NOAEL Studies
Cosmetic Ingredient
Dimethyl Phthalate NOAEL Studies
INCI: DIMETHYL PHTHALATE
CAS: 131-11-3
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
NTP_ICE_acute_oral 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_acute_oral | LD50 | =2860 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | NLM Hazardous Substances Data Bank (undated); record_id=acute_oral_2167; row=5598; data_type=In Vivo; mixture=Chemical; chemical_name=Dimethyl phthalate; preferred_name=Dimethyl phthalate; dtxsid=DTXSID3022455; url=https://pubchem.ncbi.nlm.nih.gov/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID3022455; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID3022455; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | =6800 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | NLM Hazardous Substances Data Bank (undated); record_id=acute_oral_2168; row=5599; data_type=In Vivo; mixture=Chemical; chemical_name=Dimethyl phthalate; preferred_name=Dimethyl phthalate; dtxsid=DTXSID3022455; url=https://pubchem.ncbi.nlm.nih.gov/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID3022455; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID3022455; source_file=acute_oral.xlsx |
NTP_ICE_adme_parameters 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_adme_parameters | Clint | 22.26 | uL/min/10^6 cells | Human | - | - | Measured; httk, Human Hepatic Intrinsic Clearance | sheet=Data; excel_row=1213; Record_ID=adme_parameters_107; Data_Type=Measured; DTXSID=DTXSID3022455; Assay=httk, Human Hepatic Intrinsic Clearance; Endpoint=Clint; Response=22.26; Response_Unit=ul/min/10^6 cells; Species=Human; Reference=httk2.3.1, Wetmore 2012; URL=https://cran.r-project.org/web/packages/httk/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID3022455; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID3022455 |
| NTP_ICE_adme_parameters | Fu | 0.656 | fraction | Human | - | - | Measured; httk, Human Plasma Fraction Unbound | sheet=Data; excel_row=1212; Record_ID=adme_parameters_107; Data_Type=Measured; DTXSID=DTXSID3022455; Assay=httk, Human Plasma Fraction Unbound; Endpoint=Fu; Response=0.656; Response_Unit=Unitless Fraction; Species=Human; Reference=httk2.3.1, Wetmore 2012; URL=https://cran.r-project.org/web/packages/httk/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID3022455; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID3022455 |
NTP_ICE_endocrine 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_endocrine | Model Score | 0 | unitless | - | - | - | ARPathway2016; AR Pathway Model, Agonist | sheet=Integrated_approaches; excel_row=8272; RecordID=ARPathway2016_774; DatasetName=ARPathway2016; DTXSID=DTXSID3022455; Assay=AR Pathway Model, Agonist; Endpoint=Model Score; Response=0; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID3022455; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID3022455 |
SCCS_vision_codex 128 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =2982 | mg/kg | - | - | - | NOAEL study | {"dose":"SCCP/1016/06 Opinion on phthalates in cosmetic products 9 Name EINECS / CAS Maximum perfume concentration (mg/kg) NOAEL mg/kg/day Critical effect Di-methyl phthalate (DMP) 205-011-6 / 131-11-3 2982 600 Maternal toxicity Di-isobutyl phthalate (DIBP) 201-553-2 / 84-69-5 38 50 effects on liver Di-cyclohexyl phthalate (DCHP) 201-545-9 / 84-61-7 3 -...","effect":"SCCP/1016/06 Opinion on phthalates in cosmetic products 9 Name EINECS / CAS Maximum perfume concentration (mg/kg) NOAEL mg/kg/day Critical effect Di-methyl phthalate (DMP) 205-011-6 / 131-11-3 2982 600 Maternal toxicity Di-isobutyl phthalate (DIBP) 201-553-2 / 84-69-5 38 50 effects on liver Di-cyclohexyl phthalate (DCHP) 201-545-9 / 84-61-7 3 - DMP was found at a concentration as high as 2982 mg/kg or 0.3% in one perfume, in the other 15 perfumes the concentration was between 0.1 and 1.9 mg/kg. COLIPA has stated (letter of 29 November 2002) that “there is no intentional use of DMP…as a cosmetic ingredient’. Consequently, the pres","page":9,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_001"} |
| SCCS_vision_codex | NOAEL | =600 | mg/kg bw/day | rat | dermal | - | dermal absorption | {"dose":"toxicity Di-isobutyl phthalate (DIBP) 201-553-2 / 84-69-5 38 50 effects on liver Di-cyclohexyl phthalate (DCHP) 201-545-9 / 84-61-7 3 - DMP was found at a concentration as high as 2982 mg/kg or 0.3% in one perfume, in the other 15 perfumes the concentration was between 0.1 and 1.9 mg/kg.","effect":"toxicity Di-isobutyl phthalate (DIBP) 201-553-2 / 84-69-5 38 50 effects on liver Di-cyclohexyl phthalate (DCHP) 201-545-9 / 84-61-7 3 - DMP was found at a concentration as high as 2982 mg/kg or 0.3% in one perfume, in the other 15 perfumes the concentration was between 0.1 and 1.9 mg/kg. COLIPA has stated (letter of 29 November 2002) that “there is no intentional use of DMP…as a cosmetic ingredient’. Consequently, the presence and purpose of dimethyl phthalate at the maximum concentration found is unclear. The NOAEL for maternal toxicity was 600 mg/kg bw/day DMP. In contrast to the observed maternal toxicity, there was no effect of DMP treatment on any parameter of embryo/foetal development (IUCLID, 2000). Dermal absorption of DMP was not reported but described as less than that of DEP (5%). (Elsisi et al, 1989) DMP and its metabolite monomethyl phthalate (MMP) have been investigated in several studies. In rats, exposure to DMP did not alter sexual differentiation of the male rat. Initially it seemed that in man, there was","page":9,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_002"} |
| SCCS_vision_codex | NOAEL | =5 | % | rat | dermal | - | dermal absorption | {"dose":"Interestingly, Hauser et al (2006) found no dose response link with sperm concentration, motility or morphology due to MMP, monoethyl phthalate and the DEHP metabolites.","effect":"tially it seemed that in man, there was a possible association of abnormal sperm morphology in the presence of MMP. Interestingly, Hauser et al (2006) found no dose response link with sperm concentration, motility or morphology due to MMP, monoethyl phthalate and the DEHP metabolites. (Duty et al, 2003; Gray et al, 2000; Hauser et al, 2006) Margin of Safety (MoS) Calculation for Traces of DMP in cosmetics A Margin of Safety, using the highest concentration (2982 mg/kg or 0.3%) found, can be calculated, based on NOAEL and dermal absorption less than 5% reported as a percentage in the literature (Elsisi et al, 1989). Only dermal exposure will be considered in the safety calculation. Maximum dermal absorption: < 5% Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Systemic Exposure Dose (SED) 17.79 x 1000 x 0.3% x 5% / 60 = 0.0445 mg/kg No observed adverse effect level (NOAEL) = 600 mg/kg bw/day (maternal toxicity in rats) DMP Margin of Safety NOAEL / SED = 13500 Conclusion DMP was found at conce","page":9,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_003"} |
| SCCS_vision_codex | NOAEL | =0.0445 | mg/kg | rat | dermal | - | dermal absorption | {"dose":"y (MoS) Calculation for Traces of DMP in cosmetics A Margin of Safety, using the highest concentration (2982 mg/kg or 0.3%) found, can be calculated, based on NOAEL and dermal absorption less than 5% reported as a percentage in the literature (Elsisi et al, 1989).","effect":"y (MoS) Calculation for Traces of DMP in cosmetics A Margin of Safety, using the highest concentration (2982 mg/kg or 0.3%) found, can be calculated, based on NOAEL and dermal absorption less than 5% reported as a percentage in the literature (Elsisi et al, 1989). Only dermal exposure will be considered in the safety calculation. Maximum dermal absorption: < 5% Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Systemic Exposure Dose (SED) 17.79 x 1000 x 0.3% x 5% / 60 = 0.0445 mg/kg No observed adverse effect level (NOAEL) = 600 mg/kg bw/day (maternal toxicity in rats) DMP Margin of Safety NOAEL / SED = 13500 Conclusion DMP was found at concentration of 2982 mg/kg or 0.3% in one perfume, in the other 15 perfumes the concentration was between 0.1 and 1.9 mg/kg. Using a worst case scenario, the Margin of Safety was found to be high. This suggests that unintentional exposure from perfume and other cosmetics at the levels found in this study would have no measurable risk for the consumer.","page":9,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_004"} |
| SCCS_vision_codex | NOAEL | =3 | mg/kg | - | - | 90-day | NOAEL study | {"dose":"SCCP/1016/06 Opinion on phthalates in cosmetic products 10 DCHP was found in only 1/36 perfume samples at a concentration of 3 mg/kg.","effect":"SCCP/1016/06 Opinion on phthalates in cosmetic products 10 DCHP was found in only 1/36 perfume samples at a concentration of 3 mg/kg. There appears to be no recent work on DCHP. The 90-day studies reported in the IUCLID data sheet (IUCLID, 2000) do not seem to be according to modern standards. No NOAEL was derived from these studies. EFSA (2004) requested additional data: reproduction and teratogenicity studies, test for gene mutation and in vitro mammalian cell chromosome aberration tests. Conclusion Despite the lack of adequate toxicological data, the low concentration (3 mg/kg) of DCHP found in only one sample of perfume, suggest unintentional exposure from perfume and other cosmetics would have no measurable risk for the consumer. DIBP was found in 20/36 perfumes with concentrations ranging from 0.2 - 38","page":10,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_007"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg | rat | oral | developmental | reproductive toxicity | {"dose":"Conclusion Despite the lack of adequate toxicological data, the low concentration (3 mg/kg) of DCHP found in only one sample of perfume, suggest unintentional exposure from perfume and other cosmetics would have no measurable risk for the consumer.","effect":"tional data: reproduction and teratogenicity studies, test for gene mutation and in vitro mammalian cell chromosome aberration tests. Conclusion Despite the lack of adequate toxicological data, the low concentration (3 mg/kg) of DCHP found in only one sample of perfume, suggest unintentional exposure from perfume and other cosmetics would have no measurable risk for the consumer. DIBP was found in 20/36 perfumes with concentrations ranging from 0.2 - 38 mg/kg. It is considered a possible substitute for DBP. The NOAEL for oral toxicity was 50 mg/kg DIBP, based on liver effects. There was no data on skin absorption. (IUCLID, 2000) If dosed at 600 mg/kg bw/day to pregnant rats on gestation days 7 –21, male offspring showed similar testicular and developmental effects as found with DBP and DEHP. Further developmental and postnatal studies are needed to identify the reproductive effects of DIBP. (Borch, 2006) DIBP is classified by ECB as toxic to reproduction category 2, R61 (may cause harm to the unborn child) and category 3, R6","page":10,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_008"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw/day | rat | - | chronic | carcinogenicity | {"dose":"s beyond those which are being applied already Conclusion (iii) There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account DINP DINP was found in only 1/36 perfume samples at a concentration of 26 mg/kg.","effect":"s beyond those which are being applied already Conclusion (iii) There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account DINP DINP was found in only 1/36 perfume samples at a concentration of 26 mg/kg. The toxicological effects for DINP were an increased incidence of spongiosis hepatis, accompanied by increased serum levels of liver enzymes in males and increases in absolute and relative liver and kidney weights in both sexes. EFSA (2005a) used a NOAEL of 15 mg/kg bw/day for non-peroxisomal proliferation-related chronic hepatic and renal effects derived from a combined chronic/carcinogenicity study in rats. From the same data, CSTEE (2001) calculated a 5% response benchmark dose of 12 mg/kg/d using spongiosis hepatis as the critical endpoint of the risk characterization. This will not alter the Margin of Safety from perfume use. EFSA derived a TDI for DINP of 0.15 mg/kg bw, using the NOAEL of 15 mg/kg bw/day and an uncertainty factor of 100. Margin of Safety (","page":11,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_010"} |
| SCCS_vision_codex | NOAEL | =0.00036 | mg/kg/d | rat | oral | - | dermal absorption | {"dose":"4 % Systemic Exposure Dose (SED) 17.79 x 1000 x 0.003% x 4% / 60 = 0.00036 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in rats) DINP Margin of Safety NOAEL / SED = 41666 Systemic exposure of DINP from cosmetics is 0.24% of the TDI for DINP of 0.15 mg/kg/d derived by EFSA, (2005a) Exposure to DINP from...","effect":"Safety (MoS) Calculation for Traces of DINP in cosmetics A Margin of Safety can be calculated, using the highest concentration (0.003%) found, based on NOAELs and dermal absorption of 4 % for DINP reported as a percentage in the literature (Elsisi et al, 1989). Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Maximum dermal absorption: 4 % Systemic Exposure Dose (SED) 17.79 x 1000 x 0.003% x 4% / 60 = 0.00036 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in rats) DINP Margin of Safety NOAEL / SED = 41666 Systemic exposure of DINP from cosmetics is 0.24% of the TDI for DINP of 0.15 mg/kg/d derived by EFSA, (2005a) Exposure to DINP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA, 2005a; CSTEE, 2004, RAR, 2003). Thus the inadvertent occurrence of DINP in cosmetics does not seem to be a concern for consumer health. DIDP DIDP was found in 5/36 perfume","page":11,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_012"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw/d | rat | oral | - | dermal absorption | {"dose":"4 % Systemic Exposure Dose (SED) 17.79 x 1000 x 0.003% x 4% / 60 = 0.00036 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in rats) DINP Margin of Safety NOAEL / SED = 41666 Systemic exposure of DINP from cosmetics is 0.24% of the TDI for DINP of 0.15 mg/kg/d derived by EFSA, (2005a) Exposure to DINP from...","effect":"s of DINP in cosmetics A Margin of Safety can be calculated, using the highest concentration (0.003%) found, based on NOAELs and dermal absorption of 4 % for DINP reported as a percentage in the literature (Elsisi et al, 1989). Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Maximum dermal absorption: 4 % Systemic Exposure Dose (SED) 17.79 x 1000 x 0.003% x 4% / 60 = 0.00036 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in rats) DINP Margin of Safety NOAEL / SED = 41666 Systemic exposure of DINP from cosmetics is 0.24% of the TDI for DINP of 0.15 mg/kg/d derived by EFSA, (2005a) Exposure to DINP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA, 2005a; CSTEE, 2004, RAR, 2003). Thus the inadvertent occurrence of DINP in cosmetics does not seem to be a concern for consumer health. DIDP DIDP was found in 5/36 perfume sample","page":11,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_013"} |
| SCCS_vision_codex | NOAEL | =0.24 | % | rat | oral | - | dermal absorption | {"dose":"4 % Systemic Exposure Dose (SED) 17.79 x 1000 x 0.003% x 4% / 60 = 0.00036 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in rats) DINP Margin of Safety NOAEL / SED = 41666 Systemic exposure of DINP from cosmetics is 0.24% of the TDI for DINP of 0.15 mg/kg/d derived by EFSA, (2005a) Exposure to DINP from...","effect":"concentration (0.003%) found, based on NOAELs and dermal absorption of 4 % for DINP reported as a percentage in the literature (Elsisi et al, 1989). Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Maximum dermal absorption: 4 % Systemic Exposure Dose (SED) 17.79 x 1000 x 0.003% x 4% / 60 = 0.00036 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in rats) DINP Margin of Safety NOAEL / SED = 41666 Systemic exposure of DINP from cosmetics is 0.24% of the TDI for DINP of 0.15 mg/kg/d derived by EFSA, (2005a) Exposure to DINP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA, 2005a; CSTEE, 2004, RAR, 2003). Thus the inadvertent occurrence of DINP in cosmetics does not seem to be a concern for consumer health. DIDP DIDP was found in 5/36 perfume samples at concentrations ranging from 1.5 - 37 mg/kg. The EFSA Panel concluded that","page":11,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_014"} |
| SCCS_vision_codex | NOAEL | =33 | mg/kg bw/day | rat | oral | 13-week | NOAEL study | {"dose":"DIDP DIDP was found in 5/36 perfume samples at concentrations ranging from 1.5 - 37 mg/kg.","effect":"oducts (EFSA, 2005a; CSTEE, 2004, RAR, 2003). Thus the inadvertent occurrence of DINP in cosmetics does not seem to be a concern for consumer health. DIDP DIDP was found in 5/36 perfume samples at concentrations ranging from 1.5 - 37 mg/kg. The EFSA Panel concluded that a NOAEL of 15 mg/kg bw/day for DIDP from a 13-week oral study in dogs (a non-sensitive species to peroxisome proliferation) should be used in the risk assessment and in a 2-year rat study where there was a decrease of F2 offspring survival with a NOAEL of 33 mg/kg bw/day. From the same data, CSTEE (2001b) calculated a NOAEL of 25 mg/kg/d based on the lowest observed adverse effect level (LOAEL). Liver changes were seen at higher dose levels with a lowest observed adverse effect level LOAEL of 77 mg/kg bw/day and 88 mg/kg bw/day for male and female dogs respectively. Using the NOAEL of 15 mg/kg bw/day and of an uncertainty factor of 100, a TDI for DIDP of 0.15 mg/kg bw was derived (EFSA 2005b).","page":11,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_016"} |
| SCCS_vision_codex | NOAEL | =25 | mg/kg/d | rat | oral | 13-week | NOAEL study | {"dose":"DIDP DIDP was found in 5/36 perfume samples at concentrations ranging from 1.5 - 37 mg/kg.","effect":"ence of DINP in cosmetics does not seem to be a concern for consumer health. DIDP DIDP was found in 5/36 perfume samples at concentrations ranging from 1.5 - 37 mg/kg. The EFSA Panel concluded that a NOAEL of 15 mg/kg bw/day for DIDP from a 13-week oral study in dogs (a non-sensitive species to peroxisome proliferation) should be used in the risk assessment and in a 2-year rat study where there was a decrease of F2 offspring survival with a NOAEL of 33 mg/kg bw/day. From the same data, CSTEE (2001b) calculated a NOAEL of 25 mg/kg/d based on the lowest observed adverse effect level (LOAEL). Liver changes were seen at higher dose levels with a lowest observed adverse effect level LOAEL of 77 mg/kg bw/day and 88 mg/kg bw/day for male and female dogs respectively. Using the NOAEL of 15 mg/kg bw/day and of an uncertainty factor of 100, a TDI for DIDP of 0.15 mg/kg bw was derived (EFSA 2005b).","page":11,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_017"} |
| SCCS_vision_codex | NOAEL | =0.000009 | mg/kg/d | dog | oral | - | dermal absorption | {"dose":"1 % DIDP Systemic Exposure Dose (SED) 17.79 x 1000 x 0.0037% x 1% / 60 = 0.000009 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in dogs) DIDP Margin of Safety NOAEL / SED = 1666666 Systemic exposure from cosmetics is 0.006% of the TDI of 0.15 mg/kg/d defined by EFSA (2005b).","effect":"A Margin of Safety can be calculated, using the highest concentration (0.0037 %) based on NOAELs and dermal absorption of <1 % for DIDP reported as a percentage in the literature (Elsisi et al, 1989) though due to low recovery this may be underestimated. Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Maximum dermal absorption: 1 % DIDP Systemic Exposure Dose (SED) 17.79 x 1000 x 0.0037% x 1% / 60 = 0.000009 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in dogs) DIDP Margin of Safety NOAEL / SED = 1666666 Systemic exposure from cosmetics is 0.006% of the TDI of 0.15 mg/kg/d defined by EFSA (2005b). Exposure to DIDP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA, 2005b; CSTEE, 2004, DIDP RAR, 2003). Thus the inadvertent occurrence of DIDP in cosmetics does not seem to be a concern for consumer health. It was also noted that in 5/36 perfumes, DIDP","page":12,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_019"} |
| SCCS_vision_codex | NOAEL | =0.006 | % | dog | oral | - | dermal absorption | {"dose":"1 % DIDP Systemic Exposure Dose (SED) 17.79 x 1000 x 0.0037% x 1% / 60 = 0.000009 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in dogs) DIDP Margin of Safety NOAEL / SED = 1666666 Systemic exposure from cosmetics is 0.006% of the TDI of 0.15 mg/kg/d defined by EFSA (2005b).","effect":"ption of <1 % for DIDP reported as a percentage in the literature (Elsisi et al, 1989) though due to low recovery this may be underestimated. Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Maximum dermal absorption: 1 % DIDP Systemic Exposure Dose (SED) 17.79 x 1000 x 0.0037% x 1% / 60 = 0.000009 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in dogs) DIDP Margin of Safety NOAEL / SED = 1666666 Systemic exposure from cosmetics is 0.006% of the TDI of 0.15 mg/kg/d defined by EFSA (2005b). Exposure to DIDP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA, 2005b; CSTEE, 2004, DIDP RAR, 2003). Thus the inadvertent occurrence of DIDP in cosmetics does not seem to be a concern for consumer health. It was also noted that in 5/36 perfumes, DIDP and DINP were found below ‘reporting limit’. Although not specified, this suggests a","page":12,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_021"} |
| SCCS_vision_codex | NOAEL | =100 | ppm | - | - | developmental | reproductive toxicity | {"dose":"Do the data provided support the safety of traces of up to 100 ppm total or per substance in cosmetics products of those phthalates (DEHP, DBP and BBP), which are banned in cosmetics products?","effect":"a mixture. For this reason, a group restriction for migration from food contact materials for DINP and DIDP was considered and rejected, as though both primarily affect the liver but the end-points indicate that different mechanisms are involved (EFSA, 2005c). Question 3: Do the data provided support the safety of traces of up to 100 ppm total or per substance in cosmetics products of those phthalates (DEHP, DBP and BBP), which are banned in cosmetics products? Name EINECS / CAS Highest concentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-(2-ethylhexyl) phthalate (DEHP) 204-211-0/ 117-81-7 167 4.8 testicular and developmental toxicity 88-1000 increased liver and kidney weight, testes RAR Conclusion (ii) and (iii)* CSTEE (2004b) EFSA (2005d) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC. RAR Annex 1 607-317-00-9 Repr. Cat. 2; R60-61 (fertility;development)","page":12,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_022"} |
| SCCS_vision_codex | NOAEL | =1016 | - | - | - | - | reproductive toxicity | {"dose":"SCCP/1016/06 Opinion on phthalates in cosmetic products 13 Name EINECS / CAS Highest concentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-n-butyl phthalate (DBP) 201-557-4/ 84-74-2.","effect":"SCCP/1016/06 Opinion on phthalates in cosmetic products 13 Name EINECS / CAS Highest concentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-n-butyl phthalate (DBP) 201-557-4/ 84-74-2. 14 NOAEL 50 reproductive effects LOAEL 2 NOAEL 62.5 -152 increased peroxisomal proliferation RAR Conclusion (ii)* CSTEE (2001c) EFSA (2005e) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC, RAR Annex 1 607-318-00-4 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50 Benzylbutyl phthalate (BBP) 201-622-7 / 85-68-7 110 NOAEL 50 reproductive effects NOAEL 50 reproductive effec","page":13,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_023"} |
| SCCS_vision_codex | NOAEL | =13 | - | - | - | - | reproductive toxicity | {"dose":"13 Name EINECS / CAS Highest concentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-n-butyl phthalate (DBP) 201-557-4/ 84-74-2.","effect":"13 Name EINECS / CAS Highest concentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-n-butyl phthalate (DBP) 201-557-4/ 84-74-2. 14 NOAEL 50 reproductive effects LOAEL 2 NOAEL 62.5 -152 increased peroxisomal proliferation RAR Conclusion (ii)* CSTEE (2001c) EFSA (2005e) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC, RAR Annex 1 607-318-00-4 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50 Benzylbutyl phthalate (BBP) 201-622-7 / 85-68-7 110 NOAEL 50 reproductive effects NOAEL 50 reproductive effects RAR Draft Conclusion (ii)* SCHER (2005) EFSA (2005f) Annex 1 607-430-00-3 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50-53 * RAR Conclusion (ii): There is at present no need for further information and/or testing and for risk reduction measures beyond those which are being applied already. Conclusion (iii): There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account. T","page":13,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_024"} |
| SCCS_vision_codex | NOAEL | =201 | - | - | - | - | reproductive toxicity | {"dose":"oncentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-n-butyl phthalate (DBP) 201-557-4/ 84-74-2.","effect":"oncentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-n-butyl phthalate (DBP) 201-557-4/ 84-74-2. 14 NOAEL 50 reproductive effects LOAEL 2 NOAEL 62.5 -152 increased peroxisomal proliferation RAR Conclusion (ii)* CSTEE (2001c) EFSA (2005e) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC, RAR Annex 1 607-318-00-4 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50 Benzylbutyl phthalate (BBP) 201-622-7 / 85-68-7 110 NOAEL 50 reproductive effects NOAEL 50 reproductive effects RAR Draft Conclusion (ii)* SCHER (2005) EFSA (2005f) Annex 1 607-430-00-3 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50-53 * RAR Conclusion (ii): There is at present no need for further information and/or testing and for risk reduction measures beyond those which are being applied already. Conclusion (iii): There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account. The main concerns relating to th","page":13,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_025"} |
| SCCS_vision_codex | NOAEL | =0.0167 | % | rat | dermal | - | dermal absorption | {"dose":"SCCP/1016/06 Opinion on phthalates in cosmetic products 14 Diethylhexyl Phthalate (DEHP) was found in 14/36 perfume samples at concentrations ranging from 1 - 167 mg/kg.","effect":"SCCP/1016/06 Opinion on phthalates in cosmetic products 14 Diethylhexyl Phthalate (DEHP) was found in 14/36 perfume samples at concentrations ranging from 1 - 167 mg/kg. Margin of Safety (MoS) Calculation of DEHP in cosmetics A Margin of Safety can be calculated, using the highest concentration (0.0167 %), based on NOAEL and worst-case estimate of 5 % dermal absorption for DEHP reported in the literature (EU Risk Assessment DEHP, 2003). There are no adequate human studies, but rat skin has dermal absorption of 20% DEHP and has been shown to be 4-times more permeable than human skin. This would seem to be an overestimate as Elsisi et al (1989) showed that less than 15% of the applied dose was absorbed through rat skin. Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products 17.79 g/d D","page":14,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_026"} |
| SCCS_vision_codex | NOAEL | =4.8 | mg/kg/d | rat | dermal | 2005d | dermal absorption | {"dose":"This would seem to be an overestimate as Elsisi et al (1989) showed that less than 15% of the applied dose was absorbed through rat skin.","effect":"ermal absorption for DEHP reported in the literature (EU Risk Assessment DEHP, 2003). There are no adequate human studies, but rat skin has dermal absorption of 20% DEHP and has been shown to be 4-times more permeable than human skin. This would seem to be an overestimate as Elsisi et al (1989) showed that less than 15% of the applied dose was absorbed through rat skin. Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products 17.79 g/d Default human body weight: 60 kg NOAEL: 4.8 mg/kg/d based on testicular effects in a three generation guideline study (Wolfe et al, 2003, cited in DEHP RAR, 2003). The NOAEL has been confirmed in the opinions of the CSTEE 2004b and EFSA 2005d. Maximum dermal absorption 5 % estimated worst-case MoS for maximum traces of DEHP found in one perfume (167 ppm) Systemic Exposure Dose (SED) = 17.79 x 1000 x 0.0167% x 5% / 60 = 0.00247 mg/kg/d MoS (NOAEL / SED) = 4.8 / 0.00247 = 1920 Based on the highest level found in one perfume, the systemic exposure fro","page":14,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_027"} |
| SCCS_vision_codex | NOAEL | =0.00247 | mg/kg/d | human | dermal | 2005d | dermal absorption | {"dose":"4.8 mg/kg/d based on testicular effects in a three generation guideline study (Wolfe et al, 2003, cited in DEHP RAR, 2003).","effect":"in the safety calculation. Exposure to all cosmetic products 17.79 g/d Default human body weight: 60 kg NOAEL: 4.8 mg/kg/d based on testicular effects in a three generation guideline study (Wolfe et al, 2003, cited in DEHP RAR, 2003). The NOAEL has been confirmed in the opinions of the CSTEE 2004b and EFSA 2005d. Maximum dermal absorption 5 % estimated worst-case MoS for maximum traces of DEHP found in one perfume (167 ppm) Systemic Exposure Dose (SED) = 17.79 x 1000 x 0.0167% x 5% / 60 = 0.00247 mg/kg/d MoS (NOAEL / SED) = 4.8 / 0.00247 = 1920 Based on the highest level found in one perfume, the systemic exposure from cosmetics would be 5% of the TDI of 0.05 mg/kg/d derived by EFSA, (EFSA 2005d; EU Risk Assessment DEHP, 2003; CSTEE, DEHP, 2004b). In light of the MoS based on 167ppm DEHP, the Member State proposal of a 60 ppm DEHP limit in cosmetic products may not be required. Exposure to DEHP from cosmetics is low compared with exposure from other sources, such as food and non-food products. Thus the inadvertent occurren","page":14,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_029"} |
| SCCS_vision_codex | NOAEL | =2 | mg/kg bw/d | rat | oral | developmental | reproductive toxicity | {"dose":"A LOAEL of 2 mg/kg bw/d feed was derived, since the effects were reversible at all dose levels, particularly the lowest dose level (20 mg/kg feed, equivalent to 1.5 to 3 mg/kg bw/day) combined with other reproductive toxicity studies, with longer","effect":"al absorption of 5 % for DBP as reported in the literature (Bronaugh et al. 1982, Elsisi et al. 1989 cited in RAR and an in vitro study (Scott et al. cited in RAR). Only dermal exposure will be considered in the safety calculation. LOAEL: A developmental toxicity study in the rat (Lee et al., 2004 cited by EFSA 2005e) with dietary exposure to DBP from gestation day 15 to the end of lactation (postnatal day 21), showed effects on the development of male and female offspring at lower doses than found previously. A NOAEL could not be established. A LOAEL of 2 mg/kg bw/d feed was derived, since the effects were reversible at all dose levels, particularly the lowest dose level (20 mg/kg feed, equivalent to 1.5 to 3 mg/kg bw/day) combined with other reproductive toxicity studies, with longer","page":14,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_031"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg/d | rat | dermal | developmental | developmental toxicity | {"dose":"Benzyl Butyl Phthalate (BBP) was found in 9/36 perfume samples at concentrations ranging from 0.1 – 110 mg/kg Margin of Safety (MoS) Calculation for Traces of BBP in cosmetics A Margin of Safety can be calculated, based on NOAELs and dermal absorption 5 % based on the available data, dermal absorption is considered to be 5% as a worst case estim...","effect":"r consumer health. Benzyl Butyl Phthalate (BBP) was found in 9/36 perfume samples at concentrations ranging from 0.1 – 110 mg/kg Margin of Safety (MoS) Calculation for Traces of BBP in cosmetics A Margin of Safety can be calculated, based on NOAELs and dermal absorption 5 % based on the available data, dermal absorption is considered to be 5% as a worst case estimate (RAR) Only dermal exposure will be considered in the safety calculation. Assuming a worst case of 110ppm (0.011%) BBP in all cosmetic products NOAEL: 50 mg/kg/d (Tyl et al. 2004, cited in RAR) based on a two generation study in SD rats Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Systemic Exposure Dose (SED) = 17.79 x 1000 x 0.011% x 5% / 60 = 0.00163 mg/kg/d BBP MoS = NOAEL / SED = 50 / 0.00163 = 31250 Systemic exposure of BBP from cosmetics is 3.26% of the 0.5 mg/kg/d TDI defined by EFSA (2005f). SCHER (2005) characterized the risk for consumers by using the NOAEL for developmental toxicity as a starting point and found th","page":15,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_032"} |
| SCCS_vision_codex | NOAEL | =0.00163 | mg/kg/d | rat | dermal | developmental | developmental toxicity | {"dose":"50 mg/kg/d (Tyl et al.","effect":"absorption 5 % based on the available data, dermal absorption is considered to be 5% as a worst case estimate (RAR) Only dermal exposure will be considered in the safety calculation. Assuming a worst case of 110ppm (0.011%) BBP in all cosmetic products NOAEL: 50 mg/kg/d (Tyl et al. 2004, cited in RAR) based on a two generation study in SD rats Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Systemic Exposure Dose (SED) = 17.79 x 1000 x 0.011% x 5% / 60 = 0.00163 mg/kg/d BBP MoS = NOAEL / SED = 50 / 0.00163 = 31250 Systemic exposure of BBP from cosmetics is 3.26% of the 0.5 mg/kg/d TDI defined by EFSA (2005f). SCHER (2005) characterized the risk for consumers by using the NOAEL for developmental toxicity as a starting point and found the MoS-values derived are >> 1000. (EFSA 2005f; EU Risk Assessment BBP, 2004; SCHER, BBP, 2005) Exposure to BBP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA 2005f; CSTEE 2004, RAR 2003). Thus th","page":15,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_033"} |
