NOAEL Studies Cosmetic Ingredient

Cetylpyridinium Chloride NOAEL Studies

INCI: CETYLPYRIDINIUM CHLORIDE

CAS: 123-03-5

Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.

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NTP_ICE_acute_inhalation 1 endpoint

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
NTP_ICE_acute_inhalation	LC50	0.09	mg/L	-	Inhalation	Duration=4 hr	In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity	sheet=Data; excel_row=3716; Record_ID=acute_inhalation_1149; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID6041761; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response=0.09; Response_Unit=mg/L; Reference=ChemIDplus; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6041761

NTP_ICE_acute_oral 1 endpoint

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
NTP_ICE_acute_oral	LD50	=200	mg/kg bw	Rat	oral	acute	Rat Acute Oral Toxicity	NLM Hazardous Substances Data Bank (undated); record_id=acute_oral_1847; row=10839; data_type=In Vivo; mixture=Chemical; chemical_name=Cetylpyridinium chloride; preferred_name=Cetylpyridinium chloride; dtxsid=DTXSID6041761; url=https://pubchem.ncbi.nlm.nih.gov/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6041761; source_file=acute_oral.xlsx

SCCS_vision_codex 104 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
SCCS_vision_codex	NOAEL	=25	mg/kg bw/day	-	-	-	irritation	{"citation":"Ref.: 4 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report","dose":"g/kg bw/day and of 2/8 females at 50 mg/kg bw/day with concomitant necrosis/erosion in one female at each level.","effect":"g/kg bw/day and of 2/8 females at 50 mg/kg bw/day with concomitant necrosis/erosion in one female at each level. These histopathological changes were dose- related in incidence and severity, resulting in mortality for animals at 100 mg/kg bw/day and higher. Conclusion In conclusion, the target organ for CPC was the stomach and at dose levels from 50 mg/kg bw/day, it produced a localised toxic (i.e. irritant) action near or at the site of administration, specifically in the non-glandular region of the stomach. The NOAEL was considered to be 25 mg/kg bw/day in this study, based on histomorphological alterations in the non-glandular region of the stomach, i.e. forestomach. Ref.: 4 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report; no information was provided by the Sponsor of the study. The SCCS agrees on the NOAEL of 25 mg/kg bw/day for local effects in the forestomach probably due to the irritative properties of the test substance. The SCCS also considers 25 mg","page":24,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_001"}
SCCS_vision_codex	NOAEL	=250	mg/kg bw/day	-	-	-	NOAEL study	{"dose":"noted in 1/2 females at 500 mg/kg bw/day and in the duodenum in 1/3 females at 125 mg/kg bw/day.","effect":"noted in 1/2 females at 500 mg/kg bw/day and in the duodenum in 1/3 females at 125 mg/kg bw/day. Haemorrhage of the stomach fundus was noted in 1/2 females at 500 mg/kg bw/day and of the colon in 1/3 males at 125 mg/kg bw/day. Other histopathological findings included atrophy of the thymus at 125 and 250 mg/kg bw/day in both sexes, and lymphoid depletion and/or lymphadenitis in one or more lymph nodes (mandibular, mesenteric and tracheobronchial) in one or more animals at 125 and 250 mg/kg bw/day. Conclusion The NOAEL for systemic toxicity was considered to be 25 mg/kg bw/day in this study, based on mortality and decreased thymus weight confirmed by thymus atrophy at 125 mg/kg bw/day and above. Since the organ weight effects at 5 and 25 mg/kg bw/day were not confirmed by histopathological changes, they were not considered to be toxicologically relevant. The NOAEL for local effects was < 5 mg/kg bw/day in this study, based on effects in the gastrointestinal tract at all dose levels. Ref.: 5","page":26,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_004"}
SCCS_vision_codex	NOAEL	<5	mg/kg bw/day	-	-	-	NOAEL study	{"dose":"etion and/or lymphadenitis in one or more lymph nodes (mandibular, mesenteric and tracheobronchial) in one or more animals at 125 and 250 mg/kg bw/day.","effect":"etion and/or lymphadenitis in one or more lymph nodes (mandibular, mesenteric and tracheobronchial) in one or more animals at 125 and 250 mg/kg bw/day. Conclusion The NOAEL for systemic toxicity was considered to be 25 mg/kg bw/day in this study, based on mortality and decreased thymus weight confirmed by thymus atrophy at 125 mg/kg bw/day and above. Since the organ weight effects at 5 and 25 mg/kg bw/day were not confirmed by histopathological changes, they were not considered to be toxicologically relevant. The NOAEL for local effects was < 5 mg/kg bw/day in this study, based on effects in the gastrointestinal tract at all dose levels. Ref.: 5","page":26,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_005"}
SCCS_vision_codex	NOAEL	=15	mg/kg bw/day	-	-	-	NOAEL study	{"citation":"Ref.: 6 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report","dose":"SCCS/1548/15 Revision of the Opinion on Cetylpyridinium chloride (P97) ___________________________________________________________________________________________ 30 Conclusion The NOAEL for systemic toxicity was considered to be 15 mg/kg bw/day in this study, based on decreased glucose levels in 40 and 75 mg/kg/d animals of both sexes.","effect":"SCCS/1548/15 Revision of the Opinion on Cetylpyridinium chloride (P97) ___________________________________________________________________________________________ 30 Conclusion The NOAEL for systemic toxicity was considered to be 15 mg/kg bw/day in this study, based on decreased glucose levels in 40 and 75 mg/kg/d animals of both sexes. The NOAEL for local effects was 5 mg/kg bw/day in this study, based on acanthosis of the non-glandular region of the stomach, i.e. forestomach. Ref.: 6 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report; no information was provided by the Sponsor of the study. The SCCS agrees on the NOAEL of 5 mg","page":30,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_006"}
SCCS_vision_codex	NOAEL	=90	-	rat	-	90-day	NOAEL study	{"citation":"Ref.: 24)","effect":"escribed in secondary literature and therefore, are not consideted to add any valuable information for the safety assessment of cetylpyridinium chloride as a cosmetic ingredient. The full reports of two 90-day feeding studies of cetylpyridinium chloride (one in rats and the other in dogs) were submitted to EFSA for the evaluation of the safety and efficacy of Cecure® (Ref.: 24); the active ingredient in Cecure® is cetylpyridinium chloride. In addition, a third 90-day rat study was crucial for the setting of the NOAEL for cetylpyridinium chloride in the EFSA Opinion. The two rat studies which are also considered of relevance for the safety assessment of cetylpyridinium chloride as a cosmetic ingredient are summarised below, based on the descriptions in the EFSA Opinion. The CEF Panel considered that the 90-day dog study was not suitable for the derivation of a NOAEL; thus, this study is not considered of relevance for the safety assessment of cetylpyridinium chloride as a cosmetic ingredient and therefore, not included in this","page":30,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_010"}
SCCS_vision_codex	NOAEL	=1000	ppm	rat	oral	90-day	NOAEL study	{"citation":"Ref.: 24)","dose":"In a 13-week study, Sprague-Dawley albino rats (10/sex/group) were administered 0, 125, 250, 500, and 1000 ppm of CPC in the diet, corresponding to an average consumption of approximately 0, 9, 18, 35 and 70 mg/kg bw/day for males, and to 0, 11, 22, 42 and 84 mg/kg bw/day for females, respectively (Charles River Laboratories, 2006a, as cited","effect":"ficacy of Cecure® (Ref.: 24); the active ingredient in Cecure® is cetylpyridinium chloride. In addition, a third 90-day rat study was crucial for the setting of the NOAEL for cetylpyridinium chloride in the EFSA Opinion. The two rat studies which are also considered of relevance for the safety assessment of cetylpyridinium chloride as a cosmetic ingredient are summarised below, based on the descriptions in the EFSA Opinion. The CEF Panel considered that the 90-day dog study was not suitable for the derivation of a NOAEL; thus, this study is not considered of relevance for the safety assessment of cetylpyridinium chloride as a cosmetic ingredient and therefore, not included in this Opinion. In a 13-week study, Sprague-Dawley albino rats (10/sex/group) were administered 0, 125, 250, 500, and 1000 ppm of CPC in the diet, corresponding to an average consumption of approximately 0, 9, 18, 35 and 70 mg/kg bw/day for males, and to 0, 11, 22, 42 and 84 mg/kg bw/day for females, respectively (Charles River Laboratories, 2006a, as cited","page":30,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_011"}
SCCS_vision_codex	NOAEL	=250	ppm	rat	oral	90 days	NOAEL study	{"citation":"Ref.: 24)","dose":"In males, relative caecum weights were statistically significantly increased at 500 and 1000 ppm and relative weights of brain, heart and testis were statistically increased in males at 1000 ppm.","effect":"e 1000 ppm group. In males, relative caecum weights were statistically significantly increased at 500 and 1000 ppm and relative weights of brain, heart and testis were statistically increased in males at 1000 ppm. In females relative weights of adrenals glands, brain, caecum, heart, kidney, liver, lung, ovary and spleen were significantly increased at 1000 ppm. No histopathological changes were reported. According to the CEF Panel, taking into account the increase in caecum weights in males in the 500 ppm group, a NOAEL of 250 ppm (18 mg/kg bw/day) can be identified. Rats (6/sex/group, strain not specified) were administered 0, 125, 300, 800, 2000, 5000, 10000 ppm CPC in the diet (equivalent to approximately 0, 6.25, 15, 40, 100, 250 and 500 mg/kg bw/day) for 90 days (USAEH-HT, 1969, as cited in Ref.: 24). All animals administered 250 and 500 mg/kg bw/day died within three weeks after initiation of the test. Unspecified differences in body weight gain, relative liver and kidney weights and food utilisation at 100 mg/kg bw/day w","page":31,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_012"}
SCCS_vision_codex	NOAEL	=18	mg/kg bw/day	rat	oral	90-day	repeated dose toxicity	{"dose":"s of CPC and increases in relative caecum weight (statistically signifant at 15 mg/kg bw/day and above in females and at 40 mg/kg bw/day and above in males).","effect":"s of CPC and increases in relative caecum weight (statistically signifant at 15 mg/kg bw/day and above in females and at 40 mg/kg bw/day and above in males). Gross and microscopic examination of liver, kidneys, lung, spleen, caecum and testis from any of the administered groups were reported to show no appreciable differences compared to controls. It was noted that, as the concentration of CPC increased, the total number of microorganisms in the caecal contents decreased in both sexes. The CEF Panel identified a NOAEL of 18 mg/kg bw/day, based on increased relative caecum weights in male rats in the 90-day study. The CEF Panel considered the increase in caecum weight as relevant for risk characterisation of Cecure® as an increase in relative caecum weight has been consistently positively correlated with increased dietary levels of CPC in sub-chronic rat studies. Furthermore, in one of these studies it was noted that as the concentration of CPC increased, the total number of microorganisms in the caecal contents decreased in bot","page":31,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_013"}
SCCS_vision_codex	NOAEL	=60	mg/kg bw/day	-	-	developmental	developmental toxicity	{"citation":"Ref.: 10","dose":"Conclusion No evidence of developmental toxicity was observed in the 60 mg/kg bw/day group nor in any of the dose groups.","effect":"SCCS-rejected applicant NOAEL: on of the jugal, incomplete ossification of the cervical vertebral arches and ischium, presence of 14th thoracic vertebra and/or 5th lumbar vertebra, unossified 5th sternebra, bent rib, 12 full pairs of ribs, a rudimentary rib and/or full unilateral rib; the slightly higher incidences of these developmental variations were not considered indicative of a teratogenic effect by the applicant. Conclusion No evidence of developmental toxicity was observed in the 60 mg/kg bw/day group nor in any of the dose groups. The NOAEL of cetylpyridinium chloride with regard to maternal toxicity was 15 mg/kg/day, and 60 mg/kg/day with respect to developmental toxicity. Ref.: 10","page":37,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_020"}
SCCS_vision_codex	NOAEL	=100	mg/kg bw/day	rat	-	-	developmental toxicity	{"citation":"Ref.: 11 SCCS comment The SCCS notes that the purity and stability of the test material was not provided","dose":"An increased incidence of skeletal variations was observed at 25 mg/kg bw/day and included missing sternebrae and 13th rib variations.","effect":"on of the Opinion on Cetylpyridinium chloride (P97) ___________________________________________________________________________________________ 39 changes in the incidence of soft tissue anomalies or skeletal malformations were noted. An increased incidence of skeletal variations was observed at 25 mg/kg bw/day and included missing sternebrae and 13th rib variations. Conclusion The data demonstrated that these materials were not teratogenic in rabbits at doses ranging up to those fatal to the dam; therefore, the NOAEL for teratogenicity was greater than or equal to 100 mg/kg bw/day. Ref.: 11 SCCS comment The SCCS notes that the purity and stability of the test material was not provided. Furthermore, the study was limitedly reported with only summarised tables available for the findings observed in the study. Thus, this study is considered inadequate for the safety assessment of cetylpyridinium chloride. Overall SCCS comment to the submitted teratogenicity studies Two teratogenicity studies – one in rats and the other in rab","page":39,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_021"}
SCCS_vision_codex	NOAEL	=2.5	mg/kg bw/day	-	oral	6-month	NOAEL study	{"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Oral application For oral application, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used for the MOS calculation.","effect":"SCCS/1548/15 Revision of the Opinion on Cetylpyridinium chloride (P97) ___________________________________________________________________________________________ 47 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Oral application For oral application, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used for the MOS calculation. Based on the toxicokinetic data, an oral absorption of 50% is considered. The adjusted NOAEL for the MOS calculation is 2.5 mg/kg bw/day. Product Max concentration (% in the finished product) Total oral exposure (mg/kg bw/day) Calculated SED based on an oral absorption of 50% (mg/kg bw/day) MoS (adjusted NOAEL/SED) Mouthrinse 0.1 0.033 0.016 156 Dentrifice3 (toothpaste) 0.5 0.011 0.005 500 Aggregate exposure (cosmetics) 0.021 120 Denture adhesive3 0.5 0.025 0.013 192 Denture cleanser3 0.5 0.00013 0.00006 41700 Aggregate exposure (total) 0.034 74 In conclusion, the SCCS considers that the use of c","page":47,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_023"}
SCCS_vision_codex	NOAEL	=50	%	-	oral	6-month	NOAEL study	{"dose":"ng calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Oral application For oral application, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used for the MOS calculation.","effect":"ng calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Oral application For oral application, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used for the MOS calculation. Based on the toxicokinetic data, an oral absorption of 50% is considered. The adjusted NOAEL for the MOS calculation is 2.5 mg/kg bw/day. Product Max concentration (% in the finished product) Total oral exposure (mg/kg bw/day) Calculated SED based on an oral absorption of 50% (mg/kg bw/day) MoS (adjusted NOAEL/SED) Mouthrinse 0.1 0.033 0.016 156 Dentrifice3 (toothpaste) 0.5 0.011 0.005 500 Aggregate exposure (cosmetics) 0.021 120 Denture adhesive3 0.5 0.025 0.013 192 Denture cleanser3 0.5 0.00013 0.00006 41700 Aggregate exposure (total) 0.034 74 In conclusion, the SCCS considers that the use of cetylpyridinium chloride in the single cosmetic products for oral application mentioned above is safe for the consumer. Aggregate exposure to cetylpyridinium chloride via cosmetic products and other consumer products (dentu","page":47,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_024"}
SCCS_vision_codex	NOAEL	=10	%	-	oral	-	dermal absorption	{"dose":"Dermal application For dermal application, the NOAEL of 18 mg/kg bw/day identified by the CEF Panel in the EFSA opinion is used for the MOS calculation.","effect":"ed poultry will not occur simultaneously very often. Dermal application For dermal application, the NOAEL of 18 mg/kg bw/day identified by the CEF Panel in the EFSA opinion is used for the MOS calculation. Based on the toxicokinetic data, an oral absorption of 50% is considered. The adjusted NOAEL for the MOS calculation is 9 mg/kg bw/day. Product Max concentration (% in the finished product) Total dermal exposure (mg/kg bw/day) Calculated SED based on a dermal absorption of 10% (mg/kg bw/day) MoS (adjusted NOAEL/SED) Body lotion 0.2 0.246 0.025 360 Face cream 0.2 0.048 0.0048 1875 Hand cream 0.2 0.065 0.0065 1385 Deodorant, non-spray 2.0 0.442 0.044 205 Aggregate exposure 0.080 113 In conclusion, the SCCS considers that the use of cetylpyridinium chloride in the single cosmetic products for dermal application mentioned above, as well as aggregate exposure to cetylpyridinium chloride via cosmetic products for these dermal applications is safe for the consumer. Aggregate exposure Aggregate exposure to cetylpyridini","page":48,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_027"}
SCCS_vision_codex	NOAEL	=15	mg/kg/day	rat	oral	6-month	developmental toxicity	{"dose":"Consequently, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used in the safety assessment for the MOS calculation for use of cetylpyridinium chloride as a preservative in mouthwashes cosmetic products, as well as in all other oral hygiene cosmetic products, cf.","effect":"y the applicant are considered as more relevant for the safety assessment of cetylpyridinium chloride than the dietary studies reported in the EFSA opinion. Consequently, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used in the safety assessment for the MOS calculation for use of cetylpyridinium chloride as a preservative in mouthwashes cosmetic products, as well as in all other oral hygiene cosmetic products, cf. Terms of Reference. In the teratogenicity study performed with rats, the NOAEL for maternal toxicity was 15 mg/kg/day, based on clinical signs of toxicity and decreased body weight gain; the NOAEL for developmental toxicity was 60 mg/kg/day (the highest dose level in the study). The teratogenicity study performed with rabbits was limitedly reported with only summarised tables available for the findings observed in the study and therefore, the study is considered inadequate for the safety assessment of cetylpyridinium chloride. Irritation / sensitisation Cetylpyridinium chloride at a conce","page":50,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_035"}
SCCS_vision_codex	NOAEL	=60	mg/kg/day	rat	oral	6-month	developmental toxicity	{"dose":"Consequently, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used in the safety assessment for the MOS calculation for use of cetylpyridinium chloride as a preservative in mouthwashes cosmetic products, as well as in all other oral hygiene cosmetic products, cf.","effect":"studies reported in the EFSA opinion. Consequently, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used in the safety assessment for the MOS calculation for use of cetylpyridinium chloride as a preservative in mouthwashes cosmetic products, as well as in all other oral hygiene cosmetic products, cf. Terms of Reference. In the teratogenicity study performed with rats, the NOAEL for maternal toxicity was 15 mg/kg/day, based on clinical signs of toxicity and decreased body weight gain; the NOAEL for developmental toxicity was 60 mg/kg/day (the highest dose level in the study). The teratogenicity study performed with rabbits was limitedly reported with only summarised tables available for the findings observed in the study and therefore, the study is considered inadequate for the safety assessment of cetylpyridinium chloride. Irritation / sensitisation Cetylpyridinium chloride at a concentration of 65% had a moderate to severe irritant potential to the skin of the rabbit in a study performed according t","page":50,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_036"}
SCCS_vision_codex	NOAEL	=156	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 47: Mouthrinse \| 0.1 \| 0.033 \| 0.016 \| 156","page":47,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_038"}
SCCS_vision_codex	NOAEL	=500	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 47: Dentrifice3 (toothpaste) \| 0.5 \| 0.011 \| 0.005 \| 500","page":47,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_039"}
SCCS_vision_codex	NOAEL	=120	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 47: Aggregate exposure (cosmetics) \| 0.021 \| 120","page":47,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_040"}
SCCS_vision_codex	NOAEL	=192	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 47: Denture adhesive3 \| 0.5 \| 0.025 \| 0.013 \| 192","page":47,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_041"}
SCCS_vision_codex	NOAEL	=41700	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 47: Denture cleanser3 \| 0.5 \| 0.00013 \| 0.00006 \| 41700","page":47,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_042"}
SCCS_vision_codex	NOAEL	=74	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 47: Aggregate exposure (total) \| 0.034 \| 74","page":47,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_043"}
SCCS_vision_codex	NOAEL	=360	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 48: Body lotion \| 0.2 \| 0.246 \| 0.025 \| 360","page":48,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_045"}
SCCS_vision_codex	NOAEL	=1875	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 48: Face cream \| 0.2 \| 0.048 \| 0.0048 \| 1875","page":48,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_046"}
SCCS_vision_codex	NOAEL	=1385	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 48: Hand cream \| 0.2 \| 0.065 \| 0.0065 \| 1385","page":48,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_047"}
SCCS_vision_codex	NOAEL	=205	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 48: Deodorant, non-spray \| 2.0 \| 0.442 \| 0.044 \| 205","page":48,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_048"}
SCCS_vision_codex	NOAEL	=113	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 48: Aggregate exposure \| 0.080 \| 113","page":48,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_049"}
SCCS_vision_codex	NOAEL	=25	mg/kg bw/day	-	-	-	irritation	{"citation":"Ref.: 4 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report","dose":"g/kg bw/day and of 2/8 females at 50 mg/kg bw/day with concomitant necrosis/erosion in one female at each level.","effect":"g/kg bw/day and of 2/8 females at 50 mg/kg bw/day with concomitant necrosis/erosion in one female at each level. These histopathological changes were dose- related in incidence and severity, resulting in mortality for animals at 100 mg/kg bw/day and higher. Conclusion In conclusion, the target organ for CPC was the stomach and at dose levels from 50 mg/kg bw/day, it produced a localised toxic (i.e. irritant) action near or at the site of administration, specifically in the non-glandular region of the stomach. The NOAEL was considered to be 25 mg/kg bw/day in this study, based on histomorphological alterations in the non-glandular region of the stomach, i.e. forestomach. Ref.: 4 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report; no information was provided by the Sponsor of the study. The SCCS agrees on the NOAEL of 25 mg/kg bw/day for local effects in the forestomach probably due to the irritative properties of the test substance. The SCCS also considers 25 mg","page":24,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_001"}
SCCS_vision_codex	NOAEL	=250	mg/kg bw/day	-	-	-	NOAEL study	{"dose":"noted in 1/2 females at 500 mg/kg bw/day and in the duodenum in 1/3 females at 125 mg/kg bw/day.","effect":"noted in 1/2 females at 500 mg/kg bw/day and in the duodenum in 1/3 females at 125 mg/kg bw/day. Haemorrhage of the stomach fundus was noted in 1/2 females at 500 mg/kg bw/day and of the colon in 1/3 males at 125 mg/kg bw/day. Other histopathological findings included atrophy of the thymus at 125 and 250 mg/kg bw/day in both sexes, and lymphoid depletion and/or lymphadenitis in one or more lymph nodes (mandibular, mesenteric and tracheobronchial) in one or more animals at 125 and 250 mg/kg bw/day. Conclusion The NOAEL for systemic toxicity was considered to be 25 mg/kg bw/day in this study, based on mortality and decreased thymus weight confirmed by thymus atrophy at 125 mg/kg bw/day and above. Since the organ weight effects at 5 and 25 mg/kg bw/day were not confirmed by histopathological changes, they were not considered to be toxicologically relevant. The NOAEL for local effects was < 5 mg/kg bw/day in this study, based on effects in the gastrointestinal tract at all dose levels. Ref.: 5","page":26,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_004"}
