Name: Ethylhexyl Bis-Isopentylbenzoxazolylphenyl Melamine NOAEL Studies
Creator: Roots by Benda

COSMOS_DB 1 endpoint

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
COSMOS_DB	NOAEL	1400	mg/kg bw/day	rat	oral	90 day	Subchronic	SCCNFP; Jonker D., Sub-chronic oral toxicity study with ZN3044 in rats. Report V3584, January2003. TNO, NL-Zeist

SCCNFP_vision_codex 8 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
SCCNFP_vision_codex	NOAEL	=2	%	-	oral	13 weeks	NOAEL study	{"citation":"Ref.: 12","effect":"e : ZN3044 Batch no : 0100L1 Purity : 97.2% Dietary levels : 0, 0.2, 0.6 and 2.0% (equal to overall intakes of 0.13, 0.4 and 1.4 g/kg bw/day) Vehicle : diet Exposure : 13 weeks GLP : In compliance Results Clinical signs: no mortality, no treatment-related findings No treatment-related findings regarding arena testing, FOB and motor activity assessment, ophthalmoscopy, body weight, food/water intake, haematology, clinical chemistry, urinalysis, organ weights, macroscopy and histopathology. Conclusion The NOAEL was ≥ 2% ZN3044 in the diet (≥ 1.4 g ZN3044/kg bw/day). Ref.: 12","page":6,"pdf":"out290_en.pdf","row_type":"noael_study","study_id":"out290_en_noael_001"}
SCCNFP_vision_codex	NOAEL	=2	%	-	oral	13 weeks	NOAEL study	{"citation":"Ref.: 12","effect":"e : ZN3044 Batch no : 0100L1 Purity : 97.2% Dietary levels : 0, 0.2, 0.6 and 2.0% (equal to overall intakes of 0.13, 0.4 and 1.4 g/kg bw/day) Vehicle : diet Exposure : 13 weeks GLP : In compliance Results Clinical signs: no mortality, no treatment-related findings No treatment-related findings regarding arena testing, FOB and motor activity assessment, ophthalmoscopy, body weight, food/water intake, haematology, clinical chemistry, urinalysis, organ weights, macroscopy and histopathology. Conclusion The NOAEL was ≥ 2% ZN3044 in the diet (≥ 1.4 g ZN3044/kg bw/day). Ref.: 12","page":6,"pdf":"out290_en.pdf","row_type":"noael_study","study_id":"out290_en_noael_001"}
SCCNFP_vision_codex	NOAEL	=2	%	-	oral	13 weeks	NOAEL study	{"citation":"Ref.: 12","effect":"e : ZN3044 Batch no : 0100L1 Purity : 97.2% Dietary levels : 0, 0.2, 0.6 and 2.0% (equal to overall intakes of 0.13, 0.4 and 1.4 g/kg bw/day) Vehicle : diet Exposure : 13 weeks GLP : In compliance Results Clinical signs: no mortality, no treatment-related findings No treatment-related findings regarding arena testing, FOB and motor activity assessment, ophthalmoscopy, body weight, food/water intake, haematology, clinical chemistry, urinalysis, organ weights, macroscopy and histopathology. Conclusion The NOAEL was ≥ 2% ZN3044 in the diet (≥ 1.4 g ZN3044/kg bw/day). Ref.: 12","page":6,"pdf":"out290_en.pdf","row_type":"noael_study","study_id":"out290_en_noael_001"}
SCCNFP_vision_codex	NOAEL	=2	%	-	oral	13 weeks	NOAEL study	{"citation":"Ref.: 12","effect":"e : ZN3044 Batch no : 0100L1 Purity : 97.2% Dietary levels : 0, 0.2, 0.6 and 2.0% (equal to overall intakes of 0.13, 0.4 and 1.4 g/kg bw/day) Vehicle : diet Exposure : 13 weeks GLP : In compliance Results Clinical signs: no mortality, no treatment-related findings No treatment-related findings regarding arena testing, FOB and motor activity assessment, ophthalmoscopy, body weight, food/water intake, haematology, clinical chemistry, urinalysis, organ weights, macroscopy and histopathology. Conclusion The NOAEL was ≥ 2% ZN3044 in the diet (≥ 1.4 g ZN3044/kg bw/day). Ref.: 12","page":6,"pdf":"out290_en.pdf","row_type":"noael_study","study_id":"out290_en_noael_001"}
