NOAEL Studies
Cosmetic Ingredient
1-Naphthol NOAEL Studies
INCI: 1-NAPHTHOL
CAS: 90-15-3
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
COSMOS_DB 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| COSMOS_DB | LOAEL | 100 | mg/kg bw/day | rat | oral | 7-17 Gestation day | Developmental | SCCP; Oral (Gavage) Developmental Toxicity Study of RE-1141.02 in Rats, P&G Study # BTS 0704/02 (Protocol 916-020), May 2003 |
| COSMOS_DB | NOAEL | 20 | mg/kg bw/day | rat | oral | 7-17 Gestation day | Developmental | SCCP; Oral (Gavage) Developmental Toxicity Study of RE-1141.02 in Rats, P&G Study # BTS 0704/02 (Protocol 916-020), May 2003 |
NTP_ICE_acute_inhalation 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_acute_inhalation | LC50 | >0.42 | mg/L | - | Inhalation | Duration=1 hr | In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=3345; Record_ID=acute_inhalation_2838; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID6021793; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response_Modifier=>; Response=0.42; Response_Unit=mg/L; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6021793 |
NTP_ICE_acute_oral 3 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_acute_oral | LD50 | =2380 | mg/kg bw | Rat (Male) | oral | acute | Rat Acute Oral Toxicity | NLM Hazardous Substances Data Bank (undated); record_id=acute_oral_11282; row=10069; data_type=In Vivo; mixture=Chemical; chemical_name=1-Naphthol; preferred_name=1-Naphthol; dtxsid=DTXSID6021793; url=https://pubchem.ncbi.nlm.nih.gov/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6021793; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | =1870 | mg/kg bw | Rat (Male) | oral | acute | Rat Acute Oral Toxicity | NLM Hazardous Substances Data Bank (undated); record_id=acute_oral_11280; row=10070; data_type=In Vivo; mixture=Chemical; chemical_name=1-Naphthol; preferred_name=1-Naphthol; dtxsid=DTXSID6021793; url=https://pubchem.ncbi.nlm.nih.gov/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6021793; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | =2590 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | NLM Hazardous Substances Data Bank (undated); record_id=acute_oral_11284; row=10071; data_type=In Vivo; mixture=Chemical; chemical_name=1-Naphthol; preferred_name=1-Naphthol; dtxsid=DTXSID6021793; url=https://pubchem.ncbi.nlm.nih.gov/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6021793; 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 | 0 | uL/min/10^6 cells | Human | - | - | Measured; httk, Human Hepatic Intrinsic Clearance | sheet=Data; excel_row=2376; Record_ID=adme_parameters_800; Data_Type=Measured; DTXSID=DTXSID6021793; Assay=httk, Human Hepatic Intrinsic Clearance; Endpoint=Clint; Response=0.0; Response_Unit=ul/min/10^6 cells; Species=Human; Reference=httk2.3.1, Wambaugh 2019; URL=https://cran.r-project.org/web/packages/httk/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6021793 |
| NTP_ICE_adme_parameters | Fu | 0.0682 | fraction | Human | - | - | Measured; httk, Human Plasma Fraction Unbound | sheet=Data; excel_row=2377; Record_ID=adme_parameters_800; Data_Type=Measured; DTXSID=DTXSID6021793; Assay=httk, Human Plasma Fraction Unbound; Endpoint=Fu; Response=0.0682; Response_Unit=Unitless Fraction; Species=Human; Reference=httk2.3.1, Wambaugh 2019; URL=https://cran.r-project.org/web/packages/httk/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6021793 |
NTP_ICE_endocrine 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_endocrine | AC50 | 41.6250028012423 | uM | - | - | - | ERPathway2016; ER Pathway Model, Antagonist | sheet=Integrated_approaches; excel_row=1240; RecordID=ERPathway2016_328; DatasetName=ERPathway2016; DTXSID=DTXSID6021793; Assay=ER Pathway Model, Antagonist; Endpoint=AC50; Response=41.6250028012423; Response_Unit=uM; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6021793 |
| NTP_ICE_endocrine | ACC | 26.3047473279735 | uM | - | - | - | ERPathway2016; ER Pathway Model, Antagonist | sheet=Integrated_approaches; excel_row=1241; RecordID=ERPathway2016_328; DatasetName=ERPathway2016; DTXSID=DTXSID6021793; Assay=ER Pathway Model, Antagonist; Endpoint=ACC; Response=26.3047473279735; Response_Unit=uM; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6021793 |
| NTP_ICE_endocrine | Model Score | 0 | unitless | - | - | - | ARPathway2016; AR Pathway Model, Antagonist | sheet=Integrated_approaches; excel_row=1236; RecordID=ARPathway2016_1700; DatasetName=ARPathway2016; DTXSID=DTXSID6021793; Assay=AR Pathway Model, Antagonist; Endpoint=Model Score; Response=0; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6021793 |
| NTP_ICE_endocrine | Model Score | 0.0232 | unitless | - | - | - | ERPathway2016; ER Pathway Model, Agonist | sheet=Integrated_approaches; excel_row=1242; RecordID=ERPathway2016_328; DatasetName=ERPathway2016; DTXSID=DTXSID6021793; Assay=ER Pathway Model, Agonist; Endpoint=Model Score; Response=0.0232; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6021793 |
NTP_ICE_skin_sensitization 19 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_skin_sensitization | CD54, EC200 | 12.7 | ug/mL | - | Dermal | - | In Vitro; hCLAT2015; h-CLAT | sheet=Data_invitro; excel_row=3589; Record_ID=skin_sensitization_invitro_824; Data_Type=In Vitro; Internal_Data_Source=hCLAT2015; Mixture=Chemical; DTXSID=DTXSID6021793; Assay=h-CLAT; Endpoint=CD54, EC200; Reported_Response=12.7; Reported_Response_Unit=ug/mL; Response=12.7; Response_Unit=ug/mL; Reference=Ashikaga et al. 2010; 20822320; 10.1177/026119291003800403|Nukada et al. 2012; 22796097; 10.1016/j.tiv.2012.07.001|Nukada et al. 2013; 23149339; 10.1016/j.tiv.2012.11.006; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6021793 |
| NTP_ICE_skin_sensitization | CD86, EC150 | 18.3 | ug/mL | - | Dermal | - | In Vitro; hCLAT2015; h-CLAT | sheet=Data_invitro; excel_row=3592; Record_ID=skin_sensitization_invitro_824; Data_Type=In Vitro; Internal_Data_Source=hCLAT2015; Mixture=Chemical; DTXSID=DTXSID6021793; Assay=h-CLAT; Endpoint=CD86, EC150; Reported_Response=18.3; Reported_Response_Unit=ug/mL; Response=18.3; Response_Unit=ug/mL; Reference=Ashikaga et al. 2010; 20822320; 10.1177/026119291003800403|Nukada et al. 2012; 22796097; 10.1016/j.tiv.2012.07.001|Nukada et al. 2013; 23149339; 10.1016/j.tiv.2012.11.006; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6021793 |
| NTP_ICE_skin_sensitization | CD86, EC150 | 1.4 | ug/mL | - | Dermal | - | In Vitro; Urbisch_SkinSensitization2020; U-SENS | sheet=Data_invitro; excel_row=8271; Record_ID=skin_sensitization_invitro_2294; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID6021793; Assay=U-SENS; Endpoint=CD86, EC150; Reported_Response=9.710556068; Reported_Response_Unit=uM; Conversion_Factor_Value=144.173; Conversion_Factor_Source=EPA Dashboard; Converted_Response=1.4; Converted_Response_Unit=ug/mL; Response=1.4; Response_Unit=ug/mL; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6021793 |
| NTP_ICE_skin_sensitization | CV75 | 57.2 | ug/mL | - | Dermal | - | In Vitro; hCLAT2015; h-CLAT | sheet=Data_invitro; excel_row=3595; Record_ID=skin_sensitization_invitro_824; Data_Type=In Vitro; Internal_Data_Source=hCLAT2015; Mixture=Chemical; DTXSID=DTXSID6021793; Assay=h-CLAT; Endpoint=CV75; Reported_Response=57.2; Reported_Response_Unit=ug/mL; Response=57.2; Response_Unit=ug/mL; Reference=Ashikaga et al. 2010; 20822320; 10.1177/026119291003800403|Nukada et al. 2012; 22796097; 10.1016/j.tiv.2012.07.001|Nukada et al. 2013; 23149339; 10.1016/j.tiv.2012.11.006; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6021793 |
| NTP_ICE_skin_sensitization | Depletion Cys | 21.8 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=269; Record_ID=skin_sensitization_invitro_90; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID6021793; Assay=DPRA; Endpoint=Depletion Cys; Reported_Response=21.8; Reported_Response_Unit=%; Response=21.8; Response_Unit=%; Reference=Nukada et al. 2013; 23149339; 10.1016/j.tiv.2012.11.006|Nukada personal communication (undated); URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6021793 |
| NTP_ICE_skin_sensitization | Depletion Cys | 68.2 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=1440; Record_ID=skin_sensitization_invitro_384; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID6021793; Assay=DPRA; Endpoint=Depletion Cys; Reported_Response=68.2; Reported_Response_Unit=%; Response=68.2; Response_Unit=%; Reference=Natsch et al. 2013; 23576290; 10.1002/jat.2868; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6021793 |
| NTP_ICE_skin_sensitization | Depletion Lys | 17.4 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=267; Record_ID=skin_sensitization_invitro_90; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID6021793; Assay=DPRA; Endpoint=Depletion Lys; Reported_Response=17.399999999999999; Reported_Response_Unit=%; Response=17.4; Response_Unit=%; Reference=Nukada et al. 2013; 23149339; 10.1016/j.tiv.2012.11.006|Nukada personal communication (undated); URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6021793 |
| NTP_ICE_skin_sensitization | Depletion Lys | 12.4 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=1439; Record_ID=skin_sensitization_invitro_384; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID6021793; Assay=DPRA; Endpoint=Depletion Lys; Reported_Response=12.4; Reported_Response_Unit=%; Response=12.4; Response_Unit=%; Reference=Natsch et al. 2013; 23576290; 10.1002/jat.2868; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6021793 |
| NTP_ICE_skin_sensitization | Depletion Lys + Cys | 20 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=272; Record_ID=skin_sensitization_invitro_90; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID6021793; Assay=DPRA; Endpoint=Depletion Lys + Cys; Reported_Response=20; Reported_Response_Unit=%; Response=20; Response_Unit=%; Reference=Nukada et al. 2013; 23149339; 10.1016/j.tiv.2012.11.006|Nukada personal communication (undated); URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6021793 |
| NTP_ICE_skin_sensitization | Depletion Lys + Cys | 40.3 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=1441; Record_ID=skin_sensitization_invitro_384; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID6021793; Assay=DPRA; Endpoint=Depletion Lys + Cys; Reported_Response=40.299999999999997; Reported_Response_Unit=%; Response=40.3; Response_Unit=%; Reference=Natsch et al. 2013; 23576290; 10.1002/jat.2868; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6021793 |
| NTP_ICE_skin_sensitization | EC1.5 | 129.6 | uM | - | Dermal | - | In Vitro; Urbisch_SkinSensitization2020; KeratinoSens | sheet=Data_invitro; excel_row=6895; Record_ID=skin_sensitization_invitro_1633; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID6021793; Assay=KeratinoSens; Endpoint=EC1.5; Reported_Response=129.6176795; Reported_Response_Unit=uM; Response=129.6; Response_Unit=uM; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6021793 |
| NTP_ICE_skin_sensitization | EC1.5 | 129.62 | uM | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6897; Record_ID=skin_sensitization_invitro_1632; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID6021793; Assay=KeratinoSens; Endpoint=EC1.5; Reported_Response=129.62; Reported_Response_Unit=uM; Response=129.62; Response_Unit=uM; Reference=Natsch et al. 2013; 23576290; 10.1002/jat.2868; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6021793 |
| NTP_ICE_skin_sensitization | EC3 | 1.3 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13472; Record_ID=skin_sensitization_invivo_3641; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID6021793; Assay=LLNA; Endpoint=EC3; Response=1.3; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Gerberick et al. 2005; 16536334; Not available; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6021793 |
| NTP_ICE_skin_sensitization | EC3 | 1.3 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13472; Record_ID=skin_sensitization_invivo_3641; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID6021793; Assay=LLNA; Endpoint=EC3; Response=1.3; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Gerberick et al. 2005; 16536334; Not available; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6021793 |
| NTP_ICE_skin_sensitization | EC3 | 1.3 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13472; Record_ID=skin_sensitization_invivo_3641; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID6021793; Assay=LLNA; Endpoint=EC3; Response=1.3; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Gerberick et al. 2005; 16536334; Not available; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6021793 |
| NTP_ICE_skin_sensitization | EC3 | 1.3 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13472; Record_ID=skin_sensitization_invivo_3641; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID6021793; Assay=LLNA; Endpoint=EC3; Response=1.3; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Gerberick et al. 2005; 16536334; Not available; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6021793 |
| NTP_ICE_skin_sensitization | IC50 | 541 | uM | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6898; Record_ID=skin_sensitization_invitro_1632; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID6021793; Assay=KeratinoSens; Endpoint=IC50; Reported_Response=541; Reported_Response_Unit=uM; Response=541; Response_Unit=uM; Reference=Natsch et al. 2013; 23576290; 10.1002/jat.2868; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6021793 |
| NTP_ICE_skin_sensitization | Imax | 1.78 | ratio | - | Dermal | - | In Vitro; Urbisch_SkinSensitization2020; KeratinoSens | sheet=Data_invitro; excel_row=6902; Record_ID=skin_sensitization_invitro_1633; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID6021793; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.780006546; Reported_Response_Unit=Unitless; Response=1.78; Response_Unit=Ratio; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6021793 |
| NTP_ICE_skin_sensitization | Imax | 1.89 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6904; Record_ID=skin_sensitization_invitro_1632; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID6021793; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.89; Reported_Response_Unit=Unitless; Response=1.89; Response_Unit=Ratio; Reference=Natsch et al. 2013; 23576290; 10.1002/jat.2868; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6021793 |
