May cause, or suspected of causing serious health effects.
Carcinogen
A chemical substance or a mixture of chemical substances which induce cancer or increase its incidence. Substances and mixtures in this hazard class are assigned to one of two hazard categories.
Carcinogenicity Information
- Subcategory 1A
- Known Human Carcinogen
- Based on human evidence
- Subcategory 1B
- Presumed Human Carcinogen
- Based on demonstrated animal carcinogenicity
- Limited evidence of human or animal carcinogenicity
Respiratory Sensitizer
A substance that induces hypersensitivity of the airways following inhalation of the substance. Substances and mixtures in this hazard class are assigned to one hazard category.
Reproductive Toxicity
Reproductive toxicity includes adverse effects on sexual function and fertility in adult males and females, as well as developmental toxicity in offspring. Substances and mixtures with reproductive and/or developmental effects are assigned to one of two hazard categories: Known or Presumed” and Suspected. Category 1 has two subcategories for reproductive and developmental effects. Materials which cause concern for the health of breastfed children have a separate category: Effects on or Via Lactation.
- Category 1A - Known
- Based on human evidence
- Category 1 B - Presumed
- Based on experimental animals
- Human or animal evidence possibly with other information
Target Organ Toxicity
The GHS distinguishes between single and repeat exposure for Toxic Organ Effects. Some existing systems distinguish between single and repeat exposure for these effects and some do not. All significant health effects, not otherwise specifically included in the GHS that can impair function, reversible and irreversible, immediate and/or delayed, are included in the nonlethal target organ/systemic toxicity class 9TOST). Narcotic effects and respiratory tract irritation are considered to be target organ systemic effects following a single exposure.
TOST: Single Exposure
Substances and mixtures of the single exposure target organ toxicity hazard class are assigned to one of three hazard categories
- Reliable, good quality human case studies or epidemiological studies
- Animal studies with significant and/or severe toxic effects relevant to humans at generally low exposure (guidance)
- Animal studies with significant toxic effects relevant to humans at generally moderate exposure (guidance)
- Human evidence in exceptional cases
- Narcotic effects
- Respiratory tract irritation
TOST: Repeated Exposure
Substances and mixtures of the repeated exposure target organ toxicity hazard class are assigned to one of two hazard categories
- Reliable, good quality human case studies or epidemiological studies
- Animals studies with significant and/or severe toxic effects relevant to humans at generally low
- Animal studies with significant toxic effects relevant to humans at generally moderate exposure (guidance)
- Human evidence in exceptional cases
In order to help reach a decision about whether a substance should be classified or not, and to what degree it should be classified (Category 1 vs. Category 2), dose/concentration “guidance values” are provided in the GHS. The guidance values and ranges for single and repeated doses are intended only for guidance purposes. This means they are to be used as part of the weight of evidence approach and to assist with decisions about classification. They are not intended as strict demarcation values. The guidance value for repeated dose effects refers to effects seen in a standard 90-day toxicity study conducted in rats. They can be used as a basis to extrapolate equivalent guidance values for toxicity studies of greater or lesser duration.
Germ Cell Mutagenicity
Known to produce heritable mutations in human germs
- Positive evidence from epidemiological studies
- Positive results in:
- In vivo heritable germ cell tests in mammals
- Human germ cell tests
- In vivo somatic Mutagenicity tests, combined with some evidence of germ cell mutagenicity
Aspiration Toxicity
Aspiration toxicity includes severe acute effects such as chemical pneumonia, varying degrees of pulmonary injury, or death following aspiration. Aspiration is the entry of a liquid or solid directly through the oral or nasal cavity, or indirectly from vomiting, into the trachea and lower respiratory system. Some hydrocarbons (petroleum distillates) and certain chlorinated hydrocarbons have been shown to pose an aspiration hazard in humans. Primary alcohols and ketones have been shown to pose an aspiration hazard only in animal studies.
Aspiration Toxicity Information
Substances and mixtures of this hazard class are assigned to one of two hazard categories in this hazard class on the basis of viscosity
- Human evidence
- Based on animal studies
- Surface tension, water solubility, boiling point