Organ system toxicity

Laughlin NK Harlow Primate Laboratory, Madison, Wl Effect of succimer therapy on lead-induced neurobehavioral and organ system toxicity (rhesus monkey) National Institute of Environmental Health Sciences... 

Lynch DW, Moorman MJ, Stober P, et al Subchronic inhalation of diethylamine vapor in Fischer-344 rats organ system toxicity. Fundam Appl Toxicol 6 559-565, 1986... 

Lynch DW, Moorman WE, Lewis TR, et al Subchronic inhalation of triethylamine vapor in Fischer 344 rats Organ system toxicity. Toxicol Ind Health 6 403-414, 1990... 

Target organ systemic toxicity is subdivided according to single or repeat dose. 

The competent authority may choose to allow communication of certain hazard information for carcinogens, reproductive toxicity and specific target organ systemic toxicity through repeated exposure on the label and on the SDS, or through the SDS alone (see speeific ehapters for details of relevant cut-offs for these classes). 

An SDS should be produced for all substances and mixtures which meet the harmonized criteria for physical, health or environmental hazards under the GHS and for all mixtures which contain substances that meet the criteria for carcinogenic, toxic to reproduction or specific target organ systemic toxicity in concentrations exceeding the cut-off limits for SDS specified by the criteria for mixtures (see 1.5.3.1). The competent authority may choose also to require SDS s for mixtures not meeting the criteria for classification as hazardous but which contain hazardous substances in certain concentrations (see 1.5.3.1). 

Specific target organ systemic toxicity (single exposure) > 1.0%... 

SPECIFIC TARGET ORGAN SYSTEMIC TOXICITY SINGLE EXPOSURE... 

The purpose of this chapter is to provide a means of classifying substances that produce specific, non lethal target organ/systemic toxicity arising from a single exposure. All significant health effects that can impair function, both reversible and irreversible, immediate and/or delayed and not specifically addressed in chapters 3.1 to 3.7 and 3.10 are included (see also para. 3.8.1.6). 

Classification identifies the chemical substance as being a specific target organ/systemic toxicant and, as such, it may present a potential for adverse health effects in people who are exposed to it. 

Specific target organ/systemic toxicity can occur by any route that is relevant for humans, i.e. principally oral, dermal or inhalation. 

Specific target organ/systemic toxicity following a repeated exposure is classified in the GHS as described in Specific target organ systemic toxicity - Repeated exposure (Chapter 3.9) and is therefore excluded from the present chapter. Other specific toxic effects, listed below are assessed separately in the GHS and consequently are not included here ... 

Weight of evidence of all data, including human incidents, epidemiology, and studies conducted in experimental animals, is used to substantiate specific target organ/systemic toxic effects that merit classification. 

The information required to evaluate specific target organ/systemic toxicity comes either fi om single exposure in humans, e.g. exposure at home, in the workplace or environmentally, or from studies conducted in experimental animals. The standard animal studies in rats or mice that provide this information are acute toxicity studies which can include clinical observations and detailed macroscopic and microscopic examination to enable the toxic effects on target tissues/organs to be identified. Results of acute toxicity studies conducted in other species may also provide relevant information. 

A chemical that has not been tested for specific target organ/systemic toxicity may in certain instances, where appropriate, be classified on the basis of data from a validated structure activity relationship and expert judgement-based extrapolation from a structural analogue that has previously been classified together with substantial support from consideration of other important factors such as formation of common significant metabolites. 

Table 3.8.2 Cut-off values/concentration limits of ingredients of a mixture classified as a specific target organ/ systemic toxicant that would trigger classification of the mixture as Category 1 or 2 ...

Category 1 Target organ systemic toxicant > 1.0% (note 1) 1.0 < ingredient < 10% (note 3)... 

Category 2 Target organ systemic toxicant >1.0% (note 4)... 

NOTE 1 If a Category 1 specific target organ/systemic toxicant is present in the mixture as an... 

Table 3.8.3 Label elements for specific target organ systemic toxicity after single exposure...

Does the mixture contain one or more ingredients classified as a Category 2 specific target organ systemic toxicant at a concentration of" ... 

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