Ethylhexyl Methoxycinnamate (EHMC), Ethylhexyl Methoxycinnamate, Opinion on

{"dose":"226-775-7/629-661-9 _________________________________________________________________________________ 46 Conclusion The study investigators established the NOAEL for EHMC at 450 mg/kg bw/day (ECHA, 2021;","effect":"SCCS/1671/24 Final version Opinion on Ethylhexyl Methoxycinnamate (EHMC) (CAS No. 5466-77-3/83834-59-7, EC No. 226-775-7/629-661-9 _________________________________________________________________________________ 46 Conclusion The study investigators established the NOAEL for EHMC at 450 mg/kg bw/day (ECHA, 2021; NICNAS, 2017) SCCS comment The range of investigations was consistent with the version of the OECD TG at the time the study was conducted, including gross and histopathological examination of the thyroid gland. No treatment-related changes were reported for food consumption, body weight, body weight gain or mortalities. This study is considered as reliable. A NOAEL of 450 mg/kg bw/day based on reduction of the glycogen content and shrinkage of hepatocytes at a dose of 1","page":46,"pdf":"sccs_o_294.pdf","row_type":"noael_study","study_id":"sccs_o_294_noael_004"}

sccs_o_294.pdf

{"dose":"226-775-7/629-661-9 _________________________________________________________________________________ 46 Conclusion The study investigators established the NOAEL for EHMC at 450 mg/kg bw/day (ECHA, 2021;","effect":"SCCS/1671/24 Final version Opinion on Ethylhexyl Methoxycinnamate (EHMC) (CAS No. 5466-77-3/83834-59-7, EC No. 226-775-7/629-661-9 _________________________________________________________________________________ 46 Conclusion The study investigators established the NOAEL for EHMC at 450 mg/kg bw/day (ECHA, 2021; NICNAS, 2017) SCCS comment The range of investigations was consistent with the version of the OECD TG at the time the study was conducted, including gross and histopathological examination of the thyroid gland. No treatment-related changes were reported for food consumption, body weight, body weight gain or mortalities. This study is considered as reliable. A NOAEL of 450 mg/kg bw/day based on reduction of the glycogen content and shrinkage of hepatocytes at a dose of 1","page":46,"pdf":"sccs_o_294.pdf","row_type":"noael_study","study_id":"sccs_o_294_noael_004"}

sccs_o_294.pdf

{"dose":"226-775-7/629-661-9 _________________________________________________________________________________ 46 Conclusion The study investigators established the NOAEL for EHMC at 450 mg/kg bw/day (ECHA, 2021;","effect":"SCCS/1671/24 Final version Opinion on Ethylhexyl Methoxycinnamate (EHMC) (CAS No. 5466-77-3/83834-59-7, EC No. 226-775-7/629-661-9 _________________________________________________________________________________ 46 Conclusion The study investigators established the NOAEL for EHMC at 450 mg/kg bw/day (ECHA, 2021; NICNAS, 2017) SCCS comment The range of investigations was consistent with the version of the OECD TG at the time the study was conducted, including gross and histopathological examination of the thyroid gland. No treatment-related changes were reported for food consumption, body weight, body weight gain or mortalities. This study is considered as reliable. A NOAEL of 450 mg/kg bw/day based on reduction of the glycogen content and shrinkage of hepatocytes at a dose of 1","page":46,"pdf":"sccs_o_294.pdf","row_type":"noael_study","study_id":"sccs_o_294_noael_004"}

sccs_o_294.pdf

{"dose":"226-775-7/629-661-9 _________________________________________________________________________________ 46 Conclusion The study investigators established the NOAEL for EHMC at 450 mg/kg bw/day (ECHA, 2021;","effect":"SCCS/1671/24 Final version Opinion on Ethylhexyl Methoxycinnamate (EHMC) (CAS No. 5466-77-3/83834-59-7, EC No. 226-775-7/629-661-9 _________________________________________________________________________________ 46 Conclusion The study investigators established the NOAEL for EHMC at 450 mg/kg bw/day (ECHA, 2021; NICNAS, 2017) SCCS comment The range of investigations was consistent with the version of the OECD TG at the time the study was conducted, including gross and histopathological examination of the thyroid gland. No treatment-related changes were reported for food consumption, body weight, body weight gain or mortalities. This study is considered as reliable. A NOAEL of 450 mg/kg bw/day based on reduction of the glycogen content and shrinkage of hepatocytes at a dose of 1","page":46,"pdf":"sccs_o_294.pdf","row_type":"noael_study","study_id":"sccs_o_294_noael_004"}