SCCNFP_vision_codex	NOAEL	=1400	mg/kg bw/day	rat	oral	subchronic	repeated dose toxicity	{"citation":"Ref.: c 2","dose":"The NOAEL in a subchronic toxicity study was more than 1400 mg/kg bw/day.","effect":"the identity of substance A, B, C and D was not revealed, this study is unsuitable for evaluation. Ref.: c 2.11. Safety evaluation Not applicable 2.12. Conclusions 2,4-Bis-[4-[5-(1,1-dimethyl-propyl)benzoxazol-2-yl]phenylimino]-6-[(2-ethylexyl)imino]-1,3,5 triazine (UVASORB® K2A) belongs to the class of secondary amines and thus it is prone to nitrosation. No data are provided on the nitrosamine content of UVASORB® K2A. The photo-stability testing is inadequate. There is no data on reproduction toxicity. The NOAEL in a subchronic toxicity study was more than 1400 mg/kg bw/day. The test substance was not irritating to the eyes and the skin. It is not a sensitiser. The skin absorption was 2.7 µg/cm². The test substance was not mutagenic on bacteria nor in a chromosome aberration test. It was, however, photoclastogenic on mammalian cells treated in vitro. 2.13. References 1. Prinsen M.K., Acute oral toxicity study with ZN3044 in rats. Report V2510/18, January 2001. TNO, NL-Zeist. 2. Prinsen M.K., Acute eye irritation/co","page":18,"pdf":"out290_en.pdf","row_type":"noael_study","study_id":"out290_en_noael_002"}
SCCNFP_vision_codex	NOAEL	=1400	mg/kg bw/day	rat	oral	subchronic	repeated dose toxicity	{"citation":"Ref.: c 2","dose":"The NOAEL in a subchronic toxicity study was more than 1400 mg/kg bw/day.","effect":"the identity of substance A, B, C and D was not revealed, this study is unsuitable for evaluation. Ref.: c 2.11. Safety evaluation Not applicable 2.12. Conclusions 2,4-Bis-[4-[5-(1,1-dimethyl-propyl)benzoxazol-2-yl]phenylimino]-6-[(2-ethylexyl)imino]-1,3,5 triazine (UVASORB® K2A) belongs to the class of secondary amines and thus it is prone to nitrosation. No data are provided on the nitrosamine content of UVASORB® K2A. The photo-stability testing is inadequate. There is no data on reproduction toxicity. The NOAEL in a subchronic toxicity study was more than 1400 mg/kg bw/day. The test substance was not irritating to the eyes and the skin. It is not a sensitiser. The skin absorption was 2.7 µg/cm². The test substance was not mutagenic on bacteria nor in a chromosome aberration test. It was, however, photoclastogenic on mammalian cells treated in vitro. 2.13. References 1. Prinsen M.K., Acute oral toxicity study with ZN3044 in rats. Report V2510/18, January 2001. TNO, NL-Zeist. 2. Prinsen M.K., Acute eye irritation/co","page":18,"pdf":"out290_en.pdf","row_type":"noael_study","study_id":"out290_en_noael_002"}
SCCNFP_vision_codex	NOAEL	=1400	mg/kg bw/day	rat	oral	subchronic	repeated dose toxicity	{"citation":"Ref.: c 2","dose":"The NOAEL in a subchronic toxicity study was more than 1400 mg/kg bw/day.","effect":"the identity of substance A, B, C and D was not revealed, this study is unsuitable for evaluation. Ref.: c 2.11. Safety evaluation Not applicable 2.12. Conclusions 2,4-Bis-[4-[5-(1,1-dimethyl-propyl)benzoxazol-2-yl]phenylimino]-6-[(2-ethylexyl)imino]-1,3,5 triazine (UVASORB® K2A) belongs to the class of secondary amines and thus it is prone to nitrosation. No data are provided on the nitrosamine content of UVASORB® K2A. The photo-stability testing is inadequate. There is no data on reproduction toxicity. The NOAEL in a subchronic toxicity study was more than 1400 mg/kg bw/day. The test substance was not irritating to the eyes and the skin. It is not a sensitiser. The skin absorption was 2.7 µg/cm². The test substance was not mutagenic on bacteria nor in a chromosome aberration test. It was, however, photoclastogenic on mammalian cells treated in vitro. 2.13. References 1. Prinsen M.K., Acute oral toxicity study with ZN3044 in rats. Report V2510/18, January 2001. TNO, NL-Zeist. 2. Prinsen M.K., Acute eye irritation/co","page":18,"pdf":"out290_en.pdf","row_type":"noael_study","study_id":"out290_en_noael_002"}