SCCS_vision_codex	NOAEL	<5	mg/kg bw/day	-	-	-	NOAEL study	{"dose":"etion and/or lymphadenitis in one or more lymph nodes (mandibular, mesenteric and tracheobronchial) in one or more animals at 125 and 250 mg/kg bw/day.","effect":"etion and/or lymphadenitis in one or more lymph nodes (mandibular, mesenteric and tracheobronchial) in one or more animals at 125 and 250 mg/kg bw/day. Conclusion The NOAEL for systemic toxicity was considered to be 25 mg/kg bw/day in this study, based on mortality and decreased thymus weight confirmed by thymus atrophy at 125 mg/kg bw/day and above. Since the organ weight effects at 5 and 25 mg/kg bw/day were not confirmed by histopathological changes, they were not considered to be toxicologically relevant. The NOAEL for local effects was < 5 mg/kg bw/day in this study, based on effects in the gastrointestinal tract at all dose levels. Ref.: 5","page":26,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_005"}
SCCS_vision_codex	NOAEL	=15	mg/kg bw/day	-	-	-	NOAEL study	{"citation":"Ref.: 6 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report","dose":"SCCS/1548/15 Revision of the Opinion on Cetylpyridinium chloride (P97) ___________________________________________________________________________________________ 30 Conclusion The NOAEL for systemic toxicity was considered to be 15 mg/kg bw/day in this study, based on decreased glucose levels in 40 and 75 mg/kg/d animals of both sexes.","effect":"SCCS/1548/15 Revision of the Opinion on Cetylpyridinium chloride (P97) ___________________________________________________________________________________________ 30 Conclusion The NOAEL for systemic toxicity was considered to be 15 mg/kg bw/day in this study, based on decreased glucose levels in 40 and 75 mg/kg/d animals of both sexes. The NOAEL for local effects was 5 mg/kg bw/day in this study, based on acanthosis of the non-glandular region of the stomach, i.e. forestomach. Ref.: 6 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report; no information was provided by the Sponsor of the study. The SCCS agrees on the NOAEL of 5 mg","page":30,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_006"}
SCCS_vision_codex	NOAEL	=90	-	rat	-	90-day	NOAEL study	{"citation":"Ref.: 24)","effect":"escribed in secondary literature and therefore, are not consideted to add any valuable information for the safety assessment of cetylpyridinium chloride as a cosmetic ingredient. The full reports of two 90-day feeding studies of cetylpyridinium chloride (one in rats and the other in dogs) were submitted to EFSA for the evaluation of the safety and efficacy of Cecure® (Ref.: 24); the active ingredient in Cecure® is cetylpyridinium chloride. In addition, a third 90-day rat study was crucial for the setting of the NOAEL for cetylpyridinium chloride in the EFSA Opinion. The two rat studies which are also considered of relevance for the safety assessment of cetylpyridinium chloride as a cosmetic ingredient are summarised below, based on the descriptions in the EFSA Opinion. The CEF Panel considered that the 90-day dog study was not suitable for the derivation of a NOAEL; thus, this study is not considered of relevance for the safety assessment of cetylpyridinium chloride as a cosmetic ingredient and therefore, not included in this","page":30,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_010"}
SCCS_vision_codex	NOAEL	=1000	ppm	rat	oral	90-day	NOAEL study	{"citation":"Ref.: 24)","dose":"In a 13-week study, Sprague-Dawley albino rats (10/sex/group) were administered 0, 125, 250, 500, and 1000 ppm of CPC in the diet, corresponding to an average consumption of approximately 0, 9, 18, 35 and 70 mg/kg bw/day for males, and to 0, 11, 22, 42 and 84 mg/kg bw/day for females, respectively (Charles River Laboratories, 2006a, as cited","effect":"ficacy of Cecure® (Ref.: 24); the active ingredient in Cecure® is cetylpyridinium chloride. In addition, a third 90-day rat study was crucial for the setting of the NOAEL for cetylpyridinium chloride in the EFSA Opinion. The two rat studies which are also considered of relevance for the safety assessment of cetylpyridinium chloride as a cosmetic ingredient are summarised below, based on the descriptions in the EFSA Opinion. The CEF Panel considered that the 90-day dog study was not suitable for the derivation of a NOAEL; thus, this study is not considered of relevance for the safety assessment of cetylpyridinium chloride as a cosmetic ingredient and therefore, not included in this Opinion. In a 13-week study, Sprague-Dawley albino rats (10/sex/group) were administered 0, 125, 250, 500, and 1000 ppm of CPC in the diet, corresponding to an average consumption of approximately 0, 9, 18, 35 and 70 mg/kg bw/day for males, and to 0, 11, 22, 42 and 84 mg/kg bw/day for females, respectively (Charles River Laboratories, 2006a, as cited","page":30,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_011"}
SCCS_vision_codex	NOAEL	=250	ppm	rat	oral	90 days	NOAEL study	{"citation":"Ref.: 24)","dose":"In males, relative caecum weights were statistically significantly increased at 500 and 1000 ppm and relative weights of brain, heart and testis were statistically increased in males at 1000 ppm.","effect":"e 1000 ppm group. In males, relative caecum weights were statistically significantly increased at 500 and 1000 ppm and relative weights of brain, heart and testis were statistically increased in males at 1000 ppm. In females relative weights of adrenals glands, brain, caecum, heart, kidney, liver, lung, ovary and spleen were significantly increased at 1000 ppm. No histopathological changes were reported. According to the CEF Panel, taking into account the increase in caecum weights in males in the 500 ppm group, a NOAEL of 250 ppm (18 mg/kg bw/day) can be identified. Rats (6/sex/group, strain not specified) were administered 0, 125, 300, 800, 2000, 5000, 10000 ppm CPC in the diet (equivalent to approximately 0, 6.25, 15, 40, 100, 250 and 500 mg/kg bw/day) for 90 days (USAEH-HT, 1969, as cited in Ref.: 24). All animals administered 250 and 500 mg/kg bw/day died within three weeks after initiation of the test. Unspecified differences in body weight gain, relative liver and kidney weights and food utilisation at 100 mg/kg bw/day w","page":31,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_012"}
SCCS_vision_codex	NOAEL	=18	mg/kg bw/day	rat	oral	90-day	repeated dose toxicity	{"dose":"s of CPC and increases in relative caecum weight (statistically signifant at 15 mg/kg bw/day and above in females and at 40 mg/kg bw/day and above in males).","effect":"s of CPC and increases in relative caecum weight (statistically signifant at 15 mg/kg bw/day and above in females and at 40 mg/kg bw/day and above in males). Gross and microscopic examination of liver, kidneys, lung, spleen, caecum and testis from any of the administered groups were reported to show no appreciable differences compared to controls. It was noted that, as the concentration of CPC increased, the total number of microorganisms in the caecal contents decreased in both sexes. The CEF Panel identified a NOAEL of 18 mg/kg bw/day, based on increased relative caecum weights in male rats in the 90-day study. The CEF Panel considered the increase in caecum weight as relevant for risk characterisation of Cecure® as an increase in relative caecum weight has been consistently positively correlated with increased dietary levels of CPC in sub-chronic rat studies. Furthermore, in one of these studies it was noted that as the concentration of CPC increased, the total number of microorganisms in the caecal contents decreased in bot","page":31,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_013"}
SCCS_vision_codex	NOAEL	=60	mg/kg bw/day	-	-	developmental	developmental toxicity	{"citation":"Ref.: 10","dose":"Conclusion No evidence of developmental toxicity was observed in the 60 mg/kg bw/day group nor in any of the dose groups.","effect":"SCCS-rejected applicant NOAEL: on of the jugal, incomplete ossification of the cervical vertebral arches and ischium, presence of 14th thoracic vertebra and/or 5th lumbar vertebra, unossified 5th sternebra, bent rib, 12 full pairs of ribs, a rudimentary rib and/or full unilateral rib; the slightly higher incidences of these developmental variations were not considered indicative of a teratogenic effect by the applicant. Conclusion No evidence of developmental toxicity was observed in the 60 mg/kg bw/day group nor in any of the dose groups. The NOAEL of cetylpyridinium chloride with regard to maternal toxicity was 15 mg/kg/day, and 60 mg/kg/day with respect to developmental toxicity. Ref.: 10","page":37,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_020"}
SCCS_vision_codex	NOAEL	=100	mg/kg bw/day	rat	-	-	developmental toxicity	{"citation":"Ref.: 11 SCCS comment The SCCS notes that the purity and stability of the test material was not provided","dose":"An increased incidence of skeletal variations was observed at 25 mg/kg bw/day and included missing sternebrae and 13th rib variations.","effect":"on of the Opinion on Cetylpyridinium chloride (P97) ___________________________________________________________________________________________ 39 changes in the incidence of soft tissue anomalies or skeletal malformations were noted. An increased incidence of skeletal variations was observed at 25 mg/kg bw/day and included missing sternebrae and 13th rib variations. Conclusion The data demonstrated that these materials were not teratogenic in rabbits at doses ranging up to those fatal to the dam; therefore, the NOAEL for teratogenicity was greater than or equal to 100 mg/kg bw/day. Ref.: 11 SCCS comment The SCCS notes that the purity and stability of the test material was not provided. Furthermore, the study was limitedly reported with only summarised tables available for the findings observed in the study. Thus, this study is considered inadequate for the safety assessment of cetylpyridinium chloride. Overall SCCS comment to the submitted teratogenicity studies Two teratogenicity studies – one in rats and the other in rab","page":39,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_021"}
SCCS_vision_codex	NOAEL	=2.5	mg/kg bw/day	-	oral	6-month	NOAEL study	{"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Oral application For oral application, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used for the MOS calculation.","effect":"SCCS/1548/15 Revision of the Opinion on Cetylpyridinium chloride (P97) ___________________________________________________________________________________________ 47 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Oral application For oral application, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used for the MOS calculation. Based on the toxicokinetic data, an oral absorption of 50% is considered. The adjusted NOAEL for the MOS calculation is 2.5 mg/kg bw/day. Product Max concentration (% in the finished product) Total oral exposure (mg/kg bw/day) Calculated SED based on an oral absorption of 50% (mg/kg bw/day) MoS (adjusted NOAEL/SED) Mouthrinse 0.1 0.033 0.016 156 Dentrifice3 (toothpaste) 0.5 0.011 0.005 500 Aggregate exposure (cosmetics) 0.021 120 Denture adhesive3 0.5 0.025 0.013 192 Denture cleanser3 0.5 0.00013 0.00006 41700 Aggregate exposure (total) 0.034 74 In conclusion, the SCCS considers that the use of c","page":47,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_023"}
SCCS_vision_codex	NOAEL	=50	%	-	oral	6-month	NOAEL study	{"dose":"ng calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Oral application For oral application, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used for the MOS calculation.","effect":"ng calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Oral application For oral application, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used for the MOS calculation. Based on the toxicokinetic data, an oral absorption of 50% is considered. The adjusted NOAEL for the MOS calculation is 2.5 mg/kg bw/day. Product Max concentration (% in the finished product) Total oral exposure (mg/kg bw/day) Calculated SED based on an oral absorption of 50% (mg/kg bw/day) MoS (adjusted NOAEL/SED) Mouthrinse 0.1 0.033 0.016 156 Dentrifice3 (toothpaste) 0.5 0.011 0.005 500 Aggregate exposure (cosmetics) 0.021 120 Denture adhesive3 0.5 0.025 0.013 192 Denture cleanser3 0.5 0.00013 0.00006 41700 Aggregate exposure (total) 0.034 74 In conclusion, the SCCS considers that the use of cetylpyridinium chloride in the single cosmetic products for oral application mentioned above is safe for the consumer. Aggregate exposure to cetylpyridinium chloride via cosmetic products and other consumer products (dentu","page":47,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_024"}
SCCS_vision_codex	NOAEL	=10	%	-	oral	-	dermal absorption	{"dose":"Dermal application For dermal application, the NOAEL of 18 mg/kg bw/day identified by the CEF Panel in the EFSA opinion is used for the MOS calculation.","effect":"ed poultry will not occur simultaneously very often. Dermal application For dermal application, the NOAEL of 18 mg/kg bw/day identified by the CEF Panel in the EFSA opinion is used for the MOS calculation. Based on the toxicokinetic data, an oral absorption of 50% is considered. The adjusted NOAEL for the MOS calculation is 9 mg/kg bw/day. Product Max concentration (% in the finished product) Total dermal exposure (mg/kg bw/day) Calculated SED based on a dermal absorption of 10% (mg/kg bw/day) MoS (adjusted NOAEL/SED) Body lotion 0.2 0.246 0.025 360 Face cream 0.2 0.048 0.0048 1875 Hand cream 0.2 0.065 0.0065 1385 Deodorant, non-spray 2.0 0.442 0.044 205 Aggregate exposure 0.080 113 In conclusion, the SCCS considers that the use of cetylpyridinium chloride in the single cosmetic products for dermal application mentioned above, as well as aggregate exposure to cetylpyridinium chloride via cosmetic products for these dermal applications is safe for the consumer. Aggregate exposure Aggregate exposure to cetylpyridini","page":48,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_027"}
SCCS_vision_codex	NOAEL	=15	mg/kg/day	rat	oral	6-month	developmental toxicity	{"dose":"Consequently, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used in the safety assessment for the MOS calculation for use of cetylpyridinium chloride as a preservative in mouthwashes cosmetic products, as well as in all other oral hygiene cosmetic products, cf.","effect":"y the applicant are considered as more relevant for the safety assessment of cetylpyridinium chloride than the dietary studies reported in the EFSA opinion. Consequently, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used in the safety assessment for the MOS calculation for use of cetylpyridinium chloride as a preservative in mouthwashes cosmetic products, as well as in all other oral hygiene cosmetic products, cf. Terms of Reference. In the teratogenicity study performed with rats, the NOAEL for maternal toxicity was 15 mg/kg/day, based on clinical signs of toxicity and decreased body weight gain; the NOAEL for developmental toxicity was 60 mg/kg/day (the highest dose level in the study). The teratogenicity study performed with rabbits was limitedly reported with only summarised tables available for the findings observed in the study and therefore, the study is considered inadequate for the safety assessment of cetylpyridinium chloride. Irritation / sensitisation Cetylpyridinium chloride at a conce","page":50,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_035"}
SCCS_vision_codex	NOAEL	=60	mg/kg/day	rat	oral	6-month	developmental toxicity	{"dose":"Consequently, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used in the safety assessment for the MOS calculation for use of cetylpyridinium chloride as a preservative in mouthwashes cosmetic products, as well as in all other oral hygiene cosmetic products, cf.","effect":"studies reported in the EFSA opinion. Consequently, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used in the safety assessment for the MOS calculation for use of cetylpyridinium chloride as a preservative in mouthwashes cosmetic products, as well as in all other oral hygiene cosmetic products, cf. Terms of Reference. In the teratogenicity study performed with rats, the NOAEL for maternal toxicity was 15 mg/kg/day, based on clinical signs of toxicity and decreased body weight gain; the NOAEL for developmental toxicity was 60 mg/kg/day (the highest dose level in the study). The teratogenicity study performed with rabbits was limitedly reported with only summarised tables available for the findings observed in the study and therefore, the study is considered inadequate for the safety assessment of cetylpyridinium chloride. Irritation / sensitisation Cetylpyridinium chloride at a concentration of 65% had a moderate to severe irritant potential to the skin of the rabbit in a study performed according t","page":50,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_036"}
SCCS_vision_codex	NOAEL	=156	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 47: Mouthrinse \| 0.1 \| 0.033 \| 0.016 \| 156","page":47,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_038"}
SCCS_vision_codex	NOAEL	=500	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 47: Dentrifice3 (toothpaste) \| 0.5 \| 0.011 \| 0.005 \| 500","page":47,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_039"}
SCCS_vision_codex	NOAEL	=120	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 47: Aggregate exposure (cosmetics) \| 0.021 \| 120","page":47,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_040"}
SCCS_vision_codex	NOAEL	=192	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 47: Denture adhesive3 \| 0.5 \| 0.025 \| 0.013 \| 192","page":47,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_041"}
SCCS_vision_codex	NOAEL	=41700	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 47: Denture cleanser3 \| 0.5 \| 0.00013 \| 0.00006 \| 41700","page":47,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_042"}
SCCS_vision_codex	NOAEL	=74	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 47: Aggregate exposure (total) \| 0.034 \| 74","page":47,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_043"}
SCCS_vision_codex	NOAEL	=360	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 48: Body lotion \| 0.2 \| 0.246 \| 0.025 \| 360","page":48,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_045"}
SCCS_vision_codex	NOAEL	=1875	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 48: Face cream \| 0.2 \| 0.048 \| 0.0048 \| 1875","page":48,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_046"}
SCCS_vision_codex	NOAEL	=1385	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 48: Hand cream \| 0.2 \| 0.065 \| 0.0065 \| 1385","page":48,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_047"}
SCCS_vision_codex	NOAEL	=205	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 48: Deodorant, non-spray \| 2.0 \| 0.442 \| 0.044 \| 205","page":48,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_048"}
SCCS_vision_codex	NOAEL	=113	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 48: Aggregate exposure \| 0.080 \| 113","page":48,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_049"}
SCCS_vision_codex	NOAEL	=25	mg/kg bw/day	-	-	-	irritation	{"citation":"Ref.: 4 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report","dose":"g/kg bw/day and of 2/8 females at 50 mg/kg bw/day with concomitant necrosis/erosion in one female at each level.","effect":"g/kg bw/day and of 2/8 females at 50 mg/kg bw/day with concomitant necrosis/erosion in one female at each level. These histopathological changes were dose- related in incidence and severity, resulting in mortality for animals at 100 mg/kg bw/day and higher. Conclusion In conclusion, the target organ for CPC was the stomach and at dose levels from 50 mg/kg bw/day, it produced a localised toxic (i.e. irritant) action near or at the site of administration, specifically in the non-glandular region of the stomach. The NOAEL was considered to be 25 mg/kg bw/day in this study, based on histomorphological alterations in the non-glandular region of the stomach, i.e. forestomach. Ref.: 4 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report; no information was provided by the Sponsor of the study. The SCCS agrees on the NOAEL of 25 mg/kg bw/day for local effects in the forestomach probably due to the irritative properties of the test substance. The SCCS also considers 25 mg","page":24,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_001"}
SCCS_vision_codex	NOAEL	=250	mg/kg bw/day	-	-	-	NOAEL study	{"dose":"noted in 1/2 females at 500 mg/kg bw/day and in the duodenum in 1/3 females at 125 mg/kg bw/day.","effect":"noted in 1/2 females at 500 mg/kg bw/day and in the duodenum in 1/3 females at 125 mg/kg bw/day. Haemorrhage of the stomach fundus was noted in 1/2 females at 500 mg/kg bw/day and of the colon in 1/3 males at 125 mg/kg bw/day. Other histopathological findings included atrophy of the thymus at 125 and 250 mg/kg bw/day in both sexes, and lymphoid depletion and/or lymphadenitis in one or more lymph nodes (mandibular, mesenteric and tracheobronchial) in one or more animals at 125 and 250 mg/kg bw/day. Conclusion The NOAEL for systemic toxicity was considered to be 25 mg/kg bw/day in this study, based on mortality and decreased thymus weight confirmed by thymus atrophy at 125 mg/kg bw/day and above. Since the organ weight effects at 5 and 25 mg/kg bw/day were not confirmed by histopathological changes, they were not considered to be toxicologically relevant. The NOAEL for local effects was < 5 mg/kg bw/day in this study, based on effects in the gastrointestinal tract at all dose levels. Ref.: 5","page":26,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_004"}
SCCS_vision_codex	NOAEL	<5	mg/kg bw/day	-	-	-	NOAEL study	{"dose":"etion and/or lymphadenitis in one or more lymph nodes (mandibular, mesenteric and tracheobronchial) in one or more animals at 125 and 250 mg/kg bw/day.","effect":"etion and/or lymphadenitis in one or more lymph nodes (mandibular, mesenteric and tracheobronchial) in one or more animals at 125 and 250 mg/kg bw/day. Conclusion The NOAEL for systemic toxicity was considered to be 25 mg/kg bw/day in this study, based on mortality and decreased thymus weight confirmed by thymus atrophy at 125 mg/kg bw/day and above. Since the organ weight effects at 5 and 25 mg/kg bw/day were not confirmed by histopathological changes, they were not considered to be toxicologically relevant. The NOAEL for local effects was < 5 mg/kg bw/day in this study, based on effects in the gastrointestinal tract at all dose levels. Ref.: 5","page":26,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_005"}
SCCS_vision_codex	NOAEL	=15	mg/kg bw/day	-	-	-	NOAEL study	{"citation":"Ref.: 6 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report","dose":"SCCS/1548/15 Revision of the Opinion on Cetylpyridinium chloride (P97) ___________________________________________________________________________________________ 30 Conclusion The NOAEL for systemic toxicity was considered to be 15 mg/kg bw/day in this study, based on decreased glucose levels in 40 and 75 mg/kg/d animals of both sexes.","effect":"SCCS/1548/15 Revision of the Opinion on Cetylpyridinium chloride (P97) ___________________________________________________________________________________________ 30 Conclusion The NOAEL for systemic toxicity was considered to be 15 mg/kg bw/day in this study, based on decreased glucose levels in 40 and 75 mg/kg/d animals of both sexes. The NOAEL for local effects was 5 mg/kg bw/day in this study, based on acanthosis of the non-glandular region of the stomach, i.e. forestomach. Ref.: 6 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report; no information was provided by the Sponsor of the study. The SCCS agrees on the NOAEL of 5 mg","page":30,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_006"}
SCCS_vision_codex	NOAEL	=90	-	rat	-	90-day	NOAEL study	{"citation":"Ref.: 24)","effect":"escribed in secondary literature and therefore, are not consideted to add any valuable information for the safety assessment of cetylpyridinium chloride as a cosmetic ingredient. The full reports of two 90-day feeding studies of cetylpyridinium chloride (one in rats and the other in dogs) were submitted to EFSA for the evaluation of the safety and efficacy of Cecure® (Ref.: 24); the active ingredient in Cecure® is cetylpyridinium chloride. In addition, a third 90-day rat study was crucial for the setting of the NOAEL for cetylpyridinium chloride in the EFSA Opinion. The two rat studies which are also considered of relevance for the safety assessment of cetylpyridinium chloride as a cosmetic ingredient are summarised below, based on the descriptions in the EFSA Opinion. The CEF Panel considered that the 90-day dog study was not suitable for the derivation of a NOAEL; thus, this study is not considered of relevance for the safety assessment of cetylpyridinium chloride as a cosmetic ingredient and therefore, not included in this","page":30,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_010"}