| SCCS_vision_codex | NOAEL | =0.5 | mg/kg/d | rat | - | developmental | developmental toxicity | {"dose":"50 mg/kg/d (Tyl et al.","effect":"worst case of 110ppm (0.011%) BBP in all cosmetic products NOAEL: 50 mg/kg/d (Tyl et al. 2004, cited in RAR) based on a two generation study in SD rats Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Systemic Exposure Dose (SED) = 17.79 x 1000 x 0.011% x 5% / 60 = 0.00163 mg/kg/d BBP MoS = NOAEL / SED = 50 / 0.00163 = 31250 Systemic exposure of BBP from cosmetics is 3.26% of the 0.5 mg/kg/d TDI defined by EFSA (2005f). SCHER (2005) characterized the risk for consumers by using the NOAEL for developmental toxicity as a starting point and found the MoS-values derived are >> 1000. (EFSA 2005f; EU Risk Assessment BBP, 2004; SCHER, BBP, 2005) Exposure to BBP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA 2005f; CSTEE 2004, RAR 2003). Thus the inadvertent occurrence of BBP in cosmetics at trace levels does not seem to be a concern for consumer health.","page":15,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_034"} |
| SCCS_vision_codex | NOAEL | =9 | - | - | - | - | NOAEL study | {"dose":"Name | EINECS / CAS | Maximum perfume concentration (mg/kg) | NOAEL mg/kg/day Critical effect","effect":"Unlabeled table on page 9: Name | EINECS / CAS | Maximum perfume concentration (mg/kg) | NOAEL mg/kg/day Critical effect","page":9,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_035"} |
| SCCS_vision_codex | NOAEL | =600 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 9: Di-methyl phthalate (DMP) | 205-011-6 / 131-11-3 | 2982 | 600 Maternal toxicity","page":9,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_036"} |
| SCCS_vision_codex | NOAEL | =50 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 9: Di-isobutyl phthalate (DIBP) | 201-553-2 / 84-69-5 | 38 | 50 effects on liver","page":9,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_037"} |
| SCCS_vision_codex | NOAEL | =10 | - | - | - | - | NOAEL study | {"dose":"Name | EINECS / CAS | Highest perfume concentration in mg/kg | NOAEL mg/kg/day | Status","effect":"Unlabeled table on page 10: Name | EINECS / CAS | Highest perfume concentration in mg/kg | NOAEL mg/kg/day | Status","page":10,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_038"} |
| SCCS_vision_codex | NOAEL | =15 | - | dog | oral | 13-week | NOAEL study | {"effect":"Unlabeled table on page 10: di-iso-decyl phthalate (DIDP) | 271-090-4 & 247- 977-1/ 68515-49-1 & 26761-40-0 | 37 | 15 13-week oral study in dogs 25 50 –600 increased liver and thyroid weight RAR Conclusion (iii) and (ii)** | EFSA (2005b) CSTEE (2001b) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC, RAR available","page":10,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_040"} |
| SCCS_vision_codex | NOAEL | =12 | - | - | - | - | NOAEL study | {"dose":"Name | EINECS / CAS | Highest concentration in mg/kg | NOAEL mg/kg bw/day Critical effect | Status","effect":"Unlabeled table on page 12: Name | EINECS / CAS | Highest concentration in mg/kg | NOAEL mg/kg bw/day Critical effect | Status","page":12,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_041"} |
| SCCS_vision_codex | NOAEL | =4.8 | - | - | - | developmental | reproductive toxicity | {"effect":"Unlabeled table on page 12: di-(2-ethylhexyl) phthalate (DEHP) | 204-211-0/ 117-81-7 | 167 | 4.8 testicular and developmental toxicity 88-1000 increased liver and kidney weight, testes RAR Conclusion (ii) and (iii)* | CSTEE (2004b) EFSA (2005d) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC. RAR Annex 1 607-317-00-9 Repr. Cat. 2; R60-61 (fertility;development)","page":12,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_042"} |
| SCCS_vision_codex | NOAEL | =2982 | mg/kg | - | - | - | NOAEL study | {"dose":"SCCP/1016/06 Opinion on phthalates in cosmetic products 9 Name EINECS / CAS Maximum perfume concentration (mg/kg) NOAEL mg/kg/day Critical effect Di-methyl phthalate (DMP) 205-011-6 / 131-11-3 2982 600 Maternal toxicity Di-isobutyl phthalate (DIBP) 201-553-2 / 84-69-5 38 50 effects on liver Di-cyclohexyl phthalate (DCHP) 201-545-9 / 84-61-7 3 -...","effect":"SCCP/1016/06 Opinion on phthalates in cosmetic products 9 Name EINECS / CAS Maximum perfume concentration (mg/kg) NOAEL mg/kg/day Critical effect Di-methyl phthalate (DMP) 205-011-6 / 131-11-3 2982 600 Maternal toxicity Di-isobutyl phthalate (DIBP) 201-553-2 / 84-69-5 38 50 effects on liver Di-cyclohexyl phthalate (DCHP) 201-545-9 / 84-61-7 3 - DMP was found at a concentration as high as 2982 mg/kg or 0.3% in one perfume, in the other 15 perfumes the concentration was between 0.1 and 1.9 mg/kg. COLIPA has stated (letter of 29 November 2002) that “there is no intentional use of DMP…as a cosmetic ingredient’. Consequently, the pres","page":9,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_001"} |
| SCCS_vision_codex | NOAEL | =600 | mg/kg bw/day | rat | dermal | - | dermal absorption | {"dose":"toxicity Di-isobutyl phthalate (DIBP) 201-553-2 / 84-69-5 38 50 effects on liver Di-cyclohexyl phthalate (DCHP) 201-545-9 / 84-61-7 3 - DMP was found at a concentration as high as 2982 mg/kg or 0.3% in one perfume, in the other 15 perfumes the concentration was between 0.1 and 1.9 mg/kg.","effect":"toxicity Di-isobutyl phthalate (DIBP) 201-553-2 / 84-69-5 38 50 effects on liver Di-cyclohexyl phthalate (DCHP) 201-545-9 / 84-61-7 3 - DMP was found at a concentration as high as 2982 mg/kg or 0.3% in one perfume, in the other 15 perfumes the concentration was between 0.1 and 1.9 mg/kg. COLIPA has stated (letter of 29 November 2002) that “there is no intentional use of DMP…as a cosmetic ingredient’. Consequently, the presence and purpose of dimethyl phthalate at the maximum concentration found is unclear. The NOAEL for maternal toxicity was 600 mg/kg bw/day DMP. In contrast to the observed maternal toxicity, there was no effect of DMP treatment on any parameter of embryo/foetal development (IUCLID, 2000). Dermal absorption of DMP was not reported but described as less than that of DEP (5%). (Elsisi et al, 1989) DMP and its metabolite monomethyl phthalate (MMP) have been investigated in several studies. In rats, exposure to DMP did not alter sexual differentiation of the male rat. Initially it seemed that in man, there was","page":9,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_002"} |
| SCCS_vision_codex | NOAEL | =5 | % | rat | dermal | - | dermal absorption | {"dose":"Interestingly, Hauser et al (2006) found no dose response link with sperm concentration, motility or morphology due to MMP, monoethyl phthalate and the DEHP metabolites.","effect":"tially it seemed that in man, there was a possible association of abnormal sperm morphology in the presence of MMP. Interestingly, Hauser et al (2006) found no dose response link with sperm concentration, motility or morphology due to MMP, monoethyl phthalate and the DEHP metabolites. (Duty et al, 2003; Gray et al, 2000; Hauser et al, 2006) Margin of Safety (MoS) Calculation for Traces of DMP in cosmetics A Margin of Safety, using the highest concentration (2982 mg/kg or 0.3%) found, can be calculated, based on NOAEL and dermal absorption less than 5% reported as a percentage in the literature (Elsisi et al, 1989). Only dermal exposure will be considered in the safety calculation. Maximum dermal absorption: < 5% Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Systemic Exposure Dose (SED) 17.79 x 1000 x 0.3% x 5% / 60 = 0.0445 mg/kg No observed adverse effect level (NOAEL) = 600 mg/kg bw/day (maternal toxicity in rats) DMP Margin of Safety NOAEL / SED = 13500 Conclusion DMP was found at conce","page":9,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_003"} |
| SCCS_vision_codex | NOAEL | =0.0445 | mg/kg | rat | dermal | - | dermal absorption | {"dose":"y (MoS) Calculation for Traces of DMP in cosmetics A Margin of Safety, using the highest concentration (2982 mg/kg or 0.3%) found, can be calculated, based on NOAEL and dermal absorption less than 5% reported as a percentage in the literature (Elsisi et al, 1989).","effect":"y (MoS) Calculation for Traces of DMP in cosmetics A Margin of Safety, using the highest concentration (2982 mg/kg or 0.3%) found, can be calculated, based on NOAEL and dermal absorption less than 5% reported as a percentage in the literature (Elsisi et al, 1989). Only dermal exposure will be considered in the safety calculation. Maximum dermal absorption: < 5% Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Systemic Exposure Dose (SED) 17.79 x 1000 x 0.3% x 5% / 60 = 0.0445 mg/kg No observed adverse effect level (NOAEL) = 600 mg/kg bw/day (maternal toxicity in rats) DMP Margin of Safety NOAEL / SED = 13500 Conclusion DMP was found at concentration of 2982 mg/kg or 0.3% in one perfume, in the other 15 perfumes the concentration was between 0.1 and 1.9 mg/kg. Using a worst case scenario, the Margin of Safety was found to be high. This suggests that unintentional exposure from perfume and other cosmetics at the levels found in this study would have no measurable risk for the consumer.","page":9,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_004"} |
| SCCS_vision_codex | NOAEL | =3 | mg/kg | - | - | 90-day | NOAEL study | {"dose":"SCCP/1016/06 Opinion on phthalates in cosmetic products 10 DCHP was found in only 1/36 perfume samples at a concentration of 3 mg/kg.","effect":"SCCP/1016/06 Opinion on phthalates in cosmetic products 10 DCHP was found in only 1/36 perfume samples at a concentration of 3 mg/kg. There appears to be no recent work on DCHP. The 90-day studies reported in the IUCLID data sheet (IUCLID, 2000) do not seem to be according to modern standards. No NOAEL was derived from these studies. EFSA (2004) requested additional data: reproduction and teratogenicity studies, test for gene mutation and in vitro mammalian cell chromosome aberration tests. Conclusion Despite the lack of adequate toxicological data, the low concentration (3 mg/kg) of DCHP found in only one sample of perfume, suggest unintentional exposure from perfume and other cosmetics would have no measurable risk for the consumer. DIBP was found in 20/36 perfumes with concentrations ranging from 0.2 - 38","page":10,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_007"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg | rat | oral | developmental | reproductive toxicity | {"dose":"Conclusion Despite the lack of adequate toxicological data, the low concentration (3 mg/kg) of DCHP found in only one sample of perfume, suggest unintentional exposure from perfume and other cosmetics would have no measurable risk for the consumer.","effect":"tional data: reproduction and teratogenicity studies, test for gene mutation and in vitro mammalian cell chromosome aberration tests. Conclusion Despite the lack of adequate toxicological data, the low concentration (3 mg/kg) of DCHP found in only one sample of perfume, suggest unintentional exposure from perfume and other cosmetics would have no measurable risk for the consumer. DIBP was found in 20/36 perfumes with concentrations ranging from 0.2 - 38 mg/kg. It is considered a possible substitute for DBP. The NOAEL for oral toxicity was 50 mg/kg DIBP, based on liver effects. There was no data on skin absorption. (IUCLID, 2000) If dosed at 600 mg/kg bw/day to pregnant rats on gestation days 7 –21, male offspring showed similar testicular and developmental effects as found with DBP and DEHP. Further developmental and postnatal studies are needed to identify the reproductive effects of DIBP. (Borch, 2006) DIBP is classified by ECB as toxic to reproduction category 2, R61 (may cause harm to the unborn child) and category 3, R6","page":10,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_008"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw/day | rat | - | chronic | carcinogenicity | {"dose":"s beyond those which are being applied already Conclusion (iii) There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account DINP DINP was found in only 1/36 perfume samples at a concentration of 26 mg/kg.","effect":"s beyond those which are being applied already Conclusion (iii) There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account DINP DINP was found in only 1/36 perfume samples at a concentration of 26 mg/kg. The toxicological effects for DINP were an increased incidence of spongiosis hepatis, accompanied by increased serum levels of liver enzymes in males and increases in absolute and relative liver and kidney weights in both sexes. EFSA (2005a) used a NOAEL of 15 mg/kg bw/day for non-peroxisomal proliferation-related chronic hepatic and renal effects derived from a combined chronic/carcinogenicity study in rats. From the same data, CSTEE (2001) calculated a 5% response benchmark dose of 12 mg/kg/d using spongiosis hepatis as the critical endpoint of the risk characterization. This will not alter the Margin of Safety from perfume use. EFSA derived a TDI for DINP of 0.15 mg/kg bw, using the NOAEL of 15 mg/kg bw/day and an uncertainty factor of 100. Margin of Safety (","page":11,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_010"} |
| SCCS_vision_codex | NOAEL | =0.00036 | mg/kg/d | rat | oral | - | dermal absorption | {"dose":"4 % Systemic Exposure Dose (SED) 17.79 x 1000 x 0.003% x 4% / 60 = 0.00036 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in rats) DINP Margin of Safety NOAEL / SED = 41666 Systemic exposure of DINP from cosmetics is 0.24% of the TDI for DINP of 0.15 mg/kg/d derived by EFSA, (2005a) Exposure to DINP from...","effect":"Safety (MoS) Calculation for Traces of DINP in cosmetics A Margin of Safety can be calculated, using the highest concentration (0.003%) found, based on NOAELs and dermal absorption of 4 % for DINP reported as a percentage in the literature (Elsisi et al, 1989). Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Maximum dermal absorption: 4 % Systemic Exposure Dose (SED) 17.79 x 1000 x 0.003% x 4% / 60 = 0.00036 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in rats) DINP Margin of Safety NOAEL / SED = 41666 Systemic exposure of DINP from cosmetics is 0.24% of the TDI for DINP of 0.15 mg/kg/d derived by EFSA, (2005a) Exposure to DINP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA, 2005a; CSTEE, 2004, RAR, 2003). Thus the inadvertent occurrence of DINP in cosmetics does not seem to be a concern for consumer health. DIDP DIDP was found in 5/36 perfume","page":11,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_012"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw/d | rat | oral | - | dermal absorption | {"dose":"4 % Systemic Exposure Dose (SED) 17.79 x 1000 x 0.003% x 4% / 60 = 0.00036 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in rats) DINP Margin of Safety NOAEL / SED = 41666 Systemic exposure of DINP from cosmetics is 0.24% of the TDI for DINP of 0.15 mg/kg/d derived by EFSA, (2005a) Exposure to DINP from...","effect":"s of DINP in cosmetics A Margin of Safety can be calculated, using the highest concentration (0.003%) found, based on NOAELs and dermal absorption of 4 % for DINP reported as a percentage in the literature (Elsisi et al, 1989). Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Maximum dermal absorption: 4 % Systemic Exposure Dose (SED) 17.79 x 1000 x 0.003% x 4% / 60 = 0.00036 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in rats) DINP Margin of Safety NOAEL / SED = 41666 Systemic exposure of DINP from cosmetics is 0.24% of the TDI for DINP of 0.15 mg/kg/d derived by EFSA, (2005a) Exposure to DINP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA, 2005a; CSTEE, 2004, RAR, 2003). Thus the inadvertent occurrence of DINP in cosmetics does not seem to be a concern for consumer health. DIDP DIDP was found in 5/36 perfume sample","page":11,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_013"} |
| SCCS_vision_codex | NOAEL | =0.24 | % | rat | oral | - | dermal absorption | {"dose":"4 % Systemic Exposure Dose (SED) 17.79 x 1000 x 0.003% x 4% / 60 = 0.00036 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in rats) DINP Margin of Safety NOAEL / SED = 41666 Systemic exposure of DINP from cosmetics is 0.24% of the TDI for DINP of 0.15 mg/kg/d derived by EFSA, (2005a) Exposure to DINP from...","effect":"concentration (0.003%) found, based on NOAELs and dermal absorption of 4 % for DINP reported as a percentage in the literature (Elsisi et al, 1989). Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Maximum dermal absorption: 4 % Systemic Exposure Dose (SED) 17.79 x 1000 x 0.003% x 4% / 60 = 0.00036 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in rats) DINP Margin of Safety NOAEL / SED = 41666 Systemic exposure of DINP from cosmetics is 0.24% of the TDI for DINP of 0.15 mg/kg/d derived by EFSA, (2005a) Exposure to DINP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA, 2005a; CSTEE, 2004, RAR, 2003). Thus the inadvertent occurrence of DINP in cosmetics does not seem to be a concern for consumer health. DIDP DIDP was found in 5/36 perfume samples at concentrations ranging from 1.5 - 37 mg/kg. The EFSA Panel concluded that","page":11,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_014"} |
| SCCS_vision_codex | NOAEL | =33 | mg/kg bw/day | rat | oral | 13-week | NOAEL study | {"dose":"DIDP DIDP was found in 5/36 perfume samples at concentrations ranging from 1.5 - 37 mg/kg.","effect":"oducts (EFSA, 2005a; CSTEE, 2004, RAR, 2003). Thus the inadvertent occurrence of DINP in cosmetics does not seem to be a concern for consumer health. DIDP DIDP was found in 5/36 perfume samples at concentrations ranging from 1.5 - 37 mg/kg. The EFSA Panel concluded that a NOAEL of 15 mg/kg bw/day for DIDP from a 13-week oral study in dogs (a non-sensitive species to peroxisome proliferation) should be used in the risk assessment and in a 2-year rat study where there was a decrease of F2 offspring survival with a NOAEL of 33 mg/kg bw/day. From the same data, CSTEE (2001b) calculated a NOAEL of 25 mg/kg/d based on the lowest observed adverse effect level (LOAEL). Liver changes were seen at higher dose levels with a lowest observed adverse effect level LOAEL of 77 mg/kg bw/day and 88 mg/kg bw/day for male and female dogs respectively. Using the NOAEL of 15 mg/kg bw/day and of an uncertainty factor of 100, a TDI for DIDP of 0.15 mg/kg bw was derived (EFSA 2005b).","page":11,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_016"} |
| SCCS_vision_codex | NOAEL | =25 | mg/kg/d | rat | oral | 13-week | NOAEL study | {"dose":"DIDP DIDP was found in 5/36 perfume samples at concentrations ranging from 1.5 - 37 mg/kg.","effect":"ence of DINP in cosmetics does not seem to be a concern for consumer health. DIDP DIDP was found in 5/36 perfume samples at concentrations ranging from 1.5 - 37 mg/kg. The EFSA Panel concluded that a NOAEL of 15 mg/kg bw/day for DIDP from a 13-week oral study in dogs (a non-sensitive species to peroxisome proliferation) should be used in the risk assessment and in a 2-year rat study where there was a decrease of F2 offspring survival with a NOAEL of 33 mg/kg bw/day. From the same data, CSTEE (2001b) calculated a NOAEL of 25 mg/kg/d based on the lowest observed adverse effect level (LOAEL). Liver changes were seen at higher dose levels with a lowest observed adverse effect level LOAEL of 77 mg/kg bw/day and 88 mg/kg bw/day for male and female dogs respectively. Using the NOAEL of 15 mg/kg bw/day and of an uncertainty factor of 100, a TDI for DIDP of 0.15 mg/kg bw was derived (EFSA 2005b).","page":11,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_017"} |
| SCCS_vision_codex | NOAEL | =0.000009 | mg/kg/d | dog | oral | - | dermal absorption | {"dose":"1 % DIDP Systemic Exposure Dose (SED) 17.79 x 1000 x 0.0037% x 1% / 60 = 0.000009 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in dogs) DIDP Margin of Safety NOAEL / SED = 1666666 Systemic exposure from cosmetics is 0.006% of the TDI of 0.15 mg/kg/d defined by EFSA (2005b).","effect":"A Margin of Safety can be calculated, using the highest concentration (0.0037 %) based on NOAELs and dermal absorption of <1 % for DIDP reported as a percentage in the literature (Elsisi et al, 1989) though due to low recovery this may be underestimated. Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Maximum dermal absorption: 1 % DIDP Systemic Exposure Dose (SED) 17.79 x 1000 x 0.0037% x 1% / 60 = 0.000009 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in dogs) DIDP Margin of Safety NOAEL / SED = 1666666 Systemic exposure from cosmetics is 0.006% of the TDI of 0.15 mg/kg/d defined by EFSA (2005b). Exposure to DIDP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA, 2005b; CSTEE, 2004, DIDP RAR, 2003). Thus the inadvertent occurrence of DIDP in cosmetics does not seem to be a concern for consumer health. It was also noted that in 5/36 perfumes, DIDP","page":12,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_019"} |
| SCCS_vision_codex | NOAEL | =0.006 | % | dog | oral | - | dermal absorption | {"dose":"1 % DIDP Systemic Exposure Dose (SED) 17.79 x 1000 x 0.0037% x 1% / 60 = 0.000009 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in dogs) DIDP Margin of Safety NOAEL / SED = 1666666 Systemic exposure from cosmetics is 0.006% of the TDI of 0.15 mg/kg/d defined by EFSA (2005b).","effect":"ption of <1 % for DIDP reported as a percentage in the literature (Elsisi et al, 1989) though due to low recovery this may be underestimated. Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Maximum dermal absorption: 1 % DIDP Systemic Exposure Dose (SED) 17.79 x 1000 x 0.0037% x 1% / 60 = 0.000009 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in dogs) DIDP Margin of Safety NOAEL / SED = 1666666 Systemic exposure from cosmetics is 0.006% of the TDI of 0.15 mg/kg/d defined by EFSA (2005b). Exposure to DIDP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA, 2005b; CSTEE, 2004, DIDP RAR, 2003). Thus the inadvertent occurrence of DIDP in cosmetics does not seem to be a concern for consumer health. It was also noted that in 5/36 perfumes, DIDP and DINP were found below ‘reporting limit’. Although not specified, this suggests a","page":12,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_021"} |
| SCCS_vision_codex | NOAEL | =100 | ppm | - | - | developmental | reproductive toxicity | {"dose":"Do the data provided support the safety of traces of up to 100 ppm total or per substance in cosmetics products of those phthalates (DEHP, DBP and BBP), which are banned in cosmetics products?","effect":"a mixture. For this reason, a group restriction for migration from food contact materials for DINP and DIDP was considered and rejected, as though both primarily affect the liver but the end-points indicate that different mechanisms are involved (EFSA, 2005c). Question 3: Do the data provided support the safety of traces of up to 100 ppm total or per substance in cosmetics products of those phthalates (DEHP, DBP and BBP), which are banned in cosmetics products? Name EINECS / CAS Highest concentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-(2-ethylhexyl) phthalate (DEHP) 204-211-0/ 117-81-7 167 4.8 testicular and developmental toxicity 88-1000 increased liver and kidney weight, testes RAR Conclusion (ii) and (iii)* CSTEE (2004b) EFSA (2005d) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC. RAR Annex 1 607-317-00-9 Repr. Cat. 2; R60-61 (fertility;development)","page":12,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_022"} |
| SCCS_vision_codex | NOAEL | =1016 | - | - | - | - | reproductive toxicity | {"dose":"SCCP/1016/06 Opinion on phthalates in cosmetic products 13 Name EINECS / CAS Highest concentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-n-butyl phthalate (DBP) 201-557-4/ 84-74-2.","effect":"SCCP/1016/06 Opinion on phthalates in cosmetic products 13 Name EINECS / CAS Highest concentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-n-butyl phthalate (DBP) 201-557-4/ 84-74-2. 14 NOAEL 50 reproductive effects LOAEL 2 NOAEL 62.5 -152 increased peroxisomal proliferation RAR Conclusion (ii)* CSTEE (2001c) EFSA (2005e) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC, RAR Annex 1 607-318-00-4 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50 Benzylbutyl phthalate (BBP) 201-622-7 / 85-68-7 110 NOAEL 50 reproductive effects NOAEL 50 reproductive effec","page":13,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_023"} |
| SCCS_vision_codex | NOAEL | =13 | - | - | - | - | reproductive toxicity | {"dose":"13 Name EINECS / CAS Highest concentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-n-butyl phthalate (DBP) 201-557-4/ 84-74-2.","effect":"13 Name EINECS / CAS Highest concentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-n-butyl phthalate (DBP) 201-557-4/ 84-74-2. 14 NOAEL 50 reproductive effects LOAEL 2 NOAEL 62.5 -152 increased peroxisomal proliferation RAR Conclusion (ii)* CSTEE (2001c) EFSA (2005e) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC, RAR Annex 1 607-318-00-4 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50 Benzylbutyl phthalate (BBP) 201-622-7 / 85-68-7 110 NOAEL 50 reproductive effects NOAEL 50 reproductive effects RAR Draft Conclusion (ii)* SCHER (2005) EFSA (2005f) Annex 1 607-430-00-3 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50-53 * RAR Conclusion (ii): There is at present no need for further information and/or testing and for risk reduction measures beyond those which are being applied already. Conclusion (iii): There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account. T","page":13,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_024"} |
| SCCS_vision_codex | NOAEL | =201 | - | - | - | - | reproductive toxicity | {"dose":"oncentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-n-butyl phthalate (DBP) 201-557-4/ 84-74-2.","effect":"oncentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-n-butyl phthalate (DBP) 201-557-4/ 84-74-2. 14 NOAEL 50 reproductive effects LOAEL 2 NOAEL 62.5 -152 increased peroxisomal proliferation RAR Conclusion (ii)* CSTEE (2001c) EFSA (2005e) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC, RAR Annex 1 607-318-00-4 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50 Benzylbutyl phthalate (BBP) 201-622-7 / 85-68-7 110 NOAEL 50 reproductive effects NOAEL 50 reproductive effects RAR Draft Conclusion (ii)* SCHER (2005) EFSA (2005f) Annex 1 607-430-00-3 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50-53 * RAR Conclusion (ii): There is at present no need for further information and/or testing and for risk reduction measures beyond those which are being applied already. Conclusion (iii): There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account. The main concerns relating to th","page":13,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_025"} |
| SCCS_vision_codex | NOAEL | =0.0167 | % | rat | dermal | - | dermal absorption | {"dose":"SCCP/1016/06 Opinion on phthalates in cosmetic products 14 Diethylhexyl Phthalate (DEHP) was found in 14/36 perfume samples at concentrations ranging from 1 - 167 mg/kg.","effect":"SCCP/1016/06 Opinion on phthalates in cosmetic products 14 Diethylhexyl Phthalate (DEHP) was found in 14/36 perfume samples at concentrations ranging from 1 - 167 mg/kg. Margin of Safety (MoS) Calculation of DEHP in cosmetics A Margin of Safety can be calculated, using the highest concentration (0.0167 %), based on NOAEL and worst-case estimate of 5 % dermal absorption for DEHP reported in the literature (EU Risk Assessment DEHP, 2003). There are no adequate human studies, but rat skin has dermal absorption of 20% DEHP and has been shown to be 4-times more permeable than human skin. This would seem to be an overestimate as Elsisi et al (1989) showed that less than 15% of the applied dose was absorbed through rat skin. Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products 17.79 g/d D","page":14,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_026"} |
| SCCS_vision_codex | NOAEL | =4.8 | mg/kg/d | rat | dermal | 2005d | dermal absorption | {"dose":"This would seem to be an overestimate as Elsisi et al (1989) showed that less than 15% of the applied dose was absorbed through rat skin.","effect":"ermal absorption for DEHP reported in the literature (EU Risk Assessment DEHP, 2003). There are no adequate human studies, but rat skin has dermal absorption of 20% DEHP and has been shown to be 4-times more permeable than human skin. This would seem to be an overestimate as Elsisi et al (1989) showed that less than 15% of the applied dose was absorbed through rat skin. Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products 17.79 g/d Default human body weight: 60 kg NOAEL: 4.8 mg/kg/d based on testicular effects in a three generation guideline study (Wolfe et al, 2003, cited in DEHP RAR, 2003). The NOAEL has been confirmed in the opinions of the CSTEE 2004b and EFSA 2005d. Maximum dermal absorption 5 % estimated worst-case MoS for maximum traces of DEHP found in one perfume (167 ppm) Systemic Exposure Dose (SED) = 17.79 x 1000 x 0.0167% x 5% / 60 = 0.00247 mg/kg/d MoS (NOAEL / SED) = 4.8 / 0.00247 = 1920 Based on the highest level found in one perfume, the systemic exposure fro","page":14,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_027"} |
| SCCS_vision_codex | NOAEL | =0.00247 | mg/kg/d | human | dermal | 2005d | dermal absorption | {"dose":"4.8 mg/kg/d based on testicular effects in a three generation guideline study (Wolfe et al, 2003, cited in DEHP RAR, 2003).","effect":"in the safety calculation. Exposure to all cosmetic products 17.79 g/d Default human body weight: 60 kg NOAEL: 4.8 mg/kg/d based on testicular effects in a three generation guideline study (Wolfe et al, 2003, cited in DEHP RAR, 2003). The NOAEL has been confirmed in the opinions of the CSTEE 2004b and EFSA 2005d. Maximum dermal absorption 5 % estimated worst-case MoS for maximum traces of DEHP found in one perfume (167 ppm) Systemic Exposure Dose (SED) = 17.79 x 1000 x 0.0167% x 5% / 60 = 0.00247 mg/kg/d MoS (NOAEL / SED) = 4.8 / 0.00247 = 1920 Based on the highest level found in one perfume, the systemic exposure from cosmetics would be 5% of the TDI of 0.05 mg/kg/d derived by EFSA, (EFSA 2005d; EU Risk Assessment DEHP, 2003; CSTEE, DEHP, 2004b). In light of the MoS based on 167ppm DEHP, the Member State proposal of a 60 ppm DEHP limit in cosmetic products may not be required. Exposure to DEHP from cosmetics is low compared with exposure from other sources, such as food and non-food products. Thus the inadvertent occurren","page":14,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_029"} |
| SCCS_vision_codex | NOAEL | =2 | mg/kg bw/d | rat | oral | developmental | reproductive toxicity | {"dose":"A LOAEL of 2 mg/kg bw/d feed was derived, since the effects were reversible at all dose levels, particularly the lowest dose level (20 mg/kg feed, equivalent to 1.5 to 3 mg/kg bw/day) combined with other reproductive toxicity studies, with longer","effect":"al absorption of 5 % for DBP as reported in the literature (Bronaugh et al. 1982, Elsisi et al. 1989 cited in RAR and an in vitro study (Scott et al. cited in RAR). Only dermal exposure will be considered in the safety calculation. LOAEL: A developmental toxicity study in the rat (Lee et al., 2004 cited by EFSA 2005e) with dietary exposure to DBP from gestation day 15 to the end of lactation (postnatal day 21), showed effects on the development of male and female offspring at lower doses than found previously. A NOAEL could not be established. A LOAEL of 2 mg/kg bw/d feed was derived, since the effects were reversible at all dose levels, particularly the lowest dose level (20 mg/kg feed, equivalent to 1.5 to 3 mg/kg bw/day) combined with other reproductive toxicity studies, with longer","page":14,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_031"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg/d | rat | dermal | developmental | developmental toxicity | {"dose":"Benzyl Butyl Phthalate (BBP) was found in 9/36 perfume samples at concentrations ranging from 0.1 – 110 mg/kg Margin of Safety (MoS) Calculation for Traces of BBP in cosmetics A Margin of Safety can be calculated, based on NOAELs and dermal absorption 5 % based on the available data, dermal absorption is considered to be 5% as a worst case estim...","effect":"r consumer health. Benzyl Butyl Phthalate (BBP) was found in 9/36 perfume samples at concentrations ranging from 0.1 – 110 mg/kg Margin of Safety (MoS) Calculation for Traces of BBP in cosmetics A Margin of Safety can be calculated, based on NOAELs and dermal absorption 5 % based on the available data, dermal absorption is considered to be 5% as a worst case estimate (RAR) Only dermal exposure will be considered in the safety calculation. Assuming a worst case of 110ppm (0.011%) BBP in all cosmetic products NOAEL: 50 mg/kg/d (Tyl et al. 2004, cited in RAR) based on a two generation study in SD rats Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Systemic Exposure Dose (SED) = 17.79 x 1000 x 0.011% x 5% / 60 = 0.00163 mg/kg/d BBP MoS = NOAEL / SED = 50 / 0.00163 = 31250 Systemic exposure of BBP from cosmetics is 3.26% of the 0.5 mg/kg/d TDI defined by EFSA (2005f). SCHER (2005) characterized the risk for consumers by using the NOAEL for developmental toxicity as a starting point and found th","page":15,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_032"} |