SCCNFP_vision_codex	NOAEL	=1400	mg/kg bw/day	rat	oral	subchronic	repeated dose toxicity	{"citation":"Ref.: c 2","dose":"The NOAEL in a subchronic toxicity study was more than 1400 mg/kg bw/day.","effect":"the identity of substance A, B, C and D was not revealed, this study is unsuitable for evaluation. Ref.: c 2.11. Safety evaluation Not applicable 2.12. Conclusions 2,4-Bis-[4-[5-(1,1-dimethyl-propyl)benzoxazol-2-yl]phenylimino]-6-[(2-ethylexyl)imino]-1,3,5 triazine (UVASORB® K2A) belongs to the class of secondary amines and thus it is prone to nitrosation. No data are provided on the nitrosamine content of UVASORB® K2A. The photo-stability testing is inadequate. There is no data on reproduction toxicity. The NOAEL in a subchronic toxicity study was more than 1400 mg/kg bw/day. The test substance was not irritating to the eyes and the skin. It is not a sensitiser. The skin absorption was 2.7 µg/cm². The test substance was not mutagenic on bacteria nor in a chromosome aberration test. It was, however, photoclastogenic on mammalian cells treated in vitro. 2.13. References 1. Prinsen M.K., Acute oral toxicity study with ZN3044 in rats. Report V2510/18, January 2001. TNO, NL-Zeist. 2. Prinsen M.K., Acute eye irritation/co","page":18,"pdf":"out290_en.pdf","row_type":"noael_study","study_id":"out290_en_noael_002"}

UnifiedCodex:SCCNFP:beta.noael_studies 2 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
UnifiedCodex:SCCNFP:beta.noael_studies	-	2	%	-	oral	13 weeks	-	SOURCE_SUBDIR=out290_en; REPORT_TITLE=OPINION CONCERNING UVASORB® K2A; OPINION_NUMBER=SCCNFP/0814/04; COMMITTEE=SCCNFP; REPORT_DATE=Adopted by the SCCNFP on 1 July 2004; VALUE_TEXT=2; EFFECT=e : ZN3044 Batch no : 0100L1 Purity : 97.2% Dietary levels : 0, 0.2, 0.6 and 2.0% (equal to overall intakes of 0.13, 0.4 and 1.4 g/kg bw/day) Vehicle : diet Exposure : 13 weeks GLP : In compliance Results Clinical signs: no mortality, no treatment-related findings No treatment-related findings regarding arena testing, FOB and motor activity assessment, ophthalmoscopy, body weight, food/water intake, haematology, clinical chemistry, urinalysis, organ weights, macroscopy and histopathology. Conclusion The NOAEL was ≥ 2% ZN3044 in the diet (≥ 1.4 g ZN3044/kg bw/day). Ref.: 12; CITATION=Ref.: 12; CITATION_NUMBERS=[12]; REFERENCE=Ref.: 12; DETAILS_JSON={"cas_number":"288254-16-0","citation":"Ref.: 12","dose":"","duration":"13 weeks","effect":"e : ZN3044 Batch no : 0100L1 Purity : 97.2% Dietary levels : 0, 0.2, 0.6 and 2.0% (equal to overall intakes of 0.13, 0.4 and 1.4 g/kg bw/day) Vehicle : diet Exposure : 13 weeks GLP : In compliance Results Clinical signs: no mortality, no treatment-related findings No treatment-related findings regarding arena testing, FOB and motor activity assessment, ophthalmoscopy, body weight, food/water intake, haematology, clinical chemistry, urinalysis, organ weights, macroscopy and histopathology. Conclusion The NOAEL was ≥ 2% ZN3044 in the diet (≥ 1.4 g ZN3044/kg bw/day). Ref.: 12","endpoint":"","ingredient":"pending","loael_value":"","noael_unit":"%","noael_value":"2","page":6,"route":"oral","species":"","study_id":"out290_en_noael_001"}