SCCS_vision_codex	NOAEL	=1000	ppm	rat	oral	90-day	NOAEL study	{"citation":"Ref.: 24)","dose":"In a 13-week study, Sprague-Dawley albino rats (10/sex/group) were administered 0, 125, 250, 500, and 1000 ppm of CPC in the diet, corresponding to an average consumption of approximately 0, 9, 18, 35 and 70 mg/kg bw/day for males, and to 0, 11, 22, 42 and 84 mg/kg bw/day for females, respectively (Charles River Laboratories, 2006a, as cited","effect":"ficacy of Cecure® (Ref.: 24); the active ingredient in Cecure® is cetylpyridinium chloride. In addition, a third 90-day rat study was crucial for the setting of the NOAEL for cetylpyridinium chloride in the EFSA Opinion. The two rat studies which are also considered of relevance for the safety assessment of cetylpyridinium chloride as a cosmetic ingredient are summarised below, based on the descriptions in the EFSA Opinion. The CEF Panel considered that the 90-day dog study was not suitable for the derivation of a NOAEL; thus, this study is not considered of relevance for the safety assessment of cetylpyridinium chloride as a cosmetic ingredient and therefore, not included in this Opinion. In a 13-week study, Sprague-Dawley albino rats (10/sex/group) were administered 0, 125, 250, 500, and 1000 ppm of CPC in the diet, corresponding to an average consumption of approximately 0, 9, 18, 35 and 70 mg/kg bw/day for males, and to 0, 11, 22, 42 and 84 mg/kg bw/day for females, respectively (Charles River Laboratories, 2006a, as cited","page":30,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_011"}
SCCS_vision_codex	NOAEL	=250	ppm	rat	oral	90 days	NOAEL study	{"citation":"Ref.: 24)","dose":"In males, relative caecum weights were statistically significantly increased at 500 and 1000 ppm and relative weights of brain, heart and testis were statistically increased in males at 1000 ppm.","effect":"e 1000 ppm group. In males, relative caecum weights were statistically significantly increased at 500 and 1000 ppm and relative weights of brain, heart and testis were statistically increased in males at 1000 ppm. In females relative weights of adrenals glands, brain, caecum, heart, kidney, liver, lung, ovary and spleen were significantly increased at 1000 ppm. No histopathological changes were reported. According to the CEF Panel, taking into account the increase in caecum weights in males in the 500 ppm group, a NOAEL of 250 ppm (18 mg/kg bw/day) can be identified. Rats (6/sex/group, strain not specified) were administered 0, 125, 300, 800, 2000, 5000, 10000 ppm CPC in the diet (equivalent to approximately 0, 6.25, 15, 40, 100, 250 and 500 mg/kg bw/day) for 90 days (USAEH-HT, 1969, as cited in Ref.: 24). All animals administered 250 and 500 mg/kg bw/day died within three weeks after initiation of the test. Unspecified differences in body weight gain, relative liver and kidney weights and food utilisation at 100 mg/kg bw/day w","page":31,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_012"}
SCCS_vision_codex	NOAEL	=18	mg/kg bw/day	rat	oral	90-day	repeated dose toxicity	{"dose":"s of CPC and increases in relative caecum weight (statistically signifant at 15 mg/kg bw/day and above in females and at 40 mg/kg bw/day and above in males).","effect":"s of CPC and increases in relative caecum weight (statistically signifant at 15 mg/kg bw/day and above in females and at 40 mg/kg bw/day and above in males). Gross and microscopic examination of liver, kidneys, lung, spleen, caecum and testis from any of the administered groups were reported to show no appreciable differences compared to controls. It was noted that, as the concentration of CPC increased, the total number of microorganisms in the caecal contents decreased in both sexes. The CEF Panel identified a NOAEL of 18 mg/kg bw/day, based on increased relative caecum weights in male rats in the 90-day study. The CEF Panel considered the increase in caecum weight as relevant for risk characterisation of Cecure® as an increase in relative caecum weight has been consistently positively correlated with increased dietary levels of CPC in sub-chronic rat studies. Furthermore, in one of these studies it was noted that as the concentration of CPC increased, the total number of microorganisms in the caecal contents decreased in bot","page":31,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_013"}
SCCS_vision_codex	NOAEL	=60	mg/kg bw/day	-	-	developmental	developmental toxicity	{"citation":"Ref.: 10","dose":"Conclusion No evidence of developmental toxicity was observed in the 60 mg/kg bw/day group nor in any of the dose groups.","effect":"SCCS-rejected applicant NOAEL: on of the jugal, incomplete ossification of the cervical vertebral arches and ischium, presence of 14th thoracic vertebra and/or 5th lumbar vertebra, unossified 5th sternebra, bent rib, 12 full pairs of ribs, a rudimentary rib and/or full unilateral rib; the slightly higher incidences of these developmental variations were not considered indicative of a teratogenic effect by the applicant. Conclusion No evidence of developmental toxicity was observed in the 60 mg/kg bw/day group nor in any of the dose groups. The NOAEL of cetylpyridinium chloride with regard to maternal toxicity was 15 mg/kg/day, and 60 mg/kg/day with respect to developmental toxicity. Ref.: 10","page":37,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_020"}
SCCS_vision_codex	NOAEL	=100	mg/kg bw/day	rat	-	-	developmental toxicity	{"citation":"Ref.: 11 SCCS comment The SCCS notes that the purity and stability of the test material was not provided","dose":"An increased incidence of skeletal variations was observed at 25 mg/kg bw/day and included missing sternebrae and 13th rib variations.","effect":"on of the Opinion on Cetylpyridinium chloride (P97) ___________________________________________________________________________________________ 39 changes in the incidence of soft tissue anomalies or skeletal malformations were noted. An increased incidence of skeletal variations was observed at 25 mg/kg bw/day and included missing sternebrae and 13th rib variations. Conclusion The data demonstrated that these materials were not teratogenic in rabbits at doses ranging up to those fatal to the dam; therefore, the NOAEL for teratogenicity was greater than or equal to 100 mg/kg bw/day. Ref.: 11 SCCS comment The SCCS notes that the purity and stability of the test material was not provided. Furthermore, the study was limitedly reported with only summarised tables available for the findings observed in the study. Thus, this study is considered inadequate for the safety assessment of cetylpyridinium chloride. Overall SCCS comment to the submitted teratogenicity studies Two teratogenicity studies – one in rats and the other in rab","page":39,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_021"}
SCCS_vision_codex	NOAEL	=2.5	mg/kg bw/day	-	oral	6-month	NOAEL study	{"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Oral application For oral application, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used for the MOS calculation.","effect":"SCCS/1548/15 Revision of the Opinion on Cetylpyridinium chloride (P97) ___________________________________________________________________________________________ 47 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Oral application For oral application, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used for the MOS calculation. Based on the toxicokinetic data, an oral absorption of 50% is considered. The adjusted NOAEL for the MOS calculation is 2.5 mg/kg bw/day. Product Max concentration (% in the finished product) Total oral exposure (mg/kg bw/day) Calculated SED based on an oral absorption of 50% (mg/kg bw/day) MoS (adjusted NOAEL/SED) Mouthrinse 0.1 0.033 0.016 156 Dentrifice3 (toothpaste) 0.5 0.011 0.005 500 Aggregate exposure (cosmetics) 0.021 120 Denture adhesive3 0.5 0.025 0.013 192 Denture cleanser3 0.5 0.00013 0.00006 41700 Aggregate exposure (total) 0.034 74 In conclusion, the SCCS considers that the use of c","page":47,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_023"}
SCCS_vision_codex	NOAEL	=50	%	-	oral	6-month	NOAEL study	{"dose":"ng calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Oral application For oral application, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used for the MOS calculation.","effect":"ng calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Oral application For oral application, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used for the MOS calculation. Based on the toxicokinetic data, an oral absorption of 50% is considered. The adjusted NOAEL for the MOS calculation is 2.5 mg/kg bw/day. Product Max concentration (% in the finished product) Total oral exposure (mg/kg bw/day) Calculated SED based on an oral absorption of 50% (mg/kg bw/day) MoS (adjusted NOAEL/SED) Mouthrinse 0.1 0.033 0.016 156 Dentrifice3 (toothpaste) 0.5 0.011 0.005 500 Aggregate exposure (cosmetics) 0.021 120 Denture adhesive3 0.5 0.025 0.013 192 Denture cleanser3 0.5 0.00013 0.00006 41700 Aggregate exposure (total) 0.034 74 In conclusion, the SCCS considers that the use of cetylpyridinium chloride in the single cosmetic products for oral application mentioned above is safe for the consumer. Aggregate exposure to cetylpyridinium chloride via cosmetic products and other consumer products (dentu","page":47,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_024"}
SCCS_vision_codex	NOAEL	=10	%	-	oral	-	dermal absorption	{"dose":"Dermal application For dermal application, the NOAEL of 18 mg/kg bw/day identified by the CEF Panel in the EFSA opinion is used for the MOS calculation.","effect":"ed poultry will not occur simultaneously very often. Dermal application For dermal application, the NOAEL of 18 mg/kg bw/day identified by the CEF Panel in the EFSA opinion is used for the MOS calculation. Based on the toxicokinetic data, an oral absorption of 50% is considered. The adjusted NOAEL for the MOS calculation is 9 mg/kg bw/day. Product Max concentration (% in the finished product) Total dermal exposure (mg/kg bw/day) Calculated SED based on a dermal absorption of 10% (mg/kg bw/day) MoS (adjusted NOAEL/SED) Body lotion 0.2 0.246 0.025 360 Face cream 0.2 0.048 0.0048 1875 Hand cream 0.2 0.065 0.0065 1385 Deodorant, non-spray 2.0 0.442 0.044 205 Aggregate exposure 0.080 113 In conclusion, the SCCS considers that the use of cetylpyridinium chloride in the single cosmetic products for dermal application mentioned above, as well as aggregate exposure to cetylpyridinium chloride via cosmetic products for these dermal applications is safe for the consumer. Aggregate exposure Aggregate exposure to cetylpyridini","page":48,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_027"}
SCCS_vision_codex	NOAEL	=15	mg/kg/day	rat	oral	6-month	developmental toxicity	{"dose":"Consequently, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used in the safety assessment for the MOS calculation for use of cetylpyridinium chloride as a preservative in mouthwashes cosmetic products, as well as in all other oral hygiene cosmetic products, cf.","effect":"y the applicant are considered as more relevant for the safety assessment of cetylpyridinium chloride than the dietary studies reported in the EFSA opinion. Consequently, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used in the safety assessment for the MOS calculation for use of cetylpyridinium chloride as a preservative in mouthwashes cosmetic products, as well as in all other oral hygiene cosmetic products, cf. Terms of Reference. In the teratogenicity study performed with rats, the NOAEL for maternal toxicity was 15 mg/kg/day, based on clinical signs of toxicity and decreased body weight gain; the NOAEL for developmental toxicity was 60 mg/kg/day (the highest dose level in the study). The teratogenicity study performed with rabbits was limitedly reported with only summarised tables available for the findings observed in the study and therefore, the study is considered inadequate for the safety assessment of cetylpyridinium chloride. Irritation / sensitisation Cetylpyridinium chloride at a conce","page":50,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_035"}
SCCS_vision_codex	NOAEL	=60	mg/kg/day	rat	oral	6-month	developmental toxicity	{"dose":"Consequently, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used in the safety assessment for the MOS calculation for use of cetylpyridinium chloride as a preservative in mouthwashes cosmetic products, as well as in all other oral hygiene cosmetic products, cf.","effect":"studies reported in the EFSA opinion. Consequently, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used in the safety assessment for the MOS calculation for use of cetylpyridinium chloride as a preservative in mouthwashes cosmetic products, as well as in all other oral hygiene cosmetic products, cf. Terms of Reference. In the teratogenicity study performed with rats, the NOAEL for maternal toxicity was 15 mg/kg/day, based on clinical signs of toxicity and decreased body weight gain; the NOAEL for developmental toxicity was 60 mg/kg/day (the highest dose level in the study). The teratogenicity study performed with rabbits was limitedly reported with only summarised tables available for the findings observed in the study and therefore, the study is considered inadequate for the safety assessment of cetylpyridinium chloride. Irritation / sensitisation Cetylpyridinium chloride at a concentration of 65% had a moderate to severe irritant potential to the skin of the rabbit in a study performed according t","page":50,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_036"}
SCCS_vision_codex	NOAEL	=156	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 47: Mouthrinse \| 0.1 \| 0.033 \| 0.016 \| 156","page":47,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_038"}
SCCS_vision_codex	NOAEL	=500	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 47: Dentrifice3 (toothpaste) \| 0.5 \| 0.011 \| 0.005 \| 500","page":47,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_039"}
SCCS_vision_codex	NOAEL	=120	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 47: Aggregate exposure (cosmetics) \| 0.021 \| 120","page":47,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_040"}
SCCS_vision_codex	NOAEL	=192	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 47: Denture adhesive3 \| 0.5 \| 0.025 \| 0.013 \| 192","page":47,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_041"}
SCCS_vision_codex	NOAEL	=41700	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 47: Denture cleanser3 \| 0.5 \| 0.00013 \| 0.00006 \| 41700","page":47,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_042"}
SCCS_vision_codex	NOAEL	=74	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 47: Aggregate exposure (total) \| 0.034 \| 74","page":47,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_043"}
SCCS_vision_codex	NOAEL	=360	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 48: Body lotion \| 0.2 \| 0.246 \| 0.025 \| 360","page":48,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_045"}
SCCS_vision_codex	NOAEL	=1875	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 48: Face cream \| 0.2 \| 0.048 \| 0.0048 \| 1875","page":48,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_046"}
SCCS_vision_codex	NOAEL	=1385	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 48: Hand cream \| 0.2 \| 0.065 \| 0.0065 \| 1385","page":48,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_047"}
SCCS_vision_codex	NOAEL	=205	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 48: Deodorant, non-spray \| 2.0 \| 0.442 \| 0.044 \| 205","page":48,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_048"}
SCCS_vision_codex	NOAEL	=113	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 48: Aggregate exposure \| 0.080 \| 113","page":48,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_049"}
SCCS_vision_codex	NOAEL	=25	mg/kg bw/day	-	-	-	irritation	{"citation":"Ref.: 4 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report","dose":"g/kg bw/day and of 2/8 females at 50 mg/kg bw/day with concomitant necrosis/erosion in one female at each level.","effect":"g/kg bw/day and of 2/8 females at 50 mg/kg bw/day with concomitant necrosis/erosion in one female at each level. These histopathological changes were dose- related in incidence and severity, resulting in mortality for animals at 100 mg/kg bw/day and higher. Conclusion In conclusion, the target organ for CPC was the stomach and at dose levels from 50 mg/kg bw/day, it produced a localised toxic (i.e. irritant) action near or at the site of administration, specifically in the non-glandular region of the stomach. The NOAEL was considered to be 25 mg/kg bw/day in this study, based on histomorphological alterations in the non-glandular region of the stomach, i.e. forestomach. Ref.: 4 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report; no information was provided by the Sponsor of the study. The SCCS agrees on the NOAEL of 25 mg/kg bw/day for local effects in the forestomach probably due to the irritative properties of the test substance. The SCCS also considers 25 mg","page":24,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_001"}
SCCS_vision_codex	NOAEL	=250	mg/kg bw/day	-	-	-	NOAEL study	{"dose":"noted in 1/2 females at 500 mg/kg bw/day and in the duodenum in 1/3 females at 125 mg/kg bw/day.","effect":"noted in 1/2 females at 500 mg/kg bw/day and in the duodenum in 1/3 females at 125 mg/kg bw/day. Haemorrhage of the stomach fundus was noted in 1/2 females at 500 mg/kg bw/day and of the colon in 1/3 males at 125 mg/kg bw/day. Other histopathological findings included atrophy of the thymus at 125 and 250 mg/kg bw/day in both sexes, and lymphoid depletion and/or lymphadenitis in one or more lymph nodes (mandibular, mesenteric and tracheobronchial) in one or more animals at 125 and 250 mg/kg bw/day. Conclusion The NOAEL for systemic toxicity was considered to be 25 mg/kg bw/day in this study, based on mortality and decreased thymus weight confirmed by thymus atrophy at 125 mg/kg bw/day and above. Since the organ weight effects at 5 and 25 mg/kg bw/day were not confirmed by histopathological changes, they were not considered to be toxicologically relevant. The NOAEL for local effects was < 5 mg/kg bw/day in this study, based on effects in the gastrointestinal tract at all dose levels. Ref.: 5","page":26,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_004"}
SCCS_vision_codex	NOAEL	<5	mg/kg bw/day	-	-	-	NOAEL study	{"dose":"etion and/or lymphadenitis in one or more lymph nodes (mandibular, mesenteric and tracheobronchial) in one or more animals at 125 and 250 mg/kg bw/day.","effect":"etion and/or lymphadenitis in one or more lymph nodes (mandibular, mesenteric and tracheobronchial) in one or more animals at 125 and 250 mg/kg bw/day. Conclusion The NOAEL for systemic toxicity was considered to be 25 mg/kg bw/day in this study, based on mortality and decreased thymus weight confirmed by thymus atrophy at 125 mg/kg bw/day and above. Since the organ weight effects at 5 and 25 mg/kg bw/day were not confirmed by histopathological changes, they were not considered to be toxicologically relevant. The NOAEL for local effects was < 5 mg/kg bw/day in this study, based on effects in the gastrointestinal tract at all dose levels. Ref.: 5","page":26,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_005"}
SCCS_vision_codex	NOAEL	=15	mg/kg bw/day	-	-	-	NOAEL study	{"citation":"Ref.: 6 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report","dose":"SCCS/1548/15 Revision of the Opinion on Cetylpyridinium chloride (P97) ___________________________________________________________________________________________ 30 Conclusion The NOAEL for systemic toxicity was considered to be 15 mg/kg bw/day in this study, based on decreased glucose levels in 40 and 75 mg/kg/d animals of both sexes.","effect":"SCCS/1548/15 Revision of the Opinion on Cetylpyridinium chloride (P97) ___________________________________________________________________________________________ 30 Conclusion The NOAEL for systemic toxicity was considered to be 15 mg/kg bw/day in this study, based on decreased glucose levels in 40 and 75 mg/kg/d animals of both sexes. The NOAEL for local effects was 5 mg/kg bw/day in this study, based on acanthosis of the non-glandular region of the stomach, i.e. forestomach. Ref.: 6 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report; no information was provided by the Sponsor of the study. The SCCS agrees on the NOAEL of 5 mg","page":30,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_006"}
SCCS_vision_codex	NOAEL	=90	-	rat	-	90-day	NOAEL study	{"citation":"Ref.: 24)","effect":"escribed in secondary literature and therefore, are not consideted to add any valuable information for the safety assessment of cetylpyridinium chloride as a cosmetic ingredient. The full reports of two 90-day feeding studies of cetylpyridinium chloride (one in rats and the other in dogs) were submitted to EFSA for the evaluation of the safety and efficacy of Cecure® (Ref.: 24); the active ingredient in Cecure® is cetylpyridinium chloride. In addition, a third 90-day rat study was crucial for the setting of the NOAEL for cetylpyridinium chloride in the EFSA Opinion. The two rat studies which are also considered of relevance for the safety assessment of cetylpyridinium chloride as a cosmetic ingredient are summarised below, based on the descriptions in the EFSA Opinion. The CEF Panel considered that the 90-day dog study was not suitable for the derivation of a NOAEL; thus, this study is not considered of relevance for the safety assessment of cetylpyridinium chloride as a cosmetic ingredient and therefore, not included in this","page":30,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_010"}
SCCS_vision_codex	NOAEL	=1000	ppm	rat	oral	90-day	NOAEL study	{"citation":"Ref.: 24)","dose":"In a 13-week study, Sprague-Dawley albino rats (10/sex/group) were administered 0, 125, 250, 500, and 1000 ppm of CPC in the diet, corresponding to an average consumption of approximately 0, 9, 18, 35 and 70 mg/kg bw/day for males, and to 0, 11, 22, 42 and 84 mg/kg bw/day for females, respectively (Charles River Laboratories, 2006a, as cited","effect":"ficacy of Cecure® (Ref.: 24); the active ingredient in Cecure® is cetylpyridinium chloride. In addition, a third 90-day rat study was crucial for the setting of the NOAEL for cetylpyridinium chloride in the EFSA Opinion. The two rat studies which are also considered of relevance for the safety assessment of cetylpyridinium chloride as a cosmetic ingredient are summarised below, based on the descriptions in the EFSA Opinion. The CEF Panel considered that the 90-day dog study was not suitable for the derivation of a NOAEL; thus, this study is not considered of relevance for the safety assessment of cetylpyridinium chloride as a cosmetic ingredient and therefore, not included in this Opinion. In a 13-week study, Sprague-Dawley albino rats (10/sex/group) were administered 0, 125, 250, 500, and 1000 ppm of CPC in the diet, corresponding to an average consumption of approximately 0, 9, 18, 35 and 70 mg/kg bw/day for males, and to 0, 11, 22, 42 and 84 mg/kg bw/day for females, respectively (Charles River Laboratories, 2006a, as cited","page":30,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_011"}
SCCS_vision_codex	NOAEL	=250	ppm	rat	oral	90 days	NOAEL study	{"citation":"Ref.: 24)","dose":"In males, relative caecum weights were statistically significantly increased at 500 and 1000 ppm and relative weights of brain, heart and testis were statistically increased in males at 1000 ppm.","effect":"e 1000 ppm group. In males, relative caecum weights were statistically significantly increased at 500 and 1000 ppm and relative weights of brain, heart and testis were statistically increased in males at 1000 ppm. In females relative weights of adrenals glands, brain, caecum, heart, kidney, liver, lung, ovary and spleen were significantly increased at 1000 ppm. No histopathological changes were reported. According to the CEF Panel, taking into account the increase in caecum weights in males in the 500 ppm group, a NOAEL of 250 ppm (18 mg/kg bw/day) can be identified. Rats (6/sex/group, strain not specified) were administered 0, 125, 300, 800, 2000, 5000, 10000 ppm CPC in the diet (equivalent to approximately 0, 6.25, 15, 40, 100, 250 and 500 mg/kg bw/day) for 90 days (USAEH-HT, 1969, as cited in Ref.: 24). All animals administered 250 and 500 mg/kg bw/day died within three weeks after initiation of the test. Unspecified differences in body weight gain, relative liver and kidney weights and food utilisation at 100 mg/kg bw/day w","page":31,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_012"}