| SCCS_vision_codex | NOAEL | =0.00163 | mg/kg/d | rat | dermal | developmental | developmental toxicity | {"dose":"50 mg/kg/d (Tyl et al.","effect":"absorption 5 % based on the available data, dermal absorption is considered to be 5% as a worst case estimate (RAR) Only dermal exposure will be considered in the safety calculation. Assuming a worst case of 110ppm (0.011%) BBP in all cosmetic products NOAEL: 50 mg/kg/d (Tyl et al. 2004, cited in RAR) based on a two generation study in SD rats Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Systemic Exposure Dose (SED) = 17.79 x 1000 x 0.011% x 5% / 60 = 0.00163 mg/kg/d BBP MoS = NOAEL / SED = 50 / 0.00163 = 31250 Systemic exposure of BBP from cosmetics is 3.26% of the 0.5 mg/kg/d TDI defined by EFSA (2005f). SCHER (2005) characterized the risk for consumers by using the NOAEL for developmental toxicity as a starting point and found the MoS-values derived are >> 1000. (EFSA 2005f; EU Risk Assessment BBP, 2004; SCHER, BBP, 2005) Exposure to BBP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA 2005f; CSTEE 2004, RAR 2003). Thus th","page":15,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_033"} |
| SCCS_vision_codex | NOAEL | =0.5 | mg/kg/d | rat | - | developmental | developmental toxicity | {"dose":"50 mg/kg/d (Tyl et al.","effect":"worst case of 110ppm (0.011%) BBP in all cosmetic products NOAEL: 50 mg/kg/d (Tyl et al. 2004, cited in RAR) based on a two generation study in SD rats Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Systemic Exposure Dose (SED) = 17.79 x 1000 x 0.011% x 5% / 60 = 0.00163 mg/kg/d BBP MoS = NOAEL / SED = 50 / 0.00163 = 31250 Systemic exposure of BBP from cosmetics is 3.26% of the 0.5 mg/kg/d TDI defined by EFSA (2005f). SCHER (2005) characterized the risk for consumers by using the NOAEL for developmental toxicity as a starting point and found the MoS-values derived are >> 1000. (EFSA 2005f; EU Risk Assessment BBP, 2004; SCHER, BBP, 2005) Exposure to BBP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA 2005f; CSTEE 2004, RAR 2003). Thus the inadvertent occurrence of BBP in cosmetics at trace levels does not seem to be a concern for consumer health.","page":15,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_034"} |
| SCCS_vision_codex | NOAEL | =9 | - | - | - | - | NOAEL study | {"dose":"Name | EINECS / CAS | Maximum perfume concentration (mg/kg) | NOAEL mg/kg/day Critical effect","effect":"Unlabeled table on page 9: Name | EINECS / CAS | Maximum perfume concentration (mg/kg) | NOAEL mg/kg/day Critical effect","page":9,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_035"} |
| SCCS_vision_codex | NOAEL | =600 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 9: Di-methyl phthalate (DMP) | 205-011-6 / 131-11-3 | 2982 | 600 Maternal toxicity","page":9,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_036"} |
| SCCS_vision_codex | NOAEL | =50 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 9: Di-isobutyl phthalate (DIBP) | 201-553-2 / 84-69-5 | 38 | 50 effects on liver","page":9,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_037"} |
| SCCS_vision_codex | NOAEL | =10 | - | - | - | - | NOAEL study | {"dose":"Name | EINECS / CAS | Highest perfume concentration in mg/kg | NOAEL mg/kg/day | Status","effect":"Unlabeled table on page 10: Name | EINECS / CAS | Highest perfume concentration in mg/kg | NOAEL mg/kg/day | Status","page":10,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_038"} |
| SCCS_vision_codex | NOAEL | =15 | - | dog | oral | 13-week | NOAEL study | {"effect":"Unlabeled table on page 10: di-iso-decyl phthalate (DIDP) | 271-090-4 & 247- 977-1/ 68515-49-1 & 26761-40-0 | 37 | 15 13-week oral study in dogs 25 50 –600 increased liver and thyroid weight RAR Conclusion (iii) and (ii)** | EFSA (2005b) CSTEE (2001b) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC, RAR available","page":10,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_040"} |
| SCCS_vision_codex | NOAEL | =12 | - | - | - | - | NOAEL study | {"dose":"Name | EINECS / CAS | Highest concentration in mg/kg | NOAEL mg/kg bw/day Critical effect | Status","effect":"Unlabeled table on page 12: Name | EINECS / CAS | Highest concentration in mg/kg | NOAEL mg/kg bw/day Critical effect | Status","page":12,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_041"} |
| SCCS_vision_codex | NOAEL | =4.8 | - | - | - | developmental | reproductive toxicity | {"effect":"Unlabeled table on page 12: di-(2-ethylhexyl) phthalate (DEHP) | 204-211-0/ 117-81-7 | 167 | 4.8 testicular and developmental toxicity 88-1000 increased liver and kidney weight, testes RAR Conclusion (ii) and (iii)* | CSTEE (2004b) EFSA (2005d) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC. RAR Annex 1 607-317-00-9 Repr. Cat. 2; R60-61 (fertility;development)","page":12,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_042"} |
| SCCS_vision_codex | NOAEL | =2982 | mg/kg | - | - | - | NOAEL study | {"dose":"SCCP/1016/06 Opinion on phthalates in cosmetic products 9 Name EINECS / CAS Maximum perfume concentration (mg/kg) NOAEL mg/kg/day Critical effect Di-methyl phthalate (DMP) 205-011-6 / 131-11-3 2982 600 Maternal toxicity Di-isobutyl phthalate (DIBP) 201-553-2 / 84-69-5 38 50 effects on liver Di-cyclohexyl phthalate (DCHP) 201-545-9 / 84-61-7 3 -...","effect":"SCCP/1016/06 Opinion on phthalates in cosmetic products 9 Name EINECS / CAS Maximum perfume concentration (mg/kg) NOAEL mg/kg/day Critical effect Di-methyl phthalate (DMP) 205-011-6 / 131-11-3 2982 600 Maternal toxicity Di-isobutyl phthalate (DIBP) 201-553-2 / 84-69-5 38 50 effects on liver Di-cyclohexyl phthalate (DCHP) 201-545-9 / 84-61-7 3 - DMP was found at a concentration as high as 2982 mg/kg or 0.3% in one perfume, in the other 15 perfumes the concentration was between 0.1 and 1.9 mg/kg. COLIPA has stated (letter of 29 November 2002) that “there is no intentional use of DMP…as a cosmetic ingredient’. Consequently, the pres","page":9,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_001"} |
| SCCS_vision_codex | NOAEL | =600 | mg/kg bw/day | rat | dermal | - | dermal absorption | {"dose":"toxicity Di-isobutyl phthalate (DIBP) 201-553-2 / 84-69-5 38 50 effects on liver Di-cyclohexyl phthalate (DCHP) 201-545-9 / 84-61-7 3 - DMP was found at a concentration as high as 2982 mg/kg or 0.3% in one perfume, in the other 15 perfumes the concentration was between 0.1 and 1.9 mg/kg.","effect":"toxicity Di-isobutyl phthalate (DIBP) 201-553-2 / 84-69-5 38 50 effects on liver Di-cyclohexyl phthalate (DCHP) 201-545-9 / 84-61-7 3 - DMP was found at a concentration as high as 2982 mg/kg or 0.3% in one perfume, in the other 15 perfumes the concentration was between 0.1 and 1.9 mg/kg. COLIPA has stated (letter of 29 November 2002) that “there is no intentional use of DMP…as a cosmetic ingredient’. Consequently, the presence and purpose of dimethyl phthalate at the maximum concentration found is unclear. The NOAEL for maternal toxicity was 600 mg/kg bw/day DMP. In contrast to the observed maternal toxicity, there was no effect of DMP treatment on any parameter of embryo/foetal development (IUCLID, 2000). Dermal absorption of DMP was not reported but described as less than that of DEP (5%). (Elsisi et al, 1989) DMP and its metabolite monomethyl phthalate (MMP) have been investigated in several studies. In rats, exposure to DMP did not alter sexual differentiation of the male rat. Initially it seemed that in man, there was","page":9,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_002"} |
| SCCS_vision_codex | NOAEL | =5 | % | rat | dermal | - | dermal absorption | {"dose":"Interestingly, Hauser et al (2006) found no dose response link with sperm concentration, motility or morphology due to MMP, monoethyl phthalate and the DEHP metabolites.","effect":"tially it seemed that in man, there was a possible association of abnormal sperm morphology in the presence of MMP. Interestingly, Hauser et al (2006) found no dose response link with sperm concentration, motility or morphology due to MMP, monoethyl phthalate and the DEHP metabolites. (Duty et al, 2003; Gray et al, 2000; Hauser et al, 2006) Margin of Safety (MoS) Calculation for Traces of DMP in cosmetics A Margin of Safety, using the highest concentration (2982 mg/kg or 0.3%) found, can be calculated, based on NOAEL and dermal absorption less than 5% reported as a percentage in the literature (Elsisi et al, 1989). Only dermal exposure will be considered in the safety calculation. Maximum dermal absorption: < 5% Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Systemic Exposure Dose (SED) 17.79 x 1000 x 0.3% x 5% / 60 = 0.0445 mg/kg No observed adverse effect level (NOAEL) = 600 mg/kg bw/day (maternal toxicity in rats) DMP Margin of Safety NOAEL / SED = 13500 Conclusion DMP was found at conce","page":9,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_003"} |
| SCCS_vision_codex | NOAEL | =0.0445 | mg/kg | rat | dermal | - | dermal absorption | {"dose":"y (MoS) Calculation for Traces of DMP in cosmetics A Margin of Safety, using the highest concentration (2982 mg/kg or 0.3%) found, can be calculated, based on NOAEL and dermal absorption less than 5% reported as a percentage in the literature (Elsisi et al, 1989).","effect":"y (MoS) Calculation for Traces of DMP in cosmetics A Margin of Safety, using the highest concentration (2982 mg/kg or 0.3%) found, can be calculated, based on NOAEL and dermal absorption less than 5% reported as a percentage in the literature (Elsisi et al, 1989). Only dermal exposure will be considered in the safety calculation. Maximum dermal absorption: < 5% Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Systemic Exposure Dose (SED) 17.79 x 1000 x 0.3% x 5% / 60 = 0.0445 mg/kg No observed adverse effect level (NOAEL) = 600 mg/kg bw/day (maternal toxicity in rats) DMP Margin of Safety NOAEL / SED = 13500 Conclusion DMP was found at concentration of 2982 mg/kg or 0.3% in one perfume, in the other 15 perfumes the concentration was between 0.1 and 1.9 mg/kg. Using a worst case scenario, the Margin of Safety was found to be high. This suggests that unintentional exposure from perfume and other cosmetics at the levels found in this study would have no measurable risk for the consumer.","page":9,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_004"} |
| SCCS_vision_codex | NOAEL | =3 | mg/kg | - | - | 90-day | NOAEL study | {"dose":"SCCP/1016/06 Opinion on phthalates in cosmetic products 10 DCHP was found in only 1/36 perfume samples at a concentration of 3 mg/kg.","effect":"SCCP/1016/06 Opinion on phthalates in cosmetic products 10 DCHP was found in only 1/36 perfume samples at a concentration of 3 mg/kg. There appears to be no recent work on DCHP. The 90-day studies reported in the IUCLID data sheet (IUCLID, 2000) do not seem to be according to modern standards. No NOAEL was derived from these studies. EFSA (2004) requested additional data: reproduction and teratogenicity studies, test for gene mutation and in vitro mammalian cell chromosome aberration tests. Conclusion Despite the lack of adequate toxicological data, the low concentration (3 mg/kg) of DCHP found in only one sample of perfume, suggest unintentional exposure from perfume and other cosmetics would have no measurable risk for the consumer. DIBP was found in 20/36 perfumes with concentrations ranging from 0.2 - 38","page":10,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_007"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg | rat | oral | developmental | reproductive toxicity | {"dose":"Conclusion Despite the lack of adequate toxicological data, the low concentration (3 mg/kg) of DCHP found in only one sample of perfume, suggest unintentional exposure from perfume and other cosmetics would have no measurable risk for the consumer.","effect":"tional data: reproduction and teratogenicity studies, test for gene mutation and in vitro mammalian cell chromosome aberration tests. Conclusion Despite the lack of adequate toxicological data, the low concentration (3 mg/kg) of DCHP found in only one sample of perfume, suggest unintentional exposure from perfume and other cosmetics would have no measurable risk for the consumer. DIBP was found in 20/36 perfumes with concentrations ranging from 0.2 - 38 mg/kg. It is considered a possible substitute for DBP. The NOAEL for oral toxicity was 50 mg/kg DIBP, based on liver effects. There was no data on skin absorption. (IUCLID, 2000) If dosed at 600 mg/kg bw/day to pregnant rats on gestation days 7 –21, male offspring showed similar testicular and developmental effects as found with DBP and DEHP. Further developmental and postnatal studies are needed to identify the reproductive effects of DIBP. (Borch, 2006) DIBP is classified by ECB as toxic to reproduction category 2, R61 (may cause harm to the unborn child) and category 3, R6","page":10,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_008"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw/day | rat | - | chronic | carcinogenicity | {"dose":"s beyond those which are being applied already Conclusion (iii) There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account DINP DINP was found in only 1/36 perfume samples at a concentration of 26 mg/kg.","effect":"s beyond those which are being applied already Conclusion (iii) There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account DINP DINP was found in only 1/36 perfume samples at a concentration of 26 mg/kg. The toxicological effects for DINP were an increased incidence of spongiosis hepatis, accompanied by increased serum levels of liver enzymes in males and increases in absolute and relative liver and kidney weights in both sexes. EFSA (2005a) used a NOAEL of 15 mg/kg bw/day for non-peroxisomal proliferation-related chronic hepatic and renal effects derived from a combined chronic/carcinogenicity study in rats. From the same data, CSTEE (2001) calculated a 5% response benchmark dose of 12 mg/kg/d using spongiosis hepatis as the critical endpoint of the risk characterization. This will not alter the Margin of Safety from perfume use. EFSA derived a TDI for DINP of 0.15 mg/kg bw, using the NOAEL of 15 mg/kg bw/day and an uncertainty factor of 100. Margin of Safety (","page":11,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_010"} |
| SCCS_vision_codex | NOAEL | =0.00036 | mg/kg/d | rat | oral | - | dermal absorption | {"dose":"4 % Systemic Exposure Dose (SED) 17.79 x 1000 x 0.003% x 4% / 60 = 0.00036 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in rats) DINP Margin of Safety NOAEL / SED = 41666 Systemic exposure of DINP from cosmetics is 0.24% of the TDI for DINP of 0.15 mg/kg/d derived by EFSA, (2005a) Exposure to DINP from...","effect":"Safety (MoS) Calculation for Traces of DINP in cosmetics A Margin of Safety can be calculated, using the highest concentration (0.003%) found, based on NOAELs and dermal absorption of 4 % for DINP reported as a percentage in the literature (Elsisi et al, 1989). Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Maximum dermal absorption: 4 % Systemic Exposure Dose (SED) 17.79 x 1000 x 0.003% x 4% / 60 = 0.00036 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in rats) DINP Margin of Safety NOAEL / SED = 41666 Systemic exposure of DINP from cosmetics is 0.24% of the TDI for DINP of 0.15 mg/kg/d derived by EFSA, (2005a) Exposure to DINP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA, 2005a; CSTEE, 2004, RAR, 2003). Thus the inadvertent occurrence of DINP in cosmetics does not seem to be a concern for consumer health. DIDP DIDP was found in 5/36 perfume","page":11,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_012"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw/d | rat | oral | - | dermal absorption | {"dose":"4 % Systemic Exposure Dose (SED) 17.79 x 1000 x 0.003% x 4% / 60 = 0.00036 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in rats) DINP Margin of Safety NOAEL / SED = 41666 Systemic exposure of DINP from cosmetics is 0.24% of the TDI for DINP of 0.15 mg/kg/d derived by EFSA, (2005a) Exposure to DINP from...","effect":"s of DINP in cosmetics A Margin of Safety can be calculated, using the highest concentration (0.003%) found, based on NOAELs and dermal absorption of 4 % for DINP reported as a percentage in the literature (Elsisi et al, 1989). Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Maximum dermal absorption: 4 % Systemic Exposure Dose (SED) 17.79 x 1000 x 0.003% x 4% / 60 = 0.00036 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in rats) DINP Margin of Safety NOAEL / SED = 41666 Systemic exposure of DINP from cosmetics is 0.24% of the TDI for DINP of 0.15 mg/kg/d derived by EFSA, (2005a) Exposure to DINP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA, 2005a; CSTEE, 2004, RAR, 2003). Thus the inadvertent occurrence of DINP in cosmetics does not seem to be a concern for consumer health. DIDP DIDP was found in 5/36 perfume sample","page":11,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_013"} |
| SCCS_vision_codex | NOAEL | =0.24 | % | rat | oral | - | dermal absorption | {"dose":"4 % Systemic Exposure Dose (SED) 17.79 x 1000 x 0.003% x 4% / 60 = 0.00036 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in rats) DINP Margin of Safety NOAEL / SED = 41666 Systemic exposure of DINP from cosmetics is 0.24% of the TDI for DINP of 0.15 mg/kg/d derived by EFSA, (2005a) Exposure to DINP from...","effect":"concentration (0.003%) found, based on NOAELs and dermal absorption of 4 % for DINP reported as a percentage in the literature (Elsisi et al, 1989). Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Maximum dermal absorption: 4 % Systemic Exposure Dose (SED) 17.79 x 1000 x 0.003% x 4% / 60 = 0.00036 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in rats) DINP Margin of Safety NOAEL / SED = 41666 Systemic exposure of DINP from cosmetics is 0.24% of the TDI for DINP of 0.15 mg/kg/d derived by EFSA, (2005a) Exposure to DINP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA, 2005a; CSTEE, 2004, RAR, 2003). Thus the inadvertent occurrence of DINP in cosmetics does not seem to be a concern for consumer health. DIDP DIDP was found in 5/36 perfume samples at concentrations ranging from 1.5 - 37 mg/kg. The EFSA Panel concluded that","page":11,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_014"} |
| SCCS_vision_codex | NOAEL | =33 | mg/kg bw/day | rat | oral | 13-week | NOAEL study | {"dose":"DIDP DIDP was found in 5/36 perfume samples at concentrations ranging from 1.5 - 37 mg/kg.","effect":"oducts (EFSA, 2005a; CSTEE, 2004, RAR, 2003). Thus the inadvertent occurrence of DINP in cosmetics does not seem to be a concern for consumer health. DIDP DIDP was found in 5/36 perfume samples at concentrations ranging from 1.5 - 37 mg/kg. The EFSA Panel concluded that a NOAEL of 15 mg/kg bw/day for DIDP from a 13-week oral study in dogs (a non-sensitive species to peroxisome proliferation) should be used in the risk assessment and in a 2-year rat study where there was a decrease of F2 offspring survival with a NOAEL of 33 mg/kg bw/day. From the same data, CSTEE (2001b) calculated a NOAEL of 25 mg/kg/d based on the lowest observed adverse effect level (LOAEL). Liver changes were seen at higher dose levels with a lowest observed adverse effect level LOAEL of 77 mg/kg bw/day and 88 mg/kg bw/day for male and female dogs respectively. Using the NOAEL of 15 mg/kg bw/day and of an uncertainty factor of 100, a TDI for DIDP of 0.15 mg/kg bw was derived (EFSA 2005b).","page":11,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_016"} |
| SCCS_vision_codex | NOAEL | =25 | mg/kg/d | rat | oral | 13-week | NOAEL study | {"dose":"DIDP DIDP was found in 5/36 perfume samples at concentrations ranging from 1.5 - 37 mg/kg.","effect":"ence of DINP in cosmetics does not seem to be a concern for consumer health. DIDP DIDP was found in 5/36 perfume samples at concentrations ranging from 1.5 - 37 mg/kg. The EFSA Panel concluded that a NOAEL of 15 mg/kg bw/day for DIDP from a 13-week oral study in dogs (a non-sensitive species to peroxisome proliferation) should be used in the risk assessment and in a 2-year rat study where there was a decrease of F2 offspring survival with a NOAEL of 33 mg/kg bw/day. From the same data, CSTEE (2001b) calculated a NOAEL of 25 mg/kg/d based on the lowest observed adverse effect level (LOAEL). Liver changes were seen at higher dose levels with a lowest observed adverse effect level LOAEL of 77 mg/kg bw/day and 88 mg/kg bw/day for male and female dogs respectively. Using the NOAEL of 15 mg/kg bw/day and of an uncertainty factor of 100, a TDI for DIDP of 0.15 mg/kg bw was derived (EFSA 2005b).","page":11,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_017"} |
| SCCS_vision_codex | NOAEL | =0.000009 | mg/kg/d | dog | oral | - | dermal absorption | {"dose":"1 % DIDP Systemic Exposure Dose (SED) 17.79 x 1000 x 0.0037% x 1% / 60 = 0.000009 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in dogs) DIDP Margin of Safety NOAEL / SED = 1666666 Systemic exposure from cosmetics is 0.006% of the TDI of 0.15 mg/kg/d defined by EFSA (2005b).","effect":"A Margin of Safety can be calculated, using the highest concentration (0.0037 %) based on NOAELs and dermal absorption of <1 % for DIDP reported as a percentage in the literature (Elsisi et al, 1989) though due to low recovery this may be underestimated. Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Maximum dermal absorption: 1 % DIDP Systemic Exposure Dose (SED) 17.79 x 1000 x 0.0037% x 1% / 60 = 0.000009 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in dogs) DIDP Margin of Safety NOAEL / SED = 1666666 Systemic exposure from cosmetics is 0.006% of the TDI of 0.15 mg/kg/d defined by EFSA (2005b). Exposure to DIDP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA, 2005b; CSTEE, 2004, DIDP RAR, 2003). Thus the inadvertent occurrence of DIDP in cosmetics does not seem to be a concern for consumer health. It was also noted that in 5/36 perfumes, DIDP","page":12,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_019"} |
| SCCS_vision_codex | NOAEL | =0.006 | % | dog | oral | - | dermal absorption | {"dose":"1 % DIDP Systemic Exposure Dose (SED) 17.79 x 1000 x 0.0037% x 1% / 60 = 0.000009 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in dogs) DIDP Margin of Safety NOAEL / SED = 1666666 Systemic exposure from cosmetics is 0.006% of the TDI of 0.15 mg/kg/d defined by EFSA (2005b).","effect":"ption of <1 % for DIDP reported as a percentage in the literature (Elsisi et al, 1989) though due to low recovery this may be underestimated. Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Maximum dermal absorption: 1 % DIDP Systemic Exposure Dose (SED) 17.79 x 1000 x 0.0037% x 1% / 60 = 0.000009 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in dogs) DIDP Margin of Safety NOAEL / SED = 1666666 Systemic exposure from cosmetics is 0.006% of the TDI of 0.15 mg/kg/d defined by EFSA (2005b). Exposure to DIDP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA, 2005b; CSTEE, 2004, DIDP RAR, 2003). Thus the inadvertent occurrence of DIDP in cosmetics does not seem to be a concern for consumer health. It was also noted that in 5/36 perfumes, DIDP and DINP were found below ‘reporting limit’. Although not specified, this suggests a","page":12,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_021"} |
| SCCS_vision_codex | NOAEL | =100 | ppm | - | - | developmental | reproductive toxicity | {"dose":"Do the data provided support the safety of traces of up to 100 ppm total or per substance in cosmetics products of those phthalates (DEHP, DBP and BBP), which are banned in cosmetics products?","effect":"a mixture. For this reason, a group restriction for migration from food contact materials for DINP and DIDP was considered and rejected, as though both primarily affect the liver but the end-points indicate that different mechanisms are involved (EFSA, 2005c). Question 3: Do the data provided support the safety of traces of up to 100 ppm total or per substance in cosmetics products of those phthalates (DEHP, DBP and BBP), which are banned in cosmetics products? Name EINECS / CAS Highest concentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-(2-ethylhexyl) phthalate (DEHP) 204-211-0/ 117-81-7 167 4.8 testicular and developmental toxicity 88-1000 increased liver and kidney weight, testes RAR Conclusion (ii) and (iii)* CSTEE (2004b) EFSA (2005d) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC. RAR Annex 1 607-317-00-9 Repr. Cat. 2; R60-61 (fertility;development)","page":12,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_022"} |
| SCCS_vision_codex | NOAEL | =1016 | - | - | - | - | reproductive toxicity | {"dose":"SCCP/1016/06 Opinion on phthalates in cosmetic products 13 Name EINECS / CAS Highest concentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-n-butyl phthalate (DBP) 201-557-4/ 84-74-2.","effect":"SCCP/1016/06 Opinion on phthalates in cosmetic products 13 Name EINECS / CAS Highest concentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-n-butyl phthalate (DBP) 201-557-4/ 84-74-2. 14 NOAEL 50 reproductive effects LOAEL 2 NOAEL 62.5 -152 increased peroxisomal proliferation RAR Conclusion (ii)* CSTEE (2001c) EFSA (2005e) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC, RAR Annex 1 607-318-00-4 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50 Benzylbutyl phthalate (BBP) 201-622-7 / 85-68-7 110 NOAEL 50 reproductive effects NOAEL 50 reproductive effec","page":13,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_023"} |
| SCCS_vision_codex | NOAEL | =13 | - | - | - | - | reproductive toxicity | {"dose":"13 Name EINECS / CAS Highest concentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-n-butyl phthalate (DBP) 201-557-4/ 84-74-2.","effect":"13 Name EINECS / CAS Highest concentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-n-butyl phthalate (DBP) 201-557-4/ 84-74-2. 14 NOAEL 50 reproductive effects LOAEL 2 NOAEL 62.5 -152 increased peroxisomal proliferation RAR Conclusion (ii)* CSTEE (2001c) EFSA (2005e) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC, RAR Annex 1 607-318-00-4 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50 Benzylbutyl phthalate (BBP) 201-622-7 / 85-68-7 110 NOAEL 50 reproductive effects NOAEL 50 reproductive effects RAR Draft Conclusion (ii)* SCHER (2005) EFSA (2005f) Annex 1 607-430-00-3 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50-53 * RAR Conclusion (ii): There is at present no need for further information and/or testing and for risk reduction measures beyond those which are being applied already. Conclusion (iii): There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account. T","page":13,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_024"} |
| SCCS_vision_codex | NOAEL | =201 | - | - | - | - | reproductive toxicity | {"dose":"oncentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-n-butyl phthalate (DBP) 201-557-4/ 84-74-2.","effect":"oncentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-n-butyl phthalate (DBP) 201-557-4/ 84-74-2. 14 NOAEL 50 reproductive effects LOAEL 2 NOAEL 62.5 -152 increased peroxisomal proliferation RAR Conclusion (ii)* CSTEE (2001c) EFSA (2005e) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC, RAR Annex 1 607-318-00-4 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50 Benzylbutyl phthalate (BBP) 201-622-7 / 85-68-7 110 NOAEL 50 reproductive effects NOAEL 50 reproductive effects RAR Draft Conclusion (ii)* SCHER (2005) EFSA (2005f) Annex 1 607-430-00-3 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50-53 * RAR Conclusion (ii): There is at present no need for further information and/or testing and for risk reduction measures beyond those which are being applied already. Conclusion (iii): There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account. The main concerns relating to th","page":13,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_025"} |
| SCCS_vision_codex | NOAEL | =0.0167 | % | rat | dermal | - | dermal absorption | {"dose":"SCCP/1016/06 Opinion on phthalates in cosmetic products 14 Diethylhexyl Phthalate (DEHP) was found in 14/36 perfume samples at concentrations ranging from 1 - 167 mg/kg.","effect":"SCCP/1016/06 Opinion on phthalates in cosmetic products 14 Diethylhexyl Phthalate (DEHP) was found in 14/36 perfume samples at concentrations ranging from 1 - 167 mg/kg. Margin of Safety (MoS) Calculation of DEHP in cosmetics A Margin of Safety can be calculated, using the highest concentration (0.0167 %), based on NOAEL and worst-case estimate of 5 % dermal absorption for DEHP reported in the literature (EU Risk Assessment DEHP, 2003). There are no adequate human studies, but rat skin has dermal absorption of 20% DEHP and has been shown to be 4-times more permeable than human skin. This would seem to be an overestimate as Elsisi et al (1989) showed that less than 15% of the applied dose was absorbed through rat skin. Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products 17.79 g/d D","page":14,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_026"} |
| SCCS_vision_codex | NOAEL | =4.8 | mg/kg/d | rat | dermal | 2005d | dermal absorption | {"dose":"This would seem to be an overestimate as Elsisi et al (1989) showed that less than 15% of the applied dose was absorbed through rat skin.","effect":"ermal absorption for DEHP reported in the literature (EU Risk Assessment DEHP, 2003). There are no adequate human studies, but rat skin has dermal absorption of 20% DEHP and has been shown to be 4-times more permeable than human skin. This would seem to be an overestimate as Elsisi et al (1989) showed that less than 15% of the applied dose was absorbed through rat skin. Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products 17.79 g/d Default human body weight: 60 kg NOAEL: 4.8 mg/kg/d based on testicular effects in a three generation guideline study (Wolfe et al, 2003, cited in DEHP RAR, 2003). The NOAEL has been confirmed in the opinions of the CSTEE 2004b and EFSA 2005d. Maximum dermal absorption 5 % estimated worst-case MoS for maximum traces of DEHP found in one perfume (167 ppm) Systemic Exposure Dose (SED) = 17.79 x 1000 x 0.0167% x 5% / 60 = 0.00247 mg/kg/d MoS (NOAEL / SED) = 4.8 / 0.00247 = 1920 Based on the highest level found in one perfume, the systemic exposure fro","page":14,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_027"} |
| SCCS_vision_codex | NOAEL | =0.00247 | mg/kg/d | human | dermal | 2005d | dermal absorption | {"dose":"4.8 mg/kg/d based on testicular effects in a three generation guideline study (Wolfe et al, 2003, cited in DEHP RAR, 2003).","effect":"in the safety calculation. Exposure to all cosmetic products 17.79 g/d Default human body weight: 60 kg NOAEL: 4.8 mg/kg/d based on testicular effects in a three generation guideline study (Wolfe et al, 2003, cited in DEHP RAR, 2003). The NOAEL has been confirmed in the opinions of the CSTEE 2004b and EFSA 2005d. Maximum dermal absorption 5 % estimated worst-case MoS for maximum traces of DEHP found in one perfume (167 ppm) Systemic Exposure Dose (SED) = 17.79 x 1000 x 0.0167% x 5% / 60 = 0.00247 mg/kg/d MoS (NOAEL / SED) = 4.8 / 0.00247 = 1920 Based on the highest level found in one perfume, the systemic exposure from cosmetics would be 5% of the TDI of 0.05 mg/kg/d derived by EFSA, (EFSA 2005d; EU Risk Assessment DEHP, 2003; CSTEE, DEHP, 2004b). In light of the MoS based on 167ppm DEHP, the Member State proposal of a 60 ppm DEHP limit in cosmetic products may not be required. Exposure to DEHP from cosmetics is low compared with exposure from other sources, such as food and non-food products. Thus the inadvertent occurren","page":14,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_029"} |
| SCCS_vision_codex | NOAEL | =2 | mg/kg bw/d | rat | oral | developmental | reproductive toxicity | {"dose":"A LOAEL of 2 mg/kg bw/d feed was derived, since the effects were reversible at all dose levels, particularly the lowest dose level (20 mg/kg feed, equivalent to 1.5 to 3 mg/kg bw/day) combined with other reproductive toxicity studies, with longer","effect":"al absorption of 5 % for DBP as reported in the literature (Bronaugh et al. 1982, Elsisi et al. 1989 cited in RAR and an in vitro study (Scott et al. cited in RAR). Only dermal exposure will be considered in the safety calculation. LOAEL: A developmental toxicity study in the rat (Lee et al., 2004 cited by EFSA 2005e) with dietary exposure to DBP from gestation day 15 to the end of lactation (postnatal day 21), showed effects on the development of male and female offspring at lower doses than found previously. A NOAEL could not be established. A LOAEL of 2 mg/kg bw/d feed was derived, since the effects were reversible at all dose levels, particularly the lowest dose level (20 mg/kg feed, equivalent to 1.5 to 3 mg/kg bw/day) combined with other reproductive toxicity studies, with longer","page":14,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_031"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg/d | rat | dermal | developmental | developmental toxicity | {"dose":"Benzyl Butyl Phthalate (BBP) was found in 9/36 perfume samples at concentrations ranging from 0.1 – 110 mg/kg Margin of Safety (MoS) Calculation for Traces of BBP in cosmetics A Margin of Safety can be calculated, based on NOAELs and dermal absorption 5 % based on the available data, dermal absorption is considered to be 5% as a worst case estim...","effect":"r consumer health. Benzyl Butyl Phthalate (BBP) was found in 9/36 perfume samples at concentrations ranging from 0.1 – 110 mg/kg Margin of Safety (MoS) Calculation for Traces of BBP in cosmetics A Margin of Safety can be calculated, based on NOAELs and dermal absorption 5 % based on the available data, dermal absorption is considered to be 5% as a worst case estimate (RAR) Only dermal exposure will be considered in the safety calculation. Assuming a worst case of 110ppm (0.011%) BBP in all cosmetic products NOAEL: 50 mg/kg/d (Tyl et al. 2004, cited in RAR) based on a two generation study in SD rats Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Systemic Exposure Dose (SED) = 17.79 x 1000 x 0.011% x 5% / 60 = 0.00163 mg/kg/d BBP MoS = NOAEL / SED = 50 / 0.00163 = 31250 Systemic exposure of BBP from cosmetics is 3.26% of the 0.5 mg/kg/d TDI defined by EFSA (2005f). SCHER (2005) characterized the risk for consumers by using the NOAEL for developmental toxicity as a starting point and found th","page":15,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_032"} |
