Toxicity for reproduction

A number of studies have been conducted to investigate the effects of SM on human and animal reproduction. To date none of these studies have produced evidence that SM expresses any significant reproductive toxicity at doses that fail to cause significant acute toxicity in either parent. However, to date no study has been conducted on the incidence of abnormalities in the offspring of veterans from previous conflicts in which SM was used or munitions factory workers. 

Azizi et al described the effects on hormones associated with reproductive function in Iranian veterans following battlefield SM exposure. All hormone levels returned to normal by 12 weeks after exposure, but a low sperm count ( 3 x lo mh ) remained in 66% of those studied 1-3 years after exposure. 

A possible explanation for the conflicting results found in the above studies could be the level of exposure to SM or simultaneous exposure to an unidentified factor. It is also possible that using infertility as a selection criteria for admission into the first study reviewed failed to take into account those individuals whose fertility had not been affected by exposure. It may be that only relatively high doses of SM are directly gonadotoxic in humans, although it must be emphasised that there are no experimental data available to support this hypothesis. 

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The majority of very high concern substances will be those classified as category 1 or 2 CMRs. There are already around 850 such CMR substances based on current classifications, and it is likely that there will be another ca 500 identified from future testing. Most endocrine disrupters would require authorisation by being classified as carcinogenic or toxic for reproduction, but there is the option to add other endocrine disruptors on an ad hoc basis. 

Toxic (T) Chronic NOEC < 0.01 mg/1 for fresh or marine water organisms, Category 1 or 2 carcinogen or mutagen or Category 1, 2 or 3 toxic for reproduction or chronically toxic (i.e., labelled with T or harmful (Xn) with R48) Not applicable... 

Substitution in 98/8/EC is maintained indirectly though the application of comparative risk assessment, which is mandated in Article 10 of the directive. In order to include active substances in Annex I, lA or IB, several requirements have to be fulfilled. For example, active substances cannot be incorporated in the list if they are carcinogenic, mutagenic, toxic for reproduction, sensitising or bioaccumulative. 

Timing for carcinogenic, mutagenic, or toxic for reproduction substances (CMR), very toxic, and R50/53 substances is as follows ... 

Lead chromate and lead chromate pigments are classified as toxic for reproduction (Unborn child Rep. Cat. 1/category Re 1, fertility Rep. Cat 3/category Rp 3) and carcinogenic (Care. Cat 3/category C 3 [3.135, 3.138]. 

A result of the risk assessments was that DEHP, DBP and BBP are toxic for reproduction. Accordingly, they were classified as CMR (carcinogen, mutagen, reprotoxic) substances, category 2 which is reflected in the classification and labelling with R-phrases 60-62 (Tables 12, 13). 

Data on carcinogenicity, mutagenicity and/or toxicity for reproduction of the substance Any other indication relevant to the risk evaluation of the substance... 

In the European Community, according to the Directive 92/32/EEC (7-th addition to the Directive 67/548/EEC), the definition toxic for reproduction)) was introduced which takes into account harmful influence on sexual function and fertility of adult men and women, and also influence on development of posterity. 

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... 

The TRGS 905 contains carcinogenic and mutagenic substances and substances toxic for reproduction and their German classification for which either a different or no classification has been established so r in Annex 1 of Directive 67/548/EEC. But they are only published in the TRGS 905 if neither MAK nor TRK value has yet been established. Verzeichnis sensibilisierender Stoffe, Ausgabe Oktober 2002. 

There are no symbols for dangers from substances that are carcinogenic, mutagenic or toxic for reproduction. 

Conversely, some molecules carcinogenic, mutagenic, or toxic for reproduction can be advantageously replaced by less toxic ones (Fig. 5.20a, b). 

If a biocidal product is classified as toxic, very toxic, carcinogenic, mutagenic or toxic for reproduction (category 1 or 2) it shall not be authorised for marketing to, or use by the general public. 

DiBP, BBzP, DEHP, and DnBP are on the candidate list for REACH authorization as toxic for reproduction (European Chemicals Agency 2013). 

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