SDS section 11 of 16
SDS Section 11: Toxicological information
Section 11 documents the health effects of the product and the evidence behind them. It describes likely routes of exposure, symptoms, delayed and chronic effects, numerical toxicity measures such as LD50 and LC50 values, and whether the chemical is listed as a carcinogen by the National Toxicology Program, IARC or OSHA. It explains why the product has the health classification in Section 2.
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What OSHA requires in Section 11
OSHA enforces the content of Section 11 under the Hazard Communication Standard.
Appendix D requires Section 11 to describe the toxicological (health) effects and the data used to identify them, including:
- Information on the likely routes of exposure (inhalation, ingestion, skin and eye contact).
- Symptoms related to the physical, chemical and toxicological characteristics.
- Delayed and immediate effects and chronic effects from short- and long-term exposure.
- Numerical measures of toxicity (such as acute toxicity estimates) where available.
- Interactive effects, if relevant and readily available.
- Whether the chemical is listed in the National Toxicology Program (NTP) Report on Carcinogens or has been found to be a potential carcinogen in the IARC Monographs, or by OSHA.
- Where chemical-specific data are not available, a statement that alternative information is used and the method used to derive it.
GHS Annex 4 and international differences
GHS Annex 4 organizes Section 11 around the health hazard classes: acute toxicity, skin corrosion/irritation, serious eye damage/irritation, respiratory or skin sensitization, germ cell mutagenicity, carcinogenicity, reproductive toxicity, specific target organ toxicity (single and repeated exposure) and aspiration hazard. It recommends a statement for each class, even if only to say "not classified" or "data not available", so readers can tell the difference between "tested and negative" and "never evaluated".
Understanding the numbers helps. Our guide to LD50 and LC50 explains what they measure and why a lower number means higher acute toxicity, and the glossary has entries for LD50.
What to look for and red flags
What to look for
- Acute toxicity values by route (oral, dermal, inhalation), with species and unit. Compare like with like.
- Irritation and sensitization findings. Sensitizers can cause reactions at very low exposures after the first sensitization.
- Chronic effects: carcinogenicity, mutagenicity and reproductive toxicity statements and the authorities that evaluated them.
- Target organs for repeated exposure.
- Data source. Is the value measured on the product, on an ingredient, or extrapolated from similar substances?
Red flags
- "No data available" across the board for a substance known to be toxic.
- Toxicity numbers without species, route or unit.
- Section 2 lists a serious health hazard but Section 11 provides no supporting data or explanation.
- Cancer or reproductive hazard listings that are missing for a substance with well-documented concerns.
Worked example: typical fields
An illustrative layout. The real values and sources for substances are on chemical pages such as methanol's toxicology section.
- Routes of exposure
- Inhalation, skin contact, eye contact, ingestion
- Acute toxicity
- LD50 (oral, dermal) or LC50 (inhalation) with species, unit and duration
- Skin / eye effects
- Irritant, corrosive or not classified, with the basis
- Sensitization
- Respiratory or skin sensitizer, or no evidence
- Carcinogenicity
- Listing status in IARC, NTP and OSHA, or not listed
- Repeated exposure
- Target organs and effects after prolonged exposure
See how this looks on a real page: methanol safety data, toxicological information section. Every chemical page uses these 16 sections with the same anchors, so you can compare any substance.
Common mistakes
- Comparing LD50s across routes. An oral LD50 and an inhalation LC50 are not interchangeable.
- Reading a high LD50 as "safe". Chronic, irritant and sensitizing effects are not captured by acute lethality tests.
- Missing the delayed effect. Some effects appear days or years later.
- Assuming animal data is meaningless. It is imperfect but is the basis for most classification and exposure limits.
- Ignoring mixture toxicity. Where only ingredient data is available, the product's toxicity is estimated by calculation, which should be stated.
Frequently asked questions
What does Section 11 of an SDS cover?
Section 11 describes the health effects of the product: routes of exposure, symptoms, acute and chronic effects, numerical toxicity data such as LD50 and LC50, and carcinogen listings by NTP, IARC and OSHA.
What does LD50 mean?
LD50 is the dose that is lethal to half of a group of test animals under stated conditions, usually given in mg per kg of body weight. A lower LD50 indicates higher acute toxicity.
Is 'not classified' the same as 'safe'?
No. 'Not classified' means the criteria for a hazard category were not met on the available data. It does not guarantee that the product is harmless, and 'data not available' means the effect was not evaluated.
How do I know if a chemical is a carcinogen?
Check Section 11 for listings by IARC, the National Toxicology Program and OSHA, and Section 2 for a carcinogenicity hazard class. Lack of a listing does not always mean the substance has been fully evaluated.