| SCCS_vision_codex | NOAEL | =0.00163 | mg/kg/d | rat | dermal | developmental | developmental toxicity | {"dose":"50 mg/kg/d (Tyl et al.","effect":"absorption 5 % based on the available data, dermal absorption is considered to be 5% as a worst case estimate (RAR) Only dermal exposure will be considered in the safety calculation. Assuming a worst case of 110ppm (0.011%) BBP in all cosmetic products NOAEL: 50 mg/kg/d (Tyl et al. 2004, cited in RAR) based on a two generation study in SD rats Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Systemic Exposure Dose (SED) = 17.79 x 1000 x 0.011% x 5% / 60 = 0.00163 mg/kg/d BBP MoS = NOAEL / SED = 50 / 0.00163 = 31250 Systemic exposure of BBP from cosmetics is 3.26% of the 0.5 mg/kg/d TDI defined by EFSA (2005f). SCHER (2005) characterized the risk for consumers by using the NOAEL for developmental toxicity as a starting point and found the MoS-values derived are >> 1000. (EFSA 2005f; EU Risk Assessment BBP, 2004; SCHER, BBP, 2005) Exposure to BBP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA 2005f; CSTEE 2004, RAR 2003). Thus th","page":15,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_033"} |
| SCCS_vision_codex | NOAEL | =0.5 | mg/kg/d | rat | - | developmental | developmental toxicity | {"dose":"50 mg/kg/d (Tyl et al.","effect":"worst case of 110ppm (0.011%) BBP in all cosmetic products NOAEL: 50 mg/kg/d (Tyl et al. 2004, cited in RAR) based on a two generation study in SD rats Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Systemic Exposure Dose (SED) = 17.79 x 1000 x 0.011% x 5% / 60 = 0.00163 mg/kg/d BBP MoS = NOAEL / SED = 50 / 0.00163 = 31250 Systemic exposure of BBP from cosmetics is 3.26% of the 0.5 mg/kg/d TDI defined by EFSA (2005f). SCHER (2005) characterized the risk for consumers by using the NOAEL for developmental toxicity as a starting point and found the MoS-values derived are >> 1000. (EFSA 2005f; EU Risk Assessment BBP, 2004; SCHER, BBP, 2005) Exposure to BBP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA 2005f; CSTEE 2004, RAR 2003). Thus the inadvertent occurrence of BBP in cosmetics at trace levels does not seem to be a concern for consumer health.","page":15,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_034"} |
| SCCS_vision_codex | NOAEL | =9 | - | - | - | - | NOAEL study | {"dose":"Name | EINECS / CAS | Maximum perfume concentration (mg/kg) | NOAEL mg/kg/day Critical effect","effect":"Unlabeled table on page 9: Name | EINECS / CAS | Maximum perfume concentration (mg/kg) | NOAEL mg/kg/day Critical effect","page":9,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_035"} |
| SCCS_vision_codex | NOAEL | =600 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 9: Di-methyl phthalate (DMP) | 205-011-6 / 131-11-3 | 2982 | 600 Maternal toxicity","page":9,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_036"} |
| SCCS_vision_codex | NOAEL | =50 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 9: Di-isobutyl phthalate (DIBP) | 201-553-2 / 84-69-5 | 38 | 50 effects on liver","page":9,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_037"} |
| SCCS_vision_codex | NOAEL | =10 | - | - | - | - | NOAEL study | {"dose":"Name | EINECS / CAS | Highest perfume concentration in mg/kg | NOAEL mg/kg/day | Status","effect":"Unlabeled table on page 10: Name | EINECS / CAS | Highest perfume concentration in mg/kg | NOAEL mg/kg/day | Status","page":10,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_038"} |
| SCCS_vision_codex | NOAEL | =15 | - | dog | oral | 13-week | NOAEL study | {"effect":"Unlabeled table on page 10: di-iso-decyl phthalate (DIDP) | 271-090-4 & 247- 977-1/ 68515-49-1 & 26761-40-0 | 37 | 15 13-week oral study in dogs 25 50 –600 increased liver and thyroid weight RAR Conclusion (iii) and (ii)** | EFSA (2005b) CSTEE (2001b) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC, RAR available","page":10,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_040"} |
| SCCS_vision_codex | NOAEL | =12 | - | - | - | - | NOAEL study | {"dose":"Name | EINECS / CAS | Highest concentration in mg/kg | NOAEL mg/kg bw/day Critical effect | Status","effect":"Unlabeled table on page 12: Name | EINECS / CAS | Highest concentration in mg/kg | NOAEL mg/kg bw/day Critical effect | Status","page":12,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_041"} |
| SCCS_vision_codex | NOAEL | =4.8 | - | - | - | developmental | reproductive toxicity | {"effect":"Unlabeled table on page 12: di-(2-ethylhexyl) phthalate (DEHP) | 204-211-0/ 117-81-7 | 167 | 4.8 testicular and developmental toxicity 88-1000 increased liver and kidney weight, testes RAR Conclusion (ii) and (iii)* | CSTEE (2004b) EFSA (2005d) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC. RAR Annex 1 607-317-00-9 Repr. Cat. 2; R60-61 (fertility;development)","page":12,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_042"} |
| SCCS_vision_codex | NOAEL | =2982 | mg/kg | - | - | - | NOAEL study | {"dose":"SCCP/1016/06 Opinion on phthalates in cosmetic products 9 Name EINECS / CAS Maximum perfume concentration (mg/kg) NOAEL mg/kg/day Critical effect Di-methyl phthalate (DMP) 205-011-6 / 131-11-3 2982 600 Maternal toxicity Di-isobutyl phthalate (DIBP) 201-553-2 / 84-69-5 38 50 effects on liver Di-cyclohexyl phthalate (DCHP) 201-545-9 / 84-61-7 3 -...","effect":"SCCP/1016/06 Opinion on phthalates in cosmetic products 9 Name EINECS / CAS Maximum perfume concentration (mg/kg) NOAEL mg/kg/day Critical effect Di-methyl phthalate (DMP) 205-011-6 / 131-11-3 2982 600 Maternal toxicity Di-isobutyl phthalate (DIBP) 201-553-2 / 84-69-5 38 50 effects on liver Di-cyclohexyl phthalate (DCHP) 201-545-9 / 84-61-7 3 - DMP was found at a concentration as high as 2982 mg/kg or 0.3% in one perfume, in the other 15 perfumes the concentration was between 0.1 and 1.9 mg/kg. COLIPA has stated (letter of 29 November 2002) that “there is no intentional use of DMP…as a cosmetic ingredient’. Consequently, the pres","page":9,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_001"} |
| SCCS_vision_codex | NOAEL | =600 | mg/kg bw/day | rat | dermal | - | dermal absorption | {"dose":"toxicity Di-isobutyl phthalate (DIBP) 201-553-2 / 84-69-5 38 50 effects on liver Di-cyclohexyl phthalate (DCHP) 201-545-9 / 84-61-7 3 - DMP was found at a concentration as high as 2982 mg/kg or 0.3% in one perfume, in the other 15 perfumes the concentration was between 0.1 and 1.9 mg/kg.","effect":"toxicity Di-isobutyl phthalate (DIBP) 201-553-2 / 84-69-5 38 50 effects on liver Di-cyclohexyl phthalate (DCHP) 201-545-9 / 84-61-7 3 - DMP was found at a concentration as high as 2982 mg/kg or 0.3% in one perfume, in the other 15 perfumes the concentration was between 0.1 and 1.9 mg/kg. COLIPA has stated (letter of 29 November 2002) that “there is no intentional use of DMP…as a cosmetic ingredient’. Consequently, the presence and purpose of dimethyl phthalate at the maximum concentration found is unclear. The NOAEL for maternal toxicity was 600 mg/kg bw/day DMP. In contrast to the observed maternal toxicity, there was no effect of DMP treatment on any parameter of embryo/foetal development (IUCLID, 2000). Dermal absorption of DMP was not reported but described as less than that of DEP (5%). (Elsisi et al, 1989) DMP and its metabolite monomethyl phthalate (MMP) have been investigated in several studies. In rats, exposure to DMP did not alter sexual differentiation of the male rat. Initially it seemed that in man, there was","page":9,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_002"} |
| SCCS_vision_codex | NOAEL | =5 | % | rat | dermal | - | dermal absorption | {"dose":"Interestingly, Hauser et al (2006) found no dose response link with sperm concentration, motility or morphology due to MMP, monoethyl phthalate and the DEHP metabolites.","effect":"tially it seemed that in man, there was a possible association of abnormal sperm morphology in the presence of MMP. Interestingly, Hauser et al (2006) found no dose response link with sperm concentration, motility or morphology due to MMP, monoethyl phthalate and the DEHP metabolites. (Duty et al, 2003; Gray et al, 2000; Hauser et al, 2006) Margin of Safety (MoS) Calculation for Traces of DMP in cosmetics A Margin of Safety, using the highest concentration (2982 mg/kg or 0.3%) found, can be calculated, based on NOAEL and dermal absorption less than 5% reported as a percentage in the literature (Elsisi et al, 1989). Only dermal exposure will be considered in the safety calculation. Maximum dermal absorption: < 5% Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Systemic Exposure Dose (SED) 17.79 x 1000 x 0.3% x 5% / 60 = 0.0445 mg/kg No observed adverse effect level (NOAEL) = 600 mg/kg bw/day (maternal toxicity in rats) DMP Margin of Safety NOAEL / SED = 13500 Conclusion DMP was found at conce","page":9,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_003"} |
| SCCS_vision_codex | NOAEL | =0.0445 | mg/kg | rat | dermal | - | dermal absorption | {"dose":"y (MoS) Calculation for Traces of DMP in cosmetics A Margin of Safety, using the highest concentration (2982 mg/kg or 0.3%) found, can be calculated, based on NOAEL and dermal absorption less than 5% reported as a percentage in the literature (Elsisi et al, 1989).","effect":"y (MoS) Calculation for Traces of DMP in cosmetics A Margin of Safety, using the highest concentration (2982 mg/kg or 0.3%) found, can be calculated, based on NOAEL and dermal absorption less than 5% reported as a percentage in the literature (Elsisi et al, 1989). Only dermal exposure will be considered in the safety calculation. Maximum dermal absorption: < 5% Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Systemic Exposure Dose (SED) 17.79 x 1000 x 0.3% x 5% / 60 = 0.0445 mg/kg No observed adverse effect level (NOAEL) = 600 mg/kg bw/day (maternal toxicity in rats) DMP Margin of Safety NOAEL / SED = 13500 Conclusion DMP was found at concentration of 2982 mg/kg or 0.3% in one perfume, in the other 15 perfumes the concentration was between 0.1 and 1.9 mg/kg. Using a worst case scenario, the Margin of Safety was found to be high. This suggests that unintentional exposure from perfume and other cosmetics at the levels found in this study would have no measurable risk for the consumer.","page":9,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_004"} |
| SCCS_vision_codex | NOAEL | =3 | mg/kg | - | - | 90-day | NOAEL study | {"dose":"SCCP/1016/06 Opinion on phthalates in cosmetic products 10 DCHP was found in only 1/36 perfume samples at a concentration of 3 mg/kg.","effect":"SCCP/1016/06 Opinion on phthalates in cosmetic products 10 DCHP was found in only 1/36 perfume samples at a concentration of 3 mg/kg. There appears to be no recent work on DCHP. The 90-day studies reported in the IUCLID data sheet (IUCLID, 2000) do not seem to be according to modern standards. No NOAEL was derived from these studies. EFSA (2004) requested additional data: reproduction and teratogenicity studies, test for gene mutation and in vitro mammalian cell chromosome aberration tests. Conclusion Despite the lack of adequate toxicological data, the low concentration (3 mg/kg) of DCHP found in only one sample of perfume, suggest unintentional exposure from perfume and other cosmetics would have no measurable risk for the consumer. DIBP was found in 20/36 perfumes with concentrations ranging from 0.2 - 38","page":10,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_007"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg | rat | oral | developmental | reproductive toxicity | {"dose":"Conclusion Despite the lack of adequate toxicological data, the low concentration (3 mg/kg) of DCHP found in only one sample of perfume, suggest unintentional exposure from perfume and other cosmetics would have no measurable risk for the consumer.","effect":"tional data: reproduction and teratogenicity studies, test for gene mutation and in vitro mammalian cell chromosome aberration tests. Conclusion Despite the lack of adequate toxicological data, the low concentration (3 mg/kg) of DCHP found in only one sample of perfume, suggest unintentional exposure from perfume and other cosmetics would have no measurable risk for the consumer. DIBP was found in 20/36 perfumes with concentrations ranging from 0.2 - 38 mg/kg. It is considered a possible substitute for DBP. The NOAEL for oral toxicity was 50 mg/kg DIBP, based on liver effects. There was no data on skin absorption. (IUCLID, 2000) If dosed at 600 mg/kg bw/day to pregnant rats on gestation days 7 –21, male offspring showed similar testicular and developmental effects as found with DBP and DEHP. Further developmental and postnatal studies are needed to identify the reproductive effects of DIBP. (Borch, 2006) DIBP is classified by ECB as toxic to reproduction category 2, R61 (may cause harm to the unborn child) and category 3, R6","page":10,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_008"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw/day | rat | - | chronic | carcinogenicity | {"dose":"s beyond those which are being applied already Conclusion (iii) There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account DINP DINP was found in only 1/36 perfume samples at a concentration of 26 mg/kg.","effect":"s beyond those which are being applied already Conclusion (iii) There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account DINP DINP was found in only 1/36 perfume samples at a concentration of 26 mg/kg. The toxicological effects for DINP were an increased incidence of spongiosis hepatis, accompanied by increased serum levels of liver enzymes in males and increases in absolute and relative liver and kidney weights in both sexes. EFSA (2005a) used a NOAEL of 15 mg/kg bw/day for non-peroxisomal proliferation-related chronic hepatic and renal effects derived from a combined chronic/carcinogenicity study in rats. From the same data, CSTEE (2001) calculated a 5% response benchmark dose of 12 mg/kg/d using spongiosis hepatis as the critical endpoint of the risk characterization. This will not alter the Margin of Safety from perfume use. EFSA derived a TDI for DINP of 0.15 mg/kg bw, using the NOAEL of 15 mg/kg bw/day and an uncertainty factor of 100. Margin of Safety (","page":11,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_010"} |
| SCCS_vision_codex | NOAEL | =0.00036 | mg/kg/d | rat | oral | - | dermal absorption | {"dose":"4 % Systemic Exposure Dose (SED) 17.79 x 1000 x 0.003% x 4% / 60 = 0.00036 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in rats) DINP Margin of Safety NOAEL / SED = 41666 Systemic exposure of DINP from cosmetics is 0.24% of the TDI for DINP of 0.15 mg/kg/d derived by EFSA, (2005a) Exposure to DINP from...","effect":"Safety (MoS) Calculation for Traces of DINP in cosmetics A Margin of Safety can be calculated, using the highest concentration (0.003%) found, based on NOAELs and dermal absorption of 4 % for DINP reported as a percentage in the literature (Elsisi et al, 1989). Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Maximum dermal absorption: 4 % Systemic Exposure Dose (SED) 17.79 x 1000 x 0.003% x 4% / 60 = 0.00036 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in rats) DINP Margin of Safety NOAEL / SED = 41666 Systemic exposure of DINP from cosmetics is 0.24% of the TDI for DINP of 0.15 mg/kg/d derived by EFSA, (2005a) Exposure to DINP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA, 2005a; CSTEE, 2004, RAR, 2003). Thus the inadvertent occurrence of DINP in cosmetics does not seem to be a concern for consumer health. DIDP DIDP was found in 5/36 perfume","page":11,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_012"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw/d | rat | oral | - | dermal absorption | {"dose":"4 % Systemic Exposure Dose (SED) 17.79 x 1000 x 0.003% x 4% / 60 = 0.00036 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in rats) DINP Margin of Safety NOAEL / SED = 41666 Systemic exposure of DINP from cosmetics is 0.24% of the TDI for DINP of 0.15 mg/kg/d derived by EFSA, (2005a) Exposure to DINP from...","effect":"s of DINP in cosmetics A Margin of Safety can be calculated, using the highest concentration (0.003%) found, based on NOAELs and dermal absorption of 4 % for DINP reported as a percentage in the literature (Elsisi et al, 1989). Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Maximum dermal absorption: 4 % Systemic Exposure Dose (SED) 17.79 x 1000 x 0.003% x 4% / 60 = 0.00036 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in rats) DINP Margin of Safety NOAEL / SED = 41666 Systemic exposure of DINP from cosmetics is 0.24% of the TDI for DINP of 0.15 mg/kg/d derived by EFSA, (2005a) Exposure to DINP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA, 2005a; CSTEE, 2004, RAR, 2003). Thus the inadvertent occurrence of DINP in cosmetics does not seem to be a concern for consumer health. DIDP DIDP was found in 5/36 perfume sample","page":11,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_013"} |
| SCCS_vision_codex | NOAEL | =0.24 | % | rat | oral | - | dermal absorption | {"dose":"4 % Systemic Exposure Dose (SED) 17.79 x 1000 x 0.003% x 4% / 60 = 0.00036 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in rats) DINP Margin of Safety NOAEL / SED = 41666 Systemic exposure of DINP from cosmetics is 0.24% of the TDI for DINP of 0.15 mg/kg/d derived by EFSA, (2005a) Exposure to DINP from...","effect":"concentration (0.003%) found, based on NOAELs and dermal absorption of 4 % for DINP reported as a percentage in the literature (Elsisi et al, 1989). Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Maximum dermal absorption: 4 % Systemic Exposure Dose (SED) 17.79 x 1000 x 0.003% x 4% / 60 = 0.00036 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in rats) DINP Margin of Safety NOAEL / SED = 41666 Systemic exposure of DINP from cosmetics is 0.24% of the TDI for DINP of 0.15 mg/kg/d derived by EFSA, (2005a) Exposure to DINP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA, 2005a; CSTEE, 2004, RAR, 2003). Thus the inadvertent occurrence of DINP in cosmetics does not seem to be a concern for consumer health. DIDP DIDP was found in 5/36 perfume samples at concentrations ranging from 1.5 - 37 mg/kg. The EFSA Panel concluded that","page":11,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_014"} |
| SCCS_vision_codex | NOAEL | =33 | mg/kg bw/day | rat | oral | 13-week | NOAEL study | {"dose":"DIDP DIDP was found in 5/36 perfume samples at concentrations ranging from 1.5 - 37 mg/kg.","effect":"oducts (EFSA, 2005a; CSTEE, 2004, RAR, 2003). Thus the inadvertent occurrence of DINP in cosmetics does not seem to be a concern for consumer health. DIDP DIDP was found in 5/36 perfume samples at concentrations ranging from 1.5 - 37 mg/kg. The EFSA Panel concluded that a NOAEL of 15 mg/kg bw/day for DIDP from a 13-week oral study in dogs (a non-sensitive species to peroxisome proliferation) should be used in the risk assessment and in a 2-year rat study where there was a decrease of F2 offspring survival with a NOAEL of 33 mg/kg bw/day. From the same data, CSTEE (2001b) calculated a NOAEL of 25 mg/kg/d based on the lowest observed adverse effect level (LOAEL). Liver changes were seen at higher dose levels with a lowest observed adverse effect level LOAEL of 77 mg/kg bw/day and 88 mg/kg bw/day for male and female dogs respectively. Using the NOAEL of 15 mg/kg bw/day and of an uncertainty factor of 100, a TDI for DIDP of 0.15 mg/kg bw was derived (EFSA 2005b).","page":11,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_016"} |
| SCCS_vision_codex | NOAEL | =25 | mg/kg/d | rat | oral | 13-week | NOAEL study | {"dose":"DIDP DIDP was found in 5/36 perfume samples at concentrations ranging from 1.5 - 37 mg/kg.","effect":"ence of DINP in cosmetics does not seem to be a concern for consumer health. DIDP DIDP was found in 5/36 perfume samples at concentrations ranging from 1.5 - 37 mg/kg. The EFSA Panel concluded that a NOAEL of 15 mg/kg bw/day for DIDP from a 13-week oral study in dogs (a non-sensitive species to peroxisome proliferation) should be used in the risk assessment and in a 2-year rat study where there was a decrease of F2 offspring survival with a NOAEL of 33 mg/kg bw/day. From the same data, CSTEE (2001b) calculated a NOAEL of 25 mg/kg/d based on the lowest observed adverse effect level (LOAEL). Liver changes were seen at higher dose levels with a lowest observed adverse effect level LOAEL of 77 mg/kg bw/day and 88 mg/kg bw/day for male and female dogs respectively. Using the NOAEL of 15 mg/kg bw/day and of an uncertainty factor of 100, a TDI for DIDP of 0.15 mg/kg bw was derived (EFSA 2005b).","page":11,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_017"} |
| SCCS_vision_codex | NOAEL | =0.000009 | mg/kg/d | dog | oral | - | dermal absorption | {"dose":"1 % DIDP Systemic Exposure Dose (SED) 17.79 x 1000 x 0.0037% x 1% / 60 = 0.000009 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in dogs) DIDP Margin of Safety NOAEL / SED = 1666666 Systemic exposure from cosmetics is 0.006% of the TDI of 0.15 mg/kg/d defined by EFSA (2005b).","effect":"A Margin of Safety can be calculated, using the highest concentration (0.0037 %) based on NOAELs and dermal absorption of <1 % for DIDP reported as a percentage in the literature (Elsisi et al, 1989) though due to low recovery this may be underestimated. Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Maximum dermal absorption: 1 % DIDP Systemic Exposure Dose (SED) 17.79 x 1000 x 0.0037% x 1% / 60 = 0.000009 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in dogs) DIDP Margin of Safety NOAEL / SED = 1666666 Systemic exposure from cosmetics is 0.006% of the TDI of 0.15 mg/kg/d defined by EFSA (2005b). Exposure to DIDP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA, 2005b; CSTEE, 2004, DIDP RAR, 2003). Thus the inadvertent occurrence of DIDP in cosmetics does not seem to be a concern for consumer health. It was also noted that in 5/36 perfumes, DIDP","page":12,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_019"} |
| SCCS_vision_codex | NOAEL | =0.006 | % | dog | oral | - | dermal absorption | {"dose":"1 % DIDP Systemic Exposure Dose (SED) 17.79 x 1000 x 0.0037% x 1% / 60 = 0.000009 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in dogs) DIDP Margin of Safety NOAEL / SED = 1666666 Systemic exposure from cosmetics is 0.006% of the TDI of 0.15 mg/kg/d defined by EFSA (2005b).","effect":"ption of <1 % for DIDP reported as a percentage in the literature (Elsisi et al, 1989) though due to low recovery this may be underestimated. Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Maximum dermal absorption: 1 % DIDP Systemic Exposure Dose (SED) 17.79 x 1000 x 0.0037% x 1% / 60 = 0.000009 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in dogs) DIDP Margin of Safety NOAEL / SED = 1666666 Systemic exposure from cosmetics is 0.006% of the TDI of 0.15 mg/kg/d defined by EFSA (2005b). Exposure to DIDP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA, 2005b; CSTEE, 2004, DIDP RAR, 2003). Thus the inadvertent occurrence of DIDP in cosmetics does not seem to be a concern for consumer health. It was also noted that in 5/36 perfumes, DIDP and DINP were found below ‘reporting limit’. Although not specified, this suggests a","page":12,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_021"} |
| SCCS_vision_codex | NOAEL | =100 | ppm | - | - | developmental | reproductive toxicity | {"dose":"Do the data provided support the safety of traces of up to 100 ppm total or per substance in cosmetics products of those phthalates (DEHP, DBP and BBP), which are banned in cosmetics products?","effect":"a mixture. For this reason, a group restriction for migration from food contact materials for DINP and DIDP was considered and rejected, as though both primarily affect the liver but the end-points indicate that different mechanisms are involved (EFSA, 2005c). Question 3: Do the data provided support the safety of traces of up to 100 ppm total or per substance in cosmetics products of those phthalates (DEHP, DBP and BBP), which are banned in cosmetics products? Name EINECS / CAS Highest concentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-(2-ethylhexyl) phthalate (DEHP) 204-211-0/ 117-81-7 167 4.8 testicular and developmental toxicity 88-1000 increased liver and kidney weight, testes RAR Conclusion (ii) and (iii)* CSTEE (2004b) EFSA (2005d) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC. RAR Annex 1 607-317-00-9 Repr. Cat. 2; R60-61 (fertility;development)","page":12,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_022"} |
| SCCS_vision_codex | NOAEL | =1016 | - | - | - | - | reproductive toxicity | {"dose":"SCCP/1016/06 Opinion on phthalates in cosmetic products 13 Name EINECS / CAS Highest concentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-n-butyl phthalate (DBP) 201-557-4/ 84-74-2.","effect":"SCCP/1016/06 Opinion on phthalates in cosmetic products 13 Name EINECS / CAS Highest concentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-n-butyl phthalate (DBP) 201-557-4/ 84-74-2. 14 NOAEL 50 reproductive effects LOAEL 2 NOAEL 62.5 -152 increased peroxisomal proliferation RAR Conclusion (ii)* CSTEE (2001c) EFSA (2005e) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC, RAR Annex 1 607-318-00-4 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50 Benzylbutyl phthalate (BBP) 201-622-7 / 85-68-7 110 NOAEL 50 reproductive effects NOAEL 50 reproductive effec","page":13,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_023"} |
| SCCS_vision_codex | NOAEL | =13 | - | - | - | - | reproductive toxicity | {"dose":"13 Name EINECS / CAS Highest concentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-n-butyl phthalate (DBP) 201-557-4/ 84-74-2.","effect":"13 Name EINECS / CAS Highest concentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-n-butyl phthalate (DBP) 201-557-4/ 84-74-2. 14 NOAEL 50 reproductive effects LOAEL 2 NOAEL 62.5 -152 increased peroxisomal proliferation RAR Conclusion (ii)* CSTEE (2001c) EFSA (2005e) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC, RAR Annex 1 607-318-00-4 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50 Benzylbutyl phthalate (BBP) 201-622-7 / 85-68-7 110 NOAEL 50 reproductive effects NOAEL 50 reproductive effects RAR Draft Conclusion (ii)* SCHER (2005) EFSA (2005f) Annex 1 607-430-00-3 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50-53 * RAR Conclusion (ii): There is at present no need for further information and/or testing and for risk reduction measures beyond those which are being applied already. Conclusion (iii): There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account. T","page":13,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_024"} |
| SCCS_vision_codex | NOAEL | =201 | - | - | - | - | reproductive toxicity | {"dose":"oncentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-n-butyl phthalate (DBP) 201-557-4/ 84-74-2.","effect":"oncentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-n-butyl phthalate (DBP) 201-557-4/ 84-74-2. 14 NOAEL 50 reproductive effects LOAEL 2 NOAEL 62.5 -152 increased peroxisomal proliferation RAR Conclusion (ii)* CSTEE (2001c) EFSA (2005e) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC, RAR Annex 1 607-318-00-4 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50 Benzylbutyl phthalate (BBP) 201-622-7 / 85-68-7 110 NOAEL 50 reproductive effects NOAEL 50 reproductive effects RAR Draft Conclusion (ii)* SCHER (2005) EFSA (2005f) Annex 1 607-430-00-3 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50-53 * RAR Conclusion (ii): There is at present no need for further information and/or testing and for risk reduction measures beyond those which are being applied already. Conclusion (iii): There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account. The main concerns relating to th","page":13,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_025"} |
| SCCS_vision_codex | NOAEL | =0.0167 | % | rat | dermal | - | dermal absorption | {"dose":"SCCP/1016/06 Opinion on phthalates in cosmetic products 14 Diethylhexyl Phthalate (DEHP) was found in 14/36 perfume samples at concentrations ranging from 1 - 167 mg/kg.","effect":"SCCP/1016/06 Opinion on phthalates in cosmetic products 14 Diethylhexyl Phthalate (DEHP) was found in 14/36 perfume samples at concentrations ranging from 1 - 167 mg/kg. Margin of Safety (MoS) Calculation of DEHP in cosmetics A Margin of Safety can be calculated, using the highest concentration (0.0167 %), based on NOAEL and worst-case estimate of 5 % dermal absorption for DEHP reported in the literature (EU Risk Assessment DEHP, 2003). There are no adequate human studies, but rat skin has dermal absorption of 20% DEHP and has been shown to be 4-times more permeable than human skin. This would seem to be an overestimate as Elsisi et al (1989) showed that less than 15% of the applied dose was absorbed through rat skin. Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products 17.79 g/d D","page":14,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_026"} |
| SCCS_vision_codex | NOAEL | =4.8 | mg/kg/d | rat | dermal | 2005d | dermal absorption | {"dose":"This would seem to be an overestimate as Elsisi et al (1989) showed that less than 15% of the applied dose was absorbed through rat skin.","effect":"ermal absorption for DEHP reported in the literature (EU Risk Assessment DEHP, 2003). There are no adequate human studies, but rat skin has dermal absorption of 20% DEHP and has been shown to be 4-times more permeable than human skin. This would seem to be an overestimate as Elsisi et al (1989) showed that less than 15% of the applied dose was absorbed through rat skin. Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products 17.79 g/d Default human body weight: 60 kg NOAEL: 4.8 mg/kg/d based on testicular effects in a three generation guideline study (Wolfe et al, 2003, cited in DEHP RAR, 2003). The NOAEL has been confirmed in the opinions of the CSTEE 2004b and EFSA 2005d. Maximum dermal absorption 5 % estimated worst-case MoS for maximum traces of DEHP found in one perfume (167 ppm) Systemic Exposure Dose (SED) = 17.79 x 1000 x 0.0167% x 5% / 60 = 0.00247 mg/kg/d MoS (NOAEL / SED) = 4.8 / 0.00247 = 1920 Based on the highest level found in one perfume, the systemic exposure fro","page":14,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_027"} |
| SCCS_vision_codex | NOAEL | =0.00247 | mg/kg/d | human | dermal | 2005d | dermal absorption | {"dose":"4.8 mg/kg/d based on testicular effects in a three generation guideline study (Wolfe et al, 2003, cited in DEHP RAR, 2003).","effect":"in the safety calculation. Exposure to all cosmetic products 17.79 g/d Default human body weight: 60 kg NOAEL: 4.8 mg/kg/d based on testicular effects in a three generation guideline study (Wolfe et al, 2003, cited in DEHP RAR, 2003). The NOAEL has been confirmed in the opinions of the CSTEE 2004b and EFSA 2005d. Maximum dermal absorption 5 % estimated worst-case MoS for maximum traces of DEHP found in one perfume (167 ppm) Systemic Exposure Dose (SED) = 17.79 x 1000 x 0.0167% x 5% / 60 = 0.00247 mg/kg/d MoS (NOAEL / SED) = 4.8 / 0.00247 = 1920 Based on the highest level found in one perfume, the systemic exposure from cosmetics would be 5% of the TDI of 0.05 mg/kg/d derived by EFSA, (EFSA 2005d; EU Risk Assessment DEHP, 2003; CSTEE, DEHP, 2004b). In light of the MoS based on 167ppm DEHP, the Member State proposal of a 60 ppm DEHP limit in cosmetic products may not be required. Exposure to DEHP from cosmetics is low compared with exposure from other sources, such as food and non-food products. Thus the inadvertent occurren","page":14,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_029"} |