sccs_o_294.pdf

{"dose":"Conclusion The study investigators established the NOAEL for EHMC 900 mg/kg bw/day in rats.","effect":"SCCS-rejected applicant NOAEL: SCCS/1671/24 Final version Opinion on Ethylhexyl Methoxycinnamate (EHMC) (CAS No. 5466-77-3/83834-59-7, EC No. 226-775-7/629-661-9 _________________________________________________________________________________ 43 decrease in the absolute weight of the heart. Further, increases in the absolute weight of the pituitary were observed at the lower doses but these were not considered to be biologically significant. Conclusion The study investigators established the NOAEL for EHMC 900 mg/kg bw/day in rats. (NICNAS, 2017; SCC, 2000) SCCS comment This study is considered of low reliability (not a guideline study, not a GLP study). Dermal exposure 1st study Guideline: No guideline Species/strain: Rabbits/ New Zealand White Group size: 5/sex/group Test substance: Ethylhexyl Methoxycinnamate Batch: Not specified Purity: Not specified Vehicle: No vehicle Dose levels: 0, 500, 1500 or 5000 mg/kg bw/day Dose volume: Not specified Route: Dermal Administration: Occ","page":43,"pdf":"sccs_o_294.pdf","row_type":"noael_study","study_id":"sccs_o_294_noael_001"}

sccs_o_294.pdf

{"dose":"Conclusion The study investigators established the NOAEL for EHMC 900 mg/kg bw/day in rats.","effect":"SCCS-rejected applicant NOAEL: SCCS/1671/24 Final version Opinion on Ethylhexyl Methoxycinnamate (EHMC) (CAS No. 5466-77-3/83834-59-7, EC No. 226-775-7/629-661-9 _________________________________________________________________________________ 43 decrease in the absolute weight of the heart. Further, increases in the absolute weight of the pituitary were observed at the lower doses but these were not considered to be biologically significant. Conclusion The study investigators established the NOAEL for EHMC 900 mg/kg bw/day in rats. (NICNAS, 2017; SCC, 2000) SCCS comment This study is considered of low reliability (not a guideline study, not a GLP study). Dermal exposure 1st study Guideline: No guideline Species/strain: Rabbits/ New Zealand White Group size: 5/sex/group Test substance: Ethylhexyl Methoxycinnamate Batch: Not specified Purity: Not specified Vehicle: No vehicle Dose levels: 0, 500, 1500 or 5000 mg/kg bw/day Dose volume: Not specified Route: Dermal Administration: Occ","page":43,"pdf":"sccs_o_294.pdf","row_type":"noael_study","study_id":"sccs_o_294_noael_001"}

sccs_o_294.pdf

{"dose":"Conclusion The study investigators established the NOAEL for EHMC 900 mg/kg bw/day in rats.","effect":"SCCS-rejected applicant NOAEL: SCCS/1671/24 Final version Opinion on Ethylhexyl Methoxycinnamate (EHMC) (CAS No. 5466-77-3/83834-59-7, EC No. 226-775-7/629-661-9 _________________________________________________________________________________ 43 decrease in the absolute weight of the heart. Further, increases in the absolute weight of the pituitary were observed at the lower doses but these were not considered to be biologically significant. Conclusion The study investigators established the NOAEL for EHMC 900 mg/kg bw/day in rats. (NICNAS, 2017; SCC, 2000) SCCS comment This study is considered of low reliability (not a guideline study, not a GLP study). Dermal exposure 1st study Guideline: No guideline Species/strain: Rabbits/ New Zealand White Group size: 5/sex/group Test substance: Ethylhexyl Methoxycinnamate Batch: Not specified Purity: Not specified Vehicle: No vehicle Dose levels: 0, 500, 1500 or 5000 mg/kg bw/day Dose volume: Not specified Route: Dermal Administration: Occ","page":43,"pdf":"sccs_o_294.pdf","row_type":"noael_study","study_id":"sccs_o_294_noael_001"}

sccs_o_294.pdf

{"dose":"Conclusion The study investigators established the NOAEL for EHMC 900 mg/kg bw/day in rats.","effect":"SCCS-rejected applicant NOAEL: SCCS/1671/24 Final version Opinion on Ethylhexyl Methoxycinnamate (EHMC) (CAS No. 5466-77-3/83834-59-7, EC No. 226-775-7/629-661-9 _________________________________________________________________________________ 43 decrease in the absolute weight of the heart. Further, increases in the absolute weight of the pituitary were observed at the lower doses but these were not considered to be biologically significant. Conclusion The study investigators established the NOAEL for EHMC 900 mg/kg bw/day in rats. (NICNAS, 2017; SCC, 2000) SCCS comment This study is considered of low reliability (not a guideline study, not a GLP study). Dermal exposure 1st study Guideline: No guideline Species/strain: Rabbits/ New Zealand White Group size: 5/sex/group Test substance: Ethylhexyl Methoxycinnamate Batch: Not specified Purity: Not specified Vehicle: No vehicle Dose levels: 0, 500, 1500 or 5000 mg/kg bw/day Dose volume: Not specified Route: Dermal Administration: Occ","page":43,"pdf":"sccs_o_294.pdf","row_type":"noael_study","study_id":"sccs_o_294_noael_001"}

