₅₀/LC₅₀ values or eye/skin irritation results obtained from the literature result in no change in WHMIS classification the following approach should be followed:
   
   
   • Use and reference the primary source if it is available on the CAS file; if it is not on the CAS file request primary source for the CAS file.
   • When the primary source is not available on the CAS file and cannot be obtained, reference at least one reliable secondary source (i.e., that source which references the primary source for the data—see Appendix I for details). Add an italicized note explaining why the primary source is not available.
   
   If other applicable but unverifiable LD₅₀/LC₅₀ values or eye/skin irritation data exist for the chemical, and have not been used in preparing the AD, the rationale for the advice provided in the AD should be included in a brief note to the screening officer.

2. Human Effects of Acute/Chronic Exposure (DISCLOSURE ONLY)

• Use and reference the primary source if it is available on the CAS file; if it is not on the CAS file request primary source for the CAS file.
• When the primary source is not available on the CAS file and cannot be obtained, reference at least one reliable secondary source (i.e., that source which references the primary source for the data—see Appendix I for details). Add an italicized note explaining why the primary source is not available.

3. All Other Toxicological Endpoints (except carcinogenicity)

1. Data resulting in a change in WHMIS classification
   
   When the study obtained from the literature will result in a change in WHMIS classification the following approach should be followed:
   • ALWAYS use and reference the primary source if it is available on the CAS file.
   • When the primary source is not available on the CAS file, request the primary source.
   • ONLY when the primary reference is not in the CAS file and it cannot be obtained, reference the advice to at least two reliable secondary sources (i.e., sources which reference the primary source and provide adequate information concerning the design, conduct and results of the study, such as: published review articles, IARC monographs, CRC Critical Reviews in Toxicology, WHO or IPCS Reports, EPA or ATSDR Reports, or other highly reputable sources). Add an italicized note explaining why the primary source is not available.
2. Data resulting in no change in WHMIS classification
   
   When the study obtained from the literature will not result in a change in WHMIS classification the following approach should be followed:
   • ALWAYS use and reference the primary source if it is available on the CAS file.
   • When the primary source is not available on the CAS file, request the primary source for the CAS file.
   • ONLY when the primary reference is not in the CAS file and it cannot be obtained, reference the advice to at least one reliable secondary source (i.e., source which references the primary source and provides adequate information concerning the design, conduct and results of the study, such as: published review articles, IARC monographs, CRC Critical Reviews in Toxicology, WHO or IPCS Reports, EPA or ATSDR Reports or other highly reputable sources). Add an italicized note explaining why the primary source is not available.