| SCCS_vision_codex | NOAEL | =2 | mg/kg bw/d | rat | oral | developmental | reproductive toxicity | {"dose":"A LOAEL of 2 mg/kg bw/d feed was derived, since the effects were reversible at all dose levels, particularly the lowest dose level (20 mg/kg feed, equivalent to 1.5 to 3 mg/kg bw/day) combined with other reproductive toxicity studies, with longer","effect":"al absorption of 5 % for DBP as reported in the literature (Bronaugh et al. 1982, Elsisi et al. 1989 cited in RAR and an in vitro study (Scott et al. cited in RAR). Only dermal exposure will be considered in the safety calculation. LOAEL: A developmental toxicity study in the rat (Lee et al., 2004 cited by EFSA 2005e) with dietary exposure to DBP from gestation day 15 to the end of lactation (postnatal day 21), showed effects on the development of male and female offspring at lower doses than found previously. A NOAEL could not be established. A LOAEL of 2 mg/kg bw/d feed was derived, since the effects were reversible at all dose levels, particularly the lowest dose level (20 mg/kg feed, equivalent to 1.5 to 3 mg/kg bw/day) combined with other reproductive toxicity studies, with longer","page":14,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_031"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg/d | rat | dermal | developmental | developmental toxicity | {"dose":"Benzyl Butyl Phthalate (BBP) was found in 9/36 perfume samples at concentrations ranging from 0.1 – 110 mg/kg Margin of Safety (MoS) Calculation for Traces of BBP in cosmetics A Margin of Safety can be calculated, based on NOAELs and dermal absorption 5 % based on the available data, dermal absorption is considered to be 5% as a worst case estim...","effect":"r consumer health. Benzyl Butyl Phthalate (BBP) was found in 9/36 perfume samples at concentrations ranging from 0.1 – 110 mg/kg Margin of Safety (MoS) Calculation for Traces of BBP in cosmetics A Margin of Safety can be calculated, based on NOAELs and dermal absorption 5 % based on the available data, dermal absorption is considered to be 5% as a worst case estimate (RAR) Only dermal exposure will be considered in the safety calculation. Assuming a worst case of 110ppm (0.011%) BBP in all cosmetic products NOAEL: 50 mg/kg/d (Tyl et al. 2004, cited in RAR) based on a two generation study in SD rats Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Systemic Exposure Dose (SED) = 17.79 x 1000 x 0.011% x 5% / 60 = 0.00163 mg/kg/d BBP MoS = NOAEL / SED = 50 / 0.00163 = 31250 Systemic exposure of BBP from cosmetics is 3.26% of the 0.5 mg/kg/d TDI defined by EFSA (2005f). SCHER (2005) characterized the risk for consumers by using the NOAEL for developmental toxicity as a starting point and found th","page":15,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_032"} |
| SCCS_vision_codex | NOAEL | =0.00163 | mg/kg/d | rat | dermal | developmental | developmental toxicity | {"dose":"50 mg/kg/d (Tyl et al.","effect":"absorption 5 % based on the available data, dermal absorption is considered to be 5% as a worst case estimate (RAR) Only dermal exposure will be considered in the safety calculation. Assuming a worst case of 110ppm (0.011%) BBP in all cosmetic products NOAEL: 50 mg/kg/d (Tyl et al. 2004, cited in RAR) based on a two generation study in SD rats Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Systemic Exposure Dose (SED) = 17.79 x 1000 x 0.011% x 5% / 60 = 0.00163 mg/kg/d BBP MoS = NOAEL / SED = 50 / 0.00163 = 31250 Systemic exposure of BBP from cosmetics is 3.26% of the 0.5 mg/kg/d TDI defined by EFSA (2005f). SCHER (2005) characterized the risk for consumers by using the NOAEL for developmental toxicity as a starting point and found the MoS-values derived are >> 1000. (EFSA 2005f; EU Risk Assessment BBP, 2004; SCHER, BBP, 2005) Exposure to BBP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA 2005f; CSTEE 2004, RAR 2003). Thus th","page":15,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_033"} |
| SCCS_vision_codex | NOAEL | =0.5 | mg/kg/d | rat | - | developmental | developmental toxicity | {"dose":"50 mg/kg/d (Tyl et al.","effect":"worst case of 110ppm (0.011%) BBP in all cosmetic products NOAEL: 50 mg/kg/d (Tyl et al. 2004, cited in RAR) based on a two generation study in SD rats Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Systemic Exposure Dose (SED) = 17.79 x 1000 x 0.011% x 5% / 60 = 0.00163 mg/kg/d BBP MoS = NOAEL / SED = 50 / 0.00163 = 31250 Systemic exposure of BBP from cosmetics is 3.26% of the 0.5 mg/kg/d TDI defined by EFSA (2005f). SCHER (2005) characterized the risk for consumers by using the NOAEL for developmental toxicity as a starting point and found the MoS-values derived are >> 1000. (EFSA 2005f; EU Risk Assessment BBP, 2004; SCHER, BBP, 2005) Exposure to BBP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA 2005f; CSTEE 2004, RAR 2003). Thus the inadvertent occurrence of BBP in cosmetics at trace levels does not seem to be a concern for consumer health.","page":15,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_034"} |
| SCCS_vision_codex | NOAEL | =9 | - | - | - | - | NOAEL study | {"dose":"Name | EINECS / CAS | Maximum perfume concentration (mg/kg) | NOAEL mg/kg/day Critical effect","effect":"Unlabeled table on page 9: Name | EINECS / CAS | Maximum perfume concentration (mg/kg) | NOAEL mg/kg/day Critical effect","page":9,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_035"} |
| SCCS_vision_codex | NOAEL | =600 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 9: Di-methyl phthalate (DMP) | 205-011-6 / 131-11-3 | 2982 | 600 Maternal toxicity","page":9,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_036"} |
| SCCS_vision_codex | NOAEL | =50 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 9: Di-isobutyl phthalate (DIBP) | 201-553-2 / 84-69-5 | 38 | 50 effects on liver","page":9,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_037"} |
| SCCS_vision_codex | NOAEL | =10 | - | - | - | - | NOAEL study | {"dose":"Name | EINECS / CAS | Highest perfume concentration in mg/kg | NOAEL mg/kg/day | Status","effect":"Unlabeled table on page 10: Name | EINECS / CAS | Highest perfume concentration in mg/kg | NOAEL mg/kg/day | Status","page":10,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_038"} |
| SCCS_vision_codex | NOAEL | =15 | - | dog | oral | 13-week | NOAEL study | {"effect":"Unlabeled table on page 10: di-iso-decyl phthalate (DIDP) | 271-090-4 & 247- 977-1/ 68515-49-1 & 26761-40-0 | 37 | 15 13-week oral study in dogs 25 50 –600 increased liver and thyroid weight RAR Conclusion (iii) and (ii)** | EFSA (2005b) CSTEE (2001b) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC, RAR available","page":10,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_040"} |
| SCCS_vision_codex | NOAEL | =12 | - | - | - | - | NOAEL study | {"dose":"Name | EINECS / CAS | Highest concentration in mg/kg | NOAEL mg/kg bw/day Critical effect | Status","effect":"Unlabeled table on page 12: Name | EINECS / CAS | Highest concentration in mg/kg | NOAEL mg/kg bw/day Critical effect | Status","page":12,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_041"} |
| SCCS_vision_codex | NOAEL | =4.8 | - | - | - | developmental | reproductive toxicity | {"effect":"Unlabeled table on page 12: di-(2-ethylhexyl) phthalate (DEHP) | 204-211-0/ 117-81-7 | 167 | 4.8 testicular and developmental toxicity 88-1000 increased liver and kidney weight, testes RAR Conclusion (ii) and (iii)* | CSTEE (2004b) EFSA (2005d) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC. RAR Annex 1 607-317-00-9 Repr. Cat. 2; R60-61 (fertility;development)","page":12,"pdf":"sccp_o_106.pdf","row_type":"noael_study","study_id":"sccp_o_106_noael_042"} |
ToxRefDB_ToxRefDB_v3_pod.csv 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxRefDB_ToxRefDB_v3_pod.csv | LEL | =3570 | mg/kg bw/day | rat (sprague dawley; CD(SD)BR) | oral | 6 GD to 15 GD | DEV | study_id=2071; toxval_study_source_id=studyid2071_Adult_F0_F_systemic; toxval_effect_list=in life observation-body weight-body weight|in life observation-body weight-body weight gain|organ weight-liver-relative to body weight|in life observation-food consumption-food consumption|in life observation-water consumption-water consumption|organ weight-kidney-relative to body weight; dose_level=3; study_year=1989; study_citation=Developmental Toxicity Evaluation of Dimethyl Phthalate (CAS 131-11-3) Administered to CD Rats on Gestational Days 6-15 (1989). NTP Study Report: TER88066.; dsstox_substance_id=DTXSID3022455; admin_method=Feed; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | NEL | =840 | mg/kg bw/day | rat (sprague dawley; CD(SD)BR) | oral | 6 GD to 15 GD | DEV | study_id=2071; toxval_study_source_id=studyid2071_Adult_F0_F_systemic; toxval_effect_list=in life observation-body weight-body weight gain|in life observation-body weight-body weight|organ weight-liver-relative to body weight|in life observation-water consumption-water consumption|in life observation-food consumption-food consumption|organ weight-kidney-relative to body weight; dose_level=2; study_year=1989; study_citation=Developmental Toxicity Evaluation of Dimethyl Phthalate (CAS 131-11-3) Administered to CD Rats on Gestational Days 6-15 (1989). NTP Study Report: TER88066.; dsstox_substance_id=DTXSID3022455; admin_method=Feed; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
ToxValDB_Alaska_DEC 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_Alaska_DEC | RfD | =9 | mg/kg bw/day | Human | dermal | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/610038e1e4b01a90a3f9ae63; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://dec.alaska.gov/spar/csp/; STUDY_GROUP=Alaska DEC:15445854:-:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=4ece426b7fee89bf4cdce3733157c544 |
| ToxValDB_Alaska_DEC | RfD | =10 | mg/kg bw/day | Human | oral | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/610038e1e4b01a90a3f9ae63; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://dec.alaska.gov/spar/csp/; STUDY_GROUP=Alaska DEC:15445855:-:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=52b743064179e37201325dec922b423b |
| ToxValDB_Alaska_DEC | RfD | =9 | mg/kg bw/day | Human | dermal | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/610038e1e4b01a90a3f9ae63; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://dec.alaska.gov/spar/csp/; STUDY_GROUP=Alaska DEC:15445854:-:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=4ece426b7fee89bf4cdce3733157c544 |
| ToxValDB_Alaska_DEC | RfD | =10 | mg/kg bw/day | Human | oral | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/610038e1e4b01a90a3f9ae63; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://dec.alaska.gov/spar/csp/; STUDY_GROUP=Alaska DEC:15445855:-:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=52b743064179e37201325dec922b423b |
ToxValDB_DOE_Protective_Action_Criteria 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_DOE_Protective_Action_Criteria | LEL | =71479.9 | mg/m3 | Human | inhalation | - | acute | LONG_REF=U.S. Department of Energy (DOE) Protective Action Criteria (PAC). 2023. PAC Chemical Database. Updated 11 October 2023. Available: https://edms3.energy.gov/pac/ (Accessed November 16, 2023); TITLE=U.S. Department of Energy (DOE) Protective Action Criteria (PAC) Chemical Database; AUTHOR=U.S. Department of Energy; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65428efee4b045b9ff7cc432; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://edms3.energy.gov/pac/TeelDocs; YEAR=2013; ORIGINAL_YEAR=2013; STUDY_GROUP=DOE Protective Action Criteria:15514876:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_41998b0a8841910dadbee070df4723b2 |
ToxValDB_ECOTOX 7 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECOTOX | NOEC | =300 | mg/L | Rat | environmental | short-term; 2 days | developmental | LONG_REF=Alt. Lab. Anim. (ATLA)32(3): 275-307 Piersma,A.H., E. Genschow, A. Verhoef, M.Q.I. Spanjersberg, N.A. Brown, M. Brady, A. Burns, N. Clemann, A. Seiler, and Validation of the Postimplantation Rat Whole-Embryo Culture Test in the International ECVAM Validation Study on Three In Vitro Embryotoxicity Tests 2004; TITLE=Validation of the Postimplantation Rat Whole-Embryo Culture Test in the International ECVAM Validation Study on Three In Vitro Embryotoxicity Tests; AUTHOR=Piersma,A.H., E. Genschow, A. Verhoef, M.Q.I. Spanjersberg, N.A. Brown, M. Brady, A. Burns, N. Clemann, A. Seiler, and; DOI=10.1177/026119290403200307; QUALITY=Control type: Multiple entries; EXTERNAL_SOURCE_ID=157474; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=2004; ORIGINAL_YEAR=2004; TOXICOLOGICAL_EFFECT=Development: Deformation; TOXICOLOGICAL_EFFECT_CATEGORY=development; STUDY_GROUP=ECOTOX_dup_EPA ORD_15600854_15605544_15610715_15610730_15610750_15610780:unknown:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=1a2e0cc91be026646165215af1e04fd9 |
| ToxValDB_ECOTOX | NOEC | =15 | mg/L | Rat | environmental | short-term; 2 days | developmental | LONG_REF=Alt. Lab. Anim. (ATLA)32(3): 275-307 Piersma,A.H., E. Genschow, A. Verhoef, M.Q.I. Spanjersberg, N.A. Brown, M. Brady, A. Burns, N. Clemann, A. Seiler, and Validation of the Postimplantation Rat Whole-Embryo Culture Test in the International ECVAM Validation Study on Three In Vitro Embryotoxicity Tests 2004; TITLE=Validation of the Postimplantation Rat Whole-Embryo Culture Test in the International ECVAM Validation Study on Three In Vitro Embryotoxicity Tests; AUTHOR=Piersma,A.H., E. Genschow, A. Verhoef, M.Q.I. Spanjersberg, N.A. Brown, M. Brady, A. Burns, N. Clemann, A. Seiler, and; DOI=10.1177/026119290403200307; QUALITY=Control type: Multiple entries; EXTERNAL_SOURCE_ID=157474; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=2004; ORIGINAL_YEAR=2004; TOXICOLOGICAL_EFFECT=Development: Deformation; TOXICOLOGICAL_EFFECT_CATEGORY=development; STUDY_GROUP=ECOTOX_dup_EPA ORD_15600854_15605544_15610715_15610730_15610750_15610780:unknown:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=3c7532fdc52dd66afd79452ef292c2ae |
| ToxValDB_ECOTOX | NOEC | >375 | mg/L | Rat | environmental | short-term; 2 days | developmental | LONG_REF=Alt. Lab. Anim. (ATLA)32(3): 275-307 Piersma,A.H., E. Genschow, A. Verhoef, M.Q.I. Spanjersberg, N.A. Brown, M. Brady, A. Burns, N. Clemann, A. Seiler, and Validation of the Postimplantation Rat Whole-Embryo Culture Test in the International ECVAM Validation Study on Three In Vitro Embryotoxicity Tests 2004; TITLE=Validation of the Postimplantation Rat Whole-Embryo Culture Test in the International ECVAM Validation Study on Three In Vitro Embryotoxicity Tests; AUTHOR=Piersma,A.H., E. Genschow, A. Verhoef, M.Q.I. Spanjersberg, N.A. Brown, M. Brady, A. Burns, N. Clemann, A. Seiler, and; DOI=10.1177/026119290403200307; QUALITY=Control type: Multiple entries; EXTERNAL_SOURCE_ID=157474; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=2004; ORIGINAL_YEAR=2004; TOXICOLOGICAL_EFFECT=Development: Deformation; TOXICOLOGICAL_EFFECT_CATEGORY=development; STUDY_GROUP=ECOTOX_dup_EPA ORD_15600854_15605544_15610715_15610730_15610750_15610780:unknown:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=5f3fbecc9b8c4009c6e83ca36226f4ce |
| ToxValDB_ECOTOX | NOEC | >750 | mg/L | Rat | environmental | short-term; 2 days | developmental | LONG_REF=Alt. Lab. Anim. (ATLA)32(3): 275-307 Piersma,A.H., E. Genschow, A. Verhoef, M.Q.I. Spanjersberg, N.A. Brown, M. Brady, A. Burns, N. Clemann, A. Seiler, and Validation of the Postimplantation Rat Whole-Embryo Culture Test in the International ECVAM Validation Study on Three In Vitro Embryotoxicity Tests 2004; TITLE=Validation of the Postimplantation Rat Whole-Embryo Culture Test in the International ECVAM Validation Study on Three In Vitro Embryotoxicity Tests; AUTHOR=Piersma,A.H., E. Genschow, A. Verhoef, M.Q.I. Spanjersberg, N.A. Brown, M. Brady, A. Burns, N. Clemann, A. Seiler, and; DOI=10.1177/026119290403200307; QUALITY=Control type: Multiple entries; EXTERNAL_SOURCE_ID=157474; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=2004; ORIGINAL_YEAR=2004; TOXICOLOGICAL_EFFECT=Development: Deformation; TOXICOLOGICAL_EFFECT_CATEGORY=development; STUDY_GROUP=ECOTOX_dup_EPA ORD_15600854_15605544_15610715_15610730_15610750_15610780:unknown:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=f7e450fa018244dd4cc743ac0008f9d4 |
| ToxValDB_ECOTOX | NOEC | >365 | mg/L | Rat | environmental | short-term; 2 days | developmental | LONG_REF=Alt. Lab. Anim. (ATLA)32(3): 275-307 Piersma,A.H., E. Genschow, A. Verhoef, M.Q.I. Spanjersberg, N.A. Brown, M. Brady, A. Burns, N. Clemann, A. Seiler, and Validation of the Postimplantation Rat Whole-Embryo Culture Test in the International ECVAM Validation Study on Three In Vitro Embryotoxicity Tests 2004; TITLE=Validation of the Postimplantation Rat Whole-Embryo Culture Test in the International ECVAM Validation Study on Three In Vitro Embryotoxicity Tests; AUTHOR=Piersma,A.H., E. Genschow, A. Verhoef, M.Q.I. Spanjersberg, N.A. Brown, M. Brady, A. Burns, N. Clemann, A. Seiler, and; DOI=10.1177/026119290403200307; QUALITY=Control type: Multiple entries; EXTERNAL_SOURCE_ID=157474; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=2004; ORIGINAL_YEAR=2004; TOXICOLOGICAL_EFFECT=Development: Deformation; TOXICOLOGICAL_EFFECT_CATEGORY=development; STUDY_GROUP=ECOTOX_dup_EPA ORD_15600854_15605544_15610715_15610730_15610750_15610780:unknown:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=fcd89ca1c869021e6604d703685498c0 |
| ToxValDB_ECOTOX | NOEC | >400 | mg/L | Rat | environmental | short-term; 2 days | developmental | LONG_REF=Alt. Lab. Anim. (ATLA)32(3): 275-307 Piersma,A.H., E. Genschow, A. Verhoef, M.Q.I. Spanjersberg, N.A. Brown, M. Brady, A. Burns, N. Clemann, A. Seiler, and Validation of the Postimplantation Rat Whole-Embryo Culture Test in the International ECVAM Validation Study on Three In Vitro Embryotoxicity Tests 2004; TITLE=Validation of the Postimplantation Rat Whole-Embryo Culture Test in the International ECVAM Validation Study on Three In Vitro Embryotoxicity Tests; AUTHOR=Piersma,A.H., E. Genschow, A. Verhoef, M.Q.I. Spanjersberg, N.A. Brown, M. Brady, A. Burns, N. Clemann, A. Seiler, and; DOI=10.1177/026119290403200307; QUALITY=Control type: Multiple entries; EXTERNAL_SOURCE_ID=157474; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=2004; ORIGINAL_YEAR=2004; TOXICOLOGICAL_EFFECT=Development: Deformation; TOXICOLOGICAL_EFFECT_CATEGORY=development; STUDY_GROUP=ECOTOX_dup_EPA ORD_15600854_15605544_15610715_15610730_15610750_15610780:unknown:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=7206c9db20cc08ef5f6044582f91700f |
| ToxValDB_ECOTOX | NOEL | =2 | % diet | Rat | oral | short-term; 7 days | short-term | LONG_REF=Toxicol. Appl. Pharmacol.53(1): 35-41 Oishi,S., and K. Hiraga Testicular Atrophy Induced by Phthalic Acid Esters: Effect on Testosterone and Zinc Concentrations 1980; TITLE=Testicular Atrophy Induced by Phthalic Acid Esters: Effect on Testosterone and Zinc Concentrations; AUTHOR=Oishi,S., and K. Hiraga; DOI=10.1016/0041-008x(80)90378-6; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=66065; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1980; ORIGINAL_YEAR=1980; TOXICOLOGICAL_EFFECT=Biochemistry: Zinc content|Growth: Weight|Morphology: Organ weight in relationship to body weight|Morphology: Weight; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|organ weight|other; STUDY_GROUP=ECOTOX_dup_EPA ORD_15598851_15608311:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=0118efe192a863a52cef528e8f4f5689 |
ToxValDB_GESTIS_DNEL 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_GESTIS_DNEL | DNEL systemic | =66.1 | mg/m3 | Human | inhalation | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6543dd69e4b045b9ff7cd87e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.dguv.de/ifa/gestis/gestis-dnel-liste/index-2.jsp; STUDY_GROUP=GESTIS DNEL:15631458:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_2acf714a9eb1e2272cedde3f2ac18da2 |
ToxValDB_HPVIS 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_HPVIS | NOAEL | =840 | mg/kg bw/day | Rat | oral | short-term; 10 days | reproduction developmental | LONG_REF=Data from this HPVIS summary were extracted from documents posted to the HPV Challenge website on March 15, 2002.Field et al., (1993). Developmental toxicity evaluation of diethyl and dimethyl phthalate in rats. Teratology 38:33-44.; QUALITY=1; EXTERNAL_SOURCE_ID=59024; EXTERNAL_SOURCE_ID_DESC=HPVIS ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/63861d6de4b04f6bb1480590; RECORD_SOURCE_LEVEL=Extraction document; YEAR=1993; ORIGINAL_YEAR=1993; STUDY_GROUP=HPVIS:15642642:F:-maternal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_12f0c03c14bb8a90706810b9a69a99ea |
| ToxValDB_HPVIS | NOAEL | >3570 | mg/kg bw/day | Rat | oral | short-term; 10 days | developmental | LONG_REF=Data from this HPVIS summary were extracted from documents posted to the HPV Challenge website on March 15, 2002.Field et al., (1993). Developmental toxicity evaluation of diethyl and dimethyl phthalate in rats. Teratology 38:33-44.; QUALITY=1; EXTERNAL_SOURCE_ID=59429; EXTERNAL_SOURCE_ID_DESC=HPVIS ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/63861d6de4b04f6bb1480590; RECORD_SOURCE_LEVEL=Extraction document; YEAR=1993; ORIGINAL_YEAR=1993; STUDY_GROUP=HPVIS:15642749:-:-fetal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_a35abdfeb847e7483f7b5fa22d69b786 |
ToxValDB_PPRTV_(CPHEA) 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_PPRTV_(CPHEA) | LOAEL | =302 | mg/kg bw/day | Rat | oral | short-term; 1 weeks | short-term | LONG_REF=Oishi, S. and K. Hiraga. 1980. Testicular atrophy induced by phthalic acid esters: effect on testosterone and zinc concentrations. Toxicol. Appl. Pharmacol. 53:35-41.; AUTHOR=Oishi, S. and K. Hiraga; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/640754bee4b08a6b3934b3df; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.epa.gov/pprtv/basic-information-about-provisional-peer-reviewed-toxicity-values-pprtvs; SUBSOURCE_URL=https://cfpub.epa.gov/ncea/pprtv/chemicalLanding.cfm?pprtv_sub_id=1716; TOXICOLOGICAL_EFFECT=increased absolute and relative liver weight and decreased serum and testicular testosterone; STUDY_GROUP=PPRTV (CPHEA):15654083:M:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_c8c03f715eaacee8e24a97fb67fcb2a7 |
| ToxValDB_PPRTV_(CPHEA) | RfD (provisional) | =0.1 | mg/kg bw/day | Human | oral | - | Toxicity Value | LONG_REF=Oishi, S. and K. Hiraga. 1980. Testicular atrophy induced by phthalic acid esters: effect on testosterone and zinc concentrations. Toxicol. Appl. Pharmacol. 53:35-41.; AUTHOR=Oishi, S. and K. Hiraga; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/640754bee4b08a6b3934b3df; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.epa.gov/pprtv/basic-information-about-provisional-peer-reviewed-toxicity-values-pprtvs; SUBSOURCE_URL=https://cfpub.epa.gov/ncea/pprtv/chemicalLanding.cfm?pprtv_sub_id=1716; TOXICOLOGICAL_EFFECT=increased absolute and relative liver weight and decreased serum and testicular testosterone in male rats; STUDY_GROUP=PPRTV (CPHEA):15653639:-:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_aa65e7742c611979224006eeef763583 |
ToxValDB_ToxRefDB 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ToxRefDB | LEL | =3570 | mg/kg bw/day | Rat | oral | short-term (developmental); 10 days | reproduction developmental | LONG_REF=Developmental Toxicity Evaluation of Dimethyl Phthalate (CAS 131-11-3) Administered to CD Rats on Gestational Days 6-15 (1989). NTP Study Report: TER88066.; TITLE=Developmental Toxicity Evaluation of Dimethyl Phthalate (CAS 131-11-3) Administered to CD Rats on Gestational Days 6-15; AUTHOR=NTP; EXTERNAL_SOURCE_ID=2071; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1989; ORIGINAL_YEAR=1989; TOXICOLOGICAL_EFFECT=systemic: organ weight-liver-relative to body weight|systemic: in life observation-food consumption-food consumption|systemic: in life observation-water consumption-water consumption|systemic: organ weight-kidney-relative to body weight|systemic: in life observation-body weight-body weight gain|systemic: in life observation-body weight-body weight; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|food and/or water consumption|organ weight; STUDY_GROUP=ToxRefDB_dup_-_15691882_15691883_15691884_15691885:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_68aabf062ad36aef4aae4268cc94b44f |
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 47 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 2982 | mg/kg | - | - | - | - | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=2982; DOSE=SCCP/1016/06 Opinion on phthalates in cosmetic products 9 Name EINECS / CAS Maximum perfume concentration (mg/kg) NOAEL mg/kg/day Critical effect Di-methyl phthalate (DMP) 205-011-6 / 131-11-3 2982 600 Maternal toxicity Di-isobutyl phthalate (DIBP) 201-553-2 / 84-69-5 38 50 effects on liver Di-cyclohexyl phthalate (DCHP) 201-545-9 / 84-61-7 3 -...; EFFECT=SCCP/1016/06 Opinion on phthalates in cosmetic products 9 Name EINECS / CAS Maximum perfume concentration (mg/kg) NOAEL mg/kg/day Critical effect Di-methyl phthalate (DMP) 205-011-6 / 131-11-3 2982 600 Maternal toxicity Di-isobutyl phthalate (DIBP) 201-553-2 / 84-69-5 38 50 effects on liver Di-cyclohexyl phthalate (DCHP) 201-545-9 / 84-61-7 3 - DMP was found at a concentration as high as 2982 mg/kg or 0.3% in one perfume, in the other 15 perfumes the concentration was between 0.1 and 1.9 mg/kg. COLIPA has stated (letter of 29 November 2002) that “there is no intentional use of DMP…as a cosmetic ingredient’. Consequently, the pres; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"SCCP/1016/06 Opinion on phthalates in cosmetic products 9 Name EINECS / CAS Maximum perfume concentration (mg/kg) NOAEL mg/kg/day Critical effect Di-methyl phthalate (DMP) 205-011-6 / 131-11-3 2982 600 Maternal toxicity Di-isobutyl phthalate (DIBP) 201-553-2 / 84-69-5 38 50 effects on liver Di-cyclohexyl phthalate (DCHP) 201-545-9 / 84-61-7 3 -...","duration":"","effect":"SCCP/1016/06 Opinion on phthalates in cosmetic products 9 Name EINECS / CAS Maximum perfume concentration (mg/kg) NOAEL mg/kg/day Critical effect Di-methyl phthalate (DMP) 205-011-6 / 131-11-3 2982 600 Maternal toxicity Di-isobutyl phthalate (DIBP) 201-553-2 / 84-69-5 38 50 effects on liver Di-cyclohexyl phthalate (DCHP) 201-545-9 / 84-61-7 3 - DMP was found at a concentration as high as 2982 mg/kg or 0.3% in one perfume, in the other 15 perfumes the concentration was between 0.1 and 1.9 mg/kg. COLIPA has stated (letter of 29 November 2002) that “there is no intentional use of DMP…as a cosmetic ingredient’. Consequently, the pres","endpoint":"","ingredient":"s.” Names in brackets","loael_value":"","noael_unit":"mg/kg","noael_value":"2982","page":9,"route":"","species":"","study_id":"sccp_o_106_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 3 | mg/kg | - | - | 90-day | - | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=3; DOSE=SCCP/1016/06 Opinion on phthalates in cosmetic products 10 DCHP was found in only 1/36 perfume samples at a concentration of 3 mg/kg.; EFFECT=SCCP/1016/06 Opinion on phthalates in cosmetic products 10 DCHP was found in only 1/36 perfume samples at a concentration of 3 mg/kg. There appears to be no recent work on DCHP. The 90-day studies reported in the IUCLID data sheet (IUCLID, 2000) do not seem to be according to modern standards. No NOAEL was derived from these studies. EFSA (2004) requested additional data: reproduction and teratogenicity studies, test for gene mutation and in vitro mammalian cell chromosome aberration tests. Conclusion Despite the lack of adequate toxicological data, the low concentration (3 mg/kg) of DCHP found in only one sample of perfume, suggest unintentional exposure from perfume and other cosmetics would have no measurable risk for the consumer. DIBP was found in 20/36 perfumes with concentrations ranging from 0.2 - 38; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"SCCP/1016/06 Opinion on phthalates in cosmetic products 10 DCHP was found in only 1/36 perfume samples at a concentration of 3 mg/kg.","duration":"90-day","effect":"SCCP/1016/06 Opinion on phthalates in cosmetic products 10 DCHP was found in only 1/36 perfume samples at a concentration of 3 mg/kg. There appears to be no recent work on DCHP. The 90-day studies reported in the IUCLID data sheet (IUCLID, 2000) do not seem to be according to modern standards. No NOAEL was derived from these studies. EFSA (2004) requested additional data: reproduction and teratogenicity studies, test for gene mutation and in vitro mammalian cell chromosome aberration tests. Conclusion Despite the lack of adequate toxicological data, the low concentration (3 mg/kg) of DCHP found in only one sample of perfume, suggest unintentional exposure from perfume and other cosmetics would have no measurable risk for the consumer. DIBP was found in 20/36 perfumes with concentrations ranging from 0.2 - 38","endpoint":"","ingredient":"s.” Names in brackets","loael_value":"","noael_unit":"mg/kg","noael_value":"3","page":10,"route":"","species":"","study_id":"sccp_o_106_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 15 | mg/kg bw/day | rat | oral | 13-week | - | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=15; DOSE=SED = 41666 Systemic exposure of DINP from cosmetics is 0.24% of the TDI for DINP of 0.15 mg/kg/d derived by EFSA, (2005a) Exposure to DINP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA, 2005a;; LOAEL_VALUE=77 mg/kg bw/day; EFFECT=SED = 41666 Systemic exposure of DINP from cosmetics is 0.24% of the TDI for DINP of 0.15 mg/kg/d derived by EFSA, (2005a) Exposure to DINP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA, 2005a; CSTEE, 2004, RAR, 2003). Thus the inadvertent occurrence of DINP in cosmetics does not seem to be a concern for consumer health. DIDP DIDP was found in 5/36 perfume samples at concentrations ranging from 1.5 - 37 mg/kg. The EFSA Panel concluded that a NOAEL of 15 mg/kg bw/day for DIDP from a 13-week oral study in dogs (a non-sensitive species to peroxisome proliferation) should be used in the risk assessment and in a 2-year rat study where there was a decrease of F2 offspring survival with a NOAEL of 33 mg/kg bw/day. From the same data, CSTEE (2001b) calculated a NOAEL of 25 mg/kg/d based on the lowest observed adverse effect level (LOAEL). Liver changes were seen at higher dose levels with a lowest observed adverse effect level LOAEL of 77 mg/kg bw/day and 88 mg/kg; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"SED = 41666 Systemic exposure of DINP from cosmetics is 0.24% of the TDI for DINP of 0.15 mg/kg/d derived by EFSA, (2005a) Exposure to DINP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA, 2005a;","duration":"13-week","effect":"SED = 41666 Systemic exposure of DINP from cosmetics is 0.24% of the TDI for DINP of 0.15 mg/kg/d derived by EFSA, (2005a) Exposure to DINP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA, 2005a; CSTEE, 2004, RAR, 2003). Thus the inadvertent occurrence of DINP in cosmetics does not seem to be a concern for consumer health. DIDP DIDP was found in 5/36 perfume samples at concentrations ranging from 1.5 - 37 mg/kg. The EFSA Panel concluded that a NOAEL of 15 mg/kg bw/day for DIDP from a 13-week oral study in dogs (a non-sensitive species to peroxisome proliferation) should be used in the risk assessment and in a 2-year rat study where there was a decrease of F2 offspring survival with a NOAEL of 33 mg/kg bw/day. From the same data, CSTEE (2001b) calculated a NOAEL of 25 mg/kg/d based on the lowest observed adverse effect level (LOAEL). Liver changes were seen at higher dose levels with a lowest observed adverse effect level LOAEL of 77 mg/kg bw/day and 88 mg/kg","endpoint":"","ingredient":"s.” Names in brackets","loael_value":"77 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"15","page":11,"route":"oral","species":"rat","study_id":"sccp_o_106_noael_015"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 33 | mg/kg bw/day | rat | oral | 13-week | - | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=33; DOSE=DIDP DIDP was found in 5/36 perfume samples at concentrations ranging from 1.5 - 37 mg/kg.; LOAEL_VALUE=77 mg/kg bw/day; EFFECT=oducts (EFSA, 2005a; CSTEE, 2004, RAR, 2003). Thus the inadvertent occurrence of DINP in cosmetics does not seem to be a concern for consumer health. DIDP DIDP was found in 5/36 perfume samples at concentrations ranging from 1.5 - 37 mg/kg. The EFSA Panel concluded that a NOAEL of 15 mg/kg bw/day for DIDP from a 13-week oral study in dogs (a non-sensitive species to peroxisome proliferation) should be used in the risk assessment and in a 2-year rat study where there was a decrease of F2 offspring survival with a NOAEL of 33 mg/kg bw/day. From the same data, CSTEE (2001b) calculated a NOAEL of 25 mg/kg/d based on the lowest observed adverse effect level (LOAEL). Liver changes were seen at higher dose levels with a lowest observed adverse effect level LOAEL of 77 mg/kg bw/day and 88 mg/kg bw/day for male and female dogs respectively. Using the NOAEL of 15 mg/kg bw/day and of an uncertainty factor of 100, a TDI for DIDP of 0.15 mg/kg bw was derived (EFSA 2005b).; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"DIDP DIDP was found in 5/36 perfume samples at concentrations ranging from 1.5 - 37 mg/kg.","duration":"13-week","effect":"oducts (EFSA, 2005a; CSTEE, 2004, RAR, 2003). Thus the inadvertent occurrence of DINP in cosmetics does not seem to be a concern for consumer health. DIDP DIDP was found in 5/36 perfume samples at concentrations ranging from 1.5 - 37 mg/kg. The EFSA Panel concluded that a NOAEL of 15 mg/kg bw/day for DIDP from a 13-week oral study in dogs (a non-sensitive species to peroxisome proliferation) should be used in the risk assessment and in a 2-year rat study where there was a decrease of F2 offspring survival with a NOAEL of 33 mg/kg bw/day. From the same data, CSTEE (2001b) calculated a NOAEL of 25 mg/kg/d based on the lowest observed adverse effect level (LOAEL). Liver changes were seen at higher dose levels with a lowest observed adverse effect level LOAEL of 77 mg/kg bw/day and 88 mg/kg bw/day for male and female dogs respectively. Using the NOAEL of 15 mg/kg bw/day and of an uncertainty factor of 100, a TDI for DIDP of 0.15 mg/kg bw was derived (EFSA 2005b).","endpoint":"","ingredient":"s.” Names in brackets","loael_value":"77 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"33","page":11,"route":"oral","species":"rat","study_id":"sccp_o_106_noael_016"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 25 | mg/kg/d | rat | oral | 13-week | - | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=25; DOSE=DIDP DIDP was found in 5/36 perfume samples at concentrations ranging from 1.5 - 37 mg/kg.; LOAEL_VALUE=77 mg/kg bw/day; EFFECT=ence of DINP in