sccs_o_294.pdf

{"dose":"226-775-7/629-661-9 _________________________________________________________________________________ 44 Conclusion Under the conditions of the study, the study investigators established the NOAEL for EHMC at 1500 mg/kg bw/day.","effect":"SCCS/1671/24 Final version Opinion on Ethylhexyl Methoxycinnamate (EHMC) (CAS No. 5466-77-3/83834-59-7, EC No. 226-775-7/629-661-9 _________________________________________________________________________________ 44 Conclusion Under the conditions of the study, the study investigators established the NOAEL for EHMC at 1500 mg/kg bw/day. (ECHA, 2021; NICNAS, 2017) SCCS comment This study is considered as reliable with restrictions as the top two doses exceeded the recommended limit dose of 1000 mg/kg/day. 2nd study Guideline: Similar to OECD Test Guideline 410 Species/strain: Rats/Sprague-Dawley Group size: 5/ sex/ group Test substance: Ethylhexyl Methoxycinnamate Batch: Not specified Purity: Not specified Vehicle: No vehicle Dose levels: 0, 500, 1500 or 5000 mg/kg bw/day Dose volume: 0, 0.5,","page":44,"pdf":"sccs_o_294.pdf","row_type":"noael_study","study_id":"sccs_o_294_noael_002"}

sccs_o_294.pdf

{"dose":"226-775-7/629-661-9 _________________________________________________________________________________ 44 Conclusion Under the conditions of the study, the study investigators established the NOAEL for EHMC at 1500 mg/kg bw/day.","effect":"SCCS/1671/24 Final version Opinion on Ethylhexyl Methoxycinnamate (EHMC) (CAS No. 5466-77-3/83834-59-7, EC No. 226-775-7/629-661-9 _________________________________________________________________________________ 44 Conclusion Under the conditions of the study, the study investigators established the NOAEL for EHMC at 1500 mg/kg bw/day. (ECHA, 2021; NICNAS, 2017) SCCS comment This study is considered as reliable with restrictions as the top two doses exceeded the recommended limit dose of 1000 mg/kg/day. 2nd study Guideline: Similar to OECD Test Guideline 410 Species/strain: Rats/Sprague-Dawley Group size: 5/ sex/ group Test substance: Ethylhexyl Methoxycinnamate Batch: Not specified Purity: Not specified Vehicle: No vehicle Dose levels: 0, 500, 1500 or 5000 mg/kg bw/day Dose volume: 0, 0.5,","page":44,"pdf":"sccs_o_294.pdf","row_type":"noael_study","study_id":"sccs_o_294_noael_002"}

sccs_o_294.pdf

{"dose":"226-775-7/629-661-9 _________________________________________________________________________________ 44 Conclusion Under the conditions of the study, the study investigators established the NOAEL for EHMC at 1500 mg/kg bw/day.","effect":"SCCS/1671/24 Final version Opinion on Ethylhexyl Methoxycinnamate (EHMC) (CAS No. 5466-77-3/83834-59-7, EC No. 226-775-7/629-661-9 _________________________________________________________________________________ 44 Conclusion Under the conditions of the study, the study investigators established the NOAEL for EHMC at 1500 mg/kg bw/day. (ECHA, 2021; NICNAS, 2017) SCCS comment This study is considered as reliable with restrictions as the top two doses exceeded the recommended limit dose of 1000 mg/kg/day. 2nd study Guideline: Similar to OECD Test Guideline 410 Species/strain: Rats/Sprague-Dawley Group size: 5/ sex/ group Test substance: Ethylhexyl Methoxycinnamate Batch: Not specified Purity: Not specified Vehicle: No vehicle Dose levels: 0, 500, 1500 or 5000 mg/kg bw/day Dose volume: 0, 0.5,","page":44,"pdf":"sccs_o_294.pdf","row_type":"noael_study","study_id":"sccs_o_294_noael_002"}

sccs_o_294.pdf

{"dose":"226-775-7/629-661-9 _________________________________________________________________________________ 44 Conclusion Under the conditions of the study, the study investigators established the NOAEL for EHMC at 1500 mg/kg bw/day.","effect":"SCCS/1671/24 Final version Opinion on Ethylhexyl Methoxycinnamate (EHMC) (CAS No. 5466-77-3/83834-59-7, EC No. 226-775-7/629-661-9 _________________________________________________________________________________ 44 Conclusion Under the conditions of the study, the study investigators established the NOAEL for EHMC at 1500 mg/kg bw/day. (ECHA, 2021; NICNAS, 2017) SCCS comment This study is considered as reliable with restrictions as the top two doses exceeded the recommended limit dose of 1000 mg/kg/day. 2nd study Guideline: Similar to OECD Test Guideline 410 Species/strain: Rats/Sprague-Dawley Group size: 5/ sex/ group Test substance: Ethylhexyl Methoxycinnamate Batch: Not specified Purity: Not specified Vehicle: No vehicle Dose levels: 0, 500, 1500 or 5000 mg/kg bw/day Dose volume: 0, 0.5,","page":44,"pdf":"sccs_o_294.pdf","row_type":"noael_study","study_id":"sccs_o_294_noael_002"}

sccs_o_294.pdf