SCCS_vision_codex	NOAEL	=18	mg/kg bw/day	rat	oral	90-day	repeated dose toxicity	{"dose":"s of CPC and increases in relative caecum weight (statistically signifant at 15 mg/kg bw/day and above in females and at 40 mg/kg bw/day and above in males).","effect":"s of CPC and increases in relative caecum weight (statistically signifant at 15 mg/kg bw/day and above in females and at 40 mg/kg bw/day and above in males). Gross and microscopic examination of liver, kidneys, lung, spleen, caecum and testis from any of the administered groups were reported to show no appreciable differences compared to controls. It was noted that, as the concentration of CPC increased, the total number of microorganisms in the caecal contents decreased in both sexes. The CEF Panel identified a NOAEL of 18 mg/kg bw/day, based on increased relative caecum weights in male rats in the 90-day study. The CEF Panel considered the increase in caecum weight as relevant for risk characterisation of Cecure® as an increase in relative caecum weight has been consistently positively correlated with increased dietary levels of CPC in sub-chronic rat studies. Furthermore, in one of these studies it was noted that as the concentration of CPC increased, the total number of microorganisms in the caecal contents decreased in bot","page":31,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_013"}
SCCS_vision_codex	NOAEL	=60	mg/kg bw/day	-	-	developmental	developmental toxicity	{"citation":"Ref.: 10","dose":"Conclusion No evidence of developmental toxicity was observed in the 60 mg/kg bw/day group nor in any of the dose groups.","effect":"SCCS-rejected applicant NOAEL: on of the jugal, incomplete ossification of the cervical vertebral arches and ischium, presence of 14th thoracic vertebra and/or 5th lumbar vertebra, unossified 5th sternebra, bent rib, 12 full pairs of ribs, a rudimentary rib and/or full unilateral rib; the slightly higher incidences of these developmental variations were not considered indicative of a teratogenic effect by the applicant. Conclusion No evidence of developmental toxicity was observed in the 60 mg/kg bw/day group nor in any of the dose groups. The NOAEL of cetylpyridinium chloride with regard to maternal toxicity was 15 mg/kg/day, and 60 mg/kg/day with respect to developmental toxicity. Ref.: 10","page":37,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_020"}
SCCS_vision_codex	NOAEL	=100	mg/kg bw/day	rat	-	-	developmental toxicity	{"citation":"Ref.: 11 SCCS comment The SCCS notes that the purity and stability of the test material was not provided","dose":"An increased incidence of skeletal variations was observed at 25 mg/kg bw/day and included missing sternebrae and 13th rib variations.","effect":"on of the Opinion on Cetylpyridinium chloride (P97) ___________________________________________________________________________________________ 39 changes in the incidence of soft tissue anomalies or skeletal malformations were noted. An increased incidence of skeletal variations was observed at 25 mg/kg bw/day and included missing sternebrae and 13th rib variations. Conclusion The data demonstrated that these materials were not teratogenic in rabbits at doses ranging up to those fatal to the dam; therefore, the NOAEL for teratogenicity was greater than or equal to 100 mg/kg bw/day. Ref.: 11 SCCS comment The SCCS notes that the purity and stability of the test material was not provided. Furthermore, the study was limitedly reported with only summarised tables available for the findings observed in the study. Thus, this study is considered inadequate for the safety assessment of cetylpyridinium chloride. Overall SCCS comment to the submitted teratogenicity studies Two teratogenicity studies – one in rats and the other in rab","page":39,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_021"}
SCCS_vision_codex	NOAEL	=2.5	mg/kg bw/day	-	oral	6-month	NOAEL study	{"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Oral application For oral application, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used for the MOS calculation.","effect":"SCCS/1548/15 Revision of the Opinion on Cetylpyridinium chloride (P97) ___________________________________________________________________________________________ 47 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Oral application For oral application, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used for the MOS calculation. Based on the toxicokinetic data, an oral absorption of 50% is considered. The adjusted NOAEL for the MOS calculation is 2.5 mg/kg bw/day. Product Max concentration (% in the finished product) Total oral exposure (mg/kg bw/day) Calculated SED based on an oral absorption of 50% (mg/kg bw/day) MoS (adjusted NOAEL/SED) Mouthrinse 0.1 0.033 0.016 156 Dentrifice3 (toothpaste) 0.5 0.011 0.005 500 Aggregate exposure (cosmetics) 0.021 120 Denture adhesive3 0.5 0.025 0.013 192 Denture cleanser3 0.5 0.00013 0.00006 41700 Aggregate exposure (total) 0.034 74 In conclusion, the SCCS considers that the use of c","page":47,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_023"}
SCCS_vision_codex	NOAEL	=50	%	-	oral	6-month	NOAEL study	{"dose":"ng calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Oral application For oral application, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used for the MOS calculation.","effect":"ng calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Oral application For oral application, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used for the MOS calculation. Based on the toxicokinetic data, an oral absorption of 50% is considered. The adjusted NOAEL for the MOS calculation is 2.5 mg/kg bw/day. Product Max concentration (% in the finished product) Total oral exposure (mg/kg bw/day) Calculated SED based on an oral absorption of 50% (mg/kg bw/day) MoS (adjusted NOAEL/SED) Mouthrinse 0.1 0.033 0.016 156 Dentrifice3 (toothpaste) 0.5 0.011 0.005 500 Aggregate exposure (cosmetics) 0.021 120 Denture adhesive3 0.5 0.025 0.013 192 Denture cleanser3 0.5 0.00013 0.00006 41700 Aggregate exposure (total) 0.034 74 In conclusion, the SCCS considers that the use of cetylpyridinium chloride in the single cosmetic products for oral application mentioned above is safe for the consumer. Aggregate exposure to cetylpyridinium chloride via cosmetic products and other consumer products (dentu","page":47,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_024"}
SCCS_vision_codex	NOAEL	=10	%	-	oral	-	dermal absorption	{"dose":"Dermal application For dermal application, the NOAEL of 18 mg/kg bw/day identified by the CEF Panel in the EFSA opinion is used for the MOS calculation.","effect":"ed poultry will not occur simultaneously very often. Dermal application For dermal application, the NOAEL of 18 mg/kg bw/day identified by the CEF Panel in the EFSA opinion is used for the MOS calculation. Based on the toxicokinetic data, an oral absorption of 50% is considered. The adjusted NOAEL for the MOS calculation is 9 mg/kg bw/day. Product Max concentration (% in the finished product) Total dermal exposure (mg/kg bw/day) Calculated SED based on a dermal absorption of 10% (mg/kg bw/day) MoS (adjusted NOAEL/SED) Body lotion 0.2 0.246 0.025 360 Face cream 0.2 0.048 0.0048 1875 Hand cream 0.2 0.065 0.0065 1385 Deodorant, non-spray 2.0 0.442 0.044 205 Aggregate exposure 0.080 113 In conclusion, the SCCS considers that the use of cetylpyridinium chloride in the single cosmetic products for dermal application mentioned above, as well as aggregate exposure to cetylpyridinium chloride via cosmetic products for these dermal applications is safe for the consumer. Aggregate exposure Aggregate exposure to cetylpyridini","page":48,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_027"}
SCCS_vision_codex	NOAEL	=15	mg/kg/day	rat	oral	6-month	developmental toxicity	{"dose":"Consequently, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used in the safety assessment for the MOS calculation for use of cetylpyridinium chloride as a preservative in mouthwashes cosmetic products, as well as in all other oral hygiene cosmetic products, cf.","effect":"y the applicant are considered as more relevant for the safety assessment of cetylpyridinium chloride than the dietary studies reported in the EFSA opinion. Consequently, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used in the safety assessment for the MOS calculation for use of cetylpyridinium chloride as a preservative in mouthwashes cosmetic products, as well as in all other oral hygiene cosmetic products, cf. Terms of Reference. In the teratogenicity study performed with rats, the NOAEL for maternal toxicity was 15 mg/kg/day, based on clinical signs of toxicity and decreased body weight gain; the NOAEL for developmental toxicity was 60 mg/kg/day (the highest dose level in the study). The teratogenicity study performed with rabbits was limitedly reported with only summarised tables available for the findings observed in the study and therefore, the study is considered inadequate for the safety assessment of cetylpyridinium chloride. Irritation / sensitisation Cetylpyridinium chloride at a conce","page":50,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_035"}
SCCS_vision_codex	NOAEL	=60	mg/kg/day	rat	oral	6-month	developmental toxicity	{"dose":"Consequently, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used in the safety assessment for the MOS calculation for use of cetylpyridinium chloride as a preservative in mouthwashes cosmetic products, as well as in all other oral hygiene cosmetic products, cf.","effect":"studies reported in the EFSA opinion. Consequently, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used in the safety assessment for the MOS calculation for use of cetylpyridinium chloride as a preservative in mouthwashes cosmetic products, as well as in all other oral hygiene cosmetic products, cf. Terms of Reference. In the teratogenicity study performed with rats, the NOAEL for maternal toxicity was 15 mg/kg/day, based on clinical signs of toxicity and decreased body weight gain; the NOAEL for developmental toxicity was 60 mg/kg/day (the highest dose level in the study). The teratogenicity study performed with rabbits was limitedly reported with only summarised tables available for the findings observed in the study and therefore, the study is considered inadequate for the safety assessment of cetylpyridinium chloride. Irritation / sensitisation Cetylpyridinium chloride at a concentration of 65% had a moderate to severe irritant potential to the skin of the rabbit in a study performed according t","page":50,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_036"}
SCCS_vision_codex	NOAEL	=156	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 47: Mouthrinse \| 0.1 \| 0.033 \| 0.016 \| 156","page":47,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_038"}
SCCS_vision_codex	NOAEL	=500	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 47: Dentrifice3 (toothpaste) \| 0.5 \| 0.011 \| 0.005 \| 500","page":47,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_039"}
SCCS_vision_codex	NOAEL	=120	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 47: Aggregate exposure (cosmetics) \| 0.021 \| 120","page":47,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_040"}
SCCS_vision_codex	NOAEL	=192	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 47: Denture adhesive3 \| 0.5 \| 0.025 \| 0.013 \| 192","page":47,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_041"}
SCCS_vision_codex	NOAEL	=41700	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 47: Denture cleanser3 \| 0.5 \| 0.00013 \| 0.00006 \| 41700","page":47,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_042"}
SCCS_vision_codex	NOAEL	=74	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 47: Aggregate exposure (total) \| 0.034 \| 74","page":47,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_043"}
SCCS_vision_codex	NOAEL	=360	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 48: Body lotion \| 0.2 \| 0.246 \| 0.025 \| 360","page":48,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_045"}
SCCS_vision_codex	NOAEL	=1875	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 48: Face cream \| 0.2 \| 0.048 \| 0.0048 \| 1875","page":48,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_046"}
SCCS_vision_codex	NOAEL	=1385	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 48: Hand cream \| 0.2 \| 0.065 \| 0.0065 \| 1385","page":48,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_047"}
SCCS_vision_codex	NOAEL	=205	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 48: Deodorant, non-spray \| 2.0 \| 0.442 \| 0.044 \| 205","page":48,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_048"}
SCCS_vision_codex	NOAEL	=113	-	-	-	-	NOAEL study	{"effect":"Unlabeled table on page 48: Aggregate exposure \| 0.080 \| 113","page":48,"pdf":"sccs_o_171.pdf","row_type":"noael_study","study_id":"sccs_o_171_noael_049"}

ToxValDB_ECHA_IUCLID 4 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
ToxValDB_ECHA_IUCLID	NOAEL	=12	mg/kg bw/day	Rabbit	oral	-	reproduction developmental	QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eabd2e4b0a7c65d1bbeaa; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17221/7/9/3?documentUUID=8af45a8d-cd61-4f45-9732-360361e5cf57; YEAR=1985; ORIGINAL_YEAR=1985; STUDY_GROUP=ECHA IUCLID:15824144:F:-maternal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_5fcb189464d8c97778aff3bb6930d3c6
ToxValDB_ECHA_IUCLID	NOAEL	>25	mg/kg bw/day	Rabbit	oral	-	developmental	QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eabd2e4b0a7c65d1bbeaa; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17221/7/9/3?documentUUID=8af45a8d-cd61-4f45-9732-360361e5cf57; YEAR=1985; ORIGINAL_YEAR=1985; STUDY_GROUP=ECHA IUCLID:15824145:-:-fetal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_97c5a0808475d9b333f121986e98ab9b
ToxValDB_ECHA_IUCLID	NOAEL	=5	mg/kg bw/day	Rat	oral	-	reproduction developmental	QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaa7ee4b0a7c65d1b61a6; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17221/7/9/2?documentUUID=8af45a8d-cd61-4f45-9732-360361e5cf57; YEAR=1985; ORIGINAL_YEAR=1985; STUDY_GROUP=ECHA IUCLID:15862602:M/F:P0-; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_de110d8abdc40f6aab9e99ef6363bb6b
ToxValDB_ECHA_IUCLID	NOEL	=25	mg/kg bw/day	Rat	oral	short-term; 28 days	short-term	QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ead1be4b0a7c65d1c2837; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17221/7/6/2?documentUUID=8af45a8d-cd61-4f45-9732-360361e5cf57; YEAR=1985; ORIGINAL_YEAR=1985; STUDY_GROUP=ECHA IUCLID:15850594:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_da5d6b7e9dadbd97571b97e40e2e801d

UnifiedCodex:SCCS_SHADOW:beta.noael_studies 49 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	25	mg/kg bw/day	-	-	-	-	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=25; DOSE=to be 25 mg/kg bw/day in this study, based on histomorphological alterations in the non-glandular region of the stomach, i.e. forestomach.; EFFECT=to be 25 mg/kg bw/day in this study, based on histomorphological alterations in the non-glandular region of the stomach, i.e. forestomach. Ref.: 4 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report; no information was provided by the Sponsor of the study. The SCCS agrees on the NOAEL of 25 mg/kg bw/day for local effects in the forestomach probably due to the irritative properties of the test substance. The SCCS also considers 25 mg/kg bw/day as a NOAEL for systemic toxicity (decreased body weight gain) although it can be argued that the decreased body weight gain might be secondary to the local effects in the stomach.; CITATION=Ref.: 4 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report; CITATION_NUMBERS=[4,100]; REFERENCE=Ref.: 4 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report; DETAILS_JSON={"cas_number":"123-03-5","citation":"Ref.: 4 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report","dose":"to be 25 mg/kg bw/day in this study, based on histomorphological alterations in the non-glandular region of the stomach, i.e. forestomach.","duration":"","effect":"to be 25 mg/kg bw/day in this study, based on histomorphological alterations in the non-glandular region of the stomach, i.e. forestomach. Ref.: 4 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report; no information was provided by the Sponsor of the study. The SCCS agrees on the NOAEL of 25 mg/kg bw/day for local effects in the forestomach probably due to the irritative properties of the test substance. The SCCS also considers 25 mg/kg bw/day as a NOAEL for systemic toxicity (decreased body weight gain) although it can be argued that the decreased body weight gain might be secondary to the local effects in the stomach.","endpoint":"","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"25","page":24,"route":"","species":"","study_id":"sccs_o_171_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	250	mg/kg bw/day	-	-	-	-	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=250; DOSE=noted in 1/2 females at 500 mg/kg bw/day and in the duodenum in 1/3 females at 125 mg/kg bw/day.; EFFECT=noted in 1/2 females at 500 mg/kg bw/day and in the duodenum in 1/3 females at 125 mg/kg bw/day. Haemorrhage of the stomach fundus was noted in 1/2 females at 500 mg/kg bw/day and of the colon in 1/3 males at 125 mg/kg bw/day. Other histopathological findings included atrophy of the thymus at 125 and 250 mg/kg bw/day in both sexes, and lymphoid depletion and/or lymphadenitis in one or more lymph nodes (mandibular, mesenteric and tracheobronchial) in one or more animals at 125 and 250 mg/kg bw/day. Conclusion The NOAEL for systemic toxicity was considered to be 25 mg/kg bw/day in this study, based on mortality and decreased thymus weight confirmed by thymus atrophy at 125 mg/kg bw/day and above. Since the organ weight effects at 5 and 25 mg/kg bw/day were not confirmed by histopathological changes, they were not considered to be toxicologically relevant. The NOAEL for local effects was < 5 mg/kg bw/day in this study, based on effects in the gastrointestinal tract at all dose levels. Ref.: 5; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"123-03-5","citation":"","dose":"noted in 1/2 females at 500 mg/kg bw/day and in the duodenum in 1/3 females at 125 mg/kg bw/day.","duration":"","effect":"noted in 1/2 females at 500 mg/kg bw/day and in the duodenum in 1/3 females at 125 mg/kg bw/day. Haemorrhage of the stomach fundus was noted in 1/2 females at 500 mg/kg bw/day and of the colon in 1/3 males at 125 mg/kg bw/day. Other histopathological findings included atrophy of the thymus at 125 and 250 mg/kg bw/day in both sexes, and lymphoid depletion and/or lymphadenitis in one or more lymph nodes (mandibular, mesenteric and tracheobronchial) in one or more animals at 125 and 250 mg/kg bw/day. Conclusion The NOAEL for systemic toxicity was considered to be 25 mg/kg bw/day in this study, based on mortality and decreased thymus weight confirmed by thymus atrophy at 125 mg/kg bw/day and above. Since the organ weight effects at 5 and 25 mg/kg bw/day were not confirmed by histopathological changes, they were not considered to be toxicologically relevant. The NOAEL for local effects was < 5 mg/kg bw/day in this study, based on effects in the gastrointestinal tract at all dose levels. Ref.: 5","endpoint":"","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"250","page":26,"route":"","species":"","study_id":"sccs_o_171_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	<5	mg/kg bw/day	-	-	-	-	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=< 5; DOSE=etion and/or lymphadenitis in one or more lymph nodes (mandibular, mesenteric and tracheobronchial) in one or more animals at 125 and 250 mg/kg bw/day.; EFFECT=etion and/or lymphadenitis in one or more lymph nodes (mandibular, mesenteric and tracheobronchial) in one or more animals at 125 and 250 mg/kg bw/day. Conclusion The NOAEL for systemic toxicity was considered to be 25 mg/kg bw/day in this study, based on mortality and decreased thymus weight confirmed by thymus atrophy at 125 mg/kg bw/day and above. Since the organ weight effects at 5 and 25 mg/kg bw/day were not confirmed by histopathological changes, they were not considered to be toxicologically relevant. The NOAEL for local effects was < 5 mg/kg bw/day in this study, based on effects in the gastrointestinal tract at all dose levels. Ref.: 5; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"123-03-5","citation":"","dose":"etion and/or lymphadenitis in one or more lymph nodes (mandibular, mesenteric and tracheobronchial) in one or more animals at 125 and 250 mg/kg bw/day.","duration":"","effect":"etion and/or lymphadenitis in one or more lymph nodes (mandibular, mesenteric and tracheobronchial) in one or more animals at 125 and 250 mg/kg bw/day. Conclusion The NOAEL for systemic toxicity was considered to be 25 mg/kg bw/day in this study, based on mortality and decreased thymus weight confirmed by thymus atrophy at 125 mg/kg bw/day and above. Since the organ weight effects at 5 and 25 mg/kg bw/day were not confirmed by histopathological changes, they were not considered to be toxicologically relevant. The NOAEL for local effects was < 5 mg/kg bw/day in this study, based on effects in the gastrointestinal tract at all dose levels. Ref.: 5","endpoint":"","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"< 5","page":26,"route":"","species":"","study_id":"sccs_o_171_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	15	mg/kg bw/day	-	-	-	-	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=15; DOSE=SCCS/1548/15 Revision of the Opinion on Cetylpyridinium chloride (P97) ___________________________________________________________________________________________ 30 Conclusion The NOAEL for systemic toxicity was considered to be 15 mg/kg bw/day in this study, based on decreased glucose levels in 40 and 75 mg/kg/d animals of both sexes.; EFFECT=SCCS/1548/15 Revision of the Opinion on Cetylpyridinium chloride (P97) ___________________________________________________________________________________________ 30 Conclusion The NOAEL for systemic toxicity was considered to be 15 mg/kg bw/day in this study, based on decreased glucose levels in 40 and 75 mg/kg/d animals of both sexes. The NOAEL for local effects was 5 mg/kg bw/day in this study, based on acanthosis of the non-glandular region of the stomach, i.e. forestomach. Ref.: 6 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report; no information was provided by the Sponsor of the study. The SCCS agrees on the NOAEL of 5 mg; CITATION=Ref.: 6 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report; CITATION_NUMBERS=[6,100]; REFERENCE=Ref.: 6 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report; DETAILS_JSON={"cas_number":"123-03-5","citation":"Ref.: 6 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report","dose":"SCCS/1548/15 Revision of the Opinion on Cetylpyridinium chloride (P97) ___________________________________________________________________________________________ 30 Conclusion The NOAEL for systemic toxicity was considered to be 15 mg/kg bw/day in this study, based on decreased glucose levels in 40 and 75 mg/kg/d animals of both sexes.","duration":"","effect":"SCCS/1548/15 Revision of the Opinion on Cetylpyridinium chloride (P97) ___________________________________________________________________________________________ 30 Conclusion The NOAEL for systemic toxicity was considered to be 15 mg/kg bw/day in this study, based on decreased glucose levels in 40 and 75 mg/kg/d animals of both sexes. The NOAEL for local effects was 5 mg/kg bw/day in this study, based on acanthosis of the non-glandular region of the stomach, i.e. forestomach. Ref.: 6 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report; no information was provided by the Sponsor of the study. The SCCS agrees on the NOAEL of 5 mg","endpoint":"","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"15","page":30,"route":"","species":"","study_id":"sccs_o_171_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	5	mg/kg bw/day	-	-	-	-	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=5; DOSE=SCCS/1548/15 Revision of the Opinion on Cetylpyridinium chloride (P97) ___________________________________________________________________________________________ 30 Conclusion The NOAEL for systemic toxicity was considered to be 15 mg/kg bw/day in this study, based on decreased glucose levels in 40 and 75 mg/kg/d animals of both sexes.; EFFECT=SCCS/1548/15 Revision of the Opinion on Cetylpyridinium chloride (P97) ___________________________________________________________________________________________ 30 Conclusion The NOAEL for systemic toxicity was considered to be 15 mg/kg bw/day in this study, based on decreased glucose levels in 40 and 75 mg/kg/d animals of both sexes. The NOAEL for local effects was 5 mg/kg bw/day in this study, based on acanthosis of the non-glandular region of the stomach, i.e. forestomach. Ref.: 6 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report; no information was provided by the Sponsor of the study. The SCCS agrees on the NOAEL of 