SCCNFP_vision_codex 12 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCNFP_vision_codex | NOAEL | =100 | mg/kg bw/day | rat | - | 30-day | developmental toxicity | {"dose":"A 30-day study in mice showed gastric lesions at 200 mg/kg bw/day and the NOAEL was 100 mg/kg bw/day.","effect":"68/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products. 2.2 Request to the SCCNFP The SCCNFP is requested to answer the following questions : * Is 1-Naphthol safe for use as an oxidising colouring agent for hair dyeing? * Does the SCCNFP propose any restrictions or conditions for its use? 3. Safety Assessment & Classification The substance was not harmful on acute ingestion (LD50>2g/kg bw). A 30-day study in mice showed gastric lesions at 200 mg/kg bw/day and the NOAEL was 100 mg/kg bw/day. A 12-wk study in rats showed a NOAEL of 20 mg/kg bw/day. The substance showed neither maternal toxicity nor embryo-toxic or teratogenic effects at levels up to 80 mg/kg bw/day (highest tested dose). A concentration of 2.5% was not irritant to the rabbit skin. The substance showed minimal eye irritation at levels up to 1.5%, but was irritant to the rabbit eye at 2 and 2.5%. Sensitising potential was not properly assessed. The substance was not mutagenic or genotoxic in vitro or in vivo. Percut","page":2,"pdf":"out138_en.pdf","row_type":"noael_study","study_id":"out138_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =20 | mg/kg bw/day | rat | - | 30-day | developmental toxicity | {"dose":"A 30-day study in mice showed gastric lesions at 200 mg/kg bw/day and the NOAEL was 100 mg/kg bw/day.","effect":"the Member States relating to cosmetic products. 2.2 Request to the SCCNFP The SCCNFP is requested to answer the following questions : * Is 1-Naphthol safe for use as an oxidising colouring agent for hair dyeing? * Does the SCCNFP propose any restrictions or conditions for its use? 3. Safety Assessment & Classification The substance was not harmful on acute ingestion (LD50>2g/kg bw). A 30-day study in mice showed gastric lesions at 200 mg/kg bw/day and the NOAEL was 100 mg/kg bw/day. A 12-wk study in rats showed a NOAEL of 20 mg/kg bw/day. The substance showed neither maternal toxicity nor embryo-toxic or teratogenic effects at levels up to 80 mg/kg bw/day (highest tested dose). A concentration of 2.5% was not irritant to the rabbit skin. The substance showed minimal eye irritation at levels up to 1.5%, but was irritant to the rabbit eye at 2 and 2.5%. Sensitising potential was not properly assessed. The substance was not mutagenic or genotoxic in vitro or in vivo. Percutaneous absorption in humans under exaggerated exposure cond","page":2,"pdf":"out138_en.pdf","row_type":"noael_study","study_id":"out138_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =20 | mg/kg | rat | oral | 90 day | dermal absorption | {"dose":"Thus the usage volume of 100 ml contains at maximum 1.0 % Maximum amount of ingredient applied I (mg) = 1000 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.7% (rat study) Dermal absorption per treatment I x=A = 7.0 mg Systemic exposure dose (SED) ==== ==== ==== ==== I x A / 60 kg = 0.117 mg/kg bw No observe...","effect":"__________ 11 2.11. Safety evaluation CALCULATION OF SAFETY MARGIN 1-NAPHTHOL (Oxidation or Permanent) The maximum concentration of 2.0 % of 1-Naphthol is mixed before use with H2O2. Thus the usage volume of 100 ml contains at maximum 1.0 % Maximum amount of ingredient applied I (mg) = 1000 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.7% (rat study) Dermal absorption per treatment I x=A = 7.0 mg Systemic exposure dose (SED) ==== ==== ==== ==== I x A / 60 kg = 0.117 mg/kg bw No observed adverse effect level (mg/kg) NOAEL = 20 mg/kg (rat: 90 day oral study) Margin of Safety NOAEL / SED = 171 It should be noted that the no-effect level is based on daily exposure for 90 days. Taking into account that the application will generally not exceed once a month and that not all of the active ingredient will reach the scalp, the Margin of Safety is considered to be acceptable. 2.12. Conclusions Classification : 1 under the conditions in use : as an oxidising colouring agent for hair dyeing at a maximum concentration of 2.0 % in","page":11,"pdf":"out138_en.pdf","row_type":"noael_study","study_id":"out138_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =100 | mg/kg bw/day | rat | - | 30-day | developmental toxicity | {"dose":"A 30-day study in mice showed gastric lesions at 200 mg/kg bw/day and the NOAEL was 100 mg/kg bw/day.","effect":"68/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products. 2.2 Request to the SCCNFP The SCCNFP is requested to answer the following questions : * Is 1-Naphthol safe for use as an oxidising colouring agent for hair dyeing? * Does the SCCNFP propose any restrictions or conditions for its use? 3. Safety Assessment & Classification The substance was not harmful on acute ingestion (LD50>2g/kg bw). A 30-day study in mice showed gastric lesions at 200 mg/kg bw/day and the NOAEL was 100 mg/kg bw/day. A 12-wk study in rats showed a NOAEL of 20 mg/kg bw/day. The substance showed neither maternal toxicity nor embryo-toxic or teratogenic effects at levels up to 80 mg/kg bw/day (highest tested dose). A concentration of 2.5% was not irritant to the rabbit skin. The substance showed minimal eye irritation at levels up to 1.5%, but was irritant to the rabbit eye at 2 and 2.5%. Sensitising potential was not properly assessed. The substance was not mutagenic or genotoxic in vitro or in vivo. Percut","page":2,"pdf":"out138_en.pdf","row_type":"noael_study","study_id":"out138_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =20 | mg/kg bw/day | rat | - | 30-day | developmental toxicity | {"dose":"A 30-day study in mice showed gastric lesions at 200 mg/kg bw/day and the NOAEL was 100 mg/kg bw/day.","effect":"the Member States relating to cosmetic products. 2.2 Request to the SCCNFP The SCCNFP is requested to answer the following questions : * Is 1-Naphthol safe for use as an oxidising colouring agent for hair dyeing? * Does the SCCNFP propose any restrictions or conditions for its use? 3. Safety Assessment & Classification The substance was not harmful on acute ingestion (LD50>2g/kg bw). A 30-day study in mice showed gastric lesions at 200 mg/kg bw/day and the NOAEL was 100 mg/kg bw/day. A 12-wk study in rats showed a NOAEL of 20 mg/kg bw/day. The substance showed neither maternal toxicity nor embryo-toxic or teratogenic effects at levels up to 80 mg/kg bw/day (highest tested dose). A concentration of 2.5% was not irritant to the rabbit skin. The substance showed minimal eye irritation at levels up to 1.5%, but was irritant to the rabbit eye at 2 and 2.5%. Sensitising potential was not properly assessed. The substance was not mutagenic or genotoxic in vitro or in vivo. Percutaneous absorption in humans under exaggerated exposure cond","page":2,"pdf":"out138_en.pdf","row_type":"noael_study","study_id":"out138_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =20 | mg/kg | rat | oral | 90 day | dermal absorption | {"dose":"Thus the usage volume of 100 ml contains at maximum 1.0 % Maximum amount of ingredient applied I (mg) = 1000 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.7% (rat study) Dermal absorption per treatment I x=A = 7.0 mg Systemic exposure dose (SED) ==== ==== ==== ==== I x A / 60 kg = 0.117 mg/kg bw No observe...","effect":"__________ 11 2.11. Safety evaluation CALCULATION OF SAFETY MARGIN 1-NAPHTHOL (Oxidation or Permanent) The maximum concentration of 2.0 % of 1-Naphthol is mixed before use with H2O2. Thus the usage volume of 100 ml contains at maximum 1.0 % Maximum amount of ingredient applied I (mg) = 1000 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.7% (rat study) Dermal absorption per treatment I x=A = 7.0 mg Systemic exposure dose (SED) ==== ==== ==== ==== I x A / 60 kg = 0.117 mg/kg bw No observed adverse effect level (mg/kg) NOAEL = 20 mg/kg (rat: 90 day oral study) Margin of Safety NOAEL / SED = 171 It should be noted that the no-effect level is based on daily exposure for 90 days. Taking into account that the application will generally not exceed once a month and that not all of the active ingredient will reach the scalp, the Margin of Safety is considered to be acceptable. 2.12. Conclusions Classification : 1 under the conditions in use : as an oxidising colouring agent for hair dyeing at a maximum concentration of 2.0 % in","page":11,"pdf":"out138_en.pdf","row_type":"noael_study","study_id":"out138_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =100 | mg/kg bw/day | rat | - | 30-day | developmental toxicity | {"dose":"A 30-day study in mice showed gastric lesions at 200 mg/kg bw/day and the NOAEL was 100 mg/kg bw/day.","effect":"68/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products. 2.2 Request to the SCCNFP The SCCNFP is requested to answer the following questions : * Is 1-Naphthol safe for use as an oxidising colouring agent for hair dyeing? * Does the SCCNFP propose any restrictions or conditions for its use? 3. Safety Assessment & Classification The substance was not harmful on acute ingestion (LD50>2g/kg bw). A 30-day study in mice showed gastric lesions at 200 mg/kg bw/day and the NOAEL was 100 mg/kg bw/day. A 12-wk study in rats showed a NOAEL of 20 mg/kg bw/day. The substance showed neither maternal toxicity nor embryo-toxic or teratogenic effects at levels up to 80 mg/kg bw/day (highest tested dose). A concentration of 2.5% was not irritant to the rabbit skin. The substance showed minimal eye irritation at levels up to 1.5%, but was irritant to the rabbit eye at 2 and 2.5%. Sensitising potential was not properly assessed. The substance was not mutagenic or genotoxic in vitro or in vivo. Percut","page":2,"pdf":"out138_en.pdf","row_type":"noael_study","study_id":"out138_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =20 | mg/kg bw/day | rat | - | 30-day | developmental toxicity | {"dose":"A 30-day study in mice showed gastric lesions at 200 mg/kg bw/day and the NOAEL was 100 mg/kg bw/day.","effect":"the Member States relating to cosmetic products. 2.2 Request to the SCCNFP The SCCNFP is requested to answer the following questions : * Is 1-Naphthol safe for use as an oxidising colouring agent for hair dyeing? * Does the SCCNFP propose any restrictions or conditions for its use? 3. Safety Assessment & Classification The substance was not harmful on acute ingestion (LD50>2g/kg bw). A 30-day study in mice showed gastric lesions at 200 mg/kg bw/day and the NOAEL was 100 mg/kg bw/day. A 12-wk study in rats showed a NOAEL of 20 mg/kg bw/day. The substance showed neither maternal toxicity nor embryo-toxic or teratogenic effects at levels up to 80 mg/kg bw/day (highest tested dose). A concentration of 2.5% was not irritant to the rabbit skin. The substance showed minimal eye irritation at levels up to 1.5%, but was irritant to the rabbit eye at 2 and 2.5%. Sensitising potential was not properly assessed. The substance was not mutagenic or genotoxic in vitro or in vivo. Percutaneous absorption in humans under exaggerated exposure cond","page":2,"pdf":"out138_en.pdf","row_type":"noael_study","study_id":"out138_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =20 | mg/kg | rat | oral | 90 day | dermal absorption | {"dose":"Thus the usage volume of 100 ml contains at maximum 1.0 % Maximum amount of ingredient applied I (mg) = 1000 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.7% (rat study) Dermal absorption per treatment I x=A = 7.0 mg Systemic exposure dose (SED) ==== ==== ==== ==== I x A / 60 kg = 0.117 mg/kg bw No observe...","effect":"__________ 11 2.11. Safety evaluation CALCULATION OF SAFETY MARGIN 1-NAPHTHOL (Oxidation or Permanent) The maximum concentration of 2.0 % of 1-Naphthol is mixed before use with H2O2. Thus the usage volume of 100 ml contains at maximum 1.0 % Maximum amount of ingredient applied I (mg) = 1000 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.7% (rat study) Dermal absorption per treatment I x=A = 7.0 mg Systemic exposure dose (SED) ==== ==== ==== ==== I x A / 60 kg = 0.117 mg/kg bw No observed adverse effect level (mg/kg) NOAEL = 20 mg/kg (rat: 90 day oral study) Margin of Safety NOAEL / SED = 171 It should be noted that the no-effect level is based on daily exposure for 90 days. Taking into account that the application will generally not exceed once a month and that not all of the active ingredient will reach the scalp, the Margin of Safety is considered to be acceptable. 2.12. Conclusions Classification : 1 under the conditions in use : as an oxidising colouring agent for hair dyeing at a maximum concentration of 2.0 % in","page":11,"pdf":"out138_en.pdf","row_type":"noael_study","study_id":"out138_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =100 | mg/kg bw/day | rat | - | 30-day | developmental toxicity | {"dose":"A 30-day study in mice showed gastric lesions at 200 mg/kg bw/day and the NOAEL was 100 mg/kg bw/day.","effect":"68/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products. 2.2 Request to the SCCNFP The SCCNFP is requested to answer the following questions : * Is 1-Naphthol safe for use as an oxidising colouring agent for hair dyeing? * Does the SCCNFP propose any restrictions or conditions for its use? 3. Safety Assessment & Classification The substance was not harmful on acute ingestion (LD50>2g/kg bw). A 30-day study in mice showed gastric lesions at 200 mg/kg bw/day and the NOAEL was 100 mg/kg bw/day. A 12-wk study in rats showed a NOAEL of 20 mg/kg bw/day. The substance showed neither maternal toxicity nor embryo-toxic or teratogenic effects at levels up to 80 mg/kg bw/day (highest tested dose). A concentration of 2.5% was not irritant to the rabbit skin. The substance showed minimal eye irritation at levels up to 1.5%, but was irritant to the rabbit eye at 2 and 2.5%. Sensitising potential was not properly assessed. The substance was not mutagenic or genotoxic in vitro or in vivo. Percut","page":2,"pdf":"out138_en.pdf","row_type":"noael_study","study_id":"out138_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =20 | mg/kg bw/day | rat | - | 30-day | developmental toxicity | {"dose":"A 30-day study in mice showed gastric lesions at 200 mg/kg bw/day and the NOAEL was 100 mg/kg bw/day.","effect":"the Member States relating to cosmetic products. 2.2 Request to the SCCNFP The SCCNFP is requested to answer the following questions : * Is 1-Naphthol safe for use as an oxidising colouring agent for hair dyeing? * Does the SCCNFP propose any restrictions or conditions for its use? 3. Safety Assessment & Classification The substance was not harmful on acute ingestion (LD50>2g/kg bw). A 30-day study in mice showed gastric lesions at 200 mg/kg bw/day and the NOAEL was 100 mg/kg bw/day. A 12-wk study in rats showed a NOAEL of 20 mg/kg bw/day. The substance showed neither maternal toxicity nor embryo-toxic or teratogenic effects at levels up to 80 mg/kg bw/day (highest tested dose). A concentration of 2.5% was not irritant to the rabbit skin. The substance showed minimal eye irritation at levels up to 1.5%, but was irritant to the rabbit eye at 2 and 2.5%. Sensitising potential was not properly assessed. The substance was not mutagenic or genotoxic in vitro or in vivo. Percutaneous absorption in humans under exaggerated exposure cond","page":2,"pdf":"out138_en.pdf","row_type":"noael_study","study_id":"out138_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =20 | mg/kg | rat | oral | 90 day | dermal absorption | {"dose":"Thus the usage volume of 100 ml contains at maximum 1.0 % Maximum amount of ingredient applied I (mg) = 1000 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.7% (rat study) Dermal absorption per treatment I x=A = 7.0 mg Systemic exposure dose (SED) ==== ==== ==== ==== I x A / 60 kg = 0.117 mg/kg bw No observe...","effect":"__________ 11 2.11. Safety evaluation CALCULATION OF SAFETY MARGIN 1-NAPHTHOL (Oxidation or Permanent) The maximum concentration of 2.0 % of 1-Naphthol is mixed before use with H2O2. Thus the usage volume of 100 ml contains at maximum 1.0 % Maximum amount of ingredient applied I (mg) = 1000 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.7% (rat study) Dermal absorption per treatment I x=A = 7.0 mg Systemic exposure dose (SED) ==== ==== ==== ==== I x A / 60 kg = 0.117 mg/kg bw No observed adverse effect level (mg/kg) NOAEL = 20 mg/kg (rat: 90 day oral study) Margin of Safety NOAEL / SED = 171 It should be noted that the no-effect level is based on daily exposure for 90 days. Taking into account that the application will generally not exceed once a month and that not all of the active ingredient will reach the scalp, the Margin of Safety is considered to be acceptable. 2.12. Conclusions Classification : 1 under the conditions in use : as an oxidising colouring agent for hair dyeing at a maximum concentration of 2.0 % in","page":11,"pdf":"out138_en.pdf","row_type":"noael_study","study_id":"out138_en_noael_003"} |
