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 spec ial reactivity to mention. The vapour pressure for

based materials lik e 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 EC HA dissemination report for (please refer to http://echa.europa.eu/web/guest/informati on-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 crit eria on the basis of the test results

mentioned above.

The toxico logical profiles of are mainly based on their physical-chemical properties. T herefore, their antici pated low vapour pressure and low solubility in water together with t he fact that they are covalently bound to the particles is limiting the bioavailabili ty of the fraction significa ntly.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 to xicological effects are also not anticipated. However, due to the particle size distribution of the new substance a ll particles of the product are respirable [d ae <10 μ m]. Therefore the TLV for “Parti culates (Insoluble) Not Otherwise Classified (PNOC)” must be obs erved if dust exposure occurs.

Because of its physical-chemical properties a re sorption 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 exposur e. 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 substan ce.

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 aquat ic organisms as well as to ecosystems are expected.

Conclusion

Taken into account the physical-chemical proper ties of the new subs tance together with the toxicological information of the main ingredient and characteristics of the moiety it is concluded that adverse toxic ological and ecotoxicological effects of the new substance during reco mmended 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.