5 mg/kg bw/day for local effects in the stomach probably due to the irritative properties of the test substance. The SCCS also considers 5 mg/kg bw/day as a NOAEL for; CITATION=Ref.: 6 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report; CITATION_NUMBERS=[6,100]; REFERENCE=Ref.: 6 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report; DETAILS_JSON={"cas_number":"123-03-5","citation":"Ref.: 6 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report","dose":"SCCS/1548/15 Revision of the Opinion on Cetylpyridinium chloride (P97) ___________________________________________________________________________________________ 30 Conclusion The NOAEL for systemic toxicity was considered to be 15 mg/kg bw/day in this study, based on decreased glucose levels in 40 and 75 mg/kg/d animals of both sexes.","duration":"","effect":"SCCS/1548/15 Revision of the Opinion on Cetylpyridinium chloride (P97) ___________________________________________________________________________________________ 30 Conclusion The NOAEL for systemic toxicity was considered to be 15 mg/kg bw/day in this study, based on decreased glucose levels in 40 and 75 mg/kg/d animals of both sexes. The NOAEL for local effects was 5 mg/kg bw/day in this study, based on acanthosis of the non-glandular region of the stomach, i.e. forestomach. Ref.: 6 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report; no information was provided by the Sponsor of the study. The SCCS agrees on the NOAEL of 5 mg/kg bw/day for local effects in the stomach probably due to the irritative properties of the test substance. The SCCS also considers 5 mg/kg bw/day as a NOAEL for","endpoint":"","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"5","page":30,"route":"","species":"","study_id":"sccs_o_171_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	90	-	rat	-	90-day	-	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=unclear:escribed in secondary literature and therefore, are not consideted to add any valuable information for the safety assessment of cetylpyridinium chloride as a cosmetic ingredient. The full reports of two 90-day feeding studies of cetylpyridinium chloride (one in rats and the other in dogs) were submitted to EFSA for the evaluation of the safety and efficacy of Cecure® (Ref.: 24); the active ingredient in Cecure® is cetylpyridinium chloride. In addition, a third 90-day rat study was crucial for the setting of the NOAEL for cetylpyridinium chloride in the EFSA Opinion. The two rat studies which are also considered of relevance for the safety assessment of cetylpyridinium chloride as a cosmetic ingredient are summarised below, based on the descriptions in the EFSA Opinion. The CEF Panel considered that the 90-day dog study was not suitable for the derivation of a NOAEL; thus, this study is not considered of relevance for the safety assessment of cetylpyridinium chloride as a cosmetic ingredient and therefore, not included in this; EFFECT=escribed in secondary literature and therefore, are not consideted to add any valuable information for the safety assessment of cetylpyridinium chloride as a cosmetic ingredient. The full reports of two 90-day feeding studies of cetylpyridinium chloride (one in rats and the other in dogs) were submitted to EFSA for the evaluation of the safety and efficacy of Cecure® (Ref.: 24); the active ingredient in Cecure® is cetylpyridinium chloride. In addition, a third 90-day rat study was crucial for the setting of the NOAEL for cetylpyridinium chloride in the EFSA Opinion. The two rat studies which are also considered of relevance for the safety assessment of cetylpyridinium chloride as a cosmetic ingredient are summarised below, based on the descriptions in the EFSA Opinion. The CEF Panel considered that the 90-day dog study was not suitable for the derivation of a NOAEL; thus, this study is not considered of relevance for the safety assessment of cetylpyridinium chloride as a cosmetic ingredient and therefore, not included in this; CITATION=Ref.: 24); CITATION_NUMBERS=[24]; REFERENCE=Ref.: 24); DETAILS_JSON={"cas_number":"123-03-5","citation":"Ref.: 24)","dose":"","duration":"90-day","effect":"escribed in secondary literature and therefore, are not consideted to add any valuable information for the safety assessment of cetylpyridinium chloride as a cosmetic ingredient. The full reports of two 90-day feeding studies of cetylpyridinium chloride (one in rats and the other in dogs) were submitted to EFSA for the evaluation of the safety and efficacy of Cecure® (Ref.: 24); the active ingredient in Cecure® is cetylpyridinium chloride. In addition, a third 90-day rat study was crucial for the setting of the NOAEL for cetylpyridinium chloride in the EFSA Opinion. The two rat studies which are also considered of relevance for the safety assessment of cetylpyridinium chloride as a cosmetic ingredient are summarised below, based on the descriptions in the EFSA Opinion. The CEF Panel considered that the 90-day dog study was not suitable for the derivation of a NOAEL; thus, this study is not considered of relevance for the safety assessment of cetylpyridinium chloride as a cosmetic ingredient and therefore, not included in this","endpoint":"","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"","noael_value":"unclear:escribed in secondary literature and therefore, are not consideted to add any valuable information for the safety assessment of cetylpyridinium chloride as a cosmetic ingredient. The full reports of two 90-day feeding studies of cetylpyridinium chloride (one in rats and the other in dogs) were submitted to EFSA for the evaluation of the safety and efficacy of Cecure® (Ref.: 24); the active ingredient in Cecure® is cetylpyridinium chloride. In addition, a third 90-day rat study was crucial for the setting of the NOAEL for cetylpyridinium chloride in the EFSA Opinion. The two rat studies which are also considered of relevance for the safety assessment of cetylpyridinium chloride as a cosmetic ingredient are summarised below, based on the descriptions in the EFSA Opinion. The CEF Panel considered that the 90-day dog study was not suitable for the derivation of a NOAEL; thus, this study is not considered of relevance for the safety assessment of cetylpyridinium chloride as a cosmetic ingredient and therefore, not included in this","page":30,"route":"","species":"rat","study_id":"sccs_o_171_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	1000	ppm	rat	oral	90-day	-	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=1000; DOSE=In a 13-week study, Sprague-Dawley albino rats (10/sex/group) were administered 0, 125, 250, 500, and 1000 ppm of CPC in the diet, corresponding to an average consumption of approximately 0, 9, 18, 35 and 70 mg/kg bw/day for males, and to 0, 11, 22, 42 and 84 mg/kg bw/day for females, respectively (Charles River Laboratories, 2006a, as cited; EFFECT=ficacy of Cecure® (Ref.: 24); the active ingredient in Cecure® is cetylpyridinium chloride. In addition, a third 90-day rat study was crucial for the setting of the NOAEL for cetylpyridinium chloride in the EFSA Opinion. The two rat studies which are also considered of relevance for the safety assessment of cetylpyridinium chloride as a cosmetic ingredient are summarised below, based on the descriptions in the EFSA Opinion. The CEF Panel considered that the 90-day dog study was not suitable for the derivation of a NOAEL; thus, this study is not considered of relevance for the safety assessment of cetylpyridinium chloride as a cosmetic ingredient and therefore, not included in this Opinion. In a 13-week study, Sprague-Dawley albino rats (10/sex/group) were administered 0, 125, 250, 500, and 1000 ppm of CPC in the diet, corresponding to an average consumption of approximately 0, 9, 18, 35 and 70 mg/kg bw/day for males, and to 0, 11, 22, 42 and 84 mg/kg bw/day for females, respectively (Charles River Laboratories, 2006a, as cited; CITATION=Ref.: 24); CITATION_NUMBERS=[24]; REFERENCE=Ref.: 24); DETAILS_JSON={"cas_number":"123-03-5","citation":"Ref.: 24)","dose":"In a 13-week study, Sprague-Dawley albino rats (10/sex/group) were administered 0, 125, 250, 500, and 1000 ppm of CPC in the diet, corresponding to an average consumption of approximately 0, 9, 18, 35 and 70 mg/kg bw/day for males, and to 0, 11, 22, 42 and 84 mg/kg bw/day for females, respectively (Charles River Laboratories, 2006a, as cited","duration":"90-day","effect":"ficacy of Cecure® (Ref.: 24); the active ingredient in Cecure® is cetylpyridinium chloride. In addition, a third 90-day rat study was crucial for the setting of the NOAEL for cetylpyridinium chloride in the EFSA Opinion. The two rat studies which are also considered of relevance for the safety assessment of cetylpyridinium chloride as a cosmetic ingredient are summarised below, based on the descriptions in the EFSA Opinion. The CEF Panel considered that the 90-day dog study was not suitable for the derivation of a NOAEL; thus, this study is not considered of relevance for the safety assessment of cetylpyridinium chloride as a cosmetic ingredient and therefore, not included in this Opinion. In a 13-week study, Sprague-Dawley albino rats (10/sex/group) were administered 0, 125, 250, 500, and 1000 ppm of CPC in the diet, corresponding to an average consumption of approximately 0, 9, 18, 35 and 70 mg/kg bw/day for males, and to 0, 11, 22, 42 and 84 mg/kg bw/day for females, respectively (Charles River Laboratories, 2006a, as cited","endpoint":"","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"ppm","noael_value":"1000","page":30,"route":"oral","species":"rat","study_id":"sccs_o_171_noael_011"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	250	ppm	rat	oral	90 days	-	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=250; DOSE=In males, relative caecum weights were statistically significantly increased at 500 and 1000 ppm and relative weights of brain, heart and testis were statistically increased in males at 1000 ppm.; EFFECT=e 1000 ppm group. In males, relative caecum weights were statistically significantly increased at 500 and 1000 ppm and relative weights of brain, heart and testis were statistically increased in males at 1000 ppm. In females relative weights of adrenals glands, brain, caecum, heart, kidney, liver, lung, ovary and spleen were significantly increased at 1000 ppm. No histopathological changes were reported. According to the CEF Panel, taking into account the increase in caecum weights in males in the 500 ppm group, a NOAEL of 250 ppm (18 mg/kg bw/day) can be identified. Rats (6/sex/group, strain not specified) were administered 0, 125, 300, 800, 2000, 5000, 10000 ppm CPC in the diet (equivalent to approximately 0, 6.25, 15, 40, 100, 250 and 500 mg/kg bw/day) for 90 days (USAEH-HT, 1969, as cited in Ref.: 24). All animals administered 250 and 500 mg/kg bw/day died within three weeks after initiation of the test. Unspecified differences in body weight gain, relative liver and kidney weights and food utilisation at 100 mg/kg bw/day w; CITATION=Ref.: 24); CITATION_NUMBERS=[24]; REFERENCE=Ref.: 24); DETAILS_JSON={"cas_number":"123-03-5","citation":"Ref.: 24)","dose":"In males, relative caecum weights were statistically significantly increased at 500 and 1000 ppm and relative weights of brain, heart and testis were statistically increased in males at 1000 ppm.","duration":"90 days","effect":"e 1000 ppm group. In males, relative caecum weights were statistically significantly increased at 500 and 1000 ppm and relative weights of brain, heart and testis were statistically increased in males at 1000 ppm. In females relative weights of adrenals glands, brain, caecum, heart, kidney, liver, lung, ovary and spleen were significantly increased at 1000 ppm. No histopathological changes were reported. According to the CEF Panel, taking into account the increase in caecum weights in males in the 500 ppm group, a NOAEL of 250 ppm (18 mg/kg bw/day) can be identified. Rats (6/sex/group, strain not specified) were administered 0, 125, 300, 800, 2000, 5000, 10000 ppm CPC in the diet (equivalent to approximately 0, 6.25, 15, 40, 100, 250 and 500 mg/kg bw/day) for 90 days (USAEH-HT, 1969, as cited in Ref.: 24). All animals administered 250 and 500 mg/kg bw/day died within three weeks after initiation of the test. Unspecified differences in body weight gain, relative liver and kidney weights and food utilisation at 100 mg/kg bw/day w","endpoint":"","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"ppm","noael_value":"250","page":31,"route":"oral","species":"rat","study_id":"sccs_o_171_noael_012"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	18	mg/kg bw/day	rat	oral	90-day	-	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=18; DOSE=the CEF Panel identified a NOAEL of 18 mg/kg bw/day, based on increased relative caecum weights in male rats in one of the 90-day study.; EFFECT=the CEF Panel identified a NOAEL of 18 mg/kg bw/day, based on increased relative caecum weights in male rats in one of the 90-day study. The CEF Panel considered the increase in caecum weight as relevant for risk characterisation. The SCCS agrees with the evaluation of the EFSA CEF Panel. For dermal application, the dietary studies reported in the EFSA opinion are considered as more relevant for the safety assessment of cetylpyridinium chloride than the gavage studies submitted by the applicant. Consequently, the NOAEL of 18 mg/kg bw/day identified by the CEF Panel is used for the MOS calculation for use of cetylpyridinium chloride as a preservative in skin lotions and creams, as well as in anti-perspirant deodorants, cf. Terms of Reference. For oral application, the gavage studies submitted by the applicant are considered as more relevant for the safety assessment of cetylpyridinium chloride than the dietary studies reported in the EFSA Opinion. Consequently, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"123-03-5","citation":"","dose":"the CEF Panel identified a NOAEL of 18 mg/kg bw/day, based on increased relative caecum weights in male rats in one of the 90-day study.","duration":"90-day","effect":"the CEF Panel identified a NOAEL of 18 mg/kg bw/day, based on increased relative caecum weights in male rats in one of the 90-day study. The CEF Panel considered the increase in caecum weight as relevant for risk characterisation. The SCCS agrees with the evaluation of the EFSA CEF Panel. For dermal application, the dietary studies reported in the EFSA opinion are considered as more relevant for the safety assessment of cetylpyridinium chloride than the gavage studies submitted by the applicant. Consequently, the NOAEL of 18 mg/kg bw/day identified by the CEF Panel is used for the MOS calculation for use of cetylpyridinium chloride as a preservative in skin lotions and creams, as well as in anti-perspirant deodorants, cf. Terms of Reference. For oral application, the gavage studies submitted by the applicant are considered as more relevant for the safety assessment of cetylpyridinium chloride than the dietary studies reported in the EFSA Opinion. Consequently, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study","endpoint":"","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"18","page":32,"route":"oral","species":"rat","study_id":"sccs_o_171_noael_018"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	5	mg/kg bw/day	-	oral	6-month	-	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=5; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Oral application For oral application, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used for the MOS calculation.; EFFECT=SCCS/1548/15 Revision of the Opinion on Cetylpyridinium chloride (P97) ___________________________________________________________________________________________ 47 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Oral application For oral application, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used for the MOS calculation. Based on the toxicokinetic data, an oral absorption of 50% is considered. The adjusted NOAEL for the MOS calculation is 2.5 mg/kg bw/day. Product Max concentration (% in the finished product) Total oral exposure (mg/kg bw/day) Calculated SED based on an oral absorption of 50% (mg/kg bw/day) MoS (adjusted NOAEL/SED) Mouthrinse 0.1 0.033 0.016 156 Dentrifice3 (toothpaste) 0.5 0.011 0.005 500 Aggregate exposure (cosmetics); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"123-03-5","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Oral application For oral application, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used for the MOS calculation.","duration":"6-month","effect":"SCCS/1548/15 Revision of the Opinion on Cetylpyridinium chloride (P97) ___________________________________________________________________________________________ 47 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Oral application For oral application, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used for the MOS calculation. Based on the toxicokinetic data, an oral absorption of 50% is considered. The adjusted NOAEL for the MOS calculation is 2.5 mg/kg bw/day. Product Max concentration (% in the finished product) Total oral exposure (mg/kg bw/day) Calculated SED based on an oral absorption of 50% (mg/kg bw/day) MoS (adjusted NOAEL/SED) Mouthrinse 0.1 0.033 0.016 156 Dentrifice3 (toothpaste) 0.5 0.011 0.005 500 Aggregate exposure (cosmetics)","endpoint":"","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"5","page":47,"route":"oral","species":"","study_id":"sccs_o_171_noael_022"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	2.5	mg/kg bw/day	-	oral	6-month	-	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=2.5; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Oral application For oral application, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used for the MOS calculation.; EFFECT=SCCS/1548/15 Revision of the Opinion on Cetylpyridinium chloride (P97) ___________________________________________________________________________________________ 47 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Oral application For oral application, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used for the MOS calculation. Based on the toxicokinetic data, an oral absorption of 50% is considered. The adjusted NOAEL for the MOS calculation is 2.5 mg/kg bw/day. Product Max concentration (% in the finished product) Total oral exposure (mg/kg bw/day) Calculated SED based on an oral absorption of 50% (mg/kg bw/day) MoS (adjusted NOAEL/SED) Mouthrinse 0.1 0.033 0.016 156 Dentrifice3 (toothpaste) 0.5 0.011 0.005 500 Aggregate exposure (cosmetics) 0.021 120 Denture adhesive3 0.5 0.025 0.013 192 Denture cleanser3 0.5 0.00013 0.00006 41700 Aggregate exposure (total) 0.034 74 In conclusion, the SCCS considers that the use of c; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"123-03-5","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Oral application For oral application, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used for the MOS calculation.","duration":"6-month","effect":"SCCS/1548/15 Revision of the Opinion on Cetylpyridinium chloride (P97) ___________________________________________________________________________________________ 47 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Oral application For oral application, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used for the MOS calculation. Based on the toxicokinetic data, an oral absorption of 50% is considered. The adjusted NOAEL for the MOS calculation is 2.5 mg/kg bw/day. Product Max concentration (% in the finished product) Total oral exposure (mg/kg bw/day) Calculated SED based on an oral absorption of 50% (mg/kg bw/day) MoS (adjusted NOAEL/SED) Mouthrinse 0.1 0.033 0.016 156 Dentrifice3 (toothpaste) 0.5 0.011 0.005 500 Aggregate exposure (cosmetics) 0.021 120 Denture adhesive3 0.5 0.025 0.013 192 Denture cleanser3 0.5 0.00013 0.00006 41700 Aggregate exposure (total) 0.034 74 In conclusion, the SCCS considers that the use of c","endpoint":"","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"2.5","page":47,"route":"oral","species":"","study_id":"sccs_o_171_noael_023"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	50	%	-	oral	6-month	-	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=50; DOSE=ng calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Oral application For oral application, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used for the MOS calculation.; EFFECT=ng calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Oral application For oral application, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used for the MOS calculation. Based on the toxicokinetic data, an oral absorption of 50% is considered. The adjusted NOAEL for the MOS calculation is 2.5 mg/kg bw/day. Product Max concentration (% in the finished product) Total oral exposure (mg/kg bw/day) Calculated SED based on an oral absorption of 50% (mg/kg bw/day) MoS (adjusted NOAEL/SED) Mouthrinse 0.1 0.033 0.016 156 Dentrifice3 (toothpaste) 0.5 0.011 0.005 500 Aggregate exposure (cosmetics) 0.021 120 Denture adhesive3 0.5 0.025 0.013 192 Denture cleanser3 0.5 0.00013 0.00006 41700 Aggregate exposure (total) 0.034 74 In conclusion, the SCCS considers that the use of cetylpyridinium chloride in the single cosmetic products for oral application mentioned above is safe for the consumer. Aggregate exposure to cetylpyridinium chloride via cosmetic products and other consumer products (dentu; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"123-03-5","citation":"","dose":"ng calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Oral application For oral application, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used for the MOS calculation.","duration":"6-month","effect":"ng calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Oral application For oral application, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used for the MOS calculation. Based on the toxicokinetic data, an oral absorption of 50% is considered. The adjusted NOAEL for the MOS calculation is 2.5 mg/kg bw/day. Product Max concentration (% in the finished product) Total oral exposure (mg/kg bw/day) Calculated SED based on an oral absorption of 50% (mg/kg bw/day) MoS (adjusted NOAEL/SED) Mouthrinse 0.1 0.033 0.016 156 Dentrifice3 (toothpaste) 0.5 0.011 0.005 500 Aggregate exposure (cosmetics) 0.021 120 Denture adhesive3 0.5 0.025 0.013 192 Denture cleanser3 0.5 0.00013 0.00006 41700 Aggregate exposure (total) 0.034 74 In conclusion, the SCCS considers that the use of cetylpyridinium chloride in the single cosmetic products for oral application mentioned above is safe for the consumer. Aggregate exposure to cetylpyridinium chloride via cosmetic products and other consumer products (dentu","endpoint":"","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"%","noael_value":"50","page":47,"route":"oral","species":"","study_id":"sccs_o_171_noael_024"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	<5	mg/kg bw/day	rat	oral	28-day	-	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=<5; DOSE=General toxicity Cetylpyridinium chloride was of moderate acute oral toxicity in rats (oral LD50 value of 560 mg/kg bw) in a study performed according to OECD TG 425, of low acute dermal in rats (dermal LD50 value greater than 5000 mg/kg bw) in a study performed according to OECD TG 402, and of high acute inhalation toxicity in rats (inhalation...; EFFECT=ot been reported. General toxicity Cetylpyridinium chloride was of moderate acute oral toxicity in rats (oral LD50 value of 560 mg/kg bw) in a study performed according to OECD TG 425, of low acute dermal in rats (dermal LD50 value greater than 5000 mg/kg bw) in a study performed according to OECD TG 402, and of high acute inhalation toxicity in rats (inhalation LC50 value between 0.054 and 0.51 mg/l) in a study performed according to OECD TG 403. In the submitted 28-day studies performed with rats and dogs, a NOAEL of 25 and <5 mg/kg bw/day, respectively, can be identified based on local effects observed in the stomach. In the submitted 6-month study performed with rats, a NOAEL of 5 mg/kg bw/day can be identified based on local effects observed in the stomach. The local effects observed in the stomach are probably due to the irritative properties of cetylpyridinium chloride and related to the administration of the test material as aqueous solution (by gavage in water). Based on the submitted 6-month study, 5 mg/kg bw/day is; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"123-03-5","citation":"","dose":"General toxicity Cetylpyridinium chloride was of moderate acute oral toxicity in rats (oral LD50 value of 560 mg/kg bw) in a study performed according to OECD TG 425, of low acute dermal in rats (dermal LD50 value greater than 5000 mg/kg bw) in a study performed according to OECD TG 402, and of high acute inhalation toxicity in rats (inhalation...","duration":"28-day","effect":"ot been reported. General toxicity Cetylpyridinium chloride was of moderate acute oral toxicity in rats (oral LD50 value of 560 mg/kg bw) in a study performed according to OECD TG 425, of low acute dermal in rats (dermal LD50 value greater than 