Hazard Classification

1A. How do I determine the hazard(s) and Hazard statement(s) of a mixture?

• • For US manufacturers, OSHA provides some guidance on this topic, including definitions of health and physical hazards. As of January 2019, OSHA has not adopted the environmental hazard classes.

    • Consult Appendix A TO §1910.1200—Health Hazard Criteria (Mandatory) and APPENDIX B TO §1910.1200—PHYSICAL CRITERIA (MANDATORY)

    • Note that OSHA's classification procedures is closely, but not entirely in alignment with United Nations system. One notable difference is that OSHA did not adopt Category 5 for acute toxicity, only Categories 1-4. This table summarizes some additional differences.

    • Here is OSHA publication "Hazard Classification Guidance for Manufacturers, Importers, and Employers"

  • For manufacturers outside of the US, consult your country's laws and regulations. Most countries have adopted a version of the United Nations GHS Standard.

    • Here is a link to "Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Sixth revised edition"

  • SDScribe™ includes a "Suggestion" button under the Hazard table in the 2. Hazard tab. This report may assist you in determining health hazard(s) of a mixture. Physical hazards require laboratory testing and/or technical knowledge.

    • We recommend watching our video on the topic (report starts at 3:24). A certain technical knowledge may be necessary to understand how to interpret this report. Watch the two videos below for more information. The second video includes new enhanced functionality you will find in SDScribe 2016.

1B. I need to produce an SDS with an aquatic toxicity category, but the software does not allow me to select this category. I have set the GHS standard to US. I don’t even see it on the list. Please help.

Good question. Since the environmental hazards are not part of the US GHS standard, you will need to select a different standard, such as UN or EU which includes the environmental hazards in their standard. Once selected, you should be able to find and add the GHS hazards and associated H and P statements. See the image below.

2. Is there a list of GHS hazard classes, Hazard statements, and Precautionary statements:

• • Here are some basic definitions and lists.

    • Classifications

    • Hazard statements

    • Precautionary statements

    • Pictograms

    • Please refer to OSHA or your country's regulations for more details.

3. Are there any websites which I can use to help me classify my chemicals?

• • We have a Web search dropdown that you can use.

  • One of the resources is: ECHA (European Chemicals Agency)

  • Search by CAS or chemical name. Includes classification data submitted by manufacturers

4. Are there any governmental lists of agreed upon hazard classifications of chemicals?

• • The ECHA has a list of over 4000 chemicals which European Union manufacturers have agreed upon. This is commonly referred to as Table 3.1 of Annex VI

  • You can access the classifications by searching at ECHA

5A. I am trying to understand how to do an acute toxicity estimate for a mixture. Are there any examples I can see?

• • Here is a link that shows an example on the last two pages

Component acute toxicity measurements (on the "Toxicological table" tab of the linked Substance record).

If measured values are present for a component, the program will use those values in preference to acute toxicity classifications.

The report calculates an acute toxicity point estimate for the product as a whole (ATE_mix), using one of two equations:

· For components with unknown acute toxicity totaling less than 10 percent

ATE_mix = 100 / ∑ (C_i/ATE_i)

· For components with unknown acute toxicity totaling at or above 10 percent

ATE_mix = (100-∑ C_unknown)/ ∑ (C_i/ATE_i)

In these equations, C_i is the concentration for any individual component. C_unknown is the concentration of a component with unknown acute toxicity. ATE_i is the toxicity point value or experimental measurement for a component. The report performs the calculations separately for the different routes of exposure (oral, dermal, inhalation of gas, inhalation of vapor, and inhalation of dusts-mists).

Lookup tables then enable the program to identify the appropriate acute toxicity classification for each route of exposure, from the calculated ATE_mix values.

Where the Suggestion report has performed acute toxicity calculations of this type, the ATE_mix values appear in the summary section at the top of the report. Details of the calculations, including intermediate values, appear further down, in the body of the report.

If the user checks the second box on the "Suggestions…" dialog ("Also add corresponding H-/P-statements, pictograms, and acute toxicity estimates (ATEs)"), the program will place the calculated ATE_mix values into the Acute toxicity field, on the "11.1 Toxicological" tab.^[6]

6. I noticed that aspiration hazard depends on the kinematic viscosity. What is this?

• • Kinematic viscosity is a fluid’s resistance to flow under the influence of gravity, thus the higher the kinematic viscosity, the more viscous the material. The units of measure should be mm2/s.

7. (From OSHA letter) Is the "unknown acute toxicity" statement only required when there is no acute toxicity information on all routes of exposure (oral, dermal, and inhalation)? For example, if the acute toxicity values are available for the acute oral and dermal exposure for an ingredient and the acute inhalation toxicity data is missing, should a statement of "X% of mixture consists of ingredient(s) of unknown acute inhalation toxicity" be included in section 2 of the SDS?

• • The unknown acute toxicity statement is only required on the label and the SDS where the chemical mixture is already classified as acutely toxic for a particular route of exposure, and there are one or more other "relevant ingredients" (as defined under 29 CFR 1910.1200, Appendix A, A.1.3.3) of unknown acute toxicity for that particular route. The approach in HCS 2012 for classifying mixtures for acute toxicity is tiered, and is dependent on the amount of information available for the mixture itself and for its ingredients. See A.1.3.1. Where the mixture has been tested to determine its acute toxicity, it is classified according to the criteria provided in Table A.1.1. See A.1.3.4. If there is no acute toxicity data for the mixture, A.1.3.5 requires that classification be based on bridging principles. If bridging principles cannot be applied, classification is based on the ingredients of the mixture. See A.1.3.6. Where there is data for all ingredients, an acute toxicity estimate (ATE) is followed, per A.1.3.6.1. (for complete answer see From OSHA letter)

8. How do I determine what, if any, signal word to include?

• • The hazard category determines the applicable signal word (i.e., Danger or Warning or none). So first classify the substance or mixture. Here is a link https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10102 to OSHA’s guidance on assigning the signal word. I also attached a screen shot (below) which illustrates the associated Signal word for eye damage/irritation hazard classes.

  • Is there any way to predict flammability just based on the constituents and their flammability?

  • Good question. Some website list flash points of common mixtures (e.g., ethanol and water). The definitive way is to have it tested by a lab using an approved method.

  • In general the Department of Transportation assigned hazard class(es) should also give an indication of characteristics, such as flammability. You will want to make sure your GHS and DOT classifications are consistent.

9. Is there any way to predict flammability just based on the constituents and their flammability?

• • Good question. Some website list flash points of common mixtures (e.g., ethanol and water). Here is a technical paper providing other examples (e.g., alcohols, methanol). The definitive way is to have it tested by a lab using an approved method.

  • In general the Department of Transportation assigned hazard class(es) should also give an indication of characteristics, such as flammability. You will want to make sure your GHS and DOT classifications are consistent.

10. Can you please walk me through the steps to go from obtaining LD50 oral and dermal values to assigning the acute hazard categories for a Substance?

• • Sure. Please watch this video which shows 1) how to obtain LD50 values from TOXNET; 2) how to populate the Toxicity table with the toxicity values; and 3) How to assign a GHS acute toxicity category based on the LD50 values.