Reproductive toxicity competence

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). 

Exposure to benzene vapor produces feto-toxicity, such as growth retardation, in mice and rats at doses that are maternally toxic. In general, benzene does not appear to adversely effect reproductive competence. ... 

In a reproductive study using the continuous breeding protocol, 500mg/kg/day administered by gavage to mice caused slight generalized toxicity and reduced the number of oocytes by 33% in females and testicular sperm count by 17% in males but did not adversely affect the reproductive competence of Fq and Fi generations. ... 

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). 

As a reproductive and developmental toxicant, linuron works via androgen receptor antagonist activity, that is, it competes with testosterone for binding to the androgen receptor. 

With a relatively few new chemicals, there may be potential for wide exposure to humans or the environment, and if the initial toxicity and environmental profile data indicates concern for certain effects, there may be need for an in-depth series of studies diich could take three years or longer to complete. These studies would be chosen from a spectrum of animal tests such as studies of metabolic pathways, pharmacokinetic parameters, teratogenic, mutagenic and carcinogenic potential and reproductive competency. Normally the necessary tests are chosen by considering potential use and similarity to already characterized compounds. These decisions require professional Judgment by highly experienced experts. 

Substances supplied at <10 kg a are exempt from notification, but individual Member States may choose to require appropriate technical and commercial data to be submitted. Substances supplied at <100 kg a for scientific research and development are exempt from notification, but records of supply to customers must be available for inspection by the national Competent Authority. Substances can be supplied for process-orientated research and development to a limited number of registoed customers without tonnage limit for up to 1 year (extended to 2 years if justifiable). Individual Member States can decide what information is required, up to the maximum requirement for limited notification . If substances supplied under these three exemption categories are provisionally classified as very toxic , toxic , carcinogenic , toxic for reproduction or... 

Restricting women of childbearing age from the lead industry workforce for most of the twentieth century because of concerns about fetal exposures and toxic hazards to prenatal populations clearly reduced the prevalence and incidence of reproductive and developmental toxicity. Paternal exposures to lead in terms of reproductive competence indices has continued, based on occupational epidemiology data from several databases. 

Three approaches to evaluating reproductive competence in Pb-exposed men, largely workplace exposures, have been elucidated direct gametotoxicity through impaired spermatogenesis and quality, assessment of altered time to pregnancy, and reproductive history. These three aspects are set forth in Table 14.5. In virtually all cases, these toxic effects occurred at the relatively higher exposure levels seen in the workplace. 

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