5000 mg/kg bw) in a study performed according to OECD TG 402, and of high acute inhalation toxicity in rats (inhalation LC50 value between 0.054 and 0.51 mg/l) in a study performed according to OECD TG 403. In the submitted 28-day studies performed with rats and dogs, a NOAEL of 25 and <5 mg/kg bw/day, respectively, can be identified based on local effects observed in the stomach. In the submitted 6-month study performed with rats, a NOAEL of 5 mg/kg bw/day can be identified based on local effects observed in the stomach. The local effects observed in the stomach are probably due to the irritative properties of cetylpyridinium chloride and related to the administration of the test material as aqueous solution (by gavage in water). Based on the submitted 6-month study, 5 mg/kg bw/day is","endpoint":"","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"<5","page":49,"route":"oral","species":"rat","study_id":"sccs_o_171_noael_028"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	5	mg/kg bw/day	rat	oral	28-day	-	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=5; DOSE=ding to OECD TG 425, of low acute dermal in rats (dermal LD50 value greater than 5000 mg/kg bw) in a study performed according to OECD TG 402, and of high acute inhalation toxicity in rats (inhalation LC50 value between 0.054 and 0.51 mg/l) in a study performed according to OECD TG 403.; EFFECT=ding to OECD TG 425, of low acute dermal in rats (dermal LD50 value greater than 5000 mg/kg bw) in a study performed according to OECD TG 402, and of high acute inhalation toxicity in rats (inhalation LC50 value between 0.054 and 0.51 mg/l) in a study performed according to OECD TG 403. In the submitted 28-day studies performed with rats and dogs, a NOAEL of 25 and <5 mg/kg bw/day, respectively, can be identified based on local effects observed in the stomach. In the submitted 6-month study performed with rats, a NOAEL of 5 mg/kg bw/day can be identified based on local effects observed in the stomach. The local effects observed in the stomach are probably due to the irritative properties of cetylpyridinium chloride and related to the administration of the test material as aqueous solution (by gavage in water). Based on the submitted 6-month study, 5 mg/kg bw/day is also considered as a NOAEL for systemic toxicity (decreased body weight gain in females, 86% of control) although it can be argued that the decreased body weight gain; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"123-03-5","citation":"","dose":"ding to OECD TG 425, of low acute dermal in rats (dermal LD50 value greater than 5000 mg/kg bw) in a study performed according to OECD TG 402, and of high acute inhalation toxicity in rats (inhalation LC50 value between 0.054 and 0.51 mg/l) in a study performed according to OECD TG 403.","duration":"28-day","effect":"ding to OECD TG 425, of low acute dermal in rats (dermal LD50 value greater than 5000 mg/kg bw) in a study performed according to OECD TG 402, and of high acute inhalation toxicity in rats (inhalation LC50 value between 0.054 and 0.51 mg/l) in a study performed according to OECD TG 403. In the submitted 28-day studies performed with rats and dogs, a NOAEL of 25 and <5 mg/kg bw/day, respectively, can be identified based on local effects observed in the stomach. In the submitted 6-month study performed with rats, a NOAEL of 5 mg/kg bw/day can be identified based on local effects observed in the stomach. The local effects observed in the stomach are probably due to the irritative properties of cetylpyridinium chloride and related to the administration of the test material as aqueous solution (by gavage in water). Based on the submitted 6-month study, 5 mg/kg bw/day is also considered as a NOAEL for systemic toxicity (decreased body weight gain in females, 86% of control) although it can be argued that the decreased body weight gain","endpoint":"","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"5","page":49,"route":"oral","species":"rat","study_id":"sccs_o_171_noael_029"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	5	mg/kg bw/day	rat	oral	6-month	-	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=5; DOSE=In the submitted 6-month study performed with rats, a NOAEL of 5 mg/kg bw/day can be identified based on local effects observed in the stomach.; EFFECT=/day, respectively, can be identified based on local effects observed in the stomach. In the submitted 6-month study performed with rats, a NOAEL of 5 mg/kg bw/day can be identified based on local effects observed in the stomach. The local effects observed in the stomach are probably due to the irritative properties of cetylpyridinium chloride and related to the administration of the test material as aqueous solution (by gavage in water). Based on the submitted 6-month study, 5 mg/kg bw/day is also considered as a NOAEL for systemic toxicity (decreased body weight gain in females, 86% of control) although it can be argued that the decreased body weight gain might be secondary to the local effects in the stomach. The EFSA CEF Panel has recently published a scientific Opinion on the evaluation of the safety and efficacy of Cecure® for the removal of microbial surface contamination of raw poultry products. The active ingredient in Cecure® is cetylpyridinium chloride. Two 28-day feeding studies and two 90-day feeding studies have be; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"123-03-5","citation":"","dose":"In the submitted 6-month study performed with rats, a NOAEL of 5 mg/kg bw/day can be identified based on local effects observed in the stomach.","duration":"6-month","effect":"/day, respectively, can be identified based on local effects observed in the stomach. In the submitted 6-month study performed with rats, a NOAEL of 5 mg/kg bw/day can be identified based on local effects observed in the stomach. The local effects observed in the stomach are probably due to the irritative properties of cetylpyridinium chloride and related to the administration of the test material as aqueous solution (by gavage in water). Based on the submitted 6-month study, 5 mg/kg bw/day is also considered as a NOAEL for systemic toxicity (decreased body weight gain in females, 86% of control) although it can be argued that the decreased body weight gain might be secondary to the local effects in the stomach. The EFSA CEF Panel has recently published a scientific Opinion on the evaluation of the safety and efficacy of Cecure® for the removal of microbial surface contamination of raw poultry products. The active ingredient in Cecure® is cetylpyridinium chloride. Two 28-day feeding studies and two 90-day feeding studies have be","endpoint":"","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"5","page":49,"route":"oral","species":"rat","study_id":"sccs_o_171_noael_030"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	50	%	-	oral	-	-	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=50; DOSE=Product \| Max concentration (% in the finished product) \| Total oral exposure (mg/kg bw/day) \| Calculated SED based on an oral absorption of 50% (mg/kg bw/day) \| MoS (adjusted NOAEL/SED); EFFECT=Unlabeled table on page 47: Product \| Max concentration (% in the finished product) \| Total oral exposure (mg/kg bw/day) \| Calculated SED based on an oral absorption of 50% (mg/kg bw/day) \| MoS (adjusted NOAEL/SED); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"123-03-5","citation":"","dose":"Product \| Max concentration (% in the finished product) \| Total oral exposure (mg/kg bw/day) \| Calculated SED based on an oral absorption of 50% (mg/kg bw/day) \| MoS (adjusted NOAEL/SED)","duration":"","effect":"Unlabeled table on page 47: Product \| Max concentration (% in the finished product) \| Total oral exposure (mg/kg bw/day) \| Calculated SED based on an oral absorption of 50% (mg/kg bw/day) \| MoS (adjusted NOAEL/SED)","endpoint":"","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"%","noael_value":"50","page":47,"route":"oral","species":"","study_id":"sccs_o_171_noael_037"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	156	-	-	-	-	-	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=156; EFFECT=Unlabeled table on page 47: Mouthrinse \| 0.1 \| 0.033 \| 0.016 \| 156; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"123-03-5","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 47: Mouthrinse \| 0.1 \| 0.033 \| 0.016 \| 156","endpoint":"","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"","noael_value":"156","page":47,"route":"","species":"","study_id":"sccs_o_171_noael_038"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	500	-	-	-	-	-	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=500; EFFECT=Unlabeled table on page 47: Dentrifice3 (toothpaste) \| 0.5 \| 0.011 \| 0.005 \| 500; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"123-03-5","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 47: Dentrifice3 (toothpaste) \| 0.5 \| 0.011 \| 0.005 \| 500","endpoint":"","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"","noael_value":"500","page":47,"route":"","species":"","study_id":"sccs_o_171_noael_039"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	120	-	-	-	-	-	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=120; EFFECT=Unlabeled table on page 47: Aggregate exposure (cosmetics) \| 0.021 \| 120; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"123-03-5","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 47: Aggregate exposure (cosmetics) \| 0.021 \| 120","endpoint":"","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"","noael_value":"120","page":47,"route":"","species":"","study_id":"sccs_o_171_noael_040"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	192	-	-	-	-	-	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=192; EFFECT=Unlabeled table on page 47: Denture adhesive3 \| 0.5 \| 0.025 \| 0.013 \| 192; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"123-03-5","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 47: Denture adhesive3 \| 0.5 \| 0.025 \| 0.013 \| 192","endpoint":"","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"","noael_value":"192","page":47,"route":"","species":"","study_id":"sccs_o_171_noael_041"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	41700	-	-	-	-	-	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=41700; EFFECT=Unlabeled table on page 47: Denture cleanser3 \| 0.5 \| 0.00013 \| 0.00006 \| 41700; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"123-03-5","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 47: Denture cleanser3 \| 0.5 \| 0.00013 \| 0.00006 \| 41700","endpoint":"","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"","noael_value":"41700","page":47,"route":"","species":"","study_id":"sccs_o_171_noael_042"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	74	-	-	-	-	-	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=74; EFFECT=Unlabeled table on page 47: Aggregate exposure (total) \| 0.034 \| 74; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"123-03-5","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 47: Aggregate exposure (total) \| 0.034 \| 74","endpoint":"","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"","noael_value":"74","page":47,"route":"","species":"","study_id":"sccs_o_171_noael_043"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	360	-	-	-	-	-	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=360; EFFECT=Unlabeled table on page 48: Body lotion \| 0.2 \| 0.246 \| 0.025 \| 360; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"123-03-5","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 48: Body lotion \| 0.2 \| 0.246 \| 0.025 \| 360","endpoint":"","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"","noael_value":"360","page":48,"route":"","species":"","study_id":"sccs_o_171_noael_045"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	1875	-	-	-	-	-	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=1875; EFFECT=Unlabeled table on page 48: Face cream \| 0.2 \| 0.048 \| 0.0048 \| 1875; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"123-03-5","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 48: Face cream \| 0.2 \| 0.048 \| 0.0048 \| 1875","endpoint":"","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"","noael_value":"1875","page":48,"route":"","species":"","study_id":"sccs_o_171_noael_046"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	1385	-	-	-	-	-	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=1385; EFFECT=Unlabeled table on page 48: Hand cream \| 0.2 \| 0.065 \| 0.0065 \| 1385; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"123-03-5","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 48: Hand cream \| 0.2 \| 0.065 \| 0.0065 \| 1385","endpoint":"","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"","noael_value":"1385","page":48,"route":"","species":"","study_id":"sccs_o_171_noael_047"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	205	-	-	-	-	-	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=205; EFFECT=Unlabeled table on page 48: Deodorant, non-spray \| 2.0 \| 0.442 \| 0.044 \| 205; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"123-03-5","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 48: Deodorant, non-spray \| 2.0 \| 0.442 \| 0.044 \| 205","endpoint":"","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"","noael_value":"205","page":48,"route":"","species":"","study_id":"sccs_o_171_noael_048"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	113	-	-	-	-	-	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=113; EFFECT=Unlabeled table on page 48: Aggregate exposure \| 0.080 \| 113; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"123-03-5","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 48: Aggregate exposure \| 0.080 \| 113","endpoint":"","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"","noael_value":"113","page":48,"route":"","species":"","study_id":"sccs_o_171_noael_049"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	dermal absorption	18	mg/kg bw/day	-	oral	-	dermal absorption	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=18; DOSE=the CEF Panel in the EFSA opinion to be up to 5.7 µg/kg bw/day at the mean and to 17.8 µg/kg bw/day at the 95th percentile of treated poultry consumption.; EFFECT=the CEF Panel in the EFSA opinion to be up to 5.7 µg/kg bw/day at the mean and to 17.8 µg/kg bw/day at the 95th percentile of treated poultry consumption. Aggregate oral exposure to cetylpyridinium chloride via cosmetic products and via treated poultry may therefore, be of concern for some consumers; however, it is considered likely that oral exposure from the applications mentioned above and exposure from treated poultry will not occur simultaneously very often. Dermal application For dermal application, the NOAEL of 18 mg/kg bw/day identified by the CEF Panel in the EFSA opinion is used for the MOS calculation. Based on the toxicokinetic data, an oral absorption of 50% is considered. The adjusted NOAEL for the MOS calculation is 9 mg/kg bw/day. Product Max concentration (% in the finished product) Total dermal exposure (mg/kg bw/day) Calculated SED based on a dermal absorption of 10% (mg/kg bw/day) MoS (adjusted NOAEL/SED) Body lotion 0.2 0.246 0.025 360 Face cream 0.2 0.048 0.0048 1875 Hand cream 0.2 0.065 0.0065 1385; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"123-03-5","citation":"","dose":"the CEF Panel in the EFSA opinion to be up to 5.7 µg/kg bw/day at the mean and to 17.8 µg/kg bw/day at the 95th percentile of treated poultry consumption.","duration":"","effect":"the CEF Panel in the EFSA opinion to be up to 5.7 µg/kg bw/day at the mean and to 17.8 µg/kg bw/day at the 95th percentile of treated poultry consumption. Aggregate oral exposure to cetylpyridinium chloride via cosmetic products and via treated poultry may therefore, be of concern for some consumers; however, it is considered likely that oral exposure from the applications mentioned above and exposure from treated poultry will not occur simultaneously very often. Dermal application For dermal application, the NOAEL of 18 mg/kg bw/day identified by the CEF Panel in the EFSA opinion is used for the MOS calculation. Based on the toxicokinetic data, an oral absorption of 50% is considered. The adjusted NOAEL for the MOS calculation is 9 mg/kg bw/day. Product Max concentration (% in the finished product) Total dermal exposure (mg/kg bw/day) Calculated SED based on a dermal absorption of 10% (mg/kg bw/day) MoS (adjusted NOAEL/SED) Body lotion 0.2 0.246 0.025 360 Face cream 0.2 0.048 0.0048 1875 Hand cream 0.2 0.065 0.0065 1385","endpoint":"dermal absorption","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"18","page":48,"route":"oral","species":"","study_id":"sccs_o_171_noael_025"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	dermal absorption	50	%	-	oral	-	dermal absorption	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=50; DOSE=inium chloride via cosmetic products and via treated poultry may therefore, be of concern for some consumers; however, it is considered likely that oral exposure from the applications mentioned above and exposure from treated poultry will not occur simultaneously very often.; EFFECT=inium chloride via cosmetic products and via treated poultry may therefore, be of concern for some consumers; however, it is considered likely that oral exposure from the applications mentioned above and exposure from treated poultry will not occur simultaneously very often. Dermal application For dermal application, the NOAEL of 18 mg/kg bw/day identified by the CEF Panel in the EFSA opinion is used for the MOS calculation. Based on the toxicokinetic data, an oral absorption of 50% is considered. The adjusted NOAEL for the MOS calculation is 9 mg/kg bw/day. Product Max concentration (% in the finished product) Total dermal exposure (mg/kg bw/day) Calculated SED based on a dermal absorption of 10% (mg/kg bw/day) MoS (adjusted NOAEL/SED) Body lotion 0.2 0.246 0.025 360 Face cream 0.2 0.048 0.0048 1875 Hand cream 0.2 0.065 0.0065 1385 Deodorant, non-spray 2.0 0.442 0.044 205 Aggregate exposure 0.080 113 In conclusion, the SCCS considers that the use of cetylpyridinium chloride in the single cosmetic products for dermal; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"123-03-5","citation":"","dose":"inium chloride via cosmetic products and via treated poultry may therefore, be of concern for some consumers; however, it is considered likely that oral exposure from the applications mentioned above and exposure from treated poultry will not occur simultaneously very often.","duration":"","effect":"inium chloride via cosmetic products and via treated poultry may therefore, be of concern for some consumers; however, it is considered likely that oral exposure from the applications mentioned above and exposure from treated poultry will not occur simultaneously very often. Dermal application For dermal application, the NOAEL of 18 mg/kg bw/day identified by the CEF Panel in the EFSA opinion is used for the MOS calculation. Based on the toxicokinetic data, an oral absorption of 50% is considered. The adjusted NOAEL for the MOS calculation is 9 mg/kg bw/day. Product Max concentration (% in the finished product) Total dermal exposure (mg/kg bw/day) Calculated SED based on a dermal absorption of 10% (mg/kg bw/day) MoS (adjusted NOAEL/SED) Body lotion 0.2 0.246 0.025 360 Face cream 0.2 0.048 0.0048 1875 Hand cream 0.2 0.065 0.0065 1385 Deodorant, non-spray 2.0 0.442 0.044 205 Aggregate exposure 0.080 113 In conclusion, the SCCS considers that the use of cetylpyridinium chloride in the single cosmetic products for dermal","endpoint":"dermal absorption","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"%","noael_value":"50","page":48,"route":"oral","species":"","study_id":"sccs_o_171_noael_026"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	dermal absorption	10	%	-	oral	-	dermal absorption	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=10; DOSE=Dermal application For dermal application, the NOAEL of 18 mg/kg bw/day identified by the CEF Panel in the EFSA opinion is used for the MOS calculation.; EFFECT=ed poultry will not occur simultaneously very often. Dermal application For dermal application, the NOAEL of 18 mg/kg bw/day identified by the CEF Panel in the EFSA opinion is used for the MOS calculation. Based on the toxicokinetic data, an oral absorption of 50% is considered. The adjusted NOAEL for the MOS calculation is 9 mg/kg bw/day. Product Max concentration (% in the finished product) Total dermal exposure (mg/kg bw/day) Calculated SED based on a dermal absorption of 10% (mg/kg bw/day) MoS (adjusted NOAEL/SED) Body lotion 0.2 0.246 0.025 360 Face cream 0.2 0.048 0.0048 1875 Hand cream 0.2 0.065 0.0065 1385 Deodorant, non-spray 2.0 0.442 0.044 205 Aggregate exposure 0.080 113 In conclusion, the SCCS considers that the use of cetylpyridinium chloride in the single cosmetic products for dermal application mentioned above, as well as aggregate exposure to cetylpyridinium chloride via cosmetic products for these dermal applications is safe for the consumer. Aggregate exposure Aggregate exposure to cetylpyridini; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"123-03-5","citation":"","dose":"Dermal application For dermal application, the NOAEL of 18 mg/kg bw/day identified by the CEF Panel in the EFSA opinion is used for the MOS calculation.","duration":"","effect":"ed poultry will not occur simultaneously very often. Dermal application For dermal application, the NOAEL of 18 mg/kg bw/day identified by the CEF Panel in the EFSA opinion is used for the MOS calculation. Based on the toxicokinetic data, an oral absorption of 50% is considered. The adjusted NOAEL for the MOS calculation is 9 mg/kg bw/day. Product Max concentration (% in the finished product) Total dermal exposure (mg/kg bw/day) Calculated SED based on a dermal absorption of 10% (mg/kg bw/day) MoS (adjusted NOAEL/SED) Body lotion 0.2 0.246 0.025 360 Face cream 0.2 0.048 0.0048 1875 Hand cream 0.2 0.065 0.0065 1385 Deodorant, non-spray 2.0 0.442 0.044 205 Aggregate exposure 0.080 113 In conclusion, the SCCS considers that the use of cetylpyridinium chloride in the single cosmetic products for dermal application mentioned above, as well as aggregate exposure to cetylpyridinium chloride via cosmetic products for these dermal applications is safe for the consumer. Aggregate exposure Aggregate exposure to cetylpyridini","endpoint":"dermal absorption","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"%","noael_value":"10","page":48,"route":"oral","species":"","study_id":"sccs_o_171_noael_027"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	dermal absorption	10	%	-	dermal	-	dermal absorption	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=10; DOSE=Product \| Max concentration (% in the finished product) \| Total dermal exposure (mg/kg bw/day) \| Calculated SED based on a dermal absorption of 10% (mg/kg bw/day) \| MoS (adjusted NOAEL/SED); EFFECT=Unlabeled table on page 48: Product \| Max concentration (% in the finished product) \| Total dermal exposure (mg/kg bw/day) \| Calculated SED based on a dermal absorption of 10% (mg/kg bw/day) \| MoS (adjusted NOAEL/SED); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"123-03-5","citation":"","dose":"Product \| Max concentration (% in the finished product) \| Total dermal exposure (mg/kg bw/day) \| Calculated SED based on a dermal absorption of 10% (mg/kg bw/day) \| MoS (adjusted NOAEL/SED)","duration":"","effect":"Unlabeled table on page 48: Product \| Max concentration (% in the finished product) \| Total dermal exposure (mg/kg bw/day) \| Calculated SED based on a dermal absorption of 10% (mg/kg bw/day) \| MoS (adjusted NOAEL/SED)","endpoint":"dermal absorption","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"%","noael_value":"10","page":48,"route":"dermal","species":"","study_id":"sccs_o_171_noael_044"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	developmental toxicity	60	mg/kg bw/day	-	-	developmental	developmental toxicity	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=60; DOSE=Conclusion No evidence of developmental toxicity was observed in the 60 mg/kg bw/day group nor in any of the dose groups.; EFFECT=SCCS-rejected applicant NOAEL: on of the jugal, incomplete ossification of the cervical vertebral arches and ischium, presence of 14th thoracic vertebra and/or 5th lumbar vertebra, unossified 5th sternebra, bent rib, 12 full pairs of ribs, a rudimentary rib and/or full unilateral rib; the slightly higher incidences of these developmental variations were not considered indicative of a teratogenic effect by the applicant. Conclusion No evidence of developmental toxicity was observed in the 60 mg/kg bw/day group nor in any of the dose groups. The NOAEL of cetylpyridinium chloride with regard to maternal toxicity was 15 mg/kg/day, and 60 mg/kg/day with respect to developmental toxicity. Ref.: 10; CITATION=Ref.: 10; CITATION_NUMBERS=[10]; REFERENCE=Ref.: 10; DETAILS_JSON={"cas_number":"123-03-5","citation":"Ref.: 10","dose":"Conclusion No evidence of developmental toxicity was observed in the 60 mg/kg bw/day group nor