SCCS_vision_codex 28 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw | - | dermal | 90 day | NOAEL study | {"dose":"The Scientific Committee on Cosmetology (SCC) expressed its opinion at the 48th plenary meeting of 4 October 1991 with the conclusion that “the use of 1-naphthol in the oxidative hair dyes does not appear to present any health risk.” The SCC expressed a second opinion at the 54th plenary meeting of 10 December 1993 with the conclusion that “the...","effect":"submitted in May 1983 by COLIPA1, 2. The Scientific Committee on Cosmetology (SCC) expressed its opinion at the 48th plenary meeting of 4 October 1991 with the conclusion that “the use of 1-naphthol in the oxidative hair dyes does not appear to present any health risk.” The SCC expressed a second opinion at the 54th plenary meeting of 10 December 1993 with the conclusion that “the SCC requires cutaneous absorption study in more realistic experimental conditions.” The margin of safety was calculated as 3 based on NOAEL of 20 mg/kg bw in a single dose level 90 day study and absorption of 65%. Submission II for this substance was submitted in July 1996 by COLIPA. The Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP) adopted in the plenary session of 23 June 1999 the opinion SCCNFP/0130/99 with the conclusion, that “The SCCNFP is of the opinion that 1-Hydroxy-naphthalene can be used safely in permanent hair dye formulations at a maximum concentration of 1.0%. Since permanent hair dyes","page":5,"pdf":"sccp_o_125.pdf","row_type":"noael_study","study_id":"sccp_o_125_noael_001"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/day | rat | oral | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 4 3","dose":"No gastric effects were seen in the female mice dosed at 200 mg/kg bw/day or in the other treatment groups.","effect":"cal erosion of the glandular stomach. No gastric effects were seen in the female mice dosed at 200 mg/kg bw/day or in the other treatment groups. Exposure was accompanied by increase in white blood cell counts, the response being dose related in the female mice. However, the increases were all within historical normal limits of the laboratory. The weight gain was affected by the treatment, however the effect was not dose related. Conclusions The gastric lesions showed a sex difference, with the male mice having a NOAEL of 100 mg/kg bw/day. NOAEL for female mice was higher than the highest dose applied (200 mg/kg bw/day). Ref.: 4 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 (1981) Species/strain: Crl:CD/(SD)BR VAF/Plus rats; Group size: 15 per sex and per dose Test substance: RE1141.03 Batch: Lot n° 03 Purity: 99.7% Dose: 0, 65, 130, 400 mg/kg bw/day Route: oral, in carboxymethylcellulose 0.5% Exposure: by oral gavage GLP: in compliance Date: 20 April – 22 July 1998","page":14,"pdf":"sccp_o_125.pdf","row_type":"noael_study","study_id":"sccp_o_125_noael_002"} |
| SCCS_vision_codex | NOAEL | =130 | mg/kg bw/day | rat | - | 90-days | NOAEL study | {"citation":"Ref.: 12 Comment The SCCP agrees with the study authors to set the NOAEL at 130 mg/kg bw","dose":"dular stomach were present in all males and most females given 400 mg/kg bw/day; and in both sexes at130 mg/kg bw/day.","effect":"dular stomach were present in all males and most females given 400 mg/kg bw/day; and in both sexes at130 mg/kg bw/day. At the high-dose level, gastric changes were moderate to severe and in both sexes given 130 mg/kg bw/day were minimal to mild. In the spleen sections, increased pigment deposits (hemosiderin) were minimally to slightly increased in the 400 mg/kg bw/day group. Treatment-related stomach or changes in spleen were not observed in rats at the 65 mg/kg bw/day group. Conclusion The study authors set the NOAEL for RE1141.03 at 130 mg/kg bw/day, based on the microscopical changes in stomach and in spleen. In the submission, however, a value of 65 mg/kg bw/day was mentioned. Ref.: 12 Comment The SCCP agrees with the study authors to set the NOAEL at 130 mg/kg bw. In contrast to the teratogenicity study (ref 19), lacrimation was not reported in the 90-days study. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted","page":15,"pdf":"sccp_o_125.pdf","row_type":"noael_study","study_id":"sccp_o_125_noael_004"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw/day | human | - | developmental | developmental toxicity | {"citation":"Ref.: 19 3","dose":"No other Caesarean-sectioning or litter parameters were affected by exposure to the test substance to the dams at dosages as high as 400 mg/kg bw/day.","effect":"ge group; these reductions were significant for total and female foetal body weights. No other Caesarean-sectioning or litter parameters were affected by exposure to the test substance to the dams at dosages as high as 400 mg/kg bw/day. (No typical changes in skeletal ossification those are indicative of developmental delay and which would have been expected to accompany significant foetal weight decrements). The slight foetal body weight reduction might be influenced by maternal toxicity. Conclusion The maternal NOEL of RE-1141.02 was 20 mg/kg bw/day because of a significant incidence of chromorhinorrhea, dilated pupils and lacrimation of some animals in the 100 mg/kg bw/day group. The developmental NOAEL was set at 400 mg/kg bw/day, the highest dose applied. Ref.: 19 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human dat","page":23,"pdf":"sccp_o_125.pdf","row_type":"noael_study","study_id":"sccp_o_125_noael_006"} |
| SCCS_vision_codex | NOAEL | =400 | mg/kg bw/day | human | - | developmental | developmental toxicity | {"citation":"Ref.: 19 3","dose":"dams at dosages as high as 400 mg/kg bw/day.","effect":"dams at dosages as high as 400 mg/kg bw/day. (No typical changes in skeletal ossification those are indicative of developmental delay and which would have been expected to accompany significant foetal weight decrements). The slight foetal body weight reduction might be influenced by maternal toxicity. Conclusion The maternal NOEL of RE-1141.02 was 20 mg/kg bw/day because of a significant incidence of chromorhinorrhea, dilated pupils and lacrimation of some animals in the 100 mg/kg bw/day group. The developmental NOAEL was set at 400 mg/kg bw/day, the highest dose applied. Ref.: 19 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted","page":23,"pdf":"sccp_o_125.pdf","row_type":"noael_study","study_id":"sccp_o_125_noael_007"} |
| SCCS_vision_codex | NOAEL | =65 | mg/kg bw/day | rat | - | developmental | developmental toxicity | {"dose":"In gastric tissues, squamous hyperplasia and hyperkeratosis of the nonglandular stomach were present in all males and most females given 400 mg/kg bw/day; and in both sexes at 130 mg/kg bw/day.","effect":"adverse. Microscopic, treatment-related changes were restricted to the stomach and spleen. In gastric tissues, squamous hyperplasia and hyperkeratosis of the nonglandular stomach were present in all males and most females given 400 mg/kg bw/day; and in both sexes at 130 mg/kg bw/day. At the high-dose level, gastric changes were moderate to severe and in both sexes given 130 mg/kg bw/day were minimal to mild. Treatment-related stomach or changes in spleen were not observed in rats at the 65 mg/kg bw/day group. The NOAEL was set at 130 mg/kg bw. The maternal NOEL of the test substance RE-1141.02 was 20 mg/kg bw/day because of a significant incidence of chromorhinorrhea, dilated pupils and lacrimation of some animals in the 100 mg/kg bw/day group. The developmental NOAEL was set at 400 mg/kg bw/day, the highest dose applied. Irritation / sensitisation A 2.5% aqueous suspension of 1-naphthol was considered not to be irritant to rabbit skin. Although all effects were transient, aqueous dilutions of 1-naphthol of 0.5 to 2.5% caused","page":24,"pdf":"sccp_o_125.pdf","row_type":"noael_study","study_id":"sccp_o_125_noael_010"} |
| SCCS_vision_codex | NOAEL | =130 | mg/kg bw | rat | - | developmental | developmental toxicity | {"dose":"In gastric tissues, squamous hyperplasia and hyperkeratosis of the nonglandular stomach were present in all males and most females given 400 mg/kg bw/day; and in both sexes at 130 mg/kg bw/day.","effect":"nges were restricted to the stomach and spleen. In gastric tissues, squamous hyperplasia and hyperkeratosis of the nonglandular stomach were present in all males and most females given 400 mg/kg bw/day; and in both sexes at 130 mg/kg bw/day. At the high-dose level, gastric changes were moderate to severe and in both sexes given 130 mg/kg bw/day were minimal to mild. Treatment-related stomach or changes in spleen were not observed in rats at the 65 mg/kg bw/day group. The NOAEL was set at 130 mg/kg bw. The maternal NOEL of the test substance RE-1141.02 was 20 mg/kg bw/day because of a significant incidence of chromorhinorrhea, dilated pupils and lacrimation of some animals in the 100 mg/kg bw/day group. The developmental NOAEL was set at 400 mg/kg bw/day, the highest dose applied. Irritation / sensitisation A 2.5% aqueous suspension of 1-naphthol was considered not to be irritant to rabbit skin. Although all effects were transient, aqueous dilutions of 1-naphthol of 0.5 to 2.5% caused eye irritation to rabbits with irritant eff","page":24,"pdf":"sccp_o_125.pdf","row_type":"noael_study","study_id":"sccp_o_125_noael_011"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw | - | dermal | 90 day | NOAEL study | {"dose":"The Scientific Committee on Cosmetology (SCC) expressed its opinion at the 48th plenary meeting of 4 October 1991 with the conclusion that “the use of 1-naphthol in the oxidative hair dyes does not appear to present any health risk.” The SCC expressed a second opinion at the 54th plenary meeting of 10 December 1993 with the conclusion that “the...","effect":"submitted in May 1983 by COLIPA1, 2. The Scientific Committee on Cosmetology (SCC) expressed its opinion at the 48th plenary meeting of 4 October 1991 with the conclusion that “the use of 1-naphthol in the oxidative hair dyes does not appear to present any health risk.” The SCC expressed a second opinion at the 54th plenary meeting of 10 December 1993 with the conclusion that “the SCC requires cutaneous absorption study in more realistic experimental conditions.” The margin of safety was calculated as 3 based on NOAEL of 20 mg/kg bw in a single dose level 90 day study and absorption of 65%. Submission II for this substance was submitted in July 1996 by COLIPA. The Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP) adopted in the plenary session of 23 June 1999 the opinion SCCNFP/0130/99 with the conclusion, that “The SCCNFP is of the opinion that 1-Hydroxy-naphthalene can be used safely in permanent hair dye formulations at a maximum concentration of 1.0%. Since permanent hair dyes","page":5,"pdf":"sccp_o_125.pdf","row_type":"noael_study","study_id":"sccp_o_125_noael_001"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/day | rat | oral | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 4 3","dose":"No gastric effects were seen in the female mice dosed at 200 mg/kg bw/day or in the other treatment groups.","effect":"cal erosion of the glandular stomach. No gastric effects were seen in the female mice dosed at 200 mg/kg bw/day or in the other treatment groups. Exposure was accompanied by increase in white blood cell counts, the response being dose related in the female mice. However, the increases were all within historical normal limits of the laboratory. The weight gain was affected by the treatment, however the effect was not dose related. Conclusions The gastric lesions showed a sex difference, with the male mice having a NOAEL of 100 mg/kg bw/day. NOAEL for female mice was higher than the highest dose applied (200 mg/kg bw/day). Ref.: 4 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 (1981) Species/strain: Crl:CD/(SD)BR VAF/Plus rats; Group size: 15 per sex and per dose Test substance: RE1141.03 Batch: Lot n° 03 Purity: 99.7% Dose: 0, 65, 130, 400 mg/kg bw/day Route: oral, in carboxymethylcellulose 0.5% Exposure: by oral gavage GLP: in compliance Date: 20 April – 22 July 1998","page":14,"pdf":"sccp_o_125.pdf","row_type":"noael_study","study_id":"sccp_o_125_noael_002"} |
| SCCS_vision_codex | NOAEL | =130 | mg/kg bw/day | rat | - | 90-days | NOAEL study | {"citation":"Ref.: 12 Comment The SCCP agrees with the study authors to set the NOAEL at 130 mg/kg bw","dose":"dular stomach were present in all males and most females given 400 mg/kg bw/day; and in both sexes at130 mg/kg bw/day.","effect":"dular stomach were present in all males and most females given 400 mg/kg bw/day; and in both sexes at130 mg/kg bw/day. At the high-dose level, gastric changes were moderate to severe and in both sexes given 130 mg/kg bw/day were minimal to mild. In the spleen sections, increased pigment deposits (hemosiderin) were minimally to slightly increased in the 400 mg/kg bw/day group. Treatment-related stomach or changes in spleen were not observed in rats at the 65 mg/kg bw/day group. Conclusion The study authors set the NOAEL for RE1141.03 at 130 mg/kg bw/day, based on the microscopical changes in stomach and in spleen. In the submission, however, a value of 65 mg/kg bw/day was mentioned. Ref.: 12 Comment The SCCP agrees with the study authors to set the NOAEL at 130 mg/kg bw. In contrast to the teratogenicity study (ref 19), lacrimation was not reported in the 90-days study. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted","page":15,"pdf":"sccp_o_125.pdf","row_type":"noael_study","study_id":"sccp_o_125_noael_004"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw/day | human | - | developmental | developmental toxicity | {"citation":"Ref.: 19 3","dose":"No other Caesarean-sectioning or litter parameters were affected by exposure to the test substance to the dams at dosages as high as 400 mg/kg bw/day.","effect":"ge group; these reductions were significant for total and female foetal body weights. No other Caesarean-sectioning or litter parameters were affected by exposure to the test substance to the dams at dosages as high as 400 mg/kg bw/day. (No typical changes in skeletal ossification those are indicative of developmental delay and which would have been expected to accompany significant foetal weight decrements). The slight foetal body weight reduction might be influenced by maternal toxicity. Conclusion The maternal NOEL of RE-1141.02 was 20 mg/kg bw/day because of a significant incidence of chromorhinorrhea, dilated pupils and lacrimation of some animals in the 100 mg/kg bw/day group. The developmental NOAEL was set at 400 mg/kg bw/day, the highest dose applied. Ref.: 19 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human dat","page":23,"pdf":"sccp_o_125.pdf","row_type":"noael_study","study_id":"sccp_o_125_noael_006"} |
| SCCS_vision_codex | NOAEL | =400 | mg/kg bw/day | human | - | developmental | developmental toxicity | {"citation":"Ref.: 19 3","dose":"dams at dosages as high as 400 mg/kg bw/day.","effect":"dams at dosages as high as 400 mg/kg bw/day. (No typical changes in skeletal ossification those are indicative of developmental delay and which would have been expected to accompany significant foetal weight decrements). The slight foetal body weight reduction might be influenced by maternal toxicity. Conclusion The maternal NOEL of RE-1141.02 was 20 mg/kg bw/day because of a significant incidence of chromorhinorrhea, dilated pupils and lacrimation of some animals in the 100 mg/kg bw/day group. The developmental NOAEL was set at 400 mg/kg bw/day, the highest dose applied. Ref.: 19 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted","page":23,"pdf":"sccp_o_125.pdf","row_type":"noael_study","study_id":"sccp_o_125_noael_007"} |
