Carcinogenicity reproduction

A substance can cause one or more effects. Common effects are acute and longterm toxicity, skin irritation, corrosiveness, sensitization, mutagenicity, carcinogenicity, reproductive effects, and developmental toxicity. 

Additionally, there are specialized studies designed to address endpoints of concern for almost all drugs (carcinogenicity, reproductive or developmental toxicity) or concerns specific to a compound or family of compounds (local irritation, neurotoxicity, or immunotoxicity, for example). When these are done, timing also requires careful consideration. It must always be kept in mind that the intention is to ensure the safety of people in whom the drug is to be evaluated (clinical trials) or used therapeutically. An understanding of special concerns for both populations should be considered essential. 

Substitution, rather than risk management is therefore essential. Chemicals identified as of very high concern, e.g. carcinogens, reproductive toxins, those that persist and bioaccumulate in the environment and affect the hormone system, should be targeted for substitution based on their intrinsic hazards. 

For most types of toxic effects (e.g., organ-specific, neurological, immunological, non-genotoxic carcinogenicity, reproductive, developmental), it is generally considered that there is a dose or... 

No information on mutagenic, carcinogenic, reproductive, or teratogenic effects of any of the compounds in question is available. 

Effects of acute exposure to product Effects of chronic exposure to product Irritancy of the product Sensitization to the product Carcinogenicity Reproductive toxicity Teratogenicity Mutagenicity... 

The EC funded project CAESAR is developing models for five endpoints specifically related to the REACH legislation [28]. The five endpoints are bioconcentration factor, skin sensitization, carcinogenicity, reproductive toxicity, and mutagenicity (in vivo studies). These five endpoints have been chosen because they are among those that will require more animal tests. Actually, other studies are also supposed to use many animals, but they were excluded because of lack of sufficient experimental values. 

Quality assurance efforts within this phase will focus on four types of studies conducted for safety evaluation (a) safety studies on regulated products, (b) safety studies that encompass the full scope of laboratory operations, (c) studies that are significant to safety assessment, e.g., carcinogenicity, reproduction, chronic toxicity studies, and (d) studies that encompass operations for several species of animals. 

An area that may be used for work with carcinogens, reproductive toxins, or substances that have a high degree of acute toxicity. A designated area may be the entire laboratory, an area of a laboratory, or a device such as a loboratory hood. Detergent... 

Extremely toxic even in very small concentrations Abdominal cramps, diarrhea, nausea, vomiting Carcinogenicity, reproductive and developmental toxicity, neurotoxicity... 

Carcinogenicity, reproductive and developmental toxicity, neurotoxicity Mutagenicity Cancer... 

Safety Profiles are text summaries of the reported hazards of the entry. The word experimental indicates that the reported effects resulted from a controlled exposure of laboratory animals to the substance. Toxic effects reported include carcinogenic, reproductive, acute lethal, and human nonlethal effects, skin and eye irritation, and positive mutation study results. 

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 hazard classification should lead directly to labelling of acute health effects, environmental and physical hazards. The labelling approach that involves a risk assessment should only be applied to chronic health hazards, e.g. carcinogenicity, reproductive toxicity, or target organ systemic toxicity based on repeated exposure. The only chemicals it may be applied to are those in the consumer product setting where consumer exposures are generally limited in quantity and duration ... 

In chronic studies with rats, exposure to aluminum phosphide fumigated chow (4.5mgm phosphine) resulted in decreases in food intake, body weight, hemoglobin, red blood cells, hematocrit, and in increases in platelet counts. Following a 4 week recovery period in many of the exposed rats symptoms were absent, suggesting apparent reversibility. Neither aluminum phosphide nor phosphine gas exhibit carcinogenic, reproductive, or developmental effects in animals. 

The assessment of adverse health effects such as acute and chronic toxicity, carcinogenicity, reproductive toxicity, but also skin sensitization require in depth scientific knowledge of the processes in the human body that absorb, distribute, biotransform (or metabolize), or excrete the foreign chemicals but also endogenous compounds and the events associated with the toxicities in... 

Phthalate Carcinogenicity Reproduction Teratogenicity Environment ECB report... 

The relationships between low-dose exposure to MeHg throughout the life span of humans and animals and carcinogenic, reproductive, neurological, and immunological effects. 

Sub-lethal effects ofTCDD include teratogenicity, carcinogenicity, reproductive complications, suppression of the immune systems, skin lesions and porphyria. Most of these effects have been studied in laboratory animals. 

Full toxicity testing would be required on a substance shown to bioaccumulate, to establish whether it is a Class 1 specified or a safe substance. A full toxicity testing programme covers chronic toxicity, mutagenicity, carcinogenicity, reproduction toxicity, teratogenicity, toxicokinetics and pharmacology. 

Based on the US ACGIH list now own system in place. - 350 main entries including group entries - Yes but not clear what the time schedule is carcinogens, reproductive hazards, and sensitising agents ... 

HUMAN HEALTH RISKS Skin human Ig for 10 minutes Acute Risks irritation of skin destructive to mucous membranes and upper respiratory tract nausea weakness narcosis vertigo convulsions blistering attaxia slurred speech drowsiness Chronic Risks carcinogen reproductive disorders effects eyes, skin, respiratory system and CNS. 

When relevant human data are available, the 0-fo d factor for intcrspecics variability may not be necessary. However, relatively few parameters are studied in humans in the assessment of pesticide safety, and data on carcinogenicity, reproduction, and chronic effects are rarely available, Consequently, JMPR rarely utilizes safety factors as low as 10-fold. ADIs of selected OP and CM pesticides are summarized in Table 2. 

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