in any of the dose groups.","duration":"developmental","effect":"SCCS-rejected applicant NOAEL: on of the jugal, incomplete ossification of the cervical vertebral arches and ischium, presence of 14th thoracic vertebra and/or 5th lumbar vertebra, unossified 5th sternebra, bent rib, 12 full pairs of ribs, a rudimentary rib and/or full unilateral rib; the slightly higher incidences of these developmental variations were not considered indicative of a teratogenic effect by the applicant. Conclusion No evidence of developmental toxicity was observed in the 60 mg/kg bw/day group nor in any of the dose groups. The NOAEL of cetylpyridinium chloride with regard to maternal toxicity was 15 mg/kg/day, and 60 mg/kg/day with respect to developmental toxicity. Ref.: 10","endpoint":"developmental toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"60","page":37,"route":"","species":"","study_id":"sccs_o_171_noael_020"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	developmental toxicity	100	mg/kg bw/day	rat	-	-	developmental toxicity	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=100; DOSE=An increased incidence of skeletal variations was observed at 25 mg/kg bw/day and included missing sternebrae and 13th rib variations.; EFFECT=on of the Opinion on Cetylpyridinium chloride (P97) ___________________________________________________________________________________________ 39 changes in the incidence of soft tissue anomalies or skeletal malformations were noted. An increased incidence of skeletal variations was observed at 25 mg/kg bw/day and included missing sternebrae and 13th rib variations. Conclusion The data demonstrated that these materials were not teratogenic in rabbits at doses ranging up to those fatal to the dam; therefore, the NOAEL for teratogenicity was greater than or equal to 100 mg/kg bw/day. Ref.: 11 SCCS comment The SCCS notes that the purity and stability of the test material was not provided. Furthermore, the study was limitedly reported with only summarised tables available for the findings observed in the study. Thus, this study is considered inadequate for the safety assessment of cetylpyridinium chloride. Overall SCCS comment to the submitted teratogenicity studies Two teratogenicity studies – one in rats and the other in rab; CITATION=Ref.: 11 SCCS comment The SCCS notes that the purity and stability of the test material was not provided; CITATION_NUMBERS=[11]; REFERENCE=Ref.: 11 SCCS comment The SCCS notes that the purity and stability of the test material was not provided; DETAILS_JSON={"cas_number":"123-03-5","citation":"Ref.: 11 SCCS comment The SCCS notes that the purity and stability of the test material was not provided","dose":"An increased incidence of skeletal variations was observed at 25 mg/kg bw/day and included missing sternebrae and 13th rib variations.","duration":"","effect":"on of the Opinion on Cetylpyridinium chloride (P97) ___________________________________________________________________________________________ 39 changes in the incidence of soft tissue anomalies or skeletal malformations were noted. An increased incidence of skeletal variations was observed at 25 mg/kg bw/day and included missing sternebrae and 13th rib variations. Conclusion The data demonstrated that these materials were not teratogenic in rabbits at doses ranging up to those fatal to the dam; therefore, the NOAEL for teratogenicity was greater than or equal to 100 mg/kg bw/day. Ref.: 11 SCCS comment The SCCS notes that the purity and stability of the test material was not provided. Furthermore, the study was limitedly reported with only summarised tables available for the findings observed in the study. Thus, this study is considered inadequate for the safety assessment of cetylpyridinium chloride. Overall SCCS comment to the submitted teratogenicity studies Two teratogenicity studies – one in rats and the other in rab","endpoint":"developmental toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":39,"route":"","species":"rat","study_id":"sccs_o_171_noael_021"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	developmental toxicity	5	mg/kg bw/day	rat	oral	6-month	developmental toxicity	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=5; DOSE=Consequently, the NOAEL of 18 mg/kg bw/day identified by the CEF Panel is used for the MOS calculation for use of cetylpyridinium chloride as a preservative in skin lotions and creams, as well as in anti-perspirant deodorants, cf.; EFFECT=avage studies submitted by the applicant. Consequently, the NOAEL of 18 mg/kg bw/day identified by the CEF Panel is used for the MOS calculation for use of cetylpyridinium chloride as a preservative in skin lotions and creams, as well as in anti-perspirant deodorants, cf. Terms of Reference. For oral application, the gavage studies submitted by the applicant are considered as more relevant for the safety assessment of cetylpyridinium chloride than the dietary studies reported in the EFSA opinion. Consequently, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used in the safety assessment for the MOS calculation for use of cetylpyridinium chloride as a preservative in mouthwashes cosmetic products, as well as in all other oral hygiene cosmetic products, cf. Terms of Reference. In the teratogenicity study performed with rats, the NOAEL for maternal toxicity was 15 mg/kg/day, based on clinical signs of toxicity and decreased body weight gain; the NOAEL for developmental toxicity was 60 mg/kg/day (the highest; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"123-03-5","citation":"","dose":"Consequently, the NOAEL of 18 mg/kg bw/day identified by the CEF Panel is used for the MOS calculation for use of cetylpyridinium chloride as a preservative in skin lotions and creams, as well as in anti-perspirant deodorants, cf.","duration":"6-month","effect":"avage studies submitted by the applicant. Consequently, the NOAEL of 18 mg/kg bw/day identified by the CEF Panel is used for the MOS calculation for use of cetylpyridinium chloride as a preservative in skin lotions and creams, as well as in anti-perspirant deodorants, cf. Terms of Reference. For oral application, the gavage studies submitted by the applicant are considered as more relevant for the safety assessment of cetylpyridinium chloride than the dietary studies reported in the EFSA opinion. Consequently, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used in the safety assessment for the MOS calculation for use of cetylpyridinium chloride as a preservative in mouthwashes cosmetic products, as well as in all other oral hygiene cosmetic products, cf. Terms of Reference. In the teratogenicity study performed with rats, the NOAEL for maternal toxicity was 15 mg/kg/day, based on clinical signs of toxicity and decreased body weight gain; the NOAEL for developmental toxicity was 60 mg/kg/day (the highest","endpoint":"developmental toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"5","page":50,"route":"oral","species":"rat","study_id":"sccs_o_171_noael_034"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	developmental toxicity	15	mg/kg/day	rat	oral	6-month	developmental toxicity	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=15; DOSE=Consequently, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used in the safety assessment for the MOS calculation for use of cetylpyridinium chloride as a preservative in mouthwashes cosmetic products, as well as in all other oral hygiene cosmetic products, cf.; EFFECT=y the applicant are considered as more relevant for the safety assessment of cetylpyridinium chloride than the dietary studies reported in the EFSA opinion. Consequently, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used in the safety assessment for the MOS calculation for use of cetylpyridinium chloride as a preservative in mouthwashes cosmetic products, as well as in all other oral hygiene cosmetic products, cf. Terms of Reference. In the teratogenicity study performed with rats, the NOAEL for maternal toxicity was 15 mg/kg/day, based on clinical signs of toxicity and decreased body weight gain; the NOAEL for developmental toxicity was 60 mg/kg/day (the highest dose level in the study). The teratogenicity study performed with rabbits was limitedly reported with only summarised tables available for the findings observed in the study and therefore, the study is considered inadequate for the safety assessment of cetylpyridinium chloride. Irritation / sensitisation Cetylpyridinium chloride at a conce; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"123-03-5","citation":"","dose":"Consequently, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used in the safety assessment for the MOS calculation for use of cetylpyridinium chloride as a preservative in mouthwashes cosmetic products, as well as in all other oral hygiene cosmetic products, cf.","duration":"6-month","effect":"y the applicant are considered as more relevant for the safety assessment of cetylpyridinium chloride than the dietary studies reported in the EFSA opinion. Consequently, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used in the safety assessment for the MOS calculation for use of cetylpyridinium chloride as a preservative in mouthwashes cosmetic products, as well as in all other oral hygiene cosmetic products, cf. Terms of Reference. In the teratogenicity study performed with rats, the NOAEL for maternal toxicity was 15 mg/kg/day, based on clinical signs of toxicity and decreased body weight gain; the NOAEL for developmental toxicity was 60 mg/kg/day (the highest dose level in the study). The teratogenicity study performed with rabbits was limitedly reported with only summarised tables available for the findings observed in the study and therefore, the study is considered inadequate for the safety assessment of cetylpyridinium chloride. Irritation / sensitisation Cetylpyridinium chloride at a conce","endpoint":"developmental toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg/day","noael_value":"15","page":50,"route":"oral","species":"rat","study_id":"sccs_o_171_noael_035"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	developmental toxicity	60	mg/kg/day	rat	oral	6-month	developmental toxicity	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=60; DOSE=Consequently, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used in the safety assessment for the MOS calculation for use of cetylpyridinium chloride as a preservative in mouthwashes cosmetic products, as well as in all other oral hygiene cosmetic products, cf.; EFFECT=studies reported in the EFSA opinion. Consequently, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used in the safety assessment for the MOS calculation for use of cetylpyridinium chloride as a preservative in mouthwashes cosmetic products, as well as in all other oral hygiene cosmetic products, cf. Terms of Reference. In the teratogenicity study performed with rats, the NOAEL for maternal toxicity was 15 mg/kg/day, based on clinical signs of toxicity and decreased body weight gain; the NOAEL for developmental toxicity was 60 mg/kg/day (the highest dose level in the study). The teratogenicity study performed with rabbits was limitedly reported with only summarised tables available for the findings observed in the study and therefore, the study is considered inadequate for the safety assessment of cetylpyridinium chloride. Irritation / sensitisation Cetylpyridinium chloride at a concentration of 65% had a moderate to severe irritant potential to the skin of the rabbit in a study performed according t; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"123-03-5","citation":"","dose":"Consequently, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used in the safety assessment for the MOS calculation for use of cetylpyridinium chloride as a preservative in mouthwashes cosmetic products, as well as in all other oral hygiene cosmetic products, cf.","duration":"6-month","effect":"studies reported in the EFSA opinion. Consequently, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used in the safety assessment for the MOS calculation for use of cetylpyridinium chloride as a preservative in mouthwashes cosmetic products, as well as in all other oral hygiene cosmetic products, cf. Terms of Reference. In the teratogenicity study performed with rats, the NOAEL for maternal toxicity was 15 mg/kg/day, based on clinical signs of toxicity and decreased body weight gain; the NOAEL for developmental toxicity was 60 mg/kg/day (the highest dose level in the study). The teratogenicity study performed with rabbits was limitedly reported with only summarised tables available for the findings observed in the study and therefore, the study is considered inadequate for the safety assessment of cetylpyridinium chloride. Irritation / sensitisation Cetylpyridinium chloride at a concentration of 65% had a moderate to severe irritant potential to the skin of the rabbit in a study performed according t","endpoint":"developmental toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg/day","noael_value":"60","page":50,"route":"oral","species":"rat","study_id":"sccs_o_171_noael_036"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	genotoxicity	5	mg/kg bw/day	-	oral	6-month	genotoxicity	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=5; DOSE=Consequently, the NOAEL of 18 mg/kg bw/day identified by the CEF Panel is used for the MOS calculation for use of cetylpyridinium chloride as a preservative in skin lotions and creams, as well as in anti-perspirant deodorants, cf.; EFFECT=avage studies submitted by the applicant. Consequently, the NOAEL of 18 mg/kg bw/day identified by the CEF Panel is used for the MOS calculation for use of cetylpyridinium chloride as a preservative in skin lotions and creams, as well as in anti-perspirant deodorants, cf. Terms of Reference. For oral application, the gavage studies submitted by the applicant are considered as more relevant for the safety assessment of cetylpyridinium chloride than the dietary studies reported in the EFSA Opinion. Consequently, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used in the safety assessment for the MOS calculation for use of cetylpyridinium chloride as a preservative in mouthwashes cosmetic products, as well as in all other oral hygiene cosmetic products, cf. Terms of Reference. 3.3.5.3. Chronic (> 12 months) toxicity No data have been submitted. 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: / Species/strain: S. typhimurium; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"123-03-5","citation":"","dose":"Consequently, the NOAEL of 18 mg/kg bw/day identified by the CEF Panel is used for the MOS calculation for use of cetylpyridinium chloride as a preservative in skin lotions and creams, as well as in anti-perspirant deodorants, cf.","duration":"6-month","effect":"avage studies submitted by the applicant. Consequently, the NOAEL of 18 mg/kg bw/day identified by the CEF Panel is used for the MOS calculation for use of cetylpyridinium chloride as a preservative in skin lotions and creams, as well as in anti-perspirant deodorants, cf. Terms of Reference. For oral application, the gavage studies submitted by the applicant are considered as more relevant for the safety assessment of cetylpyridinium chloride than the dietary studies reported in the EFSA Opinion. Consequently, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study is used in the safety assessment for the MOS calculation for use of cetylpyridinium chloride as a preservative in mouthwashes cosmetic products, as well as in all other oral hygiene cosmetic products, cf. Terms of Reference. 3.3.5.3. Chronic (> 12 months) toxicity No data have been submitted. 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: / Species/strain: S. typhimurium","endpoint":"genotoxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"5","page":32,"route":"oral","species":"","study_id":"sccs_o_171_noael_019"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	irritation	25	mg/kg bw/day	-	-	-	irritation	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=25; DOSE=g/kg bw/day and of 2/8 females at 50 mg/kg bw/day with concomitant necrosis/erosion in one female at each level.; EFFECT=g/kg bw/day and of 2/8 females at 50 mg/kg bw/day with concomitant necrosis/erosion in one female at each level. These histopathological changes were dose- related in incidence and severity, resulting in mortality for animals at 100 mg/kg bw/day and higher. Conclusion In conclusion, the target organ for CPC was the stomach and at dose levels from 50 mg/kg bw/day, it produced a localised toxic (i.e. irritant) action near or at the site of administration, specifically in the non-glandular region of the stomach. The NOAEL was considered to be 25 mg/kg bw/day in this study, based on histomorphological alterations in the non-glandular region of the stomach, i.e. forestomach. Ref.: 4 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report; no information was provided by the Sponsor of the study. The SCCS agrees on the NOAEL of 25 mg/kg bw/day for local effects in the forestomach probably due to the irritative properties of the test substance. The SCCS also considers 25 mg; CITATION=Ref.: 4 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report; CITATION_NUMBERS=[4,100]; REFERENCE=Ref.: 4 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report; DETAILS_JSON={"cas_number":"123-03-5","citation":"Ref.: 4 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report","dose":"g/kg bw/day and of 2/8 females at 50 mg/kg bw/day with concomitant necrosis/erosion in one female at each level.","duration":"","effect":"g/kg bw/day and of 2/8 females at 50 mg/kg bw/day with concomitant necrosis/erosion in one female at each level. These histopathological changes were dose- related in incidence and severity, resulting in mortality for animals at 100 mg/kg bw/day and higher. Conclusion In conclusion, the target organ for CPC was the stomach and at dose levels from 50 mg/kg bw/day, it produced a localised toxic (i.e. irritant) action near or at the site of administration, specifically in the non-glandular region of the stomach. The NOAEL was considered to be 25 mg/kg bw/day in this study, based on histomorphological alterations in the non-glandular region of the stomach, i.e. forestomach. Ref.: 4 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report; no information was provided by the Sponsor of the study. The SCCS agrees on the NOAEL of 25 mg/kg bw/day for local effects in the forestomach probably due to the irritative properties of the test substance. The SCCS also considers 25 mg","endpoint":"irritation","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"25","page":24,"route":"","species":"","study_id":"sccs_o_171_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	irritation	25	mg/kg bw/day	-	-	-	irritation	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=25; DOSE=The NOAEL was considered to be 25 mg/kg bw/day in this study, based on histomorphological alterations in the non-glandular region of the stomach, i.e. forestomach.; EFFECT=produced a localised toxic (i.e. irritant) action near or at the site of administration, specifically in the non-glandular region of the stomach. The NOAEL was considered to be 25 mg/kg bw/day in this study, based on histomorphological alterations in the non-glandular region of the stomach, i.e. forestomach. Ref.: 4 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report; no information was provided by the Sponsor of the study. The SCCS agrees on the NOAEL of 25 mg/kg bw/day for local effects in the forestomach probably due to the irritative properties of the test substance. The SCCS also considers 25 mg/kg bw/day as a NOAEL for systemic toxicity (decreased body weight gain) although it can be argued that the decreased body weight gain might be secondary to the local effects in the stomach.; CITATION=Ref.: 4 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report; CITATION_NUMBERS=[4,100]; REFERENCE=Ref.: 4 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report; DETAILS_JSON={"cas_number":"123-03-5","citation":"Ref.: 4 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report","dose":"The NOAEL was considered to be 25 mg/kg bw/day in this study, based on histomorphological alterations in the non-glandular region of the stomach, i.e. forestomach.","duration":"","effect":"produced a localised toxic (i.e. irritant) action near or at the site of administration, specifically in the non-glandular region of the stomach. The NOAEL was considered to be 25 mg/kg bw/day in this study, based on histomorphological alterations in the non-glandular region of the stomach, i.e. forestomach. Ref.: 4 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report; no information was provided by the Sponsor of the study. The SCCS agrees on the NOAEL of 25 mg/kg bw/day for local effects in the forestomach probably due to the irritative properties of the test substance. The SCCS also considers 25 mg/kg bw/day as a NOAEL for systemic toxicity (decreased body weight gain) although it can be argued that the decreased body weight gain might be secondary to the local effects in the stomach.","endpoint":"irritation","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"25","page":24,"route":"","species":"","study_id":"sccs_o_171_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	irritation	18	mg/kg bw/day	rat	oral	90-day	irritation	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=18; DOSE=SCCS/1548/15 Revision of the Opinion on Cetylpyridinium chloride (P97) ___________________________________________________________________________________________ 50 The CEF Panel identified a NOAEL of 18 mg/kg bw/day, based on increased relative caecum weights in male rats in one of the 90-day study; the CEF Panel considered the increase in cae...; EFFECT=SCCS/1548/15 Revision of the Opinion on Cetylpyridinium chloride (P97) ___________________________________________________________________________________________ 50 The CEF Panel identified a NOAEL of 18 mg/kg bw/day, based on increased relative caecum weights in male rats in one of the 90-day study; the CEF Panel considered the increase in caecum weight as relevant for risk characterisation. In these studies, decreased body weight gain was also reported for rats. No local effects (irritation) were observed in the gastrointestinal tract indicating that the irritative properties of cetylpyridinium chloride could be avoided by administration in the feed instead of an aqueous solution (by gavage in water). A NO; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"123-03-5","citation":"","dose":"SCCS/1548/15 Revision of the Opinion on Cetylpyridinium chloride (P97) ___________________________________________________________________________________________ 50 The CEF Panel identified a NOAEL of 18 mg/kg bw/day, based on increased relative caecum weights in male rats in one of the 90-day study; the CEF Panel considered the increase in cae...","duration":"90-day","effect":"SCCS/1548/15 Revision of the Opinion on Cetylpyridinium chloride (P97) ___________________________________________________________________________________________ 50 The CEF Panel identified a NOAEL of 18 mg/kg bw/day, based on increased relative caecum weights in male rats in one of the 90-day study; the CEF Panel considered the increase in caecum weight as relevant for risk characterisation. In these studies, decreased body weight gain was also reported for rats. No local effects (irritation) were observed in the gastrointestinal tract indicating that the irritative properties of cetylpyridinium chloride could be avoided by administration in the feed instead of an aqueous solution (by gavage in water). A NO","endpoint":"irritation","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"18","page":50,"route":"oral","species":"rat","study_id":"sccs_o_171_noael_031"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	5	mg/kg bw/day	rat	oral	subchronic	repeated dose toxicity	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=5; DOSE=ion The NOAEL for systemic toxicity was considered to be 15 mg/kg bw/day in this study, based on decreased glucose levels in 40 and 75 mg/kg/d animals of both sexes.; EFFECT=ion The NOAEL for systemic toxicity was considered to be 15 mg/kg bw/day in this study, based on decreased glucose levels in 40 and 75 mg/kg/d animals of both sexes. The NOAEL for local effects was 5 mg/kg bw/day in this study, based on acanthosis of the non-glandular region of the stomach, i.e. forestomach. Ref.: 6 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report; no information was provided by the Sponsor of the study. The SCCS agrees on the NOAEL of 5 mg/kg bw/day for local effects in the stomach probably due to the irritative properties of the test substance. The SCCS also considers 5 mg/kg bw/day as a NOAEL for systemic toxicity (decreased body weight gain in females, 86% of control) although it can be argued that the decreased body weight gain might be secondary to the local effects in the stomach. Overall SCCS comment to the submitted subchronic toxicity studies An oral 26-week study in rats