Human Health and Environment Assessment Page 1 of 2 

HUMAN HEALTH AND ENVIRONMENT ASSESSMENT 

Physical-chemical data

The new substance is a with a medium particle size of . The new substance is virtually insoluble in water which is in line 

with the very low solubility of the core material Source: ECHA Dissemination Report) and there is no special reactivity to mention. The vapour pressure for 

based materials like the new substance is anticipated to be negligibly low. 

Toxicological data

Toxicological data is not available for the new substance. The new substance consists up to 

 the toxicological assessment can be based 

on the characteristics of the main ingredient 

 

Several study results are available for in the scientific community. The best up-todate overview can be gained in the ECHA dissemination report for (please refer to 

http://echa.europa.eu/web/guest/information-on-chemicals/registered-substances for CAS 

no. . 

The following table summarizes some of the key findings: 

Test Result 

Acute oral toxicity (rat) LD50 > 2000 mg/kg 

Skin irritation/corrosion (rabbit, 4h) not irritating 

Eye irritation/corrosion (rabbit) not irritating 

Skin sensitization (guinea pig) not sensitizing 

Mutagenicity (In vitro Mammalian Cell Gene Mutation Test) not mutagenic 

 is “non-hazardous” under OSHA and EEC criteria on the basis of the test results 

mentioned above. 

The toxicological profiles of 

 are mainly 

based on their physical-chemical properties. Therefore, their anticipated low vapour pressure and low solubility in water together with the fact that they are covalently bound to the 

 particles is limiting the bioavailability of the fraction significantly. 
Human Health and Environment Assessment Page 2 of 2 

Assessment

The negligible vapour pressure indicates that inhalation of the new substance is not expected. In case of dust inhalation specific toxicological effects are also not anticipated. 

However, due to the particle size distribution of the new substance all particles of the product are respirable [dae <10 μm]. Therefore the TLV for “Particulates (Insoluble) Not Otherwise Classified (PNOC)” must be observed if dust exposure occurs. 

Because of its physical-chemical properties a resorption of toxicological relevant doses after oral or dermal exposure of the new substance is not probable. It can be assumed that 

the new substance is non-toxic by dermal exposure. There is no indication of mutagenic activity and no indication of relevant skin and eye irritation of the new polymer on the basis of 

the toxicity data on and the physical-chemical data of the new substance. 

According to our present knowledge the new substance can be classified as a nonhazardous substance. 

Ecotoxicology

The new substance is virtually insoluble in water and can be eliminated from wastewater by 

sedimentation. Due to its physical-chemical properties it has no potential for bioaccumulation and in addition no adverse effects to aquatic organisms as well as to ecosystems are 

expected. 

Conclusion

Taken into account the physical-chemical properties of the new substance together with the 

toxicological information of the main ingredient and characteristics of the 

 moiety it is concluded that adverse toxicological and ecotoxicological effects of the new substance during recommended handling, use and disposal can be excluded. 

The new substance is not classified according to OSHA criteria as well as to EEC dangerous substances regulation.