| SCCS_vision_codex | NOAEL | =65 | mg/kg bw/day | rat | - | developmental | developmental toxicity | {"dose":"In gastric tissues, squamous hyperplasia and hyperkeratosis of the nonglandular stomach were present in all males and most females given 400 mg/kg bw/day; and in both sexes at 130 mg/kg bw/day.","effect":"adverse. Microscopic, treatment-related changes were restricted to the stomach and spleen. In gastric tissues, squamous hyperplasia and hyperkeratosis of the nonglandular stomach were present in all males and most females given 400 mg/kg bw/day; and in both sexes at 130 mg/kg bw/day. At the high-dose level, gastric changes were moderate to severe and in both sexes given 130 mg/kg bw/day were minimal to mild. Treatment-related stomach or changes in spleen were not observed in rats at the 65 mg/kg bw/day group. The NOAEL was set at 130 mg/kg bw. The maternal NOEL of the test substance RE-1141.02 was 20 mg/kg bw/day because of a significant incidence of chromorhinorrhea, dilated pupils and lacrimation of some animals in the 100 mg/kg bw/day group. The developmental NOAEL was set at 400 mg/kg bw/day, the highest dose applied. Irritation / sensitisation A 2.5% aqueous suspension of 1-naphthol was considered not to be irritant to rabbit skin. Although all effects were transient, aqueous dilutions of 1-naphthol of 0.5 to 2.5% caused","page":24,"pdf":"sccp_o_125.pdf","row_type":"noael_study","study_id":"sccp_o_125_noael_010"} |
| SCCS_vision_codex | NOAEL | =130 | mg/kg bw | rat | - | developmental | developmental toxicity | {"dose":"In gastric tissues, squamous hyperplasia and hyperkeratosis of the nonglandular stomach were present in all males and most females given 400 mg/kg bw/day; and in both sexes at 130 mg/kg bw/day.","effect":"nges were restricted to the stomach and spleen. In gastric tissues, squamous hyperplasia and hyperkeratosis of the nonglandular stomach were present in all males and most females given 400 mg/kg bw/day; and in both sexes at 130 mg/kg bw/day. At the high-dose level, gastric changes were moderate to severe and in both sexes given 130 mg/kg bw/day were minimal to mild. Treatment-related stomach or changes in spleen were not observed in rats at the 65 mg/kg bw/day group. The NOAEL was set at 130 mg/kg bw. The maternal NOEL of the test substance RE-1141.02 was 20 mg/kg bw/day because of a significant incidence of chromorhinorrhea, dilated pupils and lacrimation of some animals in the 100 mg/kg bw/day group. The developmental NOAEL was set at 400 mg/kg bw/day, the highest dose applied. Irritation / sensitisation A 2.5% aqueous suspension of 1-naphthol was considered not to be irritant to rabbit skin. Although all effects were transient, aqueous dilutions of 1-naphthol of 0.5 to 2.5% caused eye irritation to rabbits with irritant eff","page":24,"pdf":"sccp_o_125.pdf","row_type":"noael_study","study_id":"sccp_o_125_noael_011"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw | - | dermal | 90 day | NOAEL study | {"dose":"The Scientific Committee on Cosmetology (SCC) expressed its opinion at the 48th plenary meeting of 4 October 1991 with the conclusion that “the use of 1-naphthol in the oxidative hair dyes does not appear to present any health risk.” The SCC expressed a second opinion at the 54th plenary meeting of 10 December 1993 with the conclusion that “the...","effect":"submitted in May 1983 by COLIPA1, 2. The Scientific Committee on Cosmetology (SCC) expressed its opinion at the 48th plenary meeting of 4 October 1991 with the conclusion that “the use of 1-naphthol in the oxidative hair dyes does not appear to present any health risk.” The SCC expressed a second opinion at the 54th plenary meeting of 10 December 1993 with the conclusion that “the SCC requires cutaneous absorption study in more realistic experimental conditions.” The margin of safety was calculated as 3 based on NOAEL of 20 mg/kg bw in a single dose level 90 day study and absorption of 65%. Submission II for this substance was submitted in July 1996 by COLIPA. The Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP) adopted in the plenary session of 23 June 1999 the opinion SCCNFP/0130/99 with the conclusion, that “The SCCNFP is of the opinion that 1-Hydroxy-naphthalene can be used safely in permanent hair dye formulations at a maximum concentration of 1.0%. Since permanent hair dyes","page":5,"pdf":"sccp_o_125.pdf","row_type":"noael_study","study_id":"sccp_o_125_noael_001"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/day | rat | oral | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 4 3","dose":"No gastric effects were seen in the female mice dosed at 200 mg/kg bw/day or in the other treatment groups.","effect":"cal erosion of the glandular stomach. No gastric effects were seen in the female mice dosed at 200 mg/kg bw/day or in the other treatment groups. Exposure was accompanied by increase in white blood cell counts, the response being dose related in the female mice. However, the increases were all within historical normal limits of the laboratory. The weight gain was affected by the treatment, however the effect was not dose related. Conclusions The gastric lesions showed a sex difference, with the male mice having a NOAEL of 100 mg/kg bw/day. NOAEL for female mice was higher than the highest dose applied (200 mg/kg bw/day). Ref.: 4 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 (1981) Species/strain: Crl:CD/(SD)BR VAF/Plus rats; Group size: 15 per sex and per dose Test substance: RE1141.03 Batch: Lot n° 03 Purity: 99.7% Dose: 0, 65, 130, 400 mg/kg bw/day Route: oral, in carboxymethylcellulose 0.5% Exposure: by oral gavage GLP: in compliance Date: 20 April – 22 July 1998","page":14,"pdf":"sccp_o_125.pdf","row_type":"noael_study","study_id":"sccp_o_125_noael_002"} |
| SCCS_vision_codex | NOAEL | =130 | mg/kg bw/day | rat | - | 90-days | NOAEL study | {"citation":"Ref.: 12 Comment The SCCP agrees with the study authors to set the NOAEL at 130 mg/kg bw","dose":"dular stomach were present in all males and most females given 400 mg/kg bw/day; and in both sexes at130 mg/kg bw/day.","effect":"dular stomach were present in all males and most females given 400 mg/kg bw/day; and in both sexes at130 mg/kg bw/day. At the high-dose level, gastric changes were moderate to severe and in both sexes given 130 mg/kg bw/day were minimal to mild. In the spleen sections, increased pigment deposits (hemosiderin) were minimally to slightly increased in the 400 mg/kg bw/day group. Treatment-related stomach or changes in spleen were not observed in rats at the 65 mg/kg bw/day group. Conclusion The study authors set the NOAEL for RE1141.03 at 130 mg/kg bw/day, based on the microscopical changes in stomach and in spleen. In the submission, however, a value of 65 mg/kg bw/day was mentioned. Ref.: 12 Comment The SCCP agrees with the study authors to set the NOAEL at 130 mg/kg bw. In contrast to the teratogenicity study (ref 19), lacrimation was not reported in the 90-days study. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted","page":15,"pdf":"sccp_o_125.pdf","row_type":"noael_study","study_id":"sccp_o_125_noael_004"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw/day | human | - | developmental | developmental toxicity | {"citation":"Ref.: 19 3","dose":"No other Caesarean-sectioning or litter parameters were affected by exposure to the test substance to the dams at dosages as high as 400 mg/kg bw/day.","effect":"ge group; these reductions were significant for total and female foetal body weights. No other Caesarean-sectioning or litter parameters were affected by exposure to the test substance to the dams at dosages as high as 400 mg/kg bw/day. (No typical changes in skeletal ossification those are indicative of developmental delay and which would have been expected to accompany significant foetal weight decrements). The slight foetal body weight reduction might be influenced by maternal toxicity. Conclusion The maternal NOEL of RE-1141.02 was 20 mg/kg bw/day because of a significant incidence of chromorhinorrhea, dilated pupils and lacrimation of some animals in the 100 mg/kg bw/day group. The developmental NOAEL was set at 400 mg/kg bw/day, the highest dose applied. Ref.: 19 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human dat","page":23,"pdf":"sccp_o_125.pdf","row_type":"noael_study","study_id":"sccp_o_125_noael_006"} |
| SCCS_vision_codex | NOAEL | =400 | mg/kg bw/day | human | - | developmental | developmental toxicity | {"citation":"Ref.: 19 3","dose":"dams at dosages as high as 400 mg/kg bw/day.","effect":"dams at dosages as high as 400 mg/kg bw/day. (No typical changes in skeletal ossification those are indicative of developmental delay and which would have been expected to accompany significant foetal weight decrements). The slight foetal body weight reduction might be influenced by maternal toxicity. Conclusion The maternal NOEL of RE-1141.02 was 20 mg/kg bw/day because of a significant incidence of chromorhinorrhea, dilated pupils and lacrimation of some animals in the 100 mg/kg bw/day group. The developmental NOAEL was set at 400 mg/kg bw/day, the highest dose applied. Ref.: 19 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted","page":23,"pdf":"sccp_o_125.pdf","row_type":"noael_study","study_id":"sccp_o_125_noael_007"} |
| SCCS_vision_codex | NOAEL | =65 | mg/kg bw/day | rat | - | developmental | developmental toxicity | {"dose":"In gastric tissues, squamous hyperplasia and hyperkeratosis of the nonglandular stomach were present in all males and most females given 400 mg/kg bw/day; and in both sexes at 130 mg/kg bw/day.","effect":"adverse. Microscopic, treatment-related changes were restricted to the stomach and spleen. In gastric tissues, squamous hyperplasia and hyperkeratosis of the nonglandular stomach were present in all males and most females given 400 mg/kg bw/day; and in both sexes at 130 mg/kg bw/day. At the high-dose level, gastric changes were moderate to severe and in both sexes given 130 mg/kg bw/day were minimal to mild. Treatment-related stomach or changes in spleen were not observed in rats at the 65 mg/kg bw/day group. The NOAEL was set at 130 mg/kg bw. The maternal NOEL of the test substance RE-1141.02 was 20 mg/kg bw/day because of a significant incidence of chromorhinorrhea, dilated pupils and lacrimation of some animals in the 100 mg/kg bw/day group. The developmental NOAEL was set at 400 mg/kg bw/day, the highest dose applied. Irritation / sensitisation A 2.5% aqueous suspension of 1-naphthol was considered not to be irritant to rabbit skin. Although all effects were transient, aqueous dilutions of 1-naphthol of 0.5 to 2.5% caused","page":24,"pdf":"sccp_o_125.pdf","row_type":"noael_study","study_id":"sccp_o_125_noael_010"} |
| SCCS_vision_codex | NOAEL | =130 | mg/kg bw | rat | - | developmental | developmental toxicity | {"dose":"In gastric tissues, squamous hyperplasia and hyperkeratosis of the nonglandular stomach were present in all males and most females given 400 mg/kg bw/day; and in both sexes at 130 mg/kg bw/day.","effect":"nges were restricted to the stomach and spleen. In gastric tissues, squamous hyperplasia and hyperkeratosis of the nonglandular stomach were present in all males and most females given 400 mg/kg bw/day; and in both sexes at 130 mg/kg bw/day. At the high-dose level, gastric changes were moderate to severe and in both sexes given 130 mg/kg bw/day were minimal to mild. Treatment-related stomach or changes in spleen were not observed in rats at the 65 mg/kg bw/day group. The NOAEL was set at 130 mg/kg bw. The maternal NOEL of the test substance RE-1141.02 was 20 mg/kg bw/day because of a significant incidence of chromorhinorrhea, dilated pupils and lacrimation of some animals in the 100 mg/kg bw/day group. The developmental NOAEL was set at 400 mg/kg bw/day, the highest dose applied. Irritation / sensitisation A 2.5% aqueous suspension of 1-naphthol was considered not to be irritant to rabbit skin. Although all effects were transient, aqueous dilutions of 1-naphthol of 0.5 to 2.5% caused eye irritation to rabbits with irritant eff","page":24,"pdf":"sccp_o_125.pdf","row_type":"noael_study","study_id":"sccp_o_125_noael_011"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw | - | dermal | 90 day | NOAEL study | {"dose":"The Scientific Committee on Cosmetology (SCC) expressed its opinion at the 48th plenary meeting of 4 October 1991 with the conclusion that “the use of 1-naphthol in the oxidative hair dyes does not appear to present any health risk.” The SCC expressed a second opinion at the 54th plenary meeting of 10 December 1993 with the conclusion that “the...","effect":"submitted in May 1983 by COLIPA1, 2. The Scientific Committee on Cosmetology (SCC) expressed its opinion at the 48th plenary meeting of 4 October 1991 with the conclusion that “the use of 1-naphthol in the oxidative hair dyes does not appear to present any health risk.” The SCC expressed a second opinion at the 54th plenary meeting of 10 December 1993 with the conclusion that “the SCC requires cutaneous absorption study in more realistic experimental conditions.” The margin of safety was calculated as 3 based on NOAEL of 20 mg/kg bw in a single dose level 90 day study and absorption of 65%. Submission II for this substance was submitted in July 1996 by COLIPA. The Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP) adopted in the plenary session of 23 June 1999 the opinion SCCNFP/0130/99 with the conclusion, that “The SCCNFP is of the opinion that 1-Hydroxy-naphthalene can be used safely in permanent hair dye formulations at a maximum concentration of 1.0%. Since permanent hair dyes","page":5,"pdf":"sccp_o_125.pdf","row_type":"noael_study","study_id":"sccp_o_125_noael_001"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/day | rat | oral | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 4 3","dose":"No gastric effects were seen in the female mice dosed at 200 mg/kg bw/day or in the other treatment groups.","effect":"cal erosion of the glandular stomach. No gastric effects were seen in the female mice dosed at 200 mg/kg bw/day or in the other treatment groups. Exposure was accompanied by increase in white blood cell counts, the response being dose related in the female mice. However, the increases were all within historical normal limits of the laboratory. The weight gain was affected by the treatment, however the effect was not dose related. Conclusions The gastric lesions showed a sex difference, with the male mice having a NOAEL of 100 mg/kg bw/day. NOAEL for female mice was higher than the highest dose applied (200 mg/kg bw/day). Ref.: 4 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 (1981) Species/strain: Crl:CD/(SD)BR VAF/Plus rats; Group size: 15 per sex and per dose Test substance: RE1141.03 Batch: Lot n° 03 Purity: 99.7% Dose: 0, 65, 130, 400 mg/kg bw/day Route: oral, in carboxymethylcellulose 0.5% Exposure: by oral gavage GLP: in compliance Date: 20 April – 22 July 1998","page":14,"pdf":"sccp_o_125.pdf","row_type":"noael_study","study_id":"sccp_o_125_noael_002"} |