UnifiedCodex:SCCNFP:beta.noael_studies	repeated dose toxicity	1400	mg/kg bw/day	rat	oral	subchronic	repeated dose toxicity	SOURCE_SUBDIR=out290_en; REPORT_TITLE=OPINION CONCERNING UVASORB® K2A; OPINION_NUMBER=SCCNFP/0814/04; COMMITTEE=SCCNFP; REPORT_DATE=Adopted by the SCCNFP on 1 July 2004; VALUE_TEXT=1400; DOSE=The NOAEL in a subchronic toxicity study was more than 1400 mg/kg bw/day.; EFFECT=the identity of substance A, B, C and D was not revealed, this study is unsuitable for evaluation. Ref.: c 2.11. Safety evaluation Not applicable 2.12. Conclusions 2,4-Bis-[4-[5-(1,1-dimethyl-propyl)benzoxazol-2-yl]phenylimino]-6-[(2-ethylexyl)imino]-1,3,5 triazine (UVASORB® K2A) belongs to the class of secondary amines and thus it is prone to nitrosation. No data are provided on the nitrosamine content of UVASORB® K2A. The photo-stability testing is inadequate. There is no data on reproduction toxicity. The NOAEL in a subchronic toxicity study was more than 1400 mg/kg bw/day. The test substance was not irritating to the eyes and the skin. It is not a sensitiser. The skin absorption was 2.7 µg/cm². The test substance was not mutagenic on bacteria nor in a chromosome aberration test. It was, however, photoclastogenic on mammalian cells treated in vitro. 2.13. References 1. Prinsen M.K., Acute oral toxicity study with ZN3044 in rats. Report V2510/18, January 2001. TNO, NL-Zeist. 2. Prinsen M.K., Acute eye irritation/co; CITATION=Ref.: c 2; CITATION_NUMBERS=[2]; REFERENCE=Ref.: c 2; DETAILS_JSON={"cas_number":"288254-16-0","citation":"Ref.: c 2","dose":"The NOAEL in a subchronic toxicity study was more than 1400 mg/kg bw/day.","duration":"subchronic","effect":"the identity of substance A, B, C and D was not revealed, this study is unsuitable for evaluation. Ref.: c 2.11. Safety evaluation Not applicable 2.12. Conclusions 2,4-Bis-[4-[5-(1,1-dimethyl-propyl)benzoxazol-2-yl]phenylimino]-6-[(2-ethylexyl)imino]-1,3,5 triazine (UVASORB® K2A) belongs to the class of secondary amines and thus it is prone to nitrosation. No data are provided on the nitrosamine content of UVASORB® K2A. The photo-stability testing is inadequate. There is no data on reproduction toxicity. The NOAEL in a subchronic toxicity study was more than 1400 mg/kg bw/day. The test substance was not irritating to the eyes and the skin. It is not a sensitiser. The skin absorption was 2.7 µg/cm². The test substance was not mutagenic on bacteria nor in a chromosome aberration test. It was, however, photoclastogenic on mammalian cells treated in vitro. 2.13. References 1. Prinsen M.K., Acute oral toxicity study with ZN3044 in rats. Report V2510/18, January 2001. TNO, NL-Zeist. 2. Prinsen M.K., Acute eye irritation/co","endpoint":"repeated dose toxicity","ingredient":"pending","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1400","page":18,"route":"oral","species":"rat","study_id":"out290_en_noael_002"}

openFDA substances 4 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
openFDA substances	FDA UNII substance identifier	BU9H717REF	UNII	-	-	-	chemical	{"approval_status":null,"molecular_formula":"C47H56N8O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"BU9H717REF"}
openFDA substances	FDA UNII substance identifier	BU9H717REF	UNII	-	-	-	chemical	{"approval_status":null,"molecular_formula":"C47H56N8O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"BU9H717REF"}
openFDA substances	FDA UNII substance identifier	BU9H717REF	UNII	-	-	-	chemical	{"approval_status":null,"molecular_formula":"C47H56N8O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"BU9H717REF"}
openFDA substances	FDA UNII substance identifier	BU9H717REF	UNII	-	-	-	chemical	{"approval_status":null,"molecular_formula":"C47H56N8O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"BU9H717REF"}