cosmetics does not seem to be a concern for consumer health. DIDP DIDP was found in 5/36 perfume samples at concentrations ranging from 1.5 - 37 mg/kg. The EFSA Panel concluded that a NOAEL of 15 mg/kg bw/day for DIDP from a 13-week oral study in dogs (a non-sensitive species to peroxisome proliferation) should be used in the risk assessment and in a 2-year rat study where there was a decrease of F2 offspring survival with a NOAEL of 33 mg/kg bw/day. From the same data, CSTEE (2001b) calculated a NOAEL of 25 mg/kg/d based on the lowest observed adverse effect level (LOAEL). Liver changes were seen at higher dose levels with a lowest observed adverse effect level LOAEL of 77 mg/kg bw/day and 88 mg/kg bw/day for male and female dogs respectively. Using the NOAEL of 15 mg/kg bw/day and of an uncertainty factor of 100, a TDI for DIDP of 0.15 mg/kg bw was derived (EFSA 2005b).; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"DIDP DIDP was found in 5/36 perfume samples at concentrations ranging from 1.5 - 37 mg/kg.","duration":"13-week","effect":"ence of DINP in cosmetics does not seem to be a concern for consumer health. DIDP DIDP was found in 5/36 perfume samples at concentrations ranging from 1.5 - 37 mg/kg. The EFSA Panel concluded that a NOAEL of 15 mg/kg bw/day for DIDP from a 13-week oral study in dogs (a non-sensitive species to peroxisome proliferation) should be used in the risk assessment and in a 2-year rat study where there was a decrease of F2 offspring survival with a NOAEL of 33 mg/kg bw/day. From the same data, CSTEE (2001b) calculated a NOAEL of 25 mg/kg/d based on the lowest observed adverse effect level (LOAEL). Liver changes were seen at higher dose levels with a lowest observed adverse effect level LOAEL of 77 mg/kg bw/day and 88 mg/kg bw/day for male and female dogs respectively. Using the NOAEL of 15 mg/kg bw/day and of an uncertainty factor of 100, a TDI for DIDP of 0.15 mg/kg bw was derived (EFSA 2005b).","endpoint":"","ingredient":"s.” Names in brackets","loael_value":"77 mg/kg bw/day","noael_unit":"mg/kg/d","noael_value":"25","page":11,"route":"oral","species":"rat","study_id":"sccp_o_106_noael_017"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 15 | mg/kg bw/day | rat | - | 2-year | - | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=15; DOSE=n dogs (a non-sensitive species to peroxisome proliferation) should be used in the risk assessment and in a 2-year rat study where there was a decrease of F2 offspring survival with a NOAEL of 33 mg/kg bw/day.; LOAEL_VALUE=77 mg/kg bw/day; EFFECT=n dogs (a non-sensitive species to peroxisome proliferation) should be used in the risk assessment and in a 2-year rat study where there was a decrease of F2 offspring survival with a NOAEL of 33 mg/kg bw/day. From the same data, CSTEE (2001b) calculated a NOAEL of 25 mg/kg/d based on the lowest observed adverse effect level (LOAEL). Liver changes were seen at higher dose levels with a lowest observed adverse effect level LOAEL of 77 mg/kg bw/day and 88 mg/kg bw/day for male and female dogs respectively. Using the NOAEL of 15 mg/kg bw/day and of an uncertainty factor of 100, a TDI for DIDP of 0.15 mg/kg bw was derived (EFSA 2005b).; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"n dogs (a non-sensitive species to peroxisome proliferation) should be used in the risk assessment and in a 2-year rat study where there was a decrease of F2 offspring survival with a NOAEL of 33 mg/kg bw/day.","duration":"2-year","effect":"n dogs (a non-sensitive species to peroxisome proliferation) should be used in the risk assessment and in a 2-year rat study where there was a decrease of F2 offspring survival with a NOAEL of 33 mg/kg bw/day. From the same data, CSTEE (2001b) calculated a NOAEL of 25 mg/kg/d based on the lowest observed adverse effect level (LOAEL). Liver changes were seen at higher dose levels with a lowest observed adverse effect level LOAEL of 77 mg/kg bw/day and 88 mg/kg bw/day for male and female dogs respectively. Using the NOAEL of 15 mg/kg bw/day and of an uncertainty factor of 100, a TDI for DIDP of 0.15 mg/kg bw was derived (EFSA 2005b).","endpoint":"","ingredient":"s.” Names in brackets","loael_value":"77 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"15","page":11,"route":"","species":"rat","study_id":"sccp_o_106_noael_018"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 9 | - | - | - | - | - | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=unclear:Unlabeled table on page 9: Name | EINECS / CAS | Maximum perfume concentration (mg/kg) | NOAEL mg/kg/day Critical effect; DOSE=Name | EINECS / CAS | Maximum perfume concentration (mg/kg) | NOAEL mg/kg/day Critical effect; EFFECT=Unlabeled table on page 9: Name | EINECS / CAS | Maximum perfume concentration (mg/kg) | NOAEL mg/kg/day Critical effect; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"Name | EINECS / CAS | Maximum perfume concentration (mg/kg) | NOAEL mg/kg/day Critical effect","duration":"","effect":"Unlabeled table on page 9: Name | EINECS / CAS | Maximum perfume concentration (mg/kg) | NOAEL mg/kg/day Critical effect","endpoint":"","ingredient":"s.” Names in brackets","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 9: Name | EINECS / CAS | Maximum perfume concentration (mg/kg) | NOAEL mg/kg/day Critical effect","page":9,"route":"","species":"","study_id":"sccp_o_106_noael_035"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 600 | - | - | - | - | - | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=600 Maternal toxicity; EFFECT=Unlabeled table on page 9: Di-methyl phthalate (DMP) | 205-011-6 / 131-11-3 | 2982 | 600 Maternal toxicity; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 9: Di-methyl phthalate (DMP) | 205-011-6 / 131-11-3 | 2982 | 600 Maternal toxicity","endpoint":"","ingredient":"s.” Names in brackets","loael_value":"","noael_unit":"","noael_value":"600 Maternal toxicity","page":9,"route":"","species":"","study_id":"sccp_o_106_noael_036"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 50 | - | - | - | - | - | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=50 effects on liver; EFFECT=Unlabeled table on page 9: Di-isobutyl phthalate (DIBP) | 201-553-2 / 84-69-5 | 38 | 50 effects on liver; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 9: Di-isobutyl phthalate (DIBP) | 201-553-2 / 84-69-5 | 38 | 50 effects on liver","endpoint":"","ingredient":"s.” Names in brackets","loael_value":"","noael_unit":"","noael_value":"50 effects on liver","page":9,"route":"","species":"","study_id":"sccp_o_106_noael_037"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 10 | - | - | - | - | - | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=unclear:Unlabeled table on page 10: Name | EINECS / CAS | Highest perfume concentration in mg/kg | NOAEL mg/kg/day | Status; DOSE=Name | EINECS / CAS | Highest perfume concentration in mg/kg | NOAEL mg/kg/day | Status; EFFECT=Unlabeled table on page 10: Name | EINECS / CAS | Highest perfume concentration in mg/kg | NOAEL mg/kg/day | Status; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"Name | EINECS / CAS | Highest perfume concentration in mg/kg | NOAEL mg/kg/day | Status","duration":"","effect":"Unlabeled table on page 10: Name | EINECS / CAS | Highest perfume concentration in mg/kg | NOAEL mg/kg/day | Status","endpoint":"","ingredient":"s.” Names in brackets","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 10: Name | EINECS / CAS | Highest perfume concentration in mg/kg | NOAEL mg/kg/day | Status","page":10,"route":"","species":"","study_id":"sccp_o_106_noael_038"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 5 | % | rat | - | - | - | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=5; EFFECT=Unlabeled table on page 10: di-iso-nonyl phthalate (DINP) | 271-090-9 & 249- 079-5 / 68515-48-0 & 28553-12-0 | 26 | 15 (rat) Increased liver and kidney weight 5% response BMD of 12* 15 -1000 increased liver and kidney weight, testes RAR Conclusion (ii)** | EFSA (2005a) CSTEE (2001a) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC. RAR available; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 10: di-iso-nonyl phthalate (DINP) | 271-090-9 & 249- 079-5 / 68515-48-0 & 28553-12-0 | 26 | 15 (rat) Increased liver and kidney weight 5% response BMD of 12* 15 -1000 increased liver and kidney weight, testes RAR Conclusion (ii)** | EFSA (2005a) CSTEE (2001a) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC. RAR available","endpoint":"","ingredient":"s.” Names in brackets","loael_value":"","noael_unit":"%","noael_value":"5","page":10,"route":"","species":"rat","study_id":"sccp_o_106_noael_039"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 15 | - | dog | oral | 13-week | - | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=15 13-week oral study in dogs 25 50 –600 increased liver and thyroid weight RAR Conclusion (iii) and (ii)**; EFFECT=Unlabeled table on page 10: di-iso-decyl phthalate (DIDP) | 271-090-4 & 247- 977-1/ 68515-49-1 & 26761-40-0 | 37 | 15 13-week oral study in dogs 25 50 –600 increased liver and thyroid weight RAR Conclusion (iii) and (ii)** | EFSA (2005b) CSTEE (2001b) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC, RAR available; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"","duration":"13-week","effect":"Unlabeled table on page 10: di-iso-decyl phthalate (DIDP) | 271-090-4 & 247- 977-1/ 68515-49-1 & 26761-40-0 | 37 | 15 13-week oral study in dogs 25 50 –600 increased liver and thyroid weight RAR Conclusion (iii) and (ii)** | EFSA (2005b) CSTEE (2001b) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC, RAR available","endpoint":"","ingredient":"s.” Names in brackets","loael_value":"","noael_unit":"","noael_value":"15 13-week oral study in dogs 25 50 –600 increased liver and thyroid weight RAR Conclusion (iii) and (ii)**","page":10,"route":"oral","species":"dog","study_id":"sccp_o_106_noael_040"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 12 | - | - | - | - | - | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=unclear:Unlabeled table on page 12: Name | EINECS / CAS | Highest concentration in mg/kg | NOAEL mg/kg bw/day Critical effect | Status; DOSE=Name | EINECS / CAS | Highest concentration in mg/kg | NOAEL mg/kg bw/day Critical effect | Status; EFFECT=Unlabeled table on page 12: Name | EINECS / CAS | Highest concentration in mg/kg | NOAEL mg/kg bw/day Critical effect | Status; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"Name | EINECS / CAS | Highest concentration in mg/kg | NOAEL mg/kg bw/day Critical effect | Status","duration":"","effect":"Unlabeled table on page 12: Name | EINECS / CAS | Highest concentration in mg/kg | NOAEL mg/kg bw/day Critical effect | Status","endpoint":"","ingredient":"s.” Names in brackets","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 12: Name | EINECS / CAS | Highest concentration in mg/kg | NOAEL mg/kg bw/day Critical effect | Status","page":12,"route":"","species":"","study_id":"sccp_o_106_noael_041"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 13 | - | - | - | - | - | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=unclear:Unlabeled table on page 13: Name | EINECS / CAS | Highest concentration in mg/kg | NOAEL mg/kg bw/day Critical effect | Status; DOSE=Name | EINECS / CAS | Highest concentration in mg/kg | NOAEL mg/kg bw/day Critical effect | Status; EFFECT=Unlabeled table on page 13: Name | EINECS / CAS | Highest concentration in mg/kg | NOAEL mg/kg bw/day Critical effect | Status; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"Name | EINECS / CAS | Highest concentration in mg/kg | NOAEL mg/kg bw/day Critical effect | Status","duration":"","effect":"Unlabeled table on page 13: Name | EINECS / CAS | Highest concentration in mg/kg | NOAEL mg/kg bw/day Critical effect | Status","endpoint":"","ingredient":"s.” Names in brackets","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 13: Name | EINECS / CAS | Highest concentration in mg/kg | NOAEL mg/kg bw/day Critical effect | Status","page":13,"route":"","species":"","study_id":"sccp_o_106_noael_043"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | carcinogenicity | 15 | mg/kg bw/day | rat | - | chronic | carcinogenicity | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=15; DOSE=s beyond those which are being applied already Conclusion (iii) There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account DINP DINP was found in only 1/36 perfume samples at a concentration of 26 mg/kg.; EFFECT=s beyond those which are being applied already Conclusion (iii) There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account DINP DINP was found in only 1/36 perfume samples at a concentration of 26 mg/kg. The toxicological effects for DINP were an increased incidence of spongiosis hepatis, accompanied by increased serum levels of liver enzymes in males and increases in absolute and relative liver and kidney weights in both sexes. EFSA (2005a) used a NOAEL of 15 mg/kg bw/day for non-peroxisomal proliferation-related chronic hepatic and renal effects derived from a combined chronic/carcinogenicity study in rats. From the same data, CSTEE (2001) calculated a 5% response benchmark dose of 12 mg/kg/d using spongiosis hepatis as the critical endpoint of the risk characterization. This will not alter the Margin of Safety from perfume use. EFSA derived a TDI for DINP of 0.15 mg/kg bw, using the NOAEL of 15 mg/kg bw/day and an uncertainty factor of 100. Margin of Safety (; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"s beyond those which are being applied already Conclusion (iii) There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account DINP DINP was found in only 1/36 perfume samples at a concentration of 26 mg/kg.","duration":"chronic","effect":"s beyond those which are being applied already Conclusion (iii) There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account DINP DINP was found in only 1/36 perfume samples at a concentration of 26 mg/kg. The toxicological effects for DINP were an increased incidence of spongiosis hepatis, accompanied by increased serum levels of liver enzymes in males and increases in absolute and relative liver and kidney weights in both sexes. EFSA (2005a) used a NOAEL of 15 mg/kg bw/day for non-peroxisomal proliferation-related chronic hepatic and renal effects derived from a combined chronic/carcinogenicity study in rats. From the same data, CSTEE (2001) calculated a 5% response benchmark dose of 12 mg/kg/d using spongiosis hepatis as the critical endpoint of the risk characterization. This will not alter the Margin of Safety from perfume use. EFSA derived a TDI for DINP of 0.15 mg/kg bw, using the NOAEL of 15 mg/kg bw/day and an uncertainty factor of 100. Margin of Safety (","endpoint":"carcinogenicity","ingredient":"s.” Names in brackets","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"15","page":11,"route":"","species":"rat","study_id":"sccp_o_106_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | carcinogenicity | 15 | mg/kg bw/day | rat | dermal | chronic | carcinogenicity | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=15; DOSE=EFSA (2005a) used a NOAEL of 15 mg/kg bw/day for non-peroxisomal proliferation-related chronic hepatic and renal effects derived from a combined chronic/carcinogenicity study in rats.; EFFECT=and relative liver and kidney weights in both sexes. EFSA (2005a) used a NOAEL of 15 mg/kg bw/day for non-peroxisomal proliferation-related chronic hepatic and renal effects derived from a combined chronic/carcinogenicity study in rats. From the same data, CSTEE (2001) calculated a 5% response benchmark dose of 12 mg/kg/d using spongiosis hepatis as the critical endpoint of the risk characterization. This will not alter the Margin of Safety from perfume use. EFSA derived a TDI for DINP of 0.15 mg/kg bw, using the NOAEL of 15 mg/kg bw/day and an uncertainty factor of 100. Margin of Safety (MoS) Calculation for Traces of DINP in cosmetics A Margin of Safety can be calculated, using the highest concentration (0.003%) found, based on NOAELs and dermal absorption of 4 % for DINP reported as a percentage in the literature (Elsisi et al, 1989). Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Maximum dermal absorption: 4 % Systemic Expos; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"EFSA (2005a) used a NOAEL of 15 mg/kg bw/day for non-peroxisomal proliferation-related chronic hepatic and renal effects derived from a combined chronic/carcinogenicity study in rats.","duration":"chronic","effect":"and relative liver and kidney weights in both sexes. EFSA (2005a) used a NOAEL of 15 mg/kg bw/day for non-peroxisomal proliferation-related chronic hepatic and renal effects derived from a combined chronic/carcinogenicity study in rats. From the same data, CSTEE (2001) calculated a 5% response benchmark dose of 12 mg/kg/d using spongiosis hepatis as the critical endpoint of the risk characterization. This will not alter the Margin of Safety from perfume use. EFSA derived a TDI for DINP of 0.15 mg/kg bw, using the NOAEL of 15 mg/kg bw/day and an uncertainty factor of 100. Margin of Safety (MoS) Calculation for Traces of DINP in cosmetics A Margin of Safety can be calculated, using the highest concentration (0.003%) found, based on NOAELs and dermal absorption of 4 % for DINP reported as a percentage in the literature (Elsisi et al, 1989). Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Maximum dermal absorption: 4 % Systemic Expos","endpoint":"carcinogenicity","ingredient":"s.” Names in brackets","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"15","page":11,"route":"dermal","species":"rat","study_id":"sccp_o_106_noael_011"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | 600 | mg/kg bw/day | rat | dermal | - | dermal absorption | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=600; DOSE=toxicity Di-isobutyl phthalate (DIBP) 201-553-2 / 84-69-5 38 50 effects on liver Di-cyclohexyl phthalate (DCHP) 201-545-9 / 84-61-7 3 - DMP was found at a concentration as high as 2982 mg/kg or 0.3% in one perfume, in the other 15 perfumes the concentration was between 0.1 and 1.9 mg/kg.; EFFECT=toxicity Di-isobutyl phthalate (DIBP) 201-553-2 / 84-69-5 38 50 effects on liver Di-cyclohexyl phthalate (DCHP) 201-545-9 / 84-61-7 3 - DMP was found at a concentration as high as 2982 mg/kg or 0.3% in one perfume, in the other 15 perfumes the concentration was between 0.1 and 1.9 mg/kg. COLIPA has stated (letter of 29 November 2002) that “there is no intentional use of DMP…as a cosmetic ingredient’. Consequently, the presence and purpose of dimethyl phthalate at the maximum concentration found is unclear. The NOAEL for maternal toxicity was 600 mg/kg bw/day DMP. In contrast to the observed maternal toxicity, there was no effect of DMP treatment on any parameter of embryo/foetal development (IUCLID, 2000). Dermal absorption of DMP was not reported but described as less than that of DEP (5%). (Elsisi et al, 1989) DMP and its metabolite monomethyl phthalate (MMP) have been investigated in several studies. In rats, exposure to DMP did not alter sexual differentiation of the male rat. Initially it seemed that in man, there was; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"toxicity Di-isobutyl phthalate (DIBP) 201-553-2 / 84-69-5 38 50 effects on liver Di-cyclohexyl phthalate (DCHP) 201-545-9 / 84-61-7 3 - DMP was found at a concentration as high as 2982 mg/kg or 0.3% in one perfume, in the other 15 perfumes the concentration was between 0.1 and 1.9 mg/kg.","duration":"","effect":"toxicity Di-isobutyl phthalate (DIBP) 201-553-2 / 84-69-5 38 50 effects on liver Di-cyclohexyl phthalate (DCHP) 201-545-9 / 84-61-7 3 - DMP was found at a concentration as high as 2982 mg/kg or 0.3% in one perfume, in the other 15 perfumes the concentration was between 0.1 and 1.9 mg/kg. COLIPA has stated (letter of 29 November 2002) that “there is no intentional use of DMP…as a cosmetic ingredient’. Consequently, the presence and purpose of dimethyl phthalate at the maximum concentration found is unclear. The NOAEL for maternal toxicity was 600 mg/kg bw/day DMP. In contrast to the observed maternal toxicity, there was no effect of DMP treatment on any parameter of embryo/foetal development (IUCLID, 2000). Dermal absorption of DMP was not reported but described as less than that of DEP (5%). (Elsisi et al, 1989) DMP and its metabolite monomethyl phthalate (MMP) have been investigated in several studies. In rats, exposure to DMP did not alter sexual differentiation of the male rat. Initially it seemed that in man, there was","endpoint":"dermal absorption","ingredient":"s.” Names in brackets","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"600","page":9,"route":"dermal","species":"rat","study_id":"sccp_o_106_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | 5 | % | rat | dermal | - | dermal absorption | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=5; DOSE=Interestingly, Hauser et al (2006) found no dose response link with sperm concentration, motility or morphology due to MMP, monoethyl phthalate and the DEHP metabolites.; EFFECT=tially it seemed that in man, there was a possible association of abnormal sperm morphology in the presence of MMP. Interestingly, Hauser et al (2006) found no dose response link with sperm concentration, motility or morphology due to MMP, monoethyl phthalate and the DEHP metabolites. (Duty et al, 2003; Gray et al, 2000; Hauser et al, 2006) Margin of Safety (MoS) Calculation for Traces of DMP in cosmetics A Margin of Safety, using the highest concentration (2982 mg/kg or 0.3%) found, can be calculated, based on NOAEL and dermal absorption less than 5% reported as a percentage in the literature (Elsisi et al, 1989). Only dermal exposure will be considered in the safety calculation. Maximum dermal absorption: < 5% Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Systemic Exposure Dose (SED) 17.79 x 1000 x 0.3% x 5% / 60 = 0.0445 mg/kg No observed adverse effect level (NOAEL) = 600 mg/kg bw/day (maternal toxicity in rats) DMP Margin of Safety NOAEL / SED = 13500 Conclusion DMP was found at conce; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"Interestingly, Hauser et al (2006) found no dose response link with sperm concentration, motility or morphology due to MMP, monoethyl phthalate and the DEHP metabolites.","duration":"","effect":"tially it seemed that in man, there was a possible association of abnormal sperm morphology in the presence of MMP. Interestingly, Hauser et al (2006) found no dose response link with sperm concentration, motility or morphology due to MMP, monoethyl phthalate and the DEHP metabolites. (Duty et al, 2003; Gray et al, 2000; Hauser et al, 2006) Margin of Safety (MoS) Calculation for Traces of DMP in cosmetics A Margin of Safety, using the highest concentration (2982 mg/kg or 0.3%) found, can be calculated, based on NOAEL and dermal absorption less than 5% reported as a percentage in the literature (Elsisi et al, 1989). Only dermal exposure will be considered in the safety calculation. Maximum dermal absorption: < 5% Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Systemic Exposure Dose (SED) 17.79 x 1000 x 0.3% x 5% / 60 = 0.0445 mg/kg No observed adverse effect level (NOAEL) = 600 mg/kg bw/day (maternal toxicity in rats) DMP Margin of Safety NOAEL / SED = 13500 Conclusion DMP was found at conce","endpoint":"dermal absorption","ingredient":"s.” Names in brackets","loael_value":"","noael_unit":"%","noael_value":"5","page":9,"route":"dermal","species":"rat","study_id":"sccp_o_106_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =0.0445 | mg/kg | rat | dermal | - | dermal absorption | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT== 0.0445; DOSE=y (MoS) Calculation for Traces of DMP in cosmetics A Margin of Safety, using the highest concentration (2982 mg/kg or 0.3%) found, can be calculated, based on NOAEL and dermal absorption less than 5% reported as a percentage in the literature (Elsisi et al, 1989).; EFFECT=y (MoS) Calculation for Traces of DMP in cosmetics A Margin of Safety, using the highest concentration (2982 mg/kg or 0.3%) found, can be calculated, based on NOAEL and dermal absorption less than 5% reported as a percentage in the literature (Elsisi et al, 1989). Only dermal exposure will be considered in the safety calculation. Maximum dermal absorption: < 5% Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Systemic Exposure Dose (SED) 17.79 x 1000 x 0.3% x 5% / 60 = 0.0445 mg/kg No observed adverse effect level (NOAEL) = 600 mg/kg bw/day (maternal toxicity in rats) DMP Margin of Safety NOAEL / SED = 13500 Conclusion DMP was found at concentration of 2982 mg/kg or 0.3% in one perfume, in the other 15 perfumes the concentration was between 0.1 and 1.9 mg/kg. Using a worst case scenario, the Margin of Safety was found to be high. This suggests that unintentional exposure from perfume and other cosmetics at the levels found in this study would have no measurable risk for the consumer.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"y (MoS) Calculation for Traces of DMP in cosmetics A Margin of Safety, using the highest concentration (2982 mg/kg or 0.3%) found, can be calculated, based on NOAEL and dermal absorption less than 5% reported as a percentage in the literature (Elsisi et al, 1989).","duration":"","effect":"y (MoS) Calculation for Traces of DMP in cosmetics A Margin of Safety, using the highest concentration (2982 mg/kg or 0.3%) found, can be calculated, based on NOAEL and dermal absorption less than 5% reported as a percentage in the literature (Elsisi et al, 1989). Only dermal exposure will be considered in the safety calculation. Maximum dermal absorption: < 5% Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Systemic Exposure Dose (SED) 17.79 x 1000 x 0.3% x 5% / 60 = 0.0445 mg/kg No observed adverse effect level (NOAEL) = 600 mg/kg bw/day (maternal toxicity in rats) DMP Margin of Safety NOAEL / SED = 13500 Conclusion DMP was found at concentration of 2982 mg/kg or 0.3% in one perfume, in the other 15 perfumes the concentration was between 0.1 and 1.9 mg/kg. Using a worst case scenario, the Margin of Safety was found to be high. This suggests that unintentional exposure from perfume and other cosmetics at the levels found in this study would have no measurable risk for the consumer.","endpoint":"dermal absorption","ingredient":"s.” Names in brackets","loael_value":"","noael_unit":"mg/kg","noael_value":"= 0.0445","page":9,"route":"dermal","species":"rat","study_id":"sccp_o_106_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =600 | mg/kg bw/day | rat | dermal | - | dermal absorption | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT== 600; DOSE=DMP in cosmetics A Margin of Safety, using the highest concentration (2982 mg/kg or 0.3%) found, can be calculated, based on NOAEL and dermal absorption less than 5% reported as a percentage in the literature (Elsisi et al, 1989).; EFFECT=DMP in cosmetics A Margin of Safety, using the highest concentration (2982 mg/kg or 0.3%) found, can be calculated, based on NOAEL and dermal absorption less than 5% reported as a percentage in the literature (Elsisi et al, 1989). Only dermal exposure will be considered in the safety calculation. Maximum dermal absorption: < 5% Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Systemic Exposure Dose (SED) 17.79 x 1000 x 0.3% x 5% / 60 = 0.0445 mg/kg No observed adverse effect level (NOAEL) = 600 mg/kg bw/day (maternal toxicity in rats) DMP Margin of Safety NOAEL / SED = 13500 Conclusion DMP was found at concentration of 2982 mg/kg or 0.3% in one perfume, in the other 15 perfumes the concentration was between 0.1 and 1.9 mg/kg. Using a worst case scenario, the Margin of Safety was found to be high. This suggests that unintentional exposure from perfume and other cosmetics at the levels found in this study would have no measurable risk for the consumer.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"DMP in cosmetics A Margin of Safety, using the highest concentration (2982 mg/kg or 0.3%) found, can be calculated, based on NOAEL and dermal absorption less than 5% reported as a percentage in the literature (Elsisi et al, 1989).","duration":"","effect":"DMP in cosmetics A Margin of Safety, using the highest concentration (2982 mg/kg or 0.3%) found, can be calculated, based on NOAEL and dermal absorption less than 5% reported as a percentage in the literature (Elsisi et al, 1989). Only dermal exposure will be considered in the safety calculation. Maximum dermal absorption: < 5% Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Systemic Exposure Dose (SED) 17.79 x 1000 x 0.3% x 5% / 60 = 0.0445 mg/kg No observed adverse effect level (NOAEL) = 600 mg/kg bw/day (maternal toxicity in rats) DMP Margin of Safety NOAEL / SED = 13500 Conclusion DMP was found at concentration of 2982 mg/kg or 0.3% in one perfume, in the other 15 perfumes the concentration was between 0.1 and 1.9 mg/kg. Using a worst case scenario, the Margin of Safety was found to be high. This suggests that unintentional exposure from perfume and other cosmetics at the levels found in this study would have no measurable risk for the consumer.","endpoint":"dermal absorption","ingredient":"s.” Names in brackets","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 600","page":9,"route":"dermal","species":"rat","study_id":"sccp_o_106_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =600 | mg/kg bw/day | rat | dermal | - | dermal absorption | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT== 600; DOSE=mg/kg or 0.3%) found, can be calculated, based on NOAEL and dermal absorption less than 5% reported as a percentage in the literature (Elsisi et al, 1989).; EFFECT=mg/kg or 0.3%) found, can be calculated, based on NOAEL and dermal absorption less than 5% reported as a percentage in the literature (Elsisi et al, 1989). Only dermal exposure will be considered in the safety calculation. Maximum dermal absorption: < 5% Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Systemic Exposure Dose (SED) 17.79 x 1000 x 0.3% x 5% / 60 = 0.0445 mg/kg No observed adverse effect level (NOAEL) = 600 mg/kg bw/day (maternal toxicity in rats) DMP Margin of Safety NOAEL / SED = 13500 Conclusion DMP was found at concentration of 2982 mg/kg or 0.3% in one perfume, in the other 15 perfumes the concentration was between 0.1 and 1.9 mg/kg. Using a worst case scenario, the Margin of Safety was found to be high. This suggests that unintentional exposure from perfume and other cosmetics at the levels found in this study would have no measurable risk for the consumer.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"mg/kg or 0.3%) found, can be calculated, based on NOAEL and dermal absorption less than 5% reported as a percentage in the literature (Elsisi et al, 1989).","duration":"","effect":"mg/kg or 0.3%) found, can be calculated, based on NOAEL and dermal absorption less than 5% reported as a percentage in the literature (Elsisi et al, 1989). Only dermal exposure will be considered in the safety calculation. Maximum dermal absorption: < 5% Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Systemic Exposure Dose (SED) 17.79 x 1000 x 0.3% x 5% / 60 = 0.0445 mg/kg No observed adverse effect level (NOAEL) = 600 mg/kg bw/day (maternal toxicity in rats) DMP Margin of Safety NOAEL / SED = 13500 Conclusion DMP was found at concentration of 2982 mg/kg or 0.3% in one perfume, in the other 15 perfumes the concentration was between 0.1 and 1.9 mg/kg. Using a worst case scenario, the Margin of Safety was found to be high. This suggests that unintentional exposure from perfume and other cosmetics at the levels found in this study would have no measurable risk for the consumer.","endpoint":"dermal absorption","ingredient":"s.” Names in brackets","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 600","page":9,"route":"dermal","species":"rat","study_id":"sccp_o_106_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =0.00036 | mg/kg/d | rat | oral | - | dermal absorption | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT== 0.00036; DOSE=4 % Systemic Exposure Dose (SED) 17.79 x 1000 x 0.003% x 4% / 60 = 0.00036 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in rats) DINP Margin of Safety NOAEL / SED = 41666 Systemic exposure of DINP from cosmetics is 0.24% of the TDI for DINP of 0.15 mg/kg/d derived by EFSA, (2005a) Exposure to DINP from...; EFFECT=Safety (MoS) Calculation for Traces of DINP in cosmetics A Margin of Safety can be calculated, using the highest concentration (0.003%) found, based on NOAELs and dermal absorption of 4 % for DINP reported as a percentage in the literature (Elsisi et al, 1989). Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Maximum dermal absorption: 4 % Systemic Exposure Dose (SED) 17.79 x 1000 x 0.003% x 4% / 60 = 0.00036 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in rats) DINP Margin of Safety NOAEL / SED = 41666 Systemic exposure of DINP from cosmetics is 0.24% of the TDI for DINP of 0.15 mg/kg/d derived by EFSA, (2005a) Exposure to DINP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA, 2005a; CSTEE, 2004, RAR, 2003). Thus the inadvertent occurrence of DINP in cosmetics does not seem to be a concern for consumer health. DIDP DIDP was found in 5/36 perfume; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"4 % Systemic Exposure Dose (SED) 17.79 x 1000 x 0.003% x 4% / 60 = 0.00036 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in rats) DINP Margin of Safety NOAEL / SED = 41666 Systemic exposure of DINP from cosmetics is 0.24% of the TDI for DINP of 0.15 mg/kg/d derived by EFSA, (2005a) Exposure to DINP from...","duration":"","effect":"Safety (MoS) Calculation for Traces of DINP in cosmetics A Margin of Safety can be calculated, using the highest concentration (0.003%) found, based on NOAELs and dermal absorption of 4 % for DINP reported as a percentage in the literature (Elsisi et al, 1989). Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Maximum dermal absorption: 4 % Systemic Exposure Dose (SED) 17.79 x 1000 x 0.003% x 4% / 60 = 0.00036 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in rats) DINP Margin of Safety NOAEL / SED = 41666 Systemic exposure of DINP from cosmetics is 0.24% of the TDI for DINP of 0.15 mg/kg/d derived by EFSA, (2005a) Exposure to DINP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA, 2005a; CSTEE, 2004, RAR, 2003). Thus the inadvertent occurrence of DINP in cosmetics does not seem to be a concern for consumer health. DIDP DIDP was found in 5/36 perfume","endpoint":"dermal absorption","ingredient":"s.” Names in brackets","loael_value":"","noael_unit":"mg/kg/d","noael_value":"= 0.00036","page":11,"route":"oral","species":"rat","study_id":"sccp_o_106_noael_012"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =15 | mg/kg bw/d | rat | oral | - | dermal absorption | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT== 15; DOSE=4 % Systemic Exposure Dose (SED) 17.79 x 1000 x 0.003% x 4% / 60 = 0.00036 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in rats) DINP Margin of Safety NOAEL / SED = 41666 Systemic exposure of DINP from cosmetics is 0.24% of the TDI for DINP of 0.15 mg/kg/d derived by EFSA, (2005a) Exposure to DINP from...; EFFECT=s of DINP in cosmetics A Margin of Safety can be calculated, using the highest concentration (0.003%) found, based on NOAELs and dermal absorption of 4 % for DINP reported as a percentage in the literature (Elsisi et al, 1989). Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Maximum dermal absorption: 4 % Systemic Exposure Dose (SED) 17.79 x 1000 x 0.003% x 4% / 60 = 0.00036 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in rats) DINP Margin of Safety NOAEL / SED = 41666 Systemic exposure of DINP from cosmetics is 0.24% of the TDI for DINP of 0.15 mg/kg/d derived by EFSA, (2005a) Exposure to DINP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA, 2005a; CSTEE, 2004, RAR, 2003). Thus the inadvertent occurrence of DINP in cosmetics does not seem to be a concern for consumer health. DIDP DIDP was found in 5/36 perfume sample; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"4 % Systemic Exposure Dose (SED) 17.79 x 1000 x 0.003% x 4% / 60 = 0.00036 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in rats) DINP Margin of Safety NOAEL / SED = 41666 Systemic exposure of DINP from cosmetics is 0.24% of the TDI for DINP of 0.15 mg/kg/d derived by EFSA, (2005a) Exposure to DINP from...","duration":"","effect":"s of DINP in cosmetics A Margin of Safety can be calculated, using the highest concentration (0.003%) found, based on NOAELs and dermal absorption of 4 % for DINP reported as a percentage in the literature (Elsisi et al, 1989). Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Maximum dermal absorption: 4 % Systemic Exposure Dose (SED) 17.79 x 1000 x 0.003% x 4% / 60 = 0.00036 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in rats) DINP Margin of Safety NOAEL / SED = 41666 Systemic exposure of DINP from cosmetics is 0.24% of the TDI for DINP of 0.15 mg/kg/d derived by EFSA, (2005a) Exposure to DINP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA, 2005a; CSTEE, 2004, RAR, 2003). Thus the inadvertent occurrence of DINP in cosmetics does not seem to be a concern for consumer health. DIDP DIDP was found in 5/36 perfume sample","endpoint":"dermal absorption","ingredient":"s.” Names in brackets","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 15","page":11,"route":"oral","species":"rat","study_id":"sccp_o_106_noael_013"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | 0.24 | % | rat | oral | - | dermal absorption | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=0.24; DOSE=4 % Systemic Exposure Dose (SED) 17.79 x 1000 x 0.003% x 4% / 60 = 0.00036 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in rats) DINP Margin of Safety NOAEL / SED = 41666 Systemic exposure of DINP from cosmetics is 0.24% of the TDI for DINP of 0.15 mg/kg/d derived by EFSA, (2005a) Exposure to DINP from...; EFFECT=concentration (0.003%) found, based on NOAELs and dermal absorption of 4 % for DINP reported as a percentage in the literature (Elsisi et al, 1989). Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Maximum dermal absorption: 4 % Systemic Exposure Dose (SED) 17.79 x 1000 x 0.003% x 4% / 60 = 0.00036 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in rats) DINP Margin of Safety NOAEL / SED = 41666 Systemic exposure of DINP from cosmetics is 0.24% of the TDI for DINP of 0.15 mg/kg/d derived by EFSA, (2005a) Exposure to DINP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA, 2005a; CSTEE, 2004, RAR, 2003). Thus the inadvertent occurrence of DINP in cosmetics does not seem to be a concern for consumer health. DIDP DIDP was found in 5/36 perfume samples at concentrations ranging from 1.5 - 37 mg/kg. The EFSA Panel concluded that; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"4 % Systemic Exposure Dose (SED) 17.79 x 1000 x 0.003% x 4% / 60 = 0.00036 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in rats) DINP Margin of Safety NOAEL / SED = 41666 Systemic exposure of DINP from cosmetics is 0.24% of the TDI for DINP of 0.15 mg/kg/d derived by EFSA, (2005a) Exposure to DINP from...","duration":"","effect":"concentration (0.003%) found, based on NOAELs and dermal absorption of 4 % for DINP reported as a percentage in the literature (Elsisi et al, 1989). Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Maximum dermal absorption: 4 % Systemic Exposure Dose (SED) 17.79 x 1000 x 0.003% x 4% / 60 = 0.00036 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in rats) DINP Margin of Safety NOAEL / SED = 41666 Systemic exposure of DINP from cosmetics is 0.24% of the TDI for DINP of 0.15 mg/kg/d derived by EFSA, (2005a) Exposure to DINP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA, 2005a; CSTEE, 2004, RAR, 2003). Thus the inadvertent occurrence of DINP in cosmetics does not seem to be a concern for consumer health. DIDP DIDP was found in 5/36 perfume samples at concentrations ranging from 1.5 - 37 mg/kg. The EFSA Panel concluded that","endpoint":"dermal absorption","ingredient":"s.” Names in brackets","loael_value":"","noael_unit":"%","noael_value":"0.24","page":11,"route":"oral","species":"rat","study_id":"sccp_o_106_noael_014"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =0.000009 | mg/kg/d | dog | oral | - | dermal absorption | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT== 0.000009; DOSE=1 % DIDP Systemic Exposure Dose (SED) 17.79 x 1000 x 0.0037% x 1% / 60 = 0.000009 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in dogs) DIDP Margin of Safety NOAEL / SED = 1666666 Systemic exposure from cosmetics is 0.006% of the TDI of 0.15 mg/kg/d defined by EFSA (2005b).; EFFECT=A Margin of Safety can be calculated, using the highest concentration (0.0037 %) based on NOAELs and dermal absorption of <1 % for DIDP reported as a percentage in the literature (Elsisi et al, 1989) though due to low recovery this may be underestimated. Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Maximum dermal absorption: 1 % DIDP Systemic Exposure Dose (SED) 17.79 x 1000 x 0.0037% x 1% / 60 = 0.000009 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in dogs) DIDP Margin of Safety NOAEL / SED = 1666666 Systemic exposure from cosmetics is 0.006% of the TDI of 0.15 mg/kg/d defined by EFSA (2005b). Exposure to DIDP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA, 2005b; CSTEE, 2004, DIDP RAR, 2003). Thus the inadvertent occurrence of DIDP in cosmetics does not seem to be a concern for consumer health. It was also noted that in 5/36 perfumes, DIDP; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"1 % DIDP Systemic Exposure Dose (SED) 17.79 x 1000 x 0.0037% x 1% / 60 = 0.000009 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in dogs) DIDP Margin of Safety NOAEL / SED = 1666666 Systemic exposure from cosmetics is 0.006% of the TDI of 0.15 mg/kg/d defined by EFSA (2005b).","duration":"","effect":"A Margin of Safety can be calculated, using the highest concentration (0.0037 %) based on NOAELs and dermal absorption of <1 % for DIDP reported as a percentage in the literature (Elsisi et al, 1989) though due to low recovery this may be underestimated. Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Maximum dermal absorption: 1 % DIDP Systemic Exposure Dose (SED) 17.79 x 1000 x 0.0037% x 1% / 60 = 0.000009 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in dogs) DIDP Margin of Safety NOAEL / SED = 1666666 Systemic exposure from cosmetics is 0.006% of the TDI of 0.15 mg/kg/d defined by EFSA (2005b). Exposure to DIDP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA, 2005b; CSTEE, 2004, DIDP RAR, 2003). Thus the inadvertent occurrence of DIDP in cosmetics does not seem to be a concern for consumer health. It was also noted that in 5/36 perfumes, DIDP","endpoint":"dermal absorption","ingredient":"s.” Names in brackets","loael_value":"","noael_unit":"mg/kg/d","noael_value":"= 0.000009","page":12,"route":"oral","species":"dog","study_id":"sccp_o_106_noael_019"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =15 | mg/kg bw/d | dog | oral | - | dermal absorption | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT== 15; DOSE=1 % DIDP Systemic Exposure Dose (SED) 17.79 x 1000 x 0.0037% x 1% / 60 = 0.000009 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in dogs) DIDP Margin of Safety NOAEL / SED = 1666666 Systemic exposure from cosmetics is 0.006% of the TDI of 0.15 mg/kg/d defined by EFSA (2005b).; EFFECT=ed, using the highest concentration (0.0037 %) based on NOAELs and dermal absorption of <1 % for DIDP reported as a percentage in the literature (Elsisi et al, 1989) though due to low recovery this may be underestimated. Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Maximum dermal absorption: 1 % DIDP Systemic Exposure Dose (SED) 17.79 x 1000 x 0.0037% x 1% / 60 = 0.000009 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in dogs) DIDP Margin of Safety NOAEL / SED = 1666666 Systemic exposure from cosmetics is 0.006% of the TDI of 0.15 mg/kg/d defined by EFSA (2005b). Exposure to DIDP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA, 2005b; CSTEE, 2004, DIDP RAR, 2003). Thus the inadvertent occurrence of DIDP in cosmetics does not seem to be a concern for consumer health. It was also noted that in 5/36 perfumes, DIDP and DI; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"1 % DIDP Systemic Exposure Dose (SED) 17.79 x 1000 x 0.0037% x 1% / 60 = 0.000009 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in dogs) DIDP Margin of Safety NOAEL / SED = 1666666 Systemic exposure from cosmetics is 0.006% of the TDI of 0.15 mg/kg/d defined by EFSA (2005b).","duration":"","effect":"ed, using the highest concentration (0.0037 %) based on NOAELs and dermal absorption of <1 % for DIDP reported as a percentage in the literature (Elsisi et al, 1989) though due to low recovery this may be underestimated. Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Maximum dermal absorption: 1 % DIDP Systemic Exposure Dose (SED) 17.79 x 1000 x 0.0037% x 1% / 60 = 0.000009 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in dogs) DIDP Margin of Safety NOAEL / SED = 1666666 Systemic exposure from cosmetics is 0.006% of the TDI of 0.15 mg/kg/d defined by EFSA (2005b). Exposure to DIDP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA, 2005b; CSTEE, 2004, DIDP RAR, 2003). Thus the inadvertent occurrence of DIDP in cosmetics does not seem to be a concern for consumer health. It was also noted that in 5/36 perfumes, DIDP and DI","endpoint":"dermal absorption","ingredient":"s.” Names in brackets","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 15","page":12,"route":"oral","species":"dog","study_id":"sccp_o_106_noael_020"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | 0.006 | % | dog | oral | - | dermal absorption | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=0.006; DOSE=1 % DIDP Systemic Exposure Dose (SED) 17.79 x 1000 x 0.0037% x 1% / 60 = 0.000009 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in dogs) DIDP Margin of Safety NOAEL / SED = 1666666 Systemic exposure from cosmetics is 0.006% of the TDI of 0.15 mg/kg/d defined by EFSA (2005b).; EFFECT=ption of <1 % for DIDP reported as a percentage in the literature (Elsisi et al, 1989) though due to low recovery this may be underestimated. Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Maximum dermal absorption: 1 % DIDP Systemic Exposure Dose (SED) 17.79 x 1000 x 0.0037% x 1% / 60 = 0.000009 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in dogs) DIDP Margin of Safety NOAEL / SED = 1666666 Systemic exposure from cosmetics is 0.006% of the TDI of 0.15 mg/kg/d defined by EFSA (2005b). Exposure to DIDP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA, 2005b; CSTEE, 2004, DIDP RAR, 2003). Thus the inadvertent occurrence of DIDP in cosmetics does not seem to be a concern for consumer health. It was also noted that in 5/36 perfumes, DIDP and DINP were found below ‘reporting limit’. Although not specified, this suggests a; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"1 % DIDP Systemic Exposure Dose (SED) 17.79 x 1000 x 0.0037% x 1% / 60 = 0.000009 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in dogs) DIDP Margin of Safety NOAEL / SED = 1666666 Systemic exposure from cosmetics is 0.006% of the TDI of 0.15 mg/kg/d defined by EFSA (2005b).","duration":"","effect":"ption of <1 % for DIDP reported as a percentage in the literature (Elsisi et al, 1989) though due to low recovery this may be underestimated. Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Maximum dermal absorption: 1 % DIDP Systemic Exposure Dose (SED) 17.79 x 1000 x 0.0037% x 1% / 60 = 0.000009 mg/kg/d No observed adverse effect level (NOAEL) = 15 mg/kg bw/d (oral toxicity in liver in dogs) DIDP Margin of Safety NOAEL / SED = 1666666 Systemic exposure from cosmetics is 0.006% of the TDI of 0.15 mg/kg/d defined by EFSA (2005b). Exposure to DIDP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA, 2005b; CSTEE, 2004, DIDP RAR, 2003). Thus the inadvertent occurrence of DIDP in cosmetics does not seem to be a concern for consumer health. It was also noted that in 5/36 perfumes, DIDP and DINP were found below ‘reporting limit’. Although not specified, this suggests a","endpoint":"dermal absorption","ingredient":"s.” Names in brackets","loael_value":"","noael_unit":"%","noael_value":"0.006","page":12,"route":"oral","species":"dog","study_id":"sccp_o_106_noael_021"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | 0.0167 | % | rat | dermal | - | dermal absorption | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=0.0167; DOSE=SCCP/1016/06 Opinion on phthalates in cosmetic products 14 Diethylhexyl Phthalate (DEHP) was found in 14/36 perfume samples at concentrations ranging from 1 - 167 mg/kg.; EFFECT=SCCP/1016/06 Opinion on phthalates in cosmetic products 14 Diethylhexyl Phthalate (DEHP) was found in 14/36 perfume samples at concentrations ranging from 1 - 167 mg/kg. Margin of Safety (MoS) Calculation of DEHP in cosmetics A Margin of Safety can be calculated, using the highest concentration (0.0167 %), based on NOAEL and worst-case estimate of 5 % dermal absorption for DEHP reported in the literature (EU Risk Assessment DEHP, 2003). There are no adequate human studies, but rat skin has dermal absorption of 20% DEHP and has been shown to be 4-times more permeable than human skin. This would seem to be an overestimate as Elsisi et al (1989) showed that less than 15% of the applied dose was absorbed through rat skin. Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products 17.79 g/d D; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"SCCP/1016/06 Opinion on phthalates in cosmetic products 14 Diethylhexyl Phthalate (DEHP) was found in 14/36 perfume samples at concentrations ranging from 1 - 167 mg/kg.","duration":"","effect":"SCCP/1016/06 Opinion on phthalates in cosmetic products 14 Diethylhexyl Phthalate (DEHP) was found in 14/36 perfume samples at concentrations ranging from 1 - 167 mg/kg. Margin of Safety (MoS) Calculation of DEHP in cosmetics A Margin of Safety can be calculated, using the highest concentration (0.0167 %), based on NOAEL and worst-case estimate of 5 % dermal absorption for DEHP reported in the literature (EU Risk Assessment DEHP, 2003). There are no adequate human studies, but rat skin has dermal absorption of 20% DEHP and has been shown to be 4-times more permeable than human skin. This would seem to be an overestimate as Elsisi et al (1989) showed that less than 15% of the applied dose was absorbed through rat skin. Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products 17.79 g/d D","endpoint":"dermal absorption","ingredient":"s.” Names in brackets","loael_value":"","noael_unit":"%","noael_value":"0.0167","page":14,"route":"dermal","species":"rat","study_id":"sccp_o_106_noael_026"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | 4.8 | mg/kg/d | rat | dermal | 2005d | dermal absorption | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=4.8; DOSE=This would seem to be an overestimate as Elsisi et al (1989) showed that less than 15% of the applied dose was absorbed through rat skin.; EFFECT=ermal absorption for DEHP reported in the literature (EU Risk Assessment DEHP, 2003). There are no adequate human studies, but rat skin has dermal absorption of 20% DEHP and has been shown to be 4-times more permeable than human skin. This would seem to be an overestimate as Elsisi et al (1989) showed that less than 15% of the applied dose was absorbed through rat skin. Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products 17.79 g/d Default human body weight: 60 kg NOAEL: 4.8 mg/kg/d based on testicular effects in a three generation guideline study (Wolfe et al, 2003, cited in DEHP RAR, 2003). The NOAEL has been confirmed in the opinions of the CSTEE 2004b and EFSA 2005d. Maximum dermal absorption 5 % estimated worst-case MoS for maximum traces of DEHP found in one perfume (167 ppm) Systemic Exposure Dose (SED) = 17.79 x 1000 x 0.0167% x 5% / 60 = 0.00247 mg/kg/d MoS (NOAEL / SED) = 4.8 / 0.00247 = 1920 Based on the highest level found in one perfume, the systemic exposure fro; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"This would seem to be an overestimate as Elsisi et al (1989) showed that less than 15% of the applied dose was absorbed through rat skin.","duration":"2005d","effect":"ermal absorption for DEHP reported in the literature (EU Risk Assessment DEHP, 2003). There are no adequate human studies, but rat skin has dermal absorption of 20% DEHP and has been shown to be 4-times more permeable than human skin. This would seem to be an overestimate as Elsisi et al (1989) showed that less than 15% of the applied dose was absorbed through rat skin. Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products 17.79 g/d Default human body weight: 60 kg NOAEL: 4.8 mg/kg/d based on testicular effects in a three generation guideline study (Wolfe et al, 2003, cited in DEHP RAR, 2003). The NOAEL has been confirmed in the opinions of the CSTEE 2004b and EFSA 2005d. Maximum dermal absorption 5 % estimated worst-case MoS for maximum traces of DEHP found in one perfume (167 ppm) Systemic Exposure Dose (SED) = 17.79 x 1000 x 0.0167% x 5% / 60 = 0.00247 mg/kg/d MoS (NOAEL / SED) = 4.8 / 0.00247 = 1920 Based on the highest level found in one perfume, the systemic exposure fro","endpoint":"dermal absorption","ingredient":"s.” Names in brackets","loael_value":"","noael_unit":"mg/kg/d","noael_value":"4.8","page":14,"route":"dermal","species":"rat","study_id":"sccp_o_106_noael_027"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | 5 | % | rat | dermal | 2005d | dermal absorption | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=5; DOSE=This would seem to be an overestimate as Elsisi et al (1989) showed that less than 15% of the applied dose was absorbed through rat skin.; EFFECT=has dermal absorption of 20% DEHP and has been shown to be 4-times more permeable than human skin. This would seem to be an overestimate as Elsisi et al (1989) showed that less than 15% of the applied dose was absorbed through rat skin. Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products 17.79 g/d Default human body weight: 60 kg NOAEL: 4.8 mg/kg/d based on testicular effects in a three generation guideline study (Wolfe et al, 2003, cited in DEHP RAR, 2003). The NOAEL has been confirmed in the opinions of the CSTEE 2004b and EFSA 2005d. Maximum dermal absorption 5 % estimated worst-case MoS for maximum traces of DEHP found in one perfume (167 ppm) Systemic Exposure Dose (SED) = 17.79 x 1000 x 0.0167% x 5% / 60 = 0.00247 mg/kg/d MoS (NOAEL / SED) = 4.8 / 0.00247 = 1920 Based on the highest level found in one perfume, the systemic exposure from cosmetics would be 5% of the TDI of 0.05 mg/kg/d derived by EFSA, (EFSA 2005d; EU Risk Assessment DEHP, 2003; CSTEE, DEHP, 2004b). In; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"This would seem to be an overestimate as Elsisi et al (1989) showed that less than 15% of the applied dose was absorbed through rat skin.","duration":"2005d","effect":"has dermal absorption of 20% DEHP and has been shown to be 4-times more permeable than human skin. This would seem to be an overestimate as Elsisi et al (1989) showed that less than 15% of the applied dose was absorbed through rat skin. Only dermal exposure will be considered in the safety calculation. Exposure to all cosmetic products 17.79 g/d Default human body weight: 60 kg NOAEL: 4.8 mg/kg/d based on testicular effects in a three generation guideline study (Wolfe et al, 2003, cited in DEHP RAR, 2003). The NOAEL has been confirmed in the opinions of the CSTEE 2004b and EFSA 2005d. Maximum dermal absorption 5 % estimated worst-case MoS for maximum traces of DEHP found in one perfume (167 ppm) Systemic Exposure Dose (SED) = 17.79 x 1000 x 0.0167% x 5% / 60 = 0.00247 mg/kg/d MoS (NOAEL / SED) = 4.8 / 0.00247 = 1920 Based on the highest level found in one perfume, the systemic exposure from cosmetics would be 5% of the TDI of 0.05 mg/kg/d derived by EFSA, (EFSA 2005d; EU Risk Assessment DEHP, 2003; CSTEE, DEHP, 2004b). In","endpoint":"dermal absorption","ingredient":"s.” Names in brackets","loael_value":"","noael_unit":"%","noael_value":"5","page":14,"route":"dermal","species":"rat","study_id":"sccp_o_106_noael_028"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =0.00247 | mg/kg/d | human | dermal | 2005d | dermal absorption | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT== 0.00247; DOSE=4.8 mg/kg/d based on testicular effects in a three generation guideline study (Wolfe et al, 2003, cited in DEHP RAR, 2003).; EFFECT=in the safety calculation. Exposure to all cosmetic products 17.79 g/d Default human body weight: 60 kg NOAEL: 4.8 mg/kg/d based on testicular effects in a three generation guideline study (Wolfe et al, 2003, cited in DEHP RAR, 2003). The NOAEL has been confirmed in the opinions of the CSTEE 2004b and EFSA 2005d. Maximum dermal absorption 5 % estimated worst-case MoS for maximum traces of DEHP found in one perfume (167 ppm) Systemic Exposure Dose (SED) = 17.79 x 1000 x 0.0167% x 5% / 60 = 0.00247 mg/kg/d MoS (NOAEL / SED) = 4.8 / 0.00247 = 1920 Based on the highest level found in one perfume, the systemic exposure from cosmetics would be 5% of the TDI of 0.05 mg/kg/d derived by EFSA, (EFSA 2005d; EU Risk Assessment DEHP, 2003; CSTEE, DEHP, 2004b). In light of the MoS based on 167ppm DEHP, the Member State proposal of a 60 ppm DEHP limit in cosmetic products may not be required. Exposure to DEHP from cosmetics is low compared with exposure from other sources, such as food and non-food products. Thus the inadvertent occurren; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"4.8 mg/kg/d based on testicular effects in a three generation guideline study (Wolfe et al, 2003, cited in DEHP RAR, 2003).","duration":"2005d","effect":"in the safety calculation. Exposure to all cosmetic products 17.79 g/d Default human body weight: 60 kg NOAEL: 4.8 mg/kg/d based on testicular effects in a three generation guideline study (Wolfe et al, 2003, cited in DEHP RAR, 2003). The NOAEL has been confirmed in the opinions of the CSTEE 2004b and EFSA 2005d. Maximum dermal absorption 5 % estimated worst-case MoS for maximum traces of DEHP found in one perfume (167 ppm) Systemic Exposure Dose (SED) = 17.79 x 1000 x 0.0167% x 5% / 60 = 0.00247 mg/kg/d MoS (NOAEL / SED) = 4.8 / 0.00247 = 1920 Based on the highest level found in one perfume, the systemic exposure from cosmetics would be 5% of the TDI of 0.05 mg/kg/d derived by EFSA, (EFSA 2005d; EU Risk Assessment DEHP, 2003; CSTEE, DEHP, 2004b). In light of the MoS based on 167ppm DEHP, the Member State proposal of a 60 ppm DEHP limit in cosmetic products may not be required. Exposure to DEHP from cosmetics is low compared with exposure from other sources, such as food and non-food products. Thus the inadvertent occurren","endpoint":"dermal absorption","ingredient":"s.” Names in brackets","loael_value":"","noael_unit":"mg/kg/d","noael_value":"= 0.00247","page":14,"route":"dermal","species":"human","study_id":"sccp_o_106_noael_029"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 5 | % | rat | oral | developmental | developmental toxicity | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=5; DOSE=Dibutyl Phthalate (DBP) was found in 20/36 perfume samples at concentrations ranging from 0.1 – 14 mg/kg.; EFFECT=imit in cosmetic products may not be required. Exposure to DEHP from cosmetics is low compared with exposure from other sources, such as food and non-food products. Thus the inadvertent occurrence of DEHP at trace levels in cosmetics does not seem to be a concern for consumer health. Dibutyl Phthalate (DBP) was found in 20/36 perfume samples at concentrations ranging from 0.1 – 14 mg/kg. Margin of Safety (MoS) Calculation for Traces of DBP in cosmetics A Margin of Safety was calculated based on the LOAEL as no NOAEL could be established and on dermal absorption of 5 % for DBP as reported in the literature (Bronaugh et al. 1982, Elsisi et al. 1989 cited in RAR and an in vitro study (Scott et al. cited in RAR). Only dermal exposure will be considered in the safety calculation. LOAEL: A developmental toxicity study in the rat (Lee et al., 2004 cited by EFSA 2005e) with dietary exposure to DBP from gestation day 15 to the end of lactation (postnatal day 21), showed effects on the development of male and female offspring at lowe; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"Dibutyl Phthalate (DBP) was found in 20/36 perfume samples at concentrations ranging from 0.1 – 14 mg/kg.","duration":"developmental","effect":"imit in cosmetic products may not be required. Exposure to DEHP from cosmetics is low compared with exposure from other sources, such as food and non-food products. Thus the inadvertent occurrence of DEHP at trace levels in cosmetics does not seem to be a concern for consumer health. Dibutyl Phthalate (DBP) was found in 20/36 perfume samples at concentrations ranging from 0.1 – 14 mg/kg. Margin of Safety (MoS) Calculation for Traces of DBP in cosmetics A Margin of Safety was calculated based on the LOAEL as no NOAEL could be established and on dermal absorption of 5 % for DBP as reported in the literature (Bronaugh et al. 1982, Elsisi et al. 1989 cited in RAR and an in vitro study (Scott et al. cited in RAR). Only dermal exposure will be considered in the safety calculation. LOAEL: A developmental toxicity study in the rat (Lee et al., 2004 cited by EFSA 2005e) with dietary exposure to DBP from gestation day 15 to the end of lactation (postnatal day 21), showed effects on the development of male and female offspring at lowe","endpoint":"developmental toxicity","ingredient":"s.” Names in brackets","loael_value":"","noael_unit":"%","noael_value":"5","page":14,"route":"oral","species":"rat","study_id":"sccp_o_106_noael_030"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 50 | mg/kg/d | rat | dermal | developmental | developmental toxicity | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=50; DOSE=Benzyl Butyl Phthalate (BBP) was found in 9/36 perfume samples at concentrations ranging from 0.1 – 110 mg/kg Margin of Safety (MoS) Calculation for Traces of BBP in cosmetics A Margin of Safety can be calculated, based on NOAELs and dermal absorption 5 % based on the available data, dermal absorption is considered to be 5% as a worst case estim...; EFFECT=r consumer health. Benzyl Butyl Phthalate (BBP) was found in 9/36 perfume samples at concentrations ranging from 0.1 – 110 mg/kg Margin of Safety (MoS) Calculation for Traces of BBP in cosmetics A Margin of Safety can be calculated, based on NOAELs and dermal absorption 5 % based on the available data, dermal absorption is considered to be 5% as a worst case estimate (RAR) Only dermal exposure will be considered in the safety calculation. Assuming a worst case of 110ppm (0.011%) BBP in all cosmetic products NOAEL: 50 mg/kg/d (Tyl et al. 2004, cited in RAR) based on a two generation study in SD rats Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Systemic Exposure Dose (SED) = 17.79 x 1000 x 0.011% x 5% / 60 = 0.00163 mg/kg/d BBP MoS = NOAEL / SED = 50 / 0.00163 = 31250 Systemic exposure of BBP from cosmetics is 3.26% of the 0.5 mg/kg/d TDI defined by EFSA (2005f). SCHER (2005) characterized the risk for consumers by using the NOAEL for developmental toxicity as a starting point and found th; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"Benzyl Butyl Phthalate (BBP) was found in 9/36 perfume samples at concentrations ranging from 0.1 – 110 mg/kg Margin of Safety (MoS) Calculation for Traces of BBP in cosmetics A Margin of Safety can be calculated, based on NOAELs and dermal absorption 5 % based on the available data, dermal absorption is considered to be 5% as a worst case estim...","duration":"developmental","effect":"r consumer health. Benzyl Butyl Phthalate (BBP) was found in 9/36 perfume samples at concentrations ranging from 0.1 – 110 mg/kg Margin of Safety (MoS) Calculation for Traces of BBP in cosmetics A Margin of Safety can be calculated, based on NOAELs and dermal absorption 5 % based on the available data, dermal absorption is considered to be 5% as a worst case estimate (RAR) Only dermal exposure will be considered in the safety calculation. Assuming a worst case of 110ppm (0.011%) BBP in all cosmetic products NOAEL: 50 mg/kg/d (Tyl et al. 2004, cited in RAR) based on a two generation study in SD rats Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Systemic Exposure Dose (SED) = 17.79 x 1000 x 0.011% x 5% / 60 = 0.00163 mg/kg/d BBP MoS = NOAEL / SED = 50 / 0.00163 = 31250 Systemic exposure of BBP from cosmetics is 3.26% of the 0.5 mg/kg/d TDI defined by EFSA (2005f). SCHER (2005) characterized the risk for consumers by using the NOAEL for developmental toxicity as a starting point and found th","endpoint":"developmental toxicity","ingredient":"s.” Names in brackets","loael_value":"","noael_unit":"mg/kg/d","noael_value":"50","page":15,"route":"dermal","species":"rat","study_id":"sccp_o_106_noael_032"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | =0.00163 | mg/kg/d | rat | dermal | developmental | developmental toxicity | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT== 0.00163; DOSE=50 mg/kg/d (Tyl et al.; EFFECT=absorption 5 % based on the available data, dermal absorption is considered to be 5% as a worst case estimate (RAR) Only dermal exposure will be considered in the safety calculation. Assuming a worst case of 110ppm (0.011%) BBP in all cosmetic products NOAEL: 50 mg/kg/d (Tyl et al. 2004, cited in RAR) based on a two generation study in SD rats Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Systemic Exposure Dose (SED) = 17.79 x 1000 x 0.011% x 5% / 60 = 0.00163 mg/kg/d BBP MoS = NOAEL / SED = 50 / 0.00163 = 31250 Systemic exposure of BBP from cosmetics is 3.26% of the 0.5 mg/kg/d TDI defined by EFSA (2005f). SCHER (2005) characterized the risk for consumers by using the NOAEL for developmental toxicity as a starting point and found the MoS-values derived are >> 1000. (EFSA 2005f; EU Risk Assessment BBP, 2004; SCHER, BBP, 2005) Exposure to BBP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA 2005f; CSTEE 2004, RAR 2003). Thus th; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"50 mg/kg/d (Tyl et al.","duration":"developmental","effect":"absorption 5 % based on the available data, dermal absorption is considered to be 5% as a worst case estimate (RAR) Only dermal exposure will be considered in the safety calculation. Assuming a worst case of 110ppm (0.011%) BBP in all cosmetic products NOAEL: 50 mg/kg/d (Tyl et al. 2004, cited in RAR) based on a two generation study in SD rats Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Systemic Exposure Dose (SED) = 17.79 x 1000 x 0.011% x 5% / 60 = 0.00163 mg/kg/d BBP MoS = NOAEL / SED = 50 / 0.00163 = 31250 Systemic exposure of BBP from cosmetics is 3.26% of the 0.5 mg/kg/d TDI defined by EFSA (2005f). SCHER (2005) characterized the risk for consumers by using the NOAEL for developmental toxicity as a starting point and found the MoS-values derived are >> 1000. (EFSA 2005f; EU Risk Assessment BBP, 2004; SCHER, BBP, 2005) Exposure to BBP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA 2005f; CSTEE 2004, RAR 2003). Thus th","endpoint":"developmental toxicity","ingredient":"s.” Names in brackets","loael_value":"","noael_unit":"mg/kg/d","noael_value":"= 0.00163","page":15,"route":"dermal","species":"rat","study_id":"sccp_o_106_noael_033"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 0.5 | mg/kg/d | rat | - | developmental | developmental toxicity | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=0.5; DOSE=50 mg/kg/d (Tyl et al.; EFFECT=worst case of 110ppm (0.011%) BBP in all cosmetic products NOAEL: 50 mg/kg/d (Tyl et al. 2004, cited in RAR) based on a two generation study in SD rats Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Systemic Exposure Dose (SED) = 17.79 x 1000 x 0.011% x 5% / 60 = 0.00163 mg/kg/d BBP MoS = NOAEL / SED = 50 / 0.00163 = 31250 Systemic exposure of BBP from cosmetics is 3.26% of the 0.5 mg/kg/d TDI defined by EFSA (2005f). SCHER (2005) characterized the risk for consumers by using the NOAEL for developmental toxicity as a starting point and found the MoS-values derived are >> 1000. (EFSA 2005f; EU Risk Assessment BBP, 2004; SCHER, BBP, 2005) Exposure to BBP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA 2005f; CSTEE 2004, RAR 2003). Thus the inadvertent occurrence of BBP in cosmetics at trace levels does not seem to be a concern for consumer health.