| SCCS_vision_codex | NOAEL | =130 | mg/kg bw/day | rat | - | 90-days | NOAEL study | {"citation":"Ref.: 12 Comment The SCCP agrees with the study authors to set the NOAEL at 130 mg/kg bw","dose":"dular stomach were present in all males and most females given 400 mg/kg bw/day; and in both sexes at130 mg/kg bw/day.","effect":"dular stomach were present in all males and most females given 400 mg/kg bw/day; and in both sexes at130 mg/kg bw/day. At the high-dose level, gastric changes were moderate to severe and in both sexes given 130 mg/kg bw/day were minimal to mild. In the spleen sections, increased pigment deposits (hemosiderin) were minimally to slightly increased in the 400 mg/kg bw/day group. Treatment-related stomach or changes in spleen were not observed in rats at the 65 mg/kg bw/day group. Conclusion The study authors set the NOAEL for RE1141.03 at 130 mg/kg bw/day, based on the microscopical changes in stomach and in spleen. In the submission, however, a value of 65 mg/kg bw/day was mentioned. Ref.: 12 Comment The SCCP agrees with the study authors to set the NOAEL at 130 mg/kg bw. In contrast to the teratogenicity study (ref 19), lacrimation was not reported in the 90-days study. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted","page":15,"pdf":"sccp_o_125.pdf","row_type":"noael_study","study_id":"sccp_o_125_noael_004"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw/day | human | - | developmental | developmental toxicity | {"citation":"Ref.: 19 3","dose":"No other Caesarean-sectioning or litter parameters were affected by exposure to the test substance to the dams at dosages as high as 400 mg/kg bw/day.","effect":"ge group; these reductions were significant for total and female foetal body weights. No other Caesarean-sectioning or litter parameters were affected by exposure to the test substance to the dams at dosages as high as 400 mg/kg bw/day. (No typical changes in skeletal ossification those are indicative of developmental delay and which would have been expected to accompany significant foetal weight decrements). The slight foetal body weight reduction might be influenced by maternal toxicity. Conclusion The maternal NOEL of RE-1141.02 was 20 mg/kg bw/day because of a significant incidence of chromorhinorrhea, dilated pupils and lacrimation of some animals in the 100 mg/kg bw/day group. The developmental NOAEL was set at 400 mg/kg bw/day, the highest dose applied. Ref.: 19 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human dat","page":23,"pdf":"sccp_o_125.pdf","row_type":"noael_study","study_id":"sccp_o_125_noael_006"} |
| SCCS_vision_codex | NOAEL | =400 | mg/kg bw/day | human | - | developmental | developmental toxicity | {"citation":"Ref.: 19 3","dose":"dams at dosages as high as 400 mg/kg bw/day.","effect":"dams at dosages as high as 400 mg/kg bw/day. (No typical changes in skeletal ossification those are indicative of developmental delay and which would have been expected to accompany significant foetal weight decrements). The slight foetal body weight reduction might be influenced by maternal toxicity. Conclusion The maternal NOEL of RE-1141.02 was 20 mg/kg bw/day because of a significant incidence of chromorhinorrhea, dilated pupils and lacrimation of some animals in the 100 mg/kg bw/day group. The developmental NOAEL was set at 400 mg/kg bw/day, the highest dose applied. Ref.: 19 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted","page":23,"pdf":"sccp_o_125.pdf","row_type":"noael_study","study_id":"sccp_o_125_noael_007"} |
| SCCS_vision_codex | NOAEL | =65 | mg/kg bw/day | rat | - | developmental | developmental toxicity | {"dose":"In gastric tissues, squamous hyperplasia and hyperkeratosis of the nonglandular stomach were present in all males and most females given 400 mg/kg bw/day; and in both sexes at 130 mg/kg bw/day.","effect":"adverse. Microscopic, treatment-related changes were restricted to the stomach and spleen. In gastric tissues, squamous hyperplasia and hyperkeratosis of the nonglandular stomach were present in all males and most females given 400 mg/kg bw/day; and in both sexes at 130 mg/kg bw/day. At the high-dose level, gastric changes were moderate to severe and in both sexes given 130 mg/kg bw/day were minimal to mild. Treatment-related stomach or changes in spleen were not observed in rats at the 65 mg/kg bw/day group. The NOAEL was set at 130 mg/kg bw. The maternal NOEL of the test substance RE-1141.02 was 20 mg/kg bw/day because of a significant incidence of chromorhinorrhea, dilated pupils and lacrimation of some animals in the 100 mg/kg bw/day group. The developmental NOAEL was set at 400 mg/kg bw/day, the highest dose applied. Irritation / sensitisation A 2.5% aqueous suspension of 1-naphthol was considered not to be irritant to rabbit skin. Although all effects were transient, aqueous dilutions of 1-naphthol of 0.5 to 2.5% caused","page":24,"pdf":"sccp_o_125.pdf","row_type":"noael_study","study_id":"sccp_o_125_noael_010"} |
| SCCS_vision_codex | NOAEL | =130 | mg/kg bw | rat | - | developmental | developmental toxicity | {"dose":"In gastric tissues, squamous hyperplasia and hyperkeratosis of the nonglandular stomach were present in all males and most females given 400 mg/kg bw/day; and in both sexes at 130 mg/kg bw/day.","effect":"nges were restricted to the stomach and spleen. In gastric tissues, squamous hyperplasia and hyperkeratosis of the nonglandular stomach were present in all males and most females given 400 mg/kg bw/day; and in both sexes at 130 mg/kg bw/day. At the high-dose level, gastric changes were moderate to severe and in both sexes given 130 mg/kg bw/day were minimal to mild. Treatment-related stomach or changes in spleen were not observed in rats at the 65 mg/kg bw/day group. The NOAEL was set at 130 mg/kg bw. The maternal NOEL of the test substance RE-1141.02 was 20 mg/kg bw/day because of a significant incidence of chromorhinorrhea, dilated pupils and lacrimation of some animals in the 100 mg/kg bw/day group. The developmental NOAEL was set at 400 mg/kg bw/day, the highest dose applied. Irritation / sensitisation A 2.5% aqueous suspension of 1-naphthol was considered not to be irritant to rabbit skin. Although all effects were transient, aqueous dilutions of 1-naphthol of 0.5 to 2.5% caused eye irritation to rabbits with irritant eff","page":24,"pdf":"sccp_o_125.pdf","row_type":"noael_study","study_id":"sccp_o_125_noael_011"} |
ToxValDB_ECHA_IUCLID 9 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECHA_IUCLID | LEL | =1000 | mg/kg bw/day | Rat | oral | - | acute | QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6605975fe4b063812d6fa6ed; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/22250/7/3/2?documentUUID=20e738e1-012b-4bbe-86fe-dbfa9c4ef8c2; YEAR=1990; ORIGINAL_YEAR=1990; STUDY_GROUP=ECHA IUCLID:15809458:-:--; 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_042ad43296d6032eedf9bf07a19d17c0 |
| ToxValDB_ECHA_IUCLID | LOAEL | ~600 | mg/kg bw/day | Rat | oral | short-term; 15 days | short-term | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7cc0de4b0a7c65d228cb0; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/22250/7/6/2?documentUUID=20e738e1-012b-4bbe-86fe-dbfa9c4ef8c2; YEAR=1990; ORIGINAL_YEAR=1990; TOXICOLOGICAL_EFFECT=body weight and weight gain|clinical signs|gross pathology|mortality; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical signs|gross pathology|mortality/survival; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15829977_15850929:M/F:--; 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_81c7bebef19c2f7ab4bba6645fe896b3 |
| ToxValDB_ECHA_IUCLID | LOAEL | ~400 | mg/kg bw/day | Rat | oral | subchronic; 90 days | subchronic | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaf50e4b0a7c65d1cd676; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/22250/7/6/2?documentUUID=20e738e1-012b-4bbe-86fe-dbfa9c4ef8c2; YEAR=1990; ORIGINAL_YEAR=1990; TOXICOLOGICAL_EFFECT=stomach: clinical signs|histopathology: non-neoplastic; TOXICOLOGICAL_EFFECT_CATEGORY=clinical signs|nonneoplastic histopathology; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15830132_15848825:M/F:--; 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_9ebbe43756423ec78f13560395c7a31c |
| ToxValDB_ECHA_IUCLID | NOAEL | ~400 | mg/kg bw/day | Rat | oral | - | developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac86e4b0a7c65d1bf98b; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/22250/7/9/3?documentUUID=20e738e1-012b-4bbe-86fe-dbfa9c4ef8c2; YEAR=1990; ORIGINAL_YEAR=1990; TOXICOLOGICAL_EFFECT=fetus: changes in litter size and weights; TOXICOLOGICAL_EFFECT_CATEGORY=development; STUDY_GROUP=ECHA IUCLID:15825283:M/F:-fetal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_1cc5c5eb035b3b70e54776b3d7ce4438 |
| ToxValDB_ECHA_IUCLID | NOAEL | >200 | mg/kg bw/day | Mouse | oral | short-term; 30 days | short-term | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaf50e4b0a7c65d1cd67f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/22250/7/6/2?documentUUID=20e738e1-012b-4bbe-86fe-dbfa9c4ef8c2; YEAR=1990; ORIGINAL_YEAR=1990; STUDY_GROUP=ECHA IUCLID:15848565:F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_41bc418f4e7740fbf8212b46157f2a46 |
| ToxValDB_ECHA_IUCLID | NOAEL | ~130 | mg/kg bw/day | Rat | oral | subchronic; 90 days | subchronic | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaf50e4b0a7c65d1cd676; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/22250/7/6/2?documentUUID=20e738e1-012b-4bbe-86fe-dbfa9c4ef8c2; YEAR=1990; ORIGINAL_YEAR=1990; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15830132_15848825:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_bdf8a001f2bbb4a702a60dbd2e43bc65 |
| ToxValDB_ECHA_IUCLID | NOAEL | ~100 | mg/kg bw/day | Mouse | oral | short-term; 30 days | short-term | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaf50e4b0a7c65d1cd67f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/22250/7/6/2?documentUUID=20e738e1-012b-4bbe-86fe-dbfa9c4ef8c2; YEAR=1990; ORIGINAL_YEAR=1990; TOXICOLOGICAL_EFFECT=gross pathology; TOXICOLOGICAL_EFFECT_CATEGORY=gross pathology; STUDY_GROUP=ECHA IUCLID:15849004:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_bc9568748a4880aeec0af6f435e476aa |
| ToxValDB_ECHA_IUCLID | NOAEL | ~120 | mg/kg bw/day | Rat | oral | short-term; 15 days | short-term | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7cc0de4b0a7c65d228cb0; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/22250/7/6/2?documentUUID=20e738e1-012b-4bbe-86fe-dbfa9c4ef8c2; YEAR=1990; ORIGINAL_YEAR=1990; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15829977_15850929:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_625502277c6a5c11aa0cdcc96524212f |
| ToxValDB_ECHA_IUCLID | NOEL | ~20 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac86e4b0a7c65d1bf98b; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/22250/7/9/3?documentUUID=20e738e1-012b-4bbe-86fe-dbfa9c4ef8c2; YEAR=1990; ORIGINAL_YEAR=1990; TOXICOLOGICAL_EFFECT=maternal: clinical signs; TOXICOLOGICAL_EFFECT_CATEGORY=clinical signs; STUDY_GROUP=ECHA IUCLID:15825284:F:-maternal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_39cf60adf86823f6d27ac94e4b2835fb |
ToxValDB_ECOTOX 8 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECOTOX | LOEL | =1 | mg/kg bw/day | Rat | oral | acute; 1 days | acute | LONG_REF=EPA/OTS Doc.#86-920000742:1534 p. Union Carbide Chemical and Plastics Co. Letter Submitting Multiple Enclosed Studies on Multiple Chemicals with Attachments 1991; TITLE=Letter Submitting Multiple Enclosed Studies on Multiple Chemicals with Attachments; AUTHOR=Union Carbide Chemical and Plastics Co.; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=75195; 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=1991; ORIGINAL_YEAR=1991; TOXICOLOGICAL_EFFECT=Growth: Weight; TOXICOLOGICAL_EFFECT_CATEGORY=body weight; STUDY_GROUP=ECOTOX_dup_EPA ORD_15604322_15604323:F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=5063000c3945917fde14e2480cceb5b1 |
| ToxValDB_ECOTOX | NOEL | =1000 | mg/kg bw/day | Rat | oral | short-term; 7 days | short-term | LONG_REF=EPA/OTS Doc.#86-920000269S:264 p. EPA/OTS Letter to U.S.EPA Regarding Information on the Enclosed Health and Safety Studies on Alpha-Naphthol with Attachments (Sanitized) 1991; TITLE=Letter to U.S.EPA Regarding Information on the Enclosed Health and Safety Studies on Alpha-Naphthol with Attachments (Sanitized); AUTHOR=EPA/OTS; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=88959; 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=1991; ORIGINAL_YEAR=1991; TOXICOLOGICAL_EFFECT=Enzyme(s): Cholinesterase|Feeding behavior: Food consumption|Growth: Weight|Morphology: Weight; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|food and/or water consumption|neurotransmitter|other; STUDY_GROUP=ECOTOX:15594942:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=fd32395f366a21a734652199948d5ff7 |
| ToxValDB_ECOTOX | NOEL | =1 | mg/kg bw/day | Rat | oral | short-term; 8 days | short-term | LONG_REF=EPA/OTS Doc.#86-920000742:1534 p. Union Carbide Chemical and Plastics Co. Letter Submitting Multiple Enclosed Studies on Multiple Chemicals with Attachments 1991; TITLE=Letter Submitting Multiple Enclosed Studies on Multiple Chemicals with Attachments; AUTHOR=Union Carbide Chemical and Plastics Co.; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=75195; 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=1991; ORIGINAL_YEAR=1991; TOXICOLOGICAL_EFFECT=Enzyme(s): Acetylcholinesterase|Feeding behavior: Food consumption|Morphology: Organ weight in relationship to body weight|Mortality: Mortality; TOXICOLOGICAL_EFFECT_CATEGORY=food and/or water consumption|mortality/survival|neurotransmitter|organ weight; STUDY_GROUP=ECOTOX:15599806:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=3ce443b92c809ceef1a49df2938dc832 |
| ToxValDB_ECOTOX | NOEL | =0.25 | mg/kg bw/day | Rat | oral | short-term; 30 days | short-term | LONG_REF=EPA/OTS Doc.#86-920000742:1534 p. Union Carbide Chemical and Plastics Co. Letter Submitting Multiple Enclosed Studies on Multiple Chemicals with Attachments 1991; TITLE=Letter Submitting Multiple Enclosed Studies on Multiple Chemicals with Attachments; AUTHOR=Union Carbide Chemical and Plastics Co.; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=75195; 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=1991; ORIGINAL_YEAR=1991; TOXICOLOGICAL_EFFECT=Accumulation: Residue|Growth: Weight|Morphology: Organ weight in relationship to body weight; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|organ weight|other; STUDY_GROUP=ECOTOX:15602317:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=1e27943af08522beb9844c0d1fb71945 |
| ToxValDB_ECOTOX | NOEL | =6500 | ppm | Rat | oral | short-term; 28 days | short-term | LONG_REF=EPA/OTS Doc.#86-920000514S:7 p. Industrial Bio-Test Laboratories Summary Results Concerning an Acute Oral LD50, Acute Eye Irritation, Primary Skin & Eye Irritation Indexes & 28-Day Subacute Feeding Studies with Cover Sheet & Letter (Sanitized) 1991; TITLE=Summary Results Concerning an Acute Oral LD50, Acute Eye Irritation, Primary Skin & Eye Irritation Indexes & 28-Day Subacute Feeding Studies with Cover Sheet & Letter (Sanitized); AUTHOR=Industrial Bio-Test Laboratories; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=88884; 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=1991; ORIGINAL_YEAR=1991; TOXICOLOGICAL_EFFECT=Growth: Weight; TOXICOLOGICAL_EFFECT_CATEGORY=body weight; STUDY_GROUP=ECOTOX_dup_EPA ORD_15603242_15604212_15604213:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=9c60786f54249d47a11e33cbe559a3ad |
| ToxValDB_ECOTOX | NOEL | =3250 | ppm | Rat | oral | short-term; 28 days | short-term | LONG_REF=EPA/OTS Doc.#86-920000514S:7 p. Industrial Bio-Test Laboratories Summary Results Concerning an Acute Oral LD50, Acute Eye Irritation, Primary Skin & Eye Irritation Indexes & 28-Day Subacute Feeding Studies with Cover Sheet & Letter (Sanitized) 1991; TITLE=Summary Results Concerning an Acute Oral LD50, Acute Eye Irritation, Primary Skin & Eye Irritation Indexes & 28-Day Subacute Feeding Studies with Cover Sheet & Letter (Sanitized); AUTHOR=Industrial Bio-Test Laboratories; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=88884; 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=1991; ORIGINAL_YEAR=1991; TOXICOLOGICAL_EFFECT=Morphology: Organ weight in relationship to body weight; TOXICOLOGICAL_EFFECT_CATEGORY=organ weight; STUDY_GROUP=ECOTOX_dup_EPA ORD_15603242_15604212_15604213:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=706f9e0f827a575ae6b3b0cb6fe6a31e |