is included in Submission II and in the Company Submission; CITATION=Ref.: 6 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report; CITATION_NUMBERS=[6,100]; REFERENCE=Ref.: 6 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report; DETAILS_JSON={"cas_number":"123-03-5","citation":"Ref.: 6 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report","dose":"ion The NOAEL for systemic toxicity was considered to be 15 mg/kg bw/day in this study, based on decreased glucose levels in 40 and 75 mg/kg/d animals of both sexes.","duration":"subchronic","effect":"ion The NOAEL for systemic toxicity was considered to be 15 mg/kg bw/day in this study, based on decreased glucose levels in 40 and 75 mg/kg/d animals of both sexes. The NOAEL for local effects was 5 mg/kg bw/day in this study, based on acanthosis of the non-glandular region of the stomach, i.e. forestomach. Ref.: 6 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report; no information was provided by the Sponsor of the study. The SCCS agrees on the NOAEL of 5 mg/kg bw/day for local effects in the stomach probably due to the irritative properties of the test substance. The SCCS also considers 5 mg/kg bw/day as a NOAEL for systemic toxicity (decreased body weight gain in females, 86% of control) although it can be argued that the decreased body weight gain might be secondary to the local effects in the stomach. Overall SCCS comment to the submitted subchronic toxicity studies An oral 26-week study in rats is included in Submission II and in the Company Submission","endpoint":"repeated dose toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"5","page":30,"route":"oral","species":"rat","study_id":"sccs_o_171_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	5	mg/kg bw/day	rat	oral	subchronic	repeated dose toxicity	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=5; DOSE=The NOAEL for local effects was 5 mg/kg bw/day in this study, based on acanthosis of the non-glandular region of the stomach, i.e. forestomach.; EFFECT=The NOAEL for local effects was 5 mg/kg bw/day in this study, based on acanthosis of the non-glandular region of the stomach, i.e. forestomach. Ref.: 6 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report; no information was provided by the Sponsor of the study. The SCCS agrees on the NOAEL of 5 mg/kg bw/day for local effects in the stomach probably due to the irritative properties of the test substance. The SCCS also considers 5 mg/kg bw/day as a NOAEL for systemic toxicity (decreased body weight gain in females, 86% of control) although it can be argued that the decreased body weight gain might be secondary to the local effects in the stomach. Overall SCCS comment to the submitted subchronic toxicity studies An oral 26-week study in rats is included in Submission II and in the Company Submission and described above. The SCCS notes that this study was also included in Submission I. The SCCP concluded that the quality of the dossier was such that an adequate as; CITATION=Ref.: 6 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report; CITATION_NUMBERS=[6,100]; REFERENCE=Ref.: 6 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report; DETAILS_JSON={"cas_number":"123-03-5","citation":"Ref.: 6 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report","dose":"The NOAEL for local effects was 5 mg/kg bw/day in this study, based on acanthosis of the non-glandular region of the stomach, i.e. forestomach.","duration":"subchronic","effect":"The NOAEL for local effects was 5 mg/kg bw/day in this study, based on acanthosis of the non-glandular region of the stomach, i.e. forestomach. Ref.: 6 SCCS comment The SCCS notes that the purity of the test material was assumed to be 100% according to the study report; no information was provided by the Sponsor of the study. The SCCS agrees on the NOAEL of 5 mg/kg bw/day for local effects in the stomach probably due to the irritative properties of the test substance. The SCCS also considers 5 mg/kg bw/day as a NOAEL for systemic toxicity (decreased body weight gain in females, 86% of control) although it can be argued that the decreased body weight gain might be secondary to the local effects in the stomach. Overall SCCS comment to the submitted subchronic toxicity studies An oral 26-week study in rats is included in Submission II and in the Company Submission and described above. The SCCS notes that this study was also included in Submission I. The SCCP concluded that the quality of the dossier was such that an adequate as","endpoint":"repeated dose toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"5","page":30,"route":"oral","species":"rat","study_id":"sccs_o_171_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	18	mg/kg bw/day	rat	oral	90-day	repeated dose toxicity	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=18; DOSE=s of CPC and increases in relative caecum weight (statistically signifant at 15 mg/kg bw/day and above in females and at 40 mg/kg bw/day and above in males).; EFFECT=s of CPC and increases in relative caecum weight (statistically signifant at 15 mg/kg bw/day and above in females and at 40 mg/kg bw/day and above in males). Gross and microscopic examination of liver, kidneys, lung, spleen, caecum and testis from any of the administered groups were reported to show no appreciable differences compared to controls. It was noted that, as the concentration of CPC increased, the total number of microorganisms in the caecal contents decreased in both sexes. The CEF Panel identified a NOAEL of 18 mg/kg bw/day, based on increased relative caecum weights in male rats in the 90-day study. The CEF Panel considered the increase in caecum weight as relevant for risk characterisation of Cecure® as an increase in relative caecum weight has been consistently positively correlated with increased dietary levels of CPC in sub-chronic rat studies. Furthermore, in one of these studies it was noted that as the concentration of CPC increased, the total number of microorganisms in the caecal contents decreased in bot; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"123-03-5","citation":"","dose":"s of CPC and increases in relative caecum weight (statistically signifant at 15 mg/kg bw/day and above in females and at 40 mg/kg bw/day and above in males).","duration":"90-day","effect":"s of CPC and increases in relative caecum weight (statistically signifant at 15 mg/kg bw/day and above in females and at 40 mg/kg bw/day and above in males). Gross and microscopic examination of liver, kidneys, lung, spleen, caecum and testis from any of the administered groups were reported to show no appreciable differences compared to controls. It was noted that, as the concentration of CPC increased, the total number of microorganisms in the caecal contents decreased in both sexes. The CEF Panel identified a NOAEL of 18 mg/kg bw/day, based on increased relative caecum weights in male rats in the 90-day study. The CEF Panel considered the increase in caecum weight as relevant for risk characterisation of Cecure® as an increase in relative caecum weight has been consistently positively correlated with increased dietary levels of CPC in sub-chronic rat studies. Furthermore, in one of these studies it was noted that as the concentration of CPC increased, the total number of microorganisms in the caecal contents decreased in bot","endpoint":"repeated dose toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"18","page":31,"route":"oral","species":"rat","study_id":"sccs_o_171_noael_013"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	5	mg/kg bw/day	rat	oral	6-month	repeated dose toxicity	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=5; DOSE=Overall SCCS conclusion on repeated dose toxicity Based on the submitted 6-month repeated dose toxicity study in rats described above, a NOAEL for local effects of 5 mg/kg bw/day is considered.; EFFECT=SCCS-rejected applicant NOAEL: croorganisms in the caecal contents decreased in both sexes. An increase in caecum weight in animals has also been associated elsewhere with modification on the composition of the intestinal microbiota and therefore the CEF Panel considered that the possibility of a potential similar effect of CPC occurring in the gastrointestinal microflora of humans should not be disregarded. Overall SCCS conclusion on repeated dose toxicity Based on the submitted 6-month repeated dose toxicity study in rats described above, a NOAEL for local effects of 5 mg/kg bw/day is considered. The local effects observed in the stomach of rats are probably due to the irritative properties of cetylpyridinium chloride and related to the administration of the test material as aqueous solution (by gavage in water). The SCCS also considers 5 mg/kg bw/day as a NOAEL for systemic toxicity (decreased body weight gain in females, 86% of control) although it can be argued that the decreased body weight gain might be secondary to the local effects in the stomach. H; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"123-03-5","citation":"","dose":"Overall SCCS conclusion on repeated dose toxicity Based on the submitted 6-month repeated dose toxicity study in rats described above, a NOAEL for local effects of 5 mg/kg bw/day is considered.","duration":"6-month","effect":"SCCS-rejected applicant NOAEL: croorganisms in the caecal contents decreased in both sexes. An increase in caecum weight in animals has also been associated elsewhere with modification on the composition of the intestinal microbiota and therefore the CEF Panel considered that the possibility of a potential similar effect of CPC occurring in the gastrointestinal microflora of humans should not be disregarded. Overall SCCS conclusion on repeated dose toxicity Based on the submitted 6-month repeated dose toxicity study in rats described above, a NOAEL for local effects of 5 mg/kg bw/day is considered. The local effects observed in the stomach of rats are probably due to the irritative properties of cetylpyridinium chloride and related to the administration of the test material as aqueous solution (by gavage in water). The SCCS also considers 5 mg/kg bw/day as a NOAEL for systemic toxicity (decreased body weight gain in females, 86% of control) although it can be argued that the decreased body weight gain might be secondary to the local effects in the stomach. H","endpoint":"repeated dose toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"5","page":31,"route":"oral","species":"rat","study_id":"sccs_o_171_noael_014"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	5	mg/kg bw/day	rat	oral	6-month	repeated dose toxicity	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=5; DOSE=Overall SCCS conclusion on repeated dose toxicity Based on the submitted 6-month repeated dose toxicity study in rats described above, a NOAEL for local effects of 5 mg/kg bw/day is considered.; EFFECT=SCCS-rejected applicant NOAEL: intestinal microflora of humans should not be disregarded. Overall SCCS conclusion on repeated dose toxicity Based on the submitted 6-month repeated dose toxicity study in rats described above, a NOAEL for local effects of 5 mg/kg bw/day is considered. The local effects observed in the stomach of rats are probably due to the irritative properties of cetylpyridinium chloride and related to the administration of the test material as aqueous solution (by gavage in water). The SCCS also considers 5 mg/kg bw/day as a NOAEL for systemic toxicity (decreased body weight gain in females, 86% of control) although it can be argued that the decreased body weight gain might be secondary to the local effects in the stomach. However, in the dietary studies reported in the EFSA Opinion, decreased body weight gain was also reported for rats. No local effects (irritation) were observed in the gastrointestinal tract indicating that the irritative properties of cetylpyridinium chloride could be avoided by; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"123-03-5","citation":"","dose":"Overall SCCS conclusion on repeated dose toxicity Based on the submitted 6-month repeated dose toxicity study in rats described above, a NOAEL for local effects of 5 mg/kg bw/day is considered.","duration":"6-month","effect":"SCCS-rejected applicant NOAEL: intestinal microflora of humans should not be disregarded. Overall SCCS conclusion on repeated dose toxicity Based on the submitted 6-month repeated dose toxicity study in rats described above, a NOAEL for local effects of 5 mg/kg bw/day is considered. The local effects observed in the stomach of rats are probably due to the irritative properties of cetylpyridinium chloride and related to the administration of the test material as aqueous solution (by gavage in water). The SCCS also considers 5 mg/kg bw/day as a NOAEL for systemic toxicity (decreased body weight gain in females, 86% of control) although it can be argued that the decreased body weight gain might be secondary to the local effects in the stomach. However, in the dietary studies reported in the EFSA Opinion, decreased body weight gain was also reported for rats. No local effects (irritation) were observed in the gastrointestinal tract indicating that the irritative properties of cetylpyridinium chloride could be avoided by","endpoint":"repeated dose toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"5","page":31,"route":"oral","species":"rat","study_id":"sccs_o_171_noael_015"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	25	mg/kg bw/day	rat	oral	sub-acute	repeated dose toxicity	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=25; DOSE=A NOAEL for decreased body weight gain of 25 mg/kg bw/day can be considered based on the sub-acute studies and of around 40 mg/kg bw/day based on the 90-day studies.; EFFECT=SCCS/1548/15 Revision of the Opinion on Cetylpyridinium chloride (P97) ___________________________________________________________________________________________ 32 administration in the feed instead of an aqueous solution (by gavage in water). A NOAEL for decreased body weight gain of 25 mg/kg bw/day can be considered based on the sub-acute studies and of around 40 mg/kg bw/day based on the 90-day studies. From the 90-day studies, the CEF Panel identified a NOAEL of 18 mg/kg bw/day, based on increased relative caecum weights in male rats in one of the 90-day study. The CEF Panel considered the increase in caecum weight as relevant for risk characterisation. The SCCS agrees with the evaluation of the EFSA CEF Panel. For dermal application, the dietary studies re; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"123-03-5","citation":"","dose":"A NOAEL for decreased body weight gain of 25 mg/kg bw/day can be considered based on the sub-acute studies and of around 40 mg/kg bw/day based on the 90-day studies.","duration":"sub-acute","effect":"SCCS/1548/15 Revision of the Opinion on Cetylpyridinium chloride (P97) ___________________________________________________________________________________________ 32 administration in the feed instead of an aqueous solution (by gavage in water). A NOAEL for decreased body weight gain of 25 mg/kg bw/day can be considered based on the sub-acute studies and of around 40 mg/kg bw/day based on the 90-day studies. From the 90-day studies, the CEF Panel identified a NOAEL of 18 mg/kg bw/day, based on increased relative caecum weights in male rats in one of the 90-day study. The CEF Panel considered the increase in caecum weight as relevant for risk characterisation. The SCCS agrees with the evaluation of the EFSA CEF Panel. For dermal application, the dietary studies re","endpoint":"repeated dose toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"25","page":32,"route":"oral","species":"rat","study_id":"sccs_o_171_noael_016"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	18	mg/kg bw/day	rat	oral	sub-acute	repeated dose toxicity	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=18; DOSE=A NOAEL for decreased body weight gain of 25 mg/kg bw/day can be considered based on the sub-acute studies and of around 40 mg/kg bw/day based on the 90-day studies.; EFFECT=SCCS/1548/15 Revision of the Opinion on Cetylpyridinium chloride (P97) ___________________________________________________________________________________________ 32 administration in the feed instead of an aqueous solution (by gavage in water). A NOAEL for decreased body weight gain of 25 mg/kg bw/day can be considered based on the sub-acute studies and of around 40 mg/kg bw/day based on the 90-day studies. From the 90-day studies, the CEF Panel identified a NOAEL of 18 mg/kg bw/day, based on increased relative caecum weights in male rats in one of the 90-day study. The CEF Panel considered the increase in caecum weight as relevant for risk characterisation. The SCCS agrees with the evaluation of the EFSA CEF Panel. For dermal application, the dietary studies reported in the EFSA opinion are considered as more relevant for the safety assessment of cetylpyridinium chloride than the gavage studies submitted by the applicant. Consequently, the NOAEL of 18 mg/kg bw/day identifi; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"123-03-5","citation":"","dose":"A NOAEL for decreased body weight gain of 25 mg/kg bw/day can be considered based on the sub-acute studies and of around 40 mg/kg bw/day based on the 90-day studies.","duration":"sub-acute","effect":"SCCS/1548/15 Revision of the Opinion on Cetylpyridinium chloride (P97) ___________________________________________________________________________________________ 32 administration in the feed instead of an aqueous solution (by gavage in water). A NOAEL for decreased body weight gain of 25 mg/kg bw/day can be considered based on the sub-acute studies and of around 40 mg/kg bw/day based on the 90-day studies. From the 90-day studies, the CEF Panel identified a NOAEL of 18 mg/kg bw/day, based on increased relative caecum weights in male rats in one of the 90-day study. The CEF Panel considered the increase in caecum weight as relevant for risk characterisation. The SCCS agrees with the evaluation of the EFSA CEF Panel. For dermal application, the dietary studies reported in the EFSA opinion are considered as more relevant for the safety assessment of cetylpyridinium chloride than the gavage studies submitted by the applicant. Consequently, the NOAEL of 18 mg/kg bw/day identifi","endpoint":"repeated dose toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"18","page":32,"route":"oral","species":"rat","study_id":"sccs_o_171_noael_017"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	25	mg/kg bw/day	rat	oral	90-day	repeated dose toxicity	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=25; DOSE=EL of 18 mg/kg bw/day, based on increased relative caecum weights in male rats in one of the 90-day study; the CEF Panel considered the increase in caecum weight as relevant for risk characterisation.; EFFECT=EL of 18 mg/kg bw/day, based on increased relative caecum weights in male rats in one of the 90-day study; the CEF Panel considered the increase in caecum weight as relevant for risk characterisation. In these studies, decreased body weight gain was also reported for rats. No local effects (irritation) were observed in the gastrointestinal tract indicating that the irritative properties of cetylpyridinium chloride could be avoided by administration in the feed instead of an aqueous solution (by gavage in water). A NOAEL for decreased body weight gain of 25 mg/kg bw/day can be considered based on the sub-acute studies and of around 40 mg/kg bw/day based on the 90-day studies. For dermal application, the dietary studies reported in the EFSA opinion are considered as more relevant for the safety assessment of cetylpyridinium chloride than the gavage studies submitted by the applicant. Consequently, the NOAEL of 18 mg/kg bw/day identified by the CEF Panel is used for the MOS calculation for use of cetylpyridinium chloride as a prese; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"123-03-5","citation":"","dose":"EL of 18 mg/kg bw/day, based on increased relative caecum weights in male rats in one of the 90-day study; the CEF Panel considered the increase in caecum weight as relevant for risk characterisation.","duration":"90-day","effect":"EL of 18 mg/kg bw/day, based on increased relative caecum weights in male rats in one of the 90-day study; the CEF Panel considered the increase in caecum weight as relevant for risk characterisation. In these studies, decreased body weight gain was also reported for rats. No local effects (irritation) were observed in the gastrointestinal tract indicating that the irritative properties of cetylpyridinium chloride could be avoided by administration in the feed instead of an aqueous solution (by gavage in water). A NOAEL for decreased body weight gain of 25 mg/kg bw/day can be considered based on the sub-acute studies and of around 40 mg/kg bw/day based on the 90-day studies. For dermal application, the dietary studies reported in the EFSA opinion are considered as more relevant for the safety assessment of cetylpyridinium chloride than the gavage studies submitted by the applicant. Consequently, the NOAEL of 18 mg/kg bw/day identified by the CEF Panel is used for the MOS calculation for use of cetylpyridinium chloride as a prese","endpoint":"repeated dose toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"25","page":50,"route":"oral","species":"rat","study_id":"sccs_o_171_noael_032"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	18	mg/kg bw/day	-	oral	sub-acute	repeated dose toxicity	SOURCE_SUBDIR=sccs_o_171; REPORT_TITLE=OPINION ON; OPINION_NUMBER=SCCS/1548/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=18; DOSE=A NOAEL for decreased body weight gain of 25 mg/kg bw/day can be considered based on the sub-acute studies and of around 40 mg/kg bw/day based on the 90-day studies.; EFFECT=etylpyridinium chloride could be avoided by administration in the feed instead of an aqueous solution (by gavage in water). A NOAEL for decreased body weight gain of 25 mg/kg bw/day can be considered based on the sub-acute studies and of around 40 mg/kg bw/day based on the 90-day studies. For dermal application, the dietary studies reported in the EFSA opinion are considered as more relevant for the safety assessment of cetylpyridinium chloride than the gavage studies submitted by the applicant. Consequently, the NOAEL of 18 mg/kg bw/day identified by the CEF Panel is used for the MOS calculation for use of cetylpyridinium chloride as a preservative in skin lotions and creams, as well as in anti-perspirant deodorants, cf. Terms of Reference. For oral application, the gavage studies submitted by the applicant are considered as more relevant for the safety assessment of cetylpyridinium chloride than the dietary studies reported in the EFSA opinion. Consequently, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"123-03-5","citation":"","dose":"A NOAEL for decreased body weight gain of 25 mg/kg bw/day can be considered based on the sub-acute studies and of around 40 mg/kg bw/day based on the 90-day studies.","duration":"sub-acute","effect":"etylpyridinium chloride could be avoided by administration in the feed instead of an aqueous solution (by gavage in water). A NOAEL for decreased body weight gain of 25 mg/kg bw/day can be considered based on the sub-acute studies and of around 40 mg/kg bw/day based on the 90-day studies. For dermal application, the dietary studies reported in the EFSA opinion are considered as more relevant for the safety assessment of cetylpyridinium chloride than the gavage studies submitted by the applicant. Consequently, the NOAEL of 18 mg/kg bw/day identified by the CEF Panel is used for the MOS calculation for use of cetylpyridinium chloride as a preservative in skin lotions and creams, as well as in anti-perspirant deodorants, cf. Terms of Reference. For oral application, the gavage studies submitted by the applicant are considered as more relevant for the safety assessment of cetylpyridinium chloride than the dietary studies reported in the EFSA opinion. Consequently, the NOAEL of 5 mg/kg bw/day identified in the submitted 6-month study","endpoint":"repeated dose toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"18","page":50,"route":"oral","species":"","study_id":"sccs_o_171_noael_033"}

openFDA substances 4 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
openFDA substances	FDA UNII substance identifier	6BR7T22E2S	UNII	-	-	-	chemical	{"approval_status":null,"molecular_formula":"C21H38N.Cl","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"6BR7T22E2S"}
openFDA substances	FDA UNII substance identifier	6BR7T22E2S	UNII	-	-	-	chemical	{"approval_status":null,"molecular_formula":"C21H38N.Cl","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"6BR7T22E2S"}
openFDA substances	FDA UNII substance identifier	6BR7T22E2S	UNII	-	-	-	chemical	{"approval_status":null,"molecular_formula":"C21H38N.Cl","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"6BR7T22E2S"}
openFDA substances	FDA UNII substance identifier	6BR7T22E2S	UNII	-	-	-	chemical	{"approval_status":null,"molecular_formula":"C21H38N.Cl","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"6BR7T22E2S"}