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"50 mg/kg/d (Tyl et al.","duration":"developmental","effect":"worst case of 110ppm (0.011%) BBP in all cosmetic products NOAEL: 50 mg/kg/d (Tyl et al. 2004, cited in RAR) based on a two generation study in SD rats Exposure to all cosmetic products: 17.79 g/d Default human body weight: 60 kg Systemic Exposure Dose (SED) = 17.79 x 1000 x 0.011% x 5% / 60 = 0.00163 mg/kg/d BBP MoS = NOAEL / SED = 50 / 0.00163 = 31250 Systemic exposure of BBP from cosmetics is 3.26% of the 0.5 mg/kg/d TDI defined by EFSA (2005f). SCHER (2005) characterized the risk for consumers by using the NOAEL for developmental toxicity as a starting point and found the MoS-values derived are >> 1000. (EFSA 2005f; EU Risk Assessment BBP, 2004; SCHER, BBP, 2005) Exposure to BBP from cosmetics is extremely low compared with exposure from other sources, such as food and non-food products (EFSA 2005f; CSTEE 2004, RAR 2003). Thus the inadvertent occurrence of BBP in cosmetics at trace levels does not seem to be a concern for consumer health.","endpoint":"developmental toxicity","ingredient":"s.” Names in brackets","loael_value":"","noael_unit":"mg/kg/d","noael_value":"0.5","page":15,"route":"","species":"rat","study_id":"sccp_o_106_noael_034"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 50 | mg/kg | rat | oral | developmental | reproductive toxicity | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=50; DOSE=Conclusion Despite the lack of adequate toxicological data, the low concentration (3 mg/kg) of DCHP found in only one sample of perfume, suggest unintentional exposure from perfume and other cosmetics would have no measurable risk for the consumer.; EFFECT=tional data: reproduction and teratogenicity studies, test for gene mutation and in vitro mammalian cell chromosome aberration tests. Conclusion Despite the lack of adequate toxicological data, the low concentration (3 mg/kg) of DCHP found in only one sample of perfume, suggest unintentional exposure from perfume and other cosmetics would have no measurable risk for the consumer. DIBP was found in 20/36 perfumes with concentrations ranging from 0.2 - 38 mg/kg. It is considered a possible substitute for DBP. The NOAEL for oral toxicity was 50 mg/kg DIBP, based on liver effects. There was no data on skin absorption. (IUCLID, 2000) If dosed at 600 mg/kg bw/day to pregnant rats on gestation days 7 –21, male offspring showed similar testicular and developmental effects as found with DBP and DEHP. Further developmental and postnatal studies are needed to identify the reproductive effects of DIBP. (Borch, 2006) DIBP is classified by ECB as toxic to reproduction category 2, R61 (may cause harm to the unborn child) and category 3, R6; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"Conclusion Despite the lack of adequate toxicological data, the low concentration (3 mg/kg) of DCHP found in only one sample of perfume, suggest unintentional exposure from perfume and other cosmetics would have no measurable risk for the consumer.","duration":"developmental","effect":"tional data: reproduction and teratogenicity studies, test for gene mutation and in vitro mammalian cell chromosome aberration tests. Conclusion Despite the lack of adequate toxicological data, the low concentration (3 mg/kg) of DCHP found in only one sample of perfume, suggest unintentional exposure from perfume and other cosmetics would have no measurable risk for the consumer. DIBP was found in 20/36 perfumes with concentrations ranging from 0.2 - 38 mg/kg. It is considered a possible substitute for DBP. The NOAEL for oral toxicity was 50 mg/kg DIBP, based on liver effects. There was no data on skin absorption. (IUCLID, 2000) If dosed at 600 mg/kg bw/day to pregnant rats on gestation days 7 –21, male offspring showed similar testicular and developmental effects as found with DBP and DEHP. Further developmental and postnatal studies are needed to identify the reproductive effects of DIBP. (Borch, 2006) DIBP is classified by ECB as toxic to reproduction category 2, R61 (may cause harm to the unborn child) and category 3, R6","endpoint":"reproductive toxicity","ingredient":"s.” Names in brackets","loael_value":"","noael_unit":"mg/kg","noael_value":"50","page":10,"route":"oral","species":"rat","study_id":"sccp_o_106_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 5 | % | rat | oral | 13-week | reproductive toxicity | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=5; DOSE=Conclusion The low concentrations of DIBP (0.2 - 38 mg/kg) found in samples of perfume suggest unintentional exposure from perfume and other cosmetics would pose no measurable risk for the consumer.; EFFECT=as toxic to reproduction category 2, R61 (may cause harm to the unborn child) and category 3, R62 (possible risk of impaired fertility). It is therefore prohibited from use in cosmetic products. Conclusion The low concentrations of DIBP (0.2 - 38 mg/kg) found in samples of perfume suggest unintentional exposure from perfume and other cosmetics would pose no measurable risk for the consumer. Di-iso-nonyl phthalate (DINP) and di-iso-decyl phthalate (DIDP) Name EINECS / CAS Highest perfume concentration in mg/kg NOAEL mg/kg/day Status di-iso-nonyl phthalate (DINP) 271-090-9 & 249- 079-5 / 68515-48-0 & 28553-12-0 26 15 (rat) Increased liver and kidney weight 5% response BMD of 12* 15 -1000 increased liver and kidney weight, testes RAR Conclusion (ii)** EFSA (2005a) CSTEE (2001a) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC. RAR available di-iso-decyl phthalate (DIDP) 271-090-4 & 247- 977-1/ 68515-49-1 & 26761-40-0 37 15 13-week oral study in dogs 25 50 –600 increased liver and thyroi; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"Conclusion The low concentrations of DIBP (0.2 - 38 mg/kg) found in samples of perfume suggest unintentional exposure from perfume and other cosmetics would pose no measurable risk for the consumer.","duration":"13-week","effect":"as toxic to reproduction category 2, R61 (may cause harm to the unborn child) and category 3, R62 (possible risk of impaired fertility). It is therefore prohibited from use in cosmetic products. Conclusion The low concentrations of DIBP (0.2 - 38 mg/kg) found in samples of perfume suggest unintentional exposure from perfume and other cosmetics would pose no measurable risk for the consumer. Di-iso-nonyl phthalate (DINP) and di-iso-decyl phthalate (DIDP) Name EINECS / CAS Highest perfume concentration in mg/kg NOAEL mg/kg/day Status di-iso-nonyl phthalate (DINP) 271-090-9 & 249- 079-5 / 68515-48-0 & 28553-12-0 26 15 (rat) Increased liver and kidney weight 5% response BMD of 12* 15 -1000 increased liver and kidney weight, testes RAR Conclusion (ii)** EFSA (2005a) CSTEE (2001a) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC. RAR available di-iso-decyl phthalate (DIDP) 271-090-4 & 247- 977-1/ 68515-49-1 & 26761-40-0 37 15 13-week oral study in dogs 25 50 –600 increased liver and thyroi","endpoint":"reproductive toxicity","ingredient":"s.” Names in brackets","loael_value":"","noael_unit":"%","noael_value":"5","page":10,"route":"oral","species":"rat","study_id":"sccp_o_106_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 100 | ppm | - | - | developmental | reproductive toxicity | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=100; DOSE=Do the data provided support the safety of traces of up to 100 ppm total or per substance in cosmetics products of those phthalates (DEHP, DBP and BBP), which are banned in cosmetics products?; EFFECT=a mixture. For this reason, a group restriction for migration from food contact materials for DINP and DIDP was considered and rejected, as though both primarily affect the liver but the end-points indicate that different mechanisms are involved (EFSA, 2005c). Question 3: Do the data provided support the safety of traces of up to 100 ppm total or per substance in cosmetics products of those phthalates (DEHP, DBP and BBP), which are banned in cosmetics products? Name EINECS / CAS Highest concentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-(2-ethylhexyl) phthalate (DEHP) 204-211-0/ 117-81-7 167 4.8 testicular and developmental toxicity 88-1000 increased liver and kidney weight, testes RAR Conclusion (ii) and (iii)* CSTEE (2004b) EFSA (2005d) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC. RAR Annex 1 607-317-00-9 Repr. Cat. 2; R60-61 (fertility;development); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"Do the data provided support the safety of traces of up to 100 ppm total or per substance in cosmetics products of those phthalates (DEHP, DBP and BBP), which are banned in cosmetics products?","duration":"developmental","effect":"a mixture. For this reason, a group restriction for migration from food contact materials for DINP and DIDP was considered and rejected, as though both primarily affect the liver but the end-points indicate that different mechanisms are involved (EFSA, 2005c). Question 3: Do the data provided support the safety of traces of up to 100 ppm total or per substance in cosmetics products of those phthalates (DEHP, DBP and BBP), which are banned in cosmetics products? Name EINECS / CAS Highest concentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-(2-ethylhexyl) phthalate (DEHP) 204-211-0/ 117-81-7 167 4.8 testicular and developmental toxicity 88-1000 increased liver and kidney weight, testes RAR Conclusion (ii) and (iii)* CSTEE (2004b) EFSA (2005d) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC. RAR Annex 1 607-317-00-9 Repr. Cat. 2; R60-61 (fertility;development)","endpoint":"reproductive toxicity","ingredient":"s.” Names in brackets","loael_value":"","noael_unit":"ppm","noael_value":"100","page":12,"route":"","species":"","study_id":"sccp_o_106_noael_022"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 1016 | - | - | - | - | reproductive toxicity | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=unclear:SCCP/1016/06 Opinion on phthalates in cosmetic products 13 Name EINECS / CAS Highest concentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-n-butyl phthalate (DBP) 201-557-4/ 84-74-2. 14 NOAEL 50 reproductive effects LOAEL 2 NOAEL 62.5 -152 increased peroxisomal proliferation RAR Conclusion (ii)* CSTEE (2001c) EFSA (2005e) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC, RAR Annex 1 607-318-00-4 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50 Benzylbutyl phthalate (BBP) 201-622-7 / 85-68-7 110 NOAEL 50 reproductive effects NOAEL 50 reproductive effec; DOSE=SCCP/1016/06 Opinion on phthalates in cosmetic products 13 Name EINECS / CAS Highest concentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-n-butyl phthalate (DBP) 201-557-4/ 84-74-2.; EFFECT=SCCP/1016/06 Opinion on phthalates in cosmetic products 13 Name EINECS / CAS Highest concentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-n-butyl phthalate (DBP) 201-557-4/ 84-74-2. 14 NOAEL 50 reproductive effects LOAEL 2 NOAEL 62.5 -152 increased peroxisomal proliferation RAR Conclusion (ii)* CSTEE (2001c) EFSA (2005e) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC, RAR Annex 1 607-318-00-4 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50 Benzylbutyl phthalate (BBP) 201-622-7 / 85-68-7 110 NOAEL 50 reproductive effects NOAEL 50 reproductive effec; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"SCCP/1016/06 Opinion on phthalates in cosmetic products 13 Name EINECS / CAS Highest concentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-n-butyl phthalate (DBP) 201-557-4/ 84-74-2.","duration":"","effect":"SCCP/1016/06 Opinion on phthalates in cosmetic products 13 Name EINECS / CAS Highest concentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-n-butyl phthalate (DBP) 201-557-4/ 84-74-2. 14 NOAEL 50 reproductive effects LOAEL 2 NOAEL 62.5 -152 increased peroxisomal proliferation RAR Conclusion (ii)* CSTEE (2001c) EFSA (2005e) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC, RAR Annex 1 607-318-00-4 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50 Benzylbutyl phthalate (BBP) 201-622-7 / 85-68-7 110 NOAEL 50 reproductive effects NOAEL 50 reproductive effec","endpoint":"reproductive toxicity","ingredient":"s.” Names in brackets","loael_value":"","noael_unit":"","noael_value":"unclear:SCCP/1016/06 Opinion on phthalates in cosmetic products 13 Name EINECS / CAS Highest concentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-n-butyl phthalate (DBP) 201-557-4/ 84-74-2. 14 NOAEL 50 reproductive effects LOAEL 2 NOAEL 62.5 -152 increased peroxisomal proliferation RAR Conclusion (ii)* CSTEE (2001c) EFSA (2005e) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC, RAR Annex 1 607-318-00-4 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50 Benzylbutyl phthalate (BBP) 201-622-7 / 85-68-7 110 NOAEL 50 reproductive effects NOAEL 50 reproductive effec","page":13,"route":"","species":"","study_id":"sccp_o_106_noael_023"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 13 | - | - | - | - | reproductive toxicity | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=unclear:13 Name EINECS / CAS Highest concentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-n-butyl phthalate (DBP) 201-557-4/ 84-74-2. 14 NOAEL 50 reproductive effects LOAEL 2 NOAEL 62.5 -152 increased peroxisomal proliferation RAR Conclusion (ii)* CSTEE (2001c) EFSA (2005e) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC, RAR Annex 1 607-318-00-4 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50 Benzylbutyl phthalate (BBP) 201-622-7 / 85-68-7 110 NOAEL 50 reproductive effects NOAEL 50 reproductive effects RAR Draft Conclusion (ii)* SCHER (2005) EFSA (2005f) Annex 1 607-430-00-3 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50-53 * RAR Conclusion (ii): There is at present no need for further information and/or testing and for risk reduction measures beyond those which are being applied already. Conclusion (iii): There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account. T; DOSE=13 Name EINECS / CAS Highest concentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-n-butyl phthalate (DBP) 201-557-4/ 84-74-2.; EFFECT=13 Name EINECS / CAS Highest concentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-n-butyl phthalate (DBP) 201-557-4/ 84-74-2. 14 NOAEL 50 reproductive effects LOAEL 2 NOAEL 62.5 -152 increased peroxisomal proliferation RAR Conclusion (ii)* CSTEE (2001c) EFSA (2005e) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC, RAR Annex 1 607-318-00-4 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50 Benzylbutyl phthalate (BBP) 201-622-7 / 85-68-7 110 NOAEL 50 reproductive effects NOAEL 50 reproductive effects RAR Draft Conclusion (ii)* SCHER (2005) EFSA (2005f) Annex 1 607-430-00-3 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50-53 * RAR Conclusion (ii): There is at present no need for further information and/or testing and for risk reduction measures beyond those which are being applied already. Conclusion (iii): There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account. T; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"13 Name EINECS / CAS Highest concentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-n-butyl phthalate (DBP) 201-557-4/ 84-74-2.","duration":"","effect":"13 Name EINECS / CAS Highest concentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-n-butyl phthalate (DBP) 201-557-4/ 84-74-2. 14 NOAEL 50 reproductive effects LOAEL 2 NOAEL 62.5 -152 increased peroxisomal proliferation RAR Conclusion (ii)* CSTEE (2001c) EFSA (2005e) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC, RAR Annex 1 607-318-00-4 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50 Benzylbutyl phthalate (BBP) 201-622-7 / 85-68-7 110 NOAEL 50 reproductive effects NOAEL 50 reproductive effects RAR Draft Conclusion (ii)* SCHER (2005) EFSA (2005f) Annex 1 607-430-00-3 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50-53 * RAR Conclusion (ii): There is at present no need for further information and/or testing and for risk reduction measures beyond those which are being applied already. Conclusion (iii): There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account. T","endpoint":"reproductive toxicity","ingredient":"s.” Names in brackets","loael_value":"","noael_unit":"","noael_value":"unclear:13 Name EINECS / CAS Highest concentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-n-butyl phthalate (DBP) 201-557-4/ 84-74-2. 14 NOAEL 50 reproductive effects LOAEL 2 NOAEL 62.5 -152 increased peroxisomal proliferation RAR Conclusion (ii)* CSTEE (2001c) EFSA (2005e) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC, RAR Annex 1 607-318-00-4 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50 Benzylbutyl phthalate (BBP) 201-622-7 / 85-68-7 110 NOAEL 50 reproductive effects NOAEL 50 reproductive effects RAR Draft Conclusion (ii)* SCHER (2005) EFSA (2005f) Annex 1 607-430-00-3 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50-53 * RAR Conclusion (ii): There is at present no need for further information and/or testing and for risk reduction measures beyond those which are being applied already. Conclusion (iii): There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account. T","page":13,"route":"","species":"","study_id":"sccp_o_106_noael_024"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 201 | - | - | - | - | reproductive toxicity | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=unclear:oncentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-n-butyl phthalate (DBP) 201-557-4/ 84-74-2. 14 NOAEL 50 reproductive effects LOAEL 2 NOAEL 62.5 -152 increased peroxisomal proliferation RAR Conclusion (ii)* CSTEE (2001c) EFSA (2005e) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC, RAR Annex 1 607-318-00-4 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50 Benzylbutyl phthalate (BBP) 201-622-7 / 85-68-7 110 NOAEL 50 reproductive effects NOAEL 50 reproductive effects RAR Draft Conclusion (ii)* SCHER (2005) EFSA (2005f) Annex 1 607-430-00-3 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50-53 * RAR Conclusion (ii): There is at present no need for further information and/or testing and for risk reduction measures beyond those which are being applied already. Conclusion (iii): There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account. The main concerns relating to th; DOSE=oncentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-n-butyl phthalate (DBP) 201-557-4/ 84-74-2.; EFFECT=oncentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-n-butyl phthalate (DBP) 201-557-4/ 84-74-2. 14 NOAEL 50 reproductive effects LOAEL 2 NOAEL 62.5 -152 increased peroxisomal proliferation RAR Conclusion (ii)* CSTEE (2001c) EFSA (2005e) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC, RAR Annex 1 607-318-00-4 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50 Benzylbutyl phthalate (BBP) 201-622-7 / 85-68-7 110 NOAEL 50 reproductive effects NOAEL 50 reproductive effects RAR Draft Conclusion (ii)* SCHER (2005) EFSA (2005f) Annex 1 607-430-00-3 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50-53 * RAR Conclusion (ii): There is at present no need for further information and/or testing and for risk reduction measures beyond those which are being applied already. Conclusion (iii): There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account. The main concerns relating to th; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"oncentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-n-butyl phthalate (DBP) 201-557-4/ 84-74-2.","duration":"","effect":"oncentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-n-butyl phthalate (DBP) 201-557-4/ 84-74-2. 14 NOAEL 50 reproductive effects LOAEL 2 NOAEL 62.5 -152 increased peroxisomal proliferation RAR Conclusion (ii)* CSTEE (2001c) EFSA (2005e) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC, RAR Annex 1 607-318-00-4 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50 Benzylbutyl phthalate (BBP) 201-622-7 / 85-68-7 110 NOAEL 50 reproductive effects NOAEL 50 reproductive effects RAR Draft Conclusion (ii)* SCHER (2005) EFSA (2005f) Annex 1 607-430-00-3 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50-53 * RAR Conclusion (ii): There is at present no need for further information and/or testing and for risk reduction measures beyond those which are being applied already. Conclusion (iii): There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account. The main concerns relating to th","endpoint":"reproductive toxicity","ingredient":"s.” Names in brackets","loael_value":"","noael_unit":"","noael_value":"unclear:oncentration in mg/kg NOAEL mg/kg bw/day Critical effect Status di-n-butyl phthalate (DBP) 201-557-4/ 84-74-2. 14 NOAEL 50 reproductive effects LOAEL 2 NOAEL 62.5 -152 increased peroxisomal proliferation RAR Conclusion (ii)* CSTEE (2001c) EFSA (2005e) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC, RAR Annex 1 607-318-00-4 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50 Benzylbutyl phthalate (BBP) 201-622-7 / 85-68-7 110 NOAEL 50 reproductive effects NOAEL 50 reproductive effects RAR Draft Conclusion (ii)* SCHER (2005) EFSA (2005f) Annex 1 607-430-00-3 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50-53 * RAR Conclusion (ii): There is at present no need for further information and/or testing and for risk reduction measures beyond those which are being applied already. Conclusion (iii): There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account. The main concerns relating to th","page":13,"route":"","species":"","study_id":"sccp_o_106_noael_025"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 2 | mg/kg bw/d | rat | oral | developmental | reproductive toxicity | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=2; DOSE=A LOAEL of 2 mg/kg bw/d feed was derived, since the effects were reversible at all dose levels, particularly the lowest dose level (20 mg/kg feed, equivalent to 1.5 to 3 mg/kg bw/day) combined with other reproductive toxicity studies, with longer; LOAEL_VALUE=2 mg/kg bw/d; EFFECT=al absorption of 5 % for DBP as reported in the literature (Bronaugh et al. 1982, Elsisi et al. 1989 cited in RAR and an in vitro study (Scott et al. cited in RAR). Only dermal exposure will be considered in the safety calculation. LOAEL: A developmental toxicity study in the rat (Lee et al., 2004 cited by EFSA 2005e) with dietary exposure to DBP from gestation day 15 to the end of lactation (postnatal day 21), showed effects on the development of male and female offspring at lower doses than found previously. A NOAEL could not be established. A LOAEL of 2 mg/kg bw/d feed was derived, since the effects were reversible at all dose levels, particularly the lowest dose level (20 mg/kg feed, equivalent to 1.5 to 3 mg/kg bw/day) combined with other reproductive toxicity studies, with longer; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"A LOAEL of 2 mg/kg bw/d feed was derived, since the effects were reversible at all dose levels, particularly the lowest dose level (20 mg/kg feed, equivalent to 1.5 to 3 mg/kg bw/day) combined with other reproductive toxicity studies, with longer","duration":"developmental","effect":"al absorption of 5 % for DBP as reported in the literature (Bronaugh et al. 1982, Elsisi et al. 1989 cited in RAR and an in vitro study (Scott et al. cited in RAR). Only dermal exposure will be considered in the safety calculation. LOAEL: A developmental toxicity study in the rat (Lee et al., 2004 cited by EFSA 2005e) with dietary exposure to DBP from gestation day 15 to the end of lactation (postnatal day 21), showed effects on the development of male and female offspring at lower doses than found previously. A NOAEL could not be established. A LOAEL of 2 mg/kg bw/d feed was derived, since the effects were reversible at all dose levels, particularly the lowest dose level (20 mg/kg feed, equivalent to 1.5 to 3 mg/kg bw/day) combined with other reproductive toxicity studies, with longer","endpoint":"reproductive toxicity","ingredient":"s.” Names in brackets","loael_value":"2 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"2","page":14,"route":"oral","species":"rat","study_id":"sccp_o_106_noael_031"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 4.8 | - | - | - | developmental | reproductive toxicity | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=4.8 testicular and developmental toxicity 88-1000 increased liver and kidney weight, testes RAR Conclusion (ii) and (iii)*; EFFECT=Unlabeled table on page 12: di-(2-ethylhexyl) phthalate (DEHP) | 204-211-0/ 117-81-7 | 167 | 4.8 testicular and developmental toxicity 88-1000 increased liver and kidney weight, testes RAR Conclusion (ii) and (iii)* | CSTEE (2004b) EFSA (2005d) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC. RAR Annex 1 607-317-00-9 Repr. Cat. 2; R60-61 (fertility;development); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"","duration":"developmental","effect":"Unlabeled table on page 12: di-(2-ethylhexyl) phthalate (DEHP) | 204-211-0/ 117-81-7 | 167 | 4.8 testicular and developmental toxicity 88-1000 increased liver and kidney weight, testes RAR Conclusion (ii) and (iii)* | CSTEE (2004b) EFSA (2005d) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC. RAR Annex 1 607-317-00-9 Repr. Cat. 2; R60-61 (fertility;development)","endpoint":"reproductive toxicity","ingredient":"s.” Names in brackets","loael_value":"","noael_unit":"","noael_value":"4.8 testicular and developmental toxicity 88-1000 increased liver and kidney weight, testes RAR Conclusion (ii) and (iii)*","page":12,"route":"","species":"","study_id":"sccp_o_106_noael_042"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 13 | - | - | - | - | reproductive toxicity | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=unclear:Unlabeled table on page 13: di-n-butyl phthalate (DBP) | 201-557-4/ 84-74-2. | 14 | NOAEL 50 reproductive effects LOAEL 2 NOAEL 62.5 -152 increased peroxisomal proliferation RAR Conclusion (ii)* | CSTEE (2001c) EFSA (2005e) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC, RAR Annex 1 607-318-00-4 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50; EFFECT=Unlabeled table on page 13: di-n-butyl phthalate (DBP) | 201-557-4/ 84-74-2. | 14 | NOAEL 50 reproductive effects LOAEL 2 NOAEL 62.5 -152 increased peroxisomal proliferation RAR Conclusion (ii)* | CSTEE (2001c) EFSA (2005e) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC, RAR Annex 1 607-318-00-4 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 13: di-n-butyl phthalate (DBP) | 201-557-4/ 84-74-2. | 14 | NOAEL 50 reproductive effects LOAEL 2 NOAEL 62.5 -152 increased peroxisomal proliferation RAR Conclusion (ii)* | CSTEE (2001c) EFSA (2005e) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC, RAR Annex 1 607-318-00-4 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50","endpoint":"reproductive toxicity","ingredient":"s.” Names in brackets","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 13: di-n-butyl phthalate (DBP) | 201-557-4/ 84-74-2. | 14 | NOAEL 50 reproductive effects LOAEL 2 NOAEL 62.5 -152 increased peroxisomal proliferation RAR Conclusion (ii)* | CSTEE (2001c) EFSA (2005e) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC, RAR Annex 1 607-318-00-4 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50","page":13,"route":"","species":"","study_id":"sccp_o_106_noael_044"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 13 | - | - | - | - | reproductive toxicity | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=unclear:Unlabeled table on page 13: Benzylbutyl phthalate (BBP) | 201-622-7 / 85-68-7 | 110 | NOAEL 50 reproductive effects NOAEL 50 reproductive effects RAR Draft Conclusion (ii)* | SCHER (2005) EFSA (2005f) Annex 1 607-430-00-3 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50-53; EFFECT=Unlabeled table on page 13: Benzylbutyl phthalate (BBP) | 201-622-7 / 85-68-7 | 110 | NOAEL 50 reproductive effects NOAEL 50 reproductive effects RAR Draft Conclusion (ii)* | SCHER (2005) EFSA (2005f) Annex 1 607-430-00-3 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50-53; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 13: Benzylbutyl phthalate (BBP) | 201-622-7 / 85-68-7 | 110 | NOAEL 50 reproductive effects NOAEL 50 reproductive effects RAR Draft Conclusion (ii)* | SCHER (2005) EFSA (2005f) Annex 1 607-430-00-3 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50-53","endpoint":"reproductive toxicity","ingredient":"s.” Names in brackets","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 13: Benzylbutyl phthalate (BBP) | 201-622-7 / 85-68-7 | 110 | NOAEL 50 reproductive effects NOAEL 50 reproductive effects RAR Draft Conclusion (ii)* | SCHER (2005) EFSA (2005f) Annex 1 607-430-00-3 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50-53","page":13,"route":"","species":"","study_id":"sccp_o_106_noael_045"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 50 | - | - | - | - | reproductive toxicity | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=NOAEL 50 reproductive effects LOAEL 2 NOAEL 62.5 -152 increased peroxisomal proliferation RAR Conclusion (ii)*; EFFECT=Unlabeled table on page 13: di-n-butyl phthalate (DBP) | 201-557-4/ 84-74-2. | 14 | NOAEL 50 reproductive effects LOAEL 2 NOAEL 62.5 -152 increased peroxisomal proliferation RAR Conclusion (ii)* | CSTEE (2001c) EFSA (2005e) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC, RAR Annex 1 607-318-00-4 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 13: di-n-butyl phthalate (DBP) | 201-557-4/ 84-74-2. | 14 | NOAEL 50 reproductive effects LOAEL 2 NOAEL 62.5 -152 increased peroxisomal proliferation RAR Conclusion (ii)* | CSTEE (2001c) EFSA (2005e) Evaluated under the Existing Chemicals Legislation, Council Regulation 793/93/EEC, RAR Annex 1 607-318-00-4 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50","endpoint":"reproductive toxicity","ingredient":"s.” Names in brackets","loael_value":"","noael_unit":"","noael_value":"NOAEL 50 reproductive effects LOAEL 2 NOAEL 62.5 -152 increased peroxisomal proliferation RAR Conclusion (ii)*","page":13,"route":"","species":"","study_id":"sccp_o_106_noael_046"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 50 | - | - | - | - | reproductive toxicity | SOURCE_SUBDIR=sccp_o_106; REPORT_TITLE=OPINION ON PHTHALATES IN COSMETIC PRODUCTS; OPINION_NUMBER=SCCP/1016/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=NOAEL 50 reproductive effects NOAEL 50 reproductive effects RAR Draft Conclusion (ii)*; EFFECT=Unlabeled table on page 13: Benzylbutyl phthalate (BBP) | 201-622-7 / 85-68-7 | 110 | NOAEL 50 reproductive effects NOAEL 50 reproductive effects RAR Draft Conclusion (ii)* | SCHER (2005) EFSA (2005f) Annex 1 607-430-00-3 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50-53; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-11-3","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 13: Benzylbutyl phthalate (BBP) | 201-622-7 / 85-68-7 | 110 | NOAEL 50 reproductive effects NOAEL 50 reproductive effects RAR Draft Conclusion (ii)* | SCHER (2005) EFSA (2005f) Annex 1 607-430-00-3 Repr. Cat. 2; R61 (development), Repr. Cat. 3; R62 (fertility) - N; R50-53","endpoint":"reproductive toxicity","ingredient":"s.” Names in brackets","loael_value":"","noael_unit":"","noael_value":"NOAEL 50 reproductive effects NOAEL 50 reproductive effects RAR Draft Conclusion (ii)*","page":13,"route":"","species":"","study_id":"sccp_o_106_noael_047"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | 08X7F5UDJM | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C10H10O4","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"08X7F5UDJM"} |
| openFDA substances | FDA UNII substance identifier | 08X7F5UDJM | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C10H10O4","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"08X7F5UDJM"} |
| openFDA substances | FDA UNII substance identifier | 08X7F5UDJM | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C10H10O4","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"08X7F5UDJM"} |
| openFDA substances | FDA UNII substance identifier | 08X7F5UDJM | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C10H10O4","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"08X7F5UDJM"} |