| ToxValDB_ECOTOX | NOEL | =0.5 | mg/kg bw/day | Rat | oral | acute; 1 days | acute | LONG_REF=EPA/OTS Doc.#86-920000742:1534 p. Union Carbide Chemical and Plastics Co. Letter Submitting Multiple Enclosed Studies on Multiple Chemicals with Attachments 1991; TITLE=Letter Submitting Multiple Enclosed Studies on Multiple Chemicals with Attachments; AUTHOR=Union Carbide Chemical and Plastics Co.; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=75195; 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=1991; ORIGINAL_YEAR=1991; TOXICOLOGICAL_EFFECT=Growth: Weight; TOXICOLOGICAL_EFFECT_CATEGORY=body weight; STUDY_GROUP=ECOTOX_dup_EPA ORD_15604322_15604323:F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=2b2ccebf191efaf10d6f1001852ceae8 |
| ToxValDB_ECOTOX | NOEL | =200 | mg/kg bw/day | Mouse | oral | subchronic; 31 days | subchronic | LONG_REF=- | Food Chem. Toxicol.27(4): 233-238 Poole,A., and P. Buckley 1-Naphthol-Single and Repeated Dose (30-Day) Oral Toxicity Studies in the Mouse 1989; TITLE=1-Naphthol-Single and Repeated Dose (30-Day) Oral Toxicity Studies in the Mouse; AUTHOR=Poole,A., and P. Buckley; QUALITY=Control type: Multiple control types; EXTERNAL_SOURCE_ID=53242; 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=1989; ORIGINAL_YEAR=1989; TOXICOLOGICAL_EFFECT=Histology: Lesions|Biochemistry: ALT, ALP, GLDH, TP,ALB,BUN,CREA, GLU| Haematology: Hgh, RBC, Hct,Plt,WBC, Nuetro, Lymph, Mono, Eosin; TOXICOLOGICAL_EFFECT_CATEGORY=clinical chemistry|hematology|nonneoplastic histopathology; STUDY_GROUP=ECOTOX:15613593:F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; Source overall passed QC, and this record was expert reviewed and revised from ECOTOX source; QC_STATUS=pass; SOURCE_HASH=5493dfc01157ac5a42d8c4b3cb9bbfcb |
ToxValDB_GESTIS_DNEL 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_GESTIS_DNEL | DNEL systemic | =4.58 | 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:15633718:-:--; 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_eb7952f73286b10e2f4f1c3bbfbe8cc8 |
UnifiedCodex:SCCNFP:beta.noael_studies 6 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCNFP:beta.noael_studies | - | 20 | mg/kg | rat | oral | 90 day | - | SOURCE_SUBDIR=out138_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING 1-NAPHTHOL Colipa n° A17; OPINION_NUMBER=SCCNFP/0130/99; COMMITTEE=SCCNFP; REPORT_DATE=13 March 2001; VALUE_TEXT=20; DOSE=No observed adverse effect level (mg/kg) (rat:; EFFECT=CALCULATION OF SAFETY MARGIN - 1-NAPHTHOL (Oxidation or Permanent): No observed adverse effect level (mg/kg) (rat: 90 day oral study) | NOAEL | = | 20 mg/kg; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-15-3","citation":"","dose":"No observed adverse effect level (mg/kg) (rat:","duration":"90 day","effect":"CALCULATION OF SAFETY MARGIN - 1-NAPHTHOL (Oxidation or Permanent): No observed adverse effect level (mg/kg) (rat: 90 day oral study) | NOAEL | = | 20 mg/kg","endpoint":"","ingredient":"was not harmful on acute ingestion (LD50>2g/kg bw). A 30-day study in mice","loael_value":"","noael_unit":"mg/kg","noael_value":"20","page":11,"route":"oral","species":"rat","study_id":"out138_en_noael_006"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | dermal absorption | =20 | mg/kg | rat | oral | 90 day | dermal absorption | SOURCE_SUBDIR=out138_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING 1-NAPHTHOL Colipa n° A17; OPINION_NUMBER=SCCNFP/0130/99; COMMITTEE=SCCNFP; REPORT_DATE=13 March 2001; VALUE_TEXT== 20; DOSE=Thus the usage volume of 100 ml contains at maximum 1.0 % Maximum amount of ingredient applied I (mg) = 1000 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.7% (rat study) Dermal absorption per treatment I x=A = 7.0 mg Systemic exposure dose (SED) ==== ==== ==== ==== I x A / 60 kg = 0.117 mg/kg bw No observe...; EFFECT=__________ 11 2.11. Safety evaluation CALCULATION OF SAFETY MARGIN 1-NAPHTHOL (Oxidation or Permanent) The maximum concentration of 2.0 % of 1-Naphthol is mixed before use with H2O2. Thus the usage volume of 100 ml contains at maximum 1.0 % Maximum amount of ingredient applied I (mg) = 1000 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.7% (rat study) Dermal absorption per treatment I x=A = 7.0 mg Systemic exposure dose (SED) ==== ==== ==== ==== I x A / 60 kg = 0.117 mg/kg bw No observed adverse effect level (mg/kg) NOAEL = 20 mg/kg (rat: 90 day oral study) Margin of Safety NOAEL / SED = 171 It should be noted that the no-effect level is based on daily exposure for 90 days. Taking into account that the application will generally not exceed once a month and that not all of the active ingredient will reach the scalp, the Margin of Safety is considered to be acceptable. 2.12. Conclusions Classification : 1 under the conditions in use : as an oxidising colouring agent for hair dyeing at a maximum concentration of 2.0 % in; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-15-3","citation":"","dose":"Thus the usage volume of 100 ml contains at maximum 1.0 % Maximum amount of ingredient applied I (mg) = 1000 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.7% (rat study) Dermal absorption per treatment I x=A = 7.0 mg Systemic exposure dose (SED) ==== ==== ==== ==== I x A / 60 kg = 0.117 mg/kg bw No observe...","duration":"90 day","effect":"__________ 11 2.11. Safety evaluation CALCULATION OF SAFETY MARGIN 1-NAPHTHOL (Oxidation or Permanent) The maximum concentration of 2.0 % of 1-Naphthol is mixed before use with H2O2. Thus the usage volume of 100 ml contains at maximum 1.0 % Maximum amount of ingredient applied I (mg) = 1000 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.7% (rat study) Dermal absorption per treatment I x=A = 7.0 mg Systemic exposure dose (SED) ==== ==== ==== ==== I x A / 60 kg = 0.117 mg/kg bw No observed adverse effect level (mg/kg) NOAEL = 20 mg/kg (rat: 90 day oral study) Margin of Safety NOAEL / SED = 171 It should be noted that the no-effect level is based on daily exposure for 90 days. Taking into account that the application will generally not exceed once a month and that not all of the active ingredient will reach the scalp, the Margin of Safety is considered to be acceptable. 2.12. Conclusions Classification : 1 under the conditions in use : as an oxidising colouring agent for hair dyeing at a maximum concentration of 2.0 % in","endpoint":"dermal absorption","ingredient":"was not harmful on acute ingestion (LD50>2g/kg bw). A 30-day study in mice","loael_value":"","noael_unit":"mg/kg","noael_value":"= 20","page":11,"route":"oral","species":"rat","study_id":"out138_en_noael_003"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | dermal absorption | =20 | mg/kg | rat | oral | 90 day | dermal absorption | SOURCE_SUBDIR=out138_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING 1-NAPHTHOL Colipa n° A17; OPINION_NUMBER=SCCNFP/0130/99; COMMITTEE=SCCNFP; REPORT_DATE=13 March 2001; VALUE_TEXT== 20; DOSE=Thus the usage volume of 100 ml contains at maximum 1.0 % Maximum amount of ingredient applied I (mg) = 1000 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.7% (rat study) Dermal absorption per treatment I x=A = 7.0 mg Systemic exposure dose (SED) ==== ==== ==== ==== I x A / 60 kg = 0.117 mg/kg bw No observe...; EFFECT=CULATION OF SAFETY MARGIN 1-NAPHTHOL (Oxidation or Permanent) The maximum concentration of 2.0 % of 1-Naphthol is mixed before use with H2O2. Thus the usage volume of 100 ml contains at maximum 1.0 % Maximum amount of ingredient applied I (mg) = 1000 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.7% (rat study) Dermal absorption per treatment I x=A = 7.0 mg Systemic exposure dose (SED) ==== ==== ==== ==== I x A / 60 kg = 0.117 mg/kg bw No observed adverse effect level (mg/kg) NOAEL = 20 mg/kg (rat: 90 day oral study) Margin of Safety NOAEL / SED = 171 It should be noted that the no-effect level is based on daily exposure for 90 days. Taking into account that the application will generally not exceed once a month and that not all of the active ingredient will reach the scalp, the Margin of Safety is considered to be acceptable. 2.12. Conclusions Classification : 1 under the conditions in use : as an oxidising colouring agent for hair dyeing at a maximum concentration of 2.0 % in the finished; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-15-3","citation":"","dose":"Thus the usage volume of 100 ml contains at maximum 1.0 % Maximum amount of ingredient applied I (mg) = 1000 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.7% (rat study) Dermal absorption per treatment I x=A = 7.0 mg Systemic exposure dose (SED) ==== ==== ==== ==== I x A / 60 kg = 0.117 mg/kg bw No observe...","duration":"90 day","effect":"CULATION OF SAFETY MARGIN 1-NAPHTHOL (Oxidation or Permanent) The maximum concentration of 2.0 % of 1-Naphthol is mixed before use with H2O2. Thus the usage volume of 100 ml contains at maximum 1.0 % Maximum amount of ingredient applied I (mg) = 1000 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.7% (rat study) Dermal absorption per treatment I x=A = 7.0 mg Systemic exposure dose (SED) ==== ==== ==== ==== I x A / 60 kg = 0.117 mg/kg bw No observed adverse effect level (mg/kg) NOAEL = 20 mg/kg (rat: 90 day oral study) Margin of Safety NOAEL / SED = 171 It should be noted that the no-effect level is based on daily exposure for 90 days. Taking into account that the application will generally not exceed once a month and that not all of the active ingredient will reach the scalp, the Margin of Safety is considered to be acceptable. 2.12. Conclusions Classification : 1 under the conditions in use : as an oxidising colouring agent for hair dyeing at a maximum concentration of 2.0 % in the finished","endpoint":"dermal absorption","ingredient":"was not harmful on acute ingestion (LD50>2g/kg bw). A 30-day study in mice","loael_value":"","noael_unit":"mg/kg","noael_value":"= 20","page":11,"route":"oral","species":"rat","study_id":"out138_en_noael_004"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | dermal absorption | =20 | mg/kg | rat | oral | 90 day | dermal absorption | SOURCE_SUBDIR=out138_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING 1-NAPHTHOL Colipa n° A17; OPINION_NUMBER=SCCNFP/0130/99; COMMITTEE=SCCNFP; REPORT_DATE=13 March 2001; VALUE_TEXT== 20; DOSE=Thus the usage volume of 100 ml contains at maximum 1.0 % Maximum amount of ingredient applied I (mg) = 1000 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.7% (rat study) Dermal absorption per treatment I x=A = 7.0 mg Systemic exposure dose (SED) ==== ==== ==== ==== I x A / 60 kg = 0.117 mg/kg bw No observe...; EFFECT=t) The maximum concentration of 2.0 % of 1-Naphthol is mixed before use with H2O2. Thus the usage volume of 100 ml contains at maximum 1.0 % Maximum amount of ingredient applied I (mg) = 1000 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.7% (rat study) Dermal absorption per treatment I x=A = 7.0 mg Systemic exposure dose (SED) ==== ==== ==== ==== I x A / 60 kg = 0.117 mg/kg bw No observed adverse effect level (mg/kg) NOAEL = 20 mg/kg (rat: 90 day oral study) Margin of Safety NOAEL / SED = 171 It should be noted that the no-effect level is based on daily exposure for 90 days. Taking into account that the application will generally not exceed once a month and that not all of the active ingredient will reach the scalp, the Margin of Safety is considered to be acceptable. 2.12. Conclusions Classification : 1 under the conditions in use : as an oxidising colouring agent for hair dyeing at a maximum concentration of 2.0 % in the finished cosmetic product; in; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-15-3","citation":"","dose":"Thus the usage volume of 100 ml contains at maximum 1.0 % Maximum amount of ingredient applied I (mg) = 1000 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.7% (rat study) Dermal absorption per treatment I x=A = 7.0 mg Systemic exposure dose (SED) ==== ==== ==== ==== I x A / 60 kg = 0.117 mg/kg bw No observe...","duration":"90 day","effect":"t) The maximum concentration of 2.0 % of 1-Naphthol is mixed before use with H2O2. Thus the usage volume of 100 ml contains at maximum 1.0 % Maximum amount of ingredient applied I (mg) = 1000 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.7% (rat study) Dermal absorption per treatment I x=A = 7.0 mg Systemic exposure dose (SED) ==== ==== ==== ==== I x A / 60 kg = 0.117 mg/kg bw No observed adverse effect level (mg/kg) NOAEL = 20 mg/kg (rat: 90 day oral study) Margin of Safety NOAEL / SED = 171 It should be noted that the no-effect level is based on daily exposure for 90 days. Taking into account that the application will generally not exceed once a month and that not all of the active ingredient will reach the scalp, the Margin of Safety is considered to be acceptable. 2.12. Conclusions Classification : 1 under the conditions in use : as an oxidising colouring agent for hair dyeing at a maximum concentration of 2.0 % in the finished cosmetic product; in","endpoint":"dermal absorption","ingredient":"was not harmful on acute ingestion (LD50>2g/kg bw). A 30-day study in mice","loael_value":"","noael_unit":"mg/kg","noael_value":"= 20","page":11,"route":"oral","species":"rat","study_id":"out138_en_noael_005"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | developmental toxicity | 100 | mg/kg bw/day | rat | - | 30-day | developmental toxicity | SOURCE_SUBDIR=out138_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING 1-NAPHTHOL Colipa n° A17; OPINION_NUMBER=SCCNFP/0130/99; COMMITTEE=SCCNFP; REPORT_DATE=13 March 2001; VALUE_TEXT=100; DOSE=A 30-day study in mice showed gastric lesions at 200 mg/kg bw/day and the NOAEL was 100 mg/kg bw/day.; EFFECT=68/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products. 2.2 Request to the SCCNFP The SCCNFP is requested to answer the following questions : * Is 1-Naphthol safe for use as an oxidising colouring agent for hair dyeing? * Does the SCCNFP propose any restrictions or conditions for its use? 3. Safety Assessment & Classification The substance was not harmful on acute ingestion (LD50>2g/kg bw). A 30-day study in mice showed gastric lesions at 200 mg/kg bw/day and the NOAEL was 100 mg/kg bw/day. A 12-wk study in rats showed a NOAEL of 20 mg/kg bw/day. The substance showed neither maternal toxicity nor embryo-toxic or teratogenic effects at levels up to 80 mg/kg bw/day (highest tested dose). A concentration of 2.5% was not irritant to the rabbit skin. The substance showed minimal eye irritation at levels up to 1.5%, but was irritant to the rabbit eye at 2 and 2.5%. Sensitising potential was not properly assessed. The substance was not mutagenic or genotoxic in vitro or in vivo. Percut; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-15-3","citation":"","dose":"A 30-day study in mice showed gastric lesions at 200 mg/kg bw/day and the NOAEL was 100 mg/kg bw/day.","duration":"30-day","effect":"68/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products. 2.2 Request to the SCCNFP The SCCNFP is requested to answer the following questions : * Is 1-Naphthol safe for use as an oxidising colouring agent for hair dyeing? * Does the SCCNFP propose any restrictions or conditions for its use? 3. Safety Assessment & Classification The substance was not harmful on acute ingestion (LD50>2g/kg bw). A 30-day study in mice showed gastric lesions at 200 mg/kg bw/day and the NOAEL was 100 mg/kg bw/day. A 12-wk study in rats showed a NOAEL of 20 mg/kg bw/day. The substance showed neither maternal toxicity nor embryo-toxic or teratogenic effects at levels up to 80 mg/kg bw/day (highest tested dose). A concentration of 2.5% was not irritant to the rabbit skin. The substance showed minimal eye irritation at levels up to 1.5%, but was irritant to the rabbit eye at 2 and 2.5%. Sensitising potential was not properly assessed. The substance was not mutagenic or genotoxic in vitro or in vivo. Percut","endpoint":"developmental toxicity","ingredient":"was not harmful on acute ingestion (LD50>2g/kg bw). A 30-day study in mice","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":2,"route":"","species":"rat","study_id":"out138_en_noael_001"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | developmental toxicity | 20 | mg/kg bw/day | rat | - | 30-day | developmental toxicity | SOURCE_SUBDIR=out138_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING 1-NAPHTHOL Colipa n° A17; OPINION_NUMBER=SCCNFP/0130/99; COMMITTEE=SCCNFP; REPORT_DATE=13 March 2001; VALUE_TEXT=20; DOSE=A 30-day study in mice showed gastric lesions at 200 mg/kg bw/day and the NOAEL was 100 mg/kg bw/day.; EFFECT=the Member States relating to cosmetic products. 2.2 Request to the SCCNFP The SCCNFP is requested to answer the following questions : * Is 1-Naphthol safe for use as an oxidising colouring agent for hair dyeing? * Does the SCCNFP propose any restrictions or conditions for its use? 3. Safety Assessment & Classification The substance was not harmful on acute ingestion (LD50>2g/kg bw). A 30-day study in mice showed gastric lesions at 200 mg/kg bw/day and the NOAEL was 100 mg/kg bw/day. A 12-wk study in rats showed a NOAEL of 20 mg/kg bw/day. The substance showed neither maternal toxicity nor embryo-toxic or teratogenic effects at levels up to 80 mg/kg bw/day (highest tested dose). A concentration of 2.5% was not irritant to the rabbit skin. The substance showed minimal eye irritation at levels up to 1.5%, but was irritant to the rabbit eye at 2 and 2.5%. Sensitising potential was not properly assessed. The substance was not mutagenic or genotoxic in vitro or in vivo. Percutaneous absorption in humans under exaggerated exposure cond; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-15-3","citation":"","dose":"A 30-day study in mice showed gastric lesions at 200 mg/kg bw/day and the NOAEL was 100 mg/kg bw/day.","duration":"30-day","effect":"the Member States relating to cosmetic products. 2.2 Request to the SCCNFP The SCCNFP is requested to answer the following questions : * Is 1-Naphthol safe for use as an oxidising colouring agent for hair dyeing? * Does the SCCNFP propose any restrictions or conditions for its use? 3. Safety Assessment & Classification The substance was not harmful on acute ingestion (LD50>2g/kg bw). A 30-day study in mice showed gastric lesions at 200 mg/kg bw/day and the NOAEL was 100 mg/kg bw/day. A 12-wk study in rats showed a NOAEL of 20 mg/kg bw/day. The substance showed neither maternal toxicity nor embryo-toxic or teratogenic effects at levels up to 80 mg/kg bw/day (highest tested dose). A concentration of 2.5% was not irritant to the rabbit skin. The substance showed minimal eye irritation at levels up to 1.5%, but was irritant to the rabbit eye at 2 and 2.5%. Sensitising potential was not properly assessed. The substance was not mutagenic or genotoxic in vitro or in vivo. Percutaneous absorption in humans under exaggerated exposure cond","endpoint":"developmental toxicity","ingredient":"was not harmful on acute ingestion (LD50>2g/kg bw). A 30-day study in mice","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"20","page":2,"route":"","species":"rat","study_id":"out138_en_noael_002"} |
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 12 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 20 | mg/kg bw | - | dermal | 90 day | - | SOURCE_SUBDIR=sccp_o_125; REPORT_TITLE=OPINION ON 1-Naphthol COLIPA n° A17; OPINION_NUMBER=SCCP/1123/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=20; DOSE=The Scientific Committee on Cosmetology (SCC) expressed its opinion at the 48th plenary meeting of 4 October 1991 with the conclusion that “the use of 1-naphthol in the oxidative hair dyes does not appear to present any health risk.” The SCC expressed a second opinion at the 54th plenary meeting of 10 December 1993 with the conclusion that “the...; EFFECT=submitted in May 1983 by COLIPA1, 2. The Scientific Committee on Cosmetology (SCC) expressed its opinion at the 48th plenary meeting of 4 October 1991 with the conclusion that “the use of 1-naphthol in the oxidative hair dyes does not appear to present any health risk.” The SCC expressed a second opinion at the 54th plenary meeting of 10 December 1993 with the conclusion that “the SCC requires cutaneous absorption study in more realistic experimental conditions.” The margin of safety was calculated as 3 based on NOAEL of 20 mg/kg bw in a single dose level 90 day study and absorption of 65%. Submission II for this substance was submitted in July 1996 by COLIPA. The Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP) adopted in the plenary session of 23 June 1999 the opinion SCCNFP/0130/99 with the conclusion, that “The SCCNFP is of the opinion that 1-Hydroxy-naphthalene can be used safely in permanent hair dye formulations at a maximum concentration of 1.0%. Since permanent hair dyes; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-15-3","citation":"","dose":"The Scientific Committee on Cosmetology (SCC) expressed its opinion at the 48th plenary meeting of 4 October 1991 with the conclusion that “the use of 1-naphthol in the oxidative hair dyes does not appear to present any health risk.” The SCC expressed a second opinion at the 54th plenary meeting of 10 December 1993 with the conclusion that “the...","duration":"90 day","effect":"submitted in May 1983 by COLIPA1, 2. The Scientific Committee on Cosmetology (SCC) expressed its opinion at the 48th plenary meeting of 4 October 1991 with the conclusion that “the use of 1-naphthol in the oxidative hair dyes does not appear to present any health risk.” The SCC expressed a second opinion at the 54th plenary meeting of 10 December 1993 with the conclusion that “the SCC requires cutaneous absorption study in more realistic experimental conditions.” The margin of safety was calculated as 3 based on NOAEL of 20 mg/kg bw in a single dose level 90 day study and absorption of 65%. Submission II for this substance was submitted in July 1996 by COLIPA. The Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP) adopted in the plenary session of 23 June 1999 the opinion SCCNFP/0130/99 with the conclusion, that “The SCCNFP is of the opinion that 1-Hydroxy-naphthalene can be used safely in permanent hair dye formulations at a maximum concentration of 1.0%. Since permanent hair dyes","endpoint":"","ingredient":"was submitted in July 1996 by COLIPA. The Scientific","loael_value":"","noael_unit":"mg/kg bw","noael_value":"20","page":5,"route":"dermal","species":"","study_id":"sccp_o_125_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 130 | mg/kg bw/day | rat | - | 90-days | - | SOURCE_SUBDIR=sccp_o_125; REPORT_TITLE=OPINION ON 1-Naphthol COLIPA n° A17; OPINION_NUMBER=SCCP/1123/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=130; DOSE=dular stomach were present in all males and most females given 400 mg/kg bw/day; and in both sexes at130 mg/kg bw/day.; EFFECT=dular stomach were present in all males and most females given 400 mg/kg bw/day; and in both sexes at130 mg/kg bw/day. At the high-dose level, gastric changes were moderate to severe and in both sexes given 130 mg/kg bw/day were minimal to mild. In the spleen sections, increased pigment deposits (hemosiderin) were minimally to slightly increased in the 400 mg/kg bw/day group. Treatment-related stomach or changes in spleen were not observed in rats at the 65 mg/kg bw/day group. Conclusion The study authors set the NOAEL for RE1141.03 at 130 mg/kg bw/day, based on the microscopical changes in stomach and in spleen. In the submission, however, a value of 65 mg/kg bw/day was mentioned. Ref.: 12 Comment The SCCP agrees with the study authors to set the NOAEL at 130 mg/kg bw. In contrast to the teratogenicity study (ref 19), lacrimation was not reported in the 90-days study. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted; CITATION=Ref.: 12 Comment The SCCP agrees with the study authors to set the NOAEL at 130 mg/kg bw; CITATION_NUMBERS=[12,130]; REFERENCE=Ref.: 12 Comment The SCCP agrees with the study authors to set the NOAEL at 130 mg/kg bw; DETAILS_JSON={"cas_number":"90-15-3","citation":"Ref.: 12 Comment The SCCP agrees with the study authors to set the NOAEL at 130 mg/kg bw","dose":"dular stomach were present in all males and most females given 400 mg/kg bw/day; and in both sexes at130 mg/kg bw/day.","duration":"90-days","effect":"dular stomach were present in all males and most females given 400 mg/kg bw/day; and in both sexes at130 mg/kg bw/day. At the high-dose level, gastric changes were moderate to severe and in both sexes given 130 mg/kg bw/day were minimal to mild. In the spleen sections, increased pigment deposits (hemosiderin) were minimally to slightly increased in the 400 mg/kg bw/day group. Treatment-related stomach or changes in spleen were not observed in rats at the 65 mg/kg bw/day group. Conclusion The study authors set the NOAEL for RE1141.03 at 130 mg/kg bw/day, based on the microscopical changes in stomach and in spleen. In the submission, however, a value of 65 mg/kg bw/day was mentioned. Ref.: 12 Comment The SCCP agrees with the study authors to set the NOAEL at 130 mg/kg bw. In contrast to the teratogenicity study (ref 19), lacrimation was not reported in the 90-days study. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted","endpoint":"","ingredient":"was submitted in July 1996 by COLIPA. The Scientific","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"130","page":15,"route":"","species":"rat","study_id":"sccp_o_125_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 130 | mg/kg bw | rat | - | 90-days | - | SOURCE_SUBDIR=sccp_o_125; REPORT_TITLE=OPINION ON 1-Naphthol COLIPA n° A17; OPINION_NUMBER=SCCP/1123/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=130; DOSE=In the spleen sections, increased pigment deposits (hemosiderin) were minimally to slightly increased in the 400 mg/kg bw/day group.; EFFECT=mild. In the spleen sections, increased pigment deposits (hemosiderin) were minimally to slightly increased in the 400 mg/kg bw/day group. Treatment-related stomach or changes in spleen were not observed in rats at the 65 mg/kg bw/day group. Conclusion The study authors set the NOAEL for RE1141.03 at 130 mg/kg bw/day, based on the microscopical changes in stomach and in spleen. In the submission, however, a value of 65 mg/kg bw/day was mentioned. Ref.: 12 Comment The SCCP agrees with the study authors to set the NOAEL at 130 mg/kg bw. In contrast to the teratogenicity study (ref 19), lacrimation was not reported in the 90-days study. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted; CITATION=Ref.: 12 Comment The SCCP agrees with the study authors to set the NOAEL at 130 mg/kg bw; CITATION_NUMBERS=[12,130]; REFERENCE=Ref.: 12 Comment The SCCP agrees with the study authors to set the NOAEL at 130 mg/kg bw; DETAILS_JSON={"cas_number":"90-15-3","citation":"Ref.: 12 Comment The SCCP agrees with the study authors to set the NOAEL at 130 mg/kg bw","dose":"In the spleen sections, increased pigment deposits (hemosiderin) were minimally to slightly increased in the 400 mg/kg bw/day group.","duration":"90-days","effect":"mild. In the spleen sections, increased pigment deposits (hemosiderin) were minimally to slightly increased in the 400 mg/kg bw/day group. Treatment-related stomach or changes in spleen were not observed in rats at the 65 mg/kg bw/day group. Conclusion The study authors set the NOAEL for RE1141.03 at 130 mg/kg bw/day, based on the microscopical changes in stomach and in spleen. In the submission, however, a value of 65 mg/kg bw/day was mentioned. Ref.: 12 Comment The SCCP agrees with the study authors to set the NOAEL at 130 mg/kg bw. In contrast to the teratogenicity study (ref 19), lacrimation was not reported in the 90-days study. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted","endpoint":"","ingredient":"was submitted in July 1996 by COLIPA. The Scientific","loael_value":"","noael_unit":"mg/kg bw","noael_value":"130","page":15,"route":"","species":"rat","study_id":"sccp_o_125_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =20 | mg/kg bw | rat | oral | - | dermal absorption | SOURCE_SUBDIR=sccp_o_125; REPORT_TITLE=OPINION ON 1-Naphthol COLIPA n° A17; OPINION_NUMBER=SCCP/1123/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT== 20; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (1-Naphthol) (oxidative - permanent) Maximum absorption through the skin A (µg/cm2) = 5.46 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED...; EFFECT=SCCP/1123/07 Opinion on 1-naphthol 24 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (1-Naphthol) (oxidative - permanent) Maximum absorption through the skin A (µg/cm2) = 5.46 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.064 mg/kg bw No observed effect level (mg/kg bw) NOEL = 20 mg/kg bw (maternal toxicity, oral, rat) Margin of Safety NOEL / SED = 312 3.3.14. Discussion Physico-chemical properties 1-Naphthol is used in oxidative hair dye formulations at a maximum concentration of 4.0%, which after mixing typically in 1:1 ratio with hydrogen peroxide prior to use, corresponds to a concentration of 2.0% upon application. Several batches of 1-naphthol, including unknowns, have been used in various studies submitted for the safety evaluation. However, complete chemical characterisat; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-15-3","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (1-Naphthol) (oxidative - permanent) Maximum absorption through the skin A (µg/cm2) = 5.46 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED...","duration":"","effect":"SCCP/1123/07 Opinion on 1-naphthol 24 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (1-Naphthol) (oxidative - permanent) Maximum absorption through the skin A (µg/cm2) = 5.46 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.064 mg/kg bw No observed effect level (mg/kg bw) NOEL = 20 mg/kg bw (maternal toxicity, oral, rat) Margin of Safety NOEL / SED = 312 3.3.14. Discussion Physico-chemical properties 1-Naphthol is used in oxidative hair dye formulations at a maximum concentration of 4.0%, which after mixing typically in 1:1 ratio with hydrogen peroxide prior to use, corresponds to a concentration of 2.0% upon application. Several batches of 1-naphthol, including unknowns, have been used in various studies submitted for the safety evaluation. However, complete chemical characterisat","endpoint":"dermal absorption","ingredient":"was submitted in July 1996 by COLIPA. The Scientific","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 20","page":24,"route":"oral","species":"rat","study_id":"sccp_o_125_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =20 | mg/kg bw | rat | oral | - | dermal absorption | SOURCE_SUBDIR=sccp_o_125; REPORT_TITLE=OPINION ON 1-Naphthol COLIPA n° A17; OPINION_NUMBER=SCCP/1123/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT== 20; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (1-Naphthol) (oxidative - permanent) Maximum absorption through the skin A (µg/cm2) = 5.46 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED...; EFFECT=n 1-naphthol 24 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (1-Naphthol) (oxidative - permanent) Maximum absorption through the skin A (µg/cm2) = 5.46 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.064 mg/kg bw No observed effect level (mg/kg bw) NOEL = 20 mg/kg bw (maternal toxicity, oral, rat) Margin of Safety NOEL / SED = 312 3.3.14. Discussion Physico-chemical properties 1-Naphthol is used in oxidative hair dye formulations at a maximum concentration of 4.0%, which after mixing typically in 1:1 ratio with hydrogen peroxide prior to use, corresponds to a concentration of 2.0% upon application. Several batches of 1-naphthol, including unknowns, have been used in various studies submitted for the safety evaluation. However, complete chemical characterisation is provided for only batch no. 138110. Water solubility of 1-nap; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-15-3","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (1-Naphthol) (oxidative - permanent) Maximum absorption through the skin A (µg/cm2) = 5.46 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED...","duration":"","effect":"n 1-naphthol 24 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (1-Naphthol) (oxidative - permanent) Maximum absorption through the skin A (µg/cm2) = 5.46 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.064 mg/kg bw No observed effect level (mg/kg bw) NOEL = 20 mg/kg bw (maternal toxicity, oral, rat) Margin of Safety NOEL / SED = 312 3.3.14. Discussion Physico-chemical properties 1-Naphthol is used in oxidative hair dye formulations at a maximum concentration of 4.0%, which after mixing typically in 1:1 ratio with hydrogen peroxide prior to use, corresponds to a concentration of 2.0% upon application. Several batches of 1-naphthol, including unknowns, have been used in various studies submitted for the safety evaluation. However, complete chemical characterisation is provided for only batch no. 138110. Water solubility of 1-nap","endpoint":"dermal absorption","ingredient":"was submitted in July 1996 by COLIPA. The Scientific","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 20","page":24,"route":"oral","species":"rat","study_id":"sccp_o_125_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 20 | mg/kg bw/day | human | - | developmental | developmental toxicity | SOURCE_SUBDIR=sccp_o_125; REPORT_TITLE=OPINION ON 1-Naphthol COLIPA n° A17; OPINION_NUMBER=SCCP/1123/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=20; DOSE=No other Caesarean-sectioning or litter parameters were affected by exposure to the test substance to the dams at dosages as high as 400 mg/kg bw/day.; EFFECT=ge group; these reductions were significant for total and female foetal body weights. No other Caesarean-sectioning or litter parameters were affected by exposure to the test substance to the dams at dosages as high as 400 mg/kg bw/day. (No typical changes in skeletal ossification those are indicative of developmental delay and which would have been expected to accompany significant foetal weight decrements). The slight foetal body weight reduction might be influenced by maternal toxicity. Conclusion The maternal NOEL of RE-1141.02 was 20 mg/kg bw/day because of a significant incidence of chromorhinorrhea, dilated pupils and lacrimation of some animals in the 100 mg/kg bw/day group. The developmental NOAEL was set at 400 mg/kg bw/day, the highest dose applied. Ref.: 19 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human dat; CITATION=Ref.: 19 3; CITATION_NUMBERS=[19,3]; REFERENCE=Ref.: 19 3; DETAILS_JSON={"cas_number":"90-15-3","citation":"Ref.: 19 3","dose":"No other Caesarean-sectioning or litter parameters were affected by exposure to the test substance to the dams at dosages as high as 400 mg/kg bw/day.","duration":"developmental","effect":"ge group; these reductions were significant for total and female foetal body weights. No other Caesarean-sectioning or litter parameters were affected by exposure to the test substance to the dams at dosages as high as 400 mg/kg bw/day. (No typical changes in skeletal ossification those are indicative of developmental delay and which would have been expected to accompany significant foetal weight decrements). The slight foetal body weight reduction might be influenced by maternal toxicity. Conclusion The maternal NOEL of RE-1141.02 was 20 mg/kg bw/day because of a significant incidence of chromorhinorrhea, dilated pupils and lacrimation of some animals in the 100 mg/kg bw/day group. The developmental NOAEL was set at 400 mg/kg bw/day, the highest dose applied. Ref.: 19 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human dat","endpoint":"developmental toxicity","ingredient":"was submitted in July 1996 by COLIPA. The Scientific","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"20","page":23,"route":"","species":"human","study_id":"sccp_o_125_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 400 | mg/kg bw/day | human | - | developmental | developmental toxicity | SOURCE_SUBDIR=sccp_o_125; REPORT_TITLE=OPINION ON 1-Naphthol COLIPA n° A17; OPINION_NUMBER=SCCP/1123/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=400; DOSE=dams at dosages as high as 400 mg/kg bw/day.; EFFECT=dams at dosages as high as 400 mg/kg bw/day. (No typical changes in skeletal ossification those are indicative of developmental delay and which would have been expected to accompany significant foetal weight decrements). The slight foetal body weight reduction might be influenced by maternal toxicity. Conclusion The maternal NOEL of RE-1141.02 was 20 mg/kg bw/day because of a significant incidence of chromorhinorrhea, dilated pupils and lacrimation of some animals in the 100 mg/kg bw/day group. The developmental NOAEL was set at 400 mg/kg bw/day, the highest dose applied. Ref.: 19 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted; CITATION=Ref.: 19 3; CITATION_NUMBERS=[19,3]; REFERENCE=Ref.: 19 3; DETAILS_JSON={"cas_number":"90-15-3","citation":"Ref.: 19 3","dose":"dams at dosages as high as 400 mg/kg bw/day.","duration":"developmental","effect":"dams at dosages as high as 400 mg/kg bw/day. (No typical changes in skeletal ossification those are indicative of developmental delay and which would have been expected to accompany significant foetal weight decrements). The slight foetal body weight reduction might be influenced by maternal toxicity. Conclusion The maternal NOEL of RE-1141.02 was 20 mg/kg bw/day because of a significant incidence of chromorhinorrhea, dilated pupils and lacrimation of some animals in the 100 mg/kg bw/day group. The developmental NOAEL was set at 400 mg/kg bw/day, the highest dose applied. Ref.: 19 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted","endpoint":"developmental toxicity","ingredient":"was submitted in July 1996 by COLIPA. The Scientific","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"400","page":23,"route":"","species":"human","study_id":"sccp_o_125_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 65 | mg/kg bw/day | rat | - | developmental | developmental toxicity | SOURCE_SUBDIR=sccp_o_125; REPORT_TITLE=OPINION ON 1-Naphthol COLIPA n° A17; OPINION_NUMBER=SCCP/1123/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=65; DOSE=In gastric tissues, squamous hyperplasia and hyperkeratosis of the nonglandular stomach were present in all males and most females given 400 mg/kg bw/day; and in both sexes at 130 mg/kg bw/day.; EFFECT=adverse. Microscopic, treatment-related changes were restricted to the stomach and spleen. In gastric tissues, squamous hyperplasia and hyperkeratosis of the nonglandular stomach were present in all males and most females given 400 mg/kg bw/day; and in both sexes at 130 mg/kg bw/day. At the high-dose level, gastric changes were moderate to severe and in both sexes given 130 mg/kg bw/day were minimal to mild. Treatment-related stomach or changes in spleen were not observed in rats at the 65 mg/kg bw/day group. The NOAEL was set at 130 mg/kg bw. The maternal NOEL of the test substance RE-1141.02 was 20 mg/kg bw/day because of a significant incidence of chromorhinorrhea, dilated pupils and lacrimation of some animals in the 100 mg/kg bw/day group. The developmental NOAEL was set at 400 mg/kg bw/day, the highest dose applied. Irritation / sensitisation A 2.5% aqueous suspension of 1-naphthol was considered not to be irritant to rabbit skin. Although all effects were transient, aqueous dilutions of 1-naphthol of 0.5 to 2.5% caused; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-15-3","citation":"","dose":"In gastric tissues, squamous hyperplasia and hyperkeratosis of the nonglandular stomach were present in all males and most females given 400 mg/kg bw/day; and in both sexes at 130 mg/kg bw/day.","duration":"developmental","effect":"adverse. Microscopic, treatment-related changes were restricted to the stomach and spleen. In gastric tissues, squamous hyperplasia and hyperkeratosis of the nonglandular stomach were present in all males and most females given 400 mg/kg bw/day; and in both sexes at 130 mg/kg bw/day. At the high-dose level, gastric changes were moderate to severe and in both sexes given 130 mg/kg bw/day were minimal to mild. Treatment-related stomach or changes in spleen were not observed in rats at the 65 mg/kg bw/day group. The NOAEL was set at 130 mg/kg bw. The maternal NOEL of the test substance RE-1141.02 was 20 mg/kg bw/day because of a significant incidence of chromorhinorrhea, dilated pupils and lacrimation of some animals in the 100 mg/kg bw/day group. The developmental NOAEL was set at 400 mg/kg bw/day, the highest dose applied. Irritation / sensitisation A 2.5% aqueous suspension of 1-naphthol was considered not to be irritant to rabbit skin. Although all effects were transient, aqueous dilutions of 1-naphthol of 0.5 to 2.5% caused","endpoint":"developmental toxicity","ingredient":"was submitted in July 1996 by COLIPA. The Scientific","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"65","page":24,"route":"","species":"rat","study_id":"sccp_o_125_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 130 | mg/kg bw | rat | - | developmental | developmental toxicity | SOURCE_SUBDIR=sccp_o_125; REPORT_TITLE=OPINION ON 1-Naphthol COLIPA n° A17; OPINION_NUMBER=SCCP/1123/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=130; DOSE=In gastric tissues, squamous hyperplasia and hyperkeratosis of the nonglandular stomach were present in all males and most females given 400 mg/kg bw/day; and in both sexes at 130 mg/kg bw/day.; EFFECT=nges were restricted to the stomach and spleen. In gastric tissues, squamous hyperplasia and hyperkeratosis of the nonglandular stomach were present in all males and most females given 400 mg/kg bw/day; and in both sexes at 130 mg/kg bw/day. At the high-dose level, gastric changes were moderate to severe and in both sexes given 130 mg/kg bw/day were minimal to mild. Treatment-related stomach or changes in spleen were not observed in rats at the 65 mg/kg bw/day group. The NOAEL was set at 130 mg/kg bw. The maternal NOEL of the test substance RE-1141.02 was 20 mg/kg bw/day because of a significant incidence of chromorhinorrhea, dilated pupils and lacrimation of some animals in the 100 mg/kg bw/day group. The developmental NOAEL was set at 400 mg/kg bw/day, the highest dose applied. Irritation / sensitisation A 2.5% aqueous suspension of 1-naphthol was considered not to be irritant to rabbit skin. Although all effects were transient, aqueous dilutions of 1-naphthol of 0.5 to 2.5% caused eye irritation to rabbits with irritant eff; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-15-3","citation":"","dose":"In gastric tissues, squamous hyperplasia and hyperkeratosis of the nonglandular stomach were present in all males and most females given 400 mg/kg bw/day; and in both sexes at 130 mg/kg bw/day.","duration":"developmental","effect":"nges were restricted to the stomach and spleen. In gastric tissues, squamous hyperplasia and hyperkeratosis of the nonglandular stomach were present in all males and most females given 400 mg/kg bw/day; and in both sexes at 130 mg/kg bw/day. At the high-dose level, gastric changes were moderate to severe and in both sexes given 130 mg/kg bw/day were minimal to mild. Treatment-related stomach or changes in spleen were not observed in rats at the 65 mg/kg bw/day group. The NOAEL was set at 130 mg/kg bw. The maternal NOEL of the test substance RE-1141.02 was 20 mg/kg bw/day because of a significant incidence of chromorhinorrhea, dilated pupils and lacrimation of some animals in the 100 mg/kg bw/day group. The developmental NOAEL was set at 400 mg/kg bw/day, the highest dose applied. Irritation / sensitisation A 2.5% aqueous suspension of 1-naphthol was considered not to be irritant to rabbit skin. Although all effects were transient, aqueous dilutions of 1-naphthol of 0.5 to 2.5% caused eye irritation to rabbits with irritant eff","endpoint":"developmental toxicity","ingredient":"was submitted in July 1996 by COLIPA. The Scientific","loael_value":"","noael_unit":"mg/kg bw","noael_value":"130","page":24,"route":"","species":"rat","study_id":"sccp_o_125_noael_011"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 400 | mg/kg bw/day | rat | - | developmental | developmental toxicity | SOURCE_SUBDIR=sccp_o_125; REPORT_TITLE=OPINION ON 1-Naphthol COLIPA n° A17; OPINION_NUMBER=SCCP/1123/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=400; DOSE=both sexes at 130 mg/kg bw/day.; EFFECT=both sexes at 130 mg/kg bw/day. At the high-dose level, gastric changes were moderate to severe and in both sexes given 130 mg/kg bw/day were minimal to mild. Treatment-related stomach or changes in spleen were not observed in rats at the 65 mg/kg bw/day group. The NOAEL was set at 130 mg/kg bw. The maternal NOEL of the test substance RE-1141.02 was 20 mg/kg bw/day because of a significant incidence of chromorhinorrhea, dilated pupils and lacrimation of some animals in the 100 mg/kg bw/day group. The developmental NOAEL was set at 400 mg/kg bw/day, the highest dose applied. Irritation / sensitisation A 2.5% aqueous suspension of 1-naphthol was considered not to be irritant to rabbit skin. Although all effects were transient, aqueous dilutions of 1-naphthol of 0.5 to 2.5% caused eye irritation to rabbits with irritant effects increasing with increasing dose. With an EC3 value of 1.3, 1-naphthol is a ‘strong’ sensitizer.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-15-3","citation":"","dose":"both sexes at 130 mg/kg bw/day.","duration":"developmental","effect":"both sexes at 130 mg/kg bw/day. At the high-dose level, gastric changes were moderate to severe and in both sexes given 130 mg/kg bw/day were minimal to mild. Treatment-related stomach or changes in spleen were not observed in rats at the 65 mg/kg bw/day group. The NOAEL was set at 130 mg/kg bw. The maternal NOEL of the test substance RE-1141.02 was 20 mg/kg bw/day because of a significant incidence of chromorhinorrhea, dilated pupils and lacrimation of some animals in the 100 mg/kg bw/day group. The developmental NOAEL was set at 400 mg/kg bw/day, the highest dose applied. Irritation / sensitisation A 2.5% aqueous suspension of 1-naphthol was considered not to be irritant to rabbit skin. Although all effects were transient, aqueous dilutions of 1-naphthol of 0.5 to 2.5% caused eye irritation to rabbits with irritant effects increasing with increasing dose. With an EC3 value of 1.3, 1-naphthol is a ‘strong’ sensitizer.","endpoint":"developmental toxicity","ingredient":"was submitted in July 1996 by COLIPA. The Scientific","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"400","page":24,"route":"","species":"rat","study_id":"sccp_o_125_noael_012"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 100 | mg/kg bw/day | rat | oral | Sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_125; REPORT_TITLE=OPINION ON 1-Naphthol COLIPA n° A17; OPINION_NUMBER=SCCP/1123/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=100; DOSE=No gastric effects were seen in the female mice dosed at 200 mg/kg bw/day or in the other treatment groups.; EFFECT=cal erosion of the glandular