Comment: On the basis of the results of an earlier study with 14 day exposure and 14 day recovery period, the lung changes were considered to be reversible; the lack of inflammatory response in the mediastinal lymph nodes was considered important as an inflammatory tissue response produced by dust-laden macrophages in the lymph nodes was stated to be possibly indicative of a potentially fibrogenic dust particle. Result: A no observable effect level (NOEL) of 10 mg/m3 was established in this study. Overall Assessment of Toxicological Data The notified polymer has a high molecular weight and is considered unlikely to cross the skin or other biological membranes. No acute toxicological studies were provided, as these are not usually required for a limited notification of a polymer with NAMW > 1000. The presence of moderately reactive functional groups in the polymer may however indicate potential for producing irritation or sensitisation when in contact with the skin or eyes. The single toxicological study provided was a repeat dose inhalation toxicity study of an analogue polymer. This is appropriate to the exposure routes for the notified polymer, as aerosols are encountered in the end use as a spray paint. The main observations were similar to those frequently observed in rats after inhalation exposure to particulates. The effects included increased lung weights, enlarged lymph nodes, increased numbers of macrophages and Type II cell hyperplasia. These effects were only observed in the groups exposed to 100 mg/m3. A NOEL of 10 mg/m3 was established in this study. ASSESSMENT OF ENVIRONMENTAL EFFECTS No ecotoxicological data were provided, is acceptable for a limited notification of a polymer with NAMW > 1000. ASSESSMENT OF ENVIRONMENTAL HAZARD It is possible that up to 50% (hundreds of tonnes) of the new polymer be released as a consequence of paint preparation and application. Release is expected to occur primarily in dedicated paint manufacturing facilities or OEMs, with the majority of the released material collected and disposed of in responsible manner. The majority of the material would be encapsulated in a cured polymer matrix and is expected to be insoluble and inert. Most of this solid waste would be deposited into landfill or incinerated.
Comment: On the basis of the results of an earlier study with 14 day exposure and 14 day recovery period, the lung changes were considered to be reversible; the lack of inflammatory response in the mediastinal lymph nodes was considered important as an inflammatory tissue response produced by dust-laden macrophages in the lymph nodes was stated to be possibly indicative of a potentially fibrogenic dust particle. Result: A no observable effect level (NOEL) of 10 mg/m3 was established in this study. Overall Assessment of Toxicological Data The notified polymer has a high molecular weight and is considered unlikely to cross the skin or other biological membranes. No acute toxicological studies were provided, as these are not usually required for a limited notification of a polymer with NAMW > 1000. The presence of moderately reactive functional groups in the polymer may however indicate potential for producing irritation or sensitisation when in contact with the skin or eyes. The single toxicological study provided was a repeat dose inhalation toxicity study of an analogue polymer. This is appropriate to the exposure routes for the notified polymer, as aerosols are encountered in the end use as a spray paint. The main observations were similar to those frequently observed in rats after inhalation exposure to particulates. The effects included increased lung weights, enlarged lymph nodes, increased numbers of macrophages and Type II cell hyperplasia. These effects were only observed in the groups exposed to 100 mg/m3. A NOEL of 10 mg/m3 was established in this study. ASSESSMENT OF ENVIRONMENTAL EFFECTS No ecotoxicological data were provided, is acceptable for a limited notification of a polymer with NAMW > 1000. ASSESSMENT OF ENVIRONMENTAL HAZARD It is possible that up to 50% (hundreds of tonnes) of the new polymer be released as a consequence of paint preparation and application. Release is expected to occur primarily in dedicated paint manufacturing facilities or OEMs, with the majority of the released material collected and disposed of in responsible manner. The majority of the material would be encapsulated in a cured polymer matrix and is expected to be insoluble and inert. Most of this solid waste would be deposited into landfill or incinerated.
NA691FR.docx