Specific target organ systemic toxicity - Repeated exposure

SPECIFIC TARGET ORGAN SYSTEMIC TOXICITY REPEATED EXPOSURE 

1 The purpose of this document is to provide a means of classifying substances that produce specific target organ/systemic toxicity arising from a repeated exposure. All significant health effects that can impair function, both reversible and irreversible, immediate and/or delayed are included. 

2 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. 

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

1 Substances are classified as specific target organ/systemic toxicant by expert judgement on 

---

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

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 ... 

Figure 3.9.1 Categories for specific target organ systemic toxicity/repeated exposure... 

SPECIFIC TARGET ORGAN SYSTEMIC TOXICITY (REPEATED EXPOSURE) ... 

Product classified as (1) Category 2 Flammable liquid, (2) Category 4 Acute toxicity by inhalation, and (3) Category 2 Specific target organ/Systemic toxicity, repeated exposure. 

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). 

The information required to evaluate specific target organ/systemic toxicity comes either from repeated 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 28 day, 90 day or lifetime studies (up to 2 years) that include haematological, clinico-chemical and detailed macroscopic and microscopic examination to enable the toxic effects on target... 

A2.26 Specific target organ systemic toxicity following repeated exposure (See Chapter 3.9 for details)... 

OECD has also published a document on a Harmonised integrated classification system for human health and environmental hazards of chemical substances and mixtures (OECD 2001b). Chapter 2.9 addresses a harmonized system for the classification of chemicals, which cause specific target organ oriented systemic toxicity following repeated exposure. 

Chronic toxicity more t5 ically refers to adverse health effects which result fi om repeated and/or prolonged exposures. The specific toxicity expressed will be determined by the characteristics of exposure (route, duration, frequency, magnitude), the mechanism(s) of toxic action, and the shape of the dose-response curve. When the adverse health effect results from absorption of the hazardous agent and subsequent distribution to a target organ, the term systemic toxicity is often used. Metabolism may or may not be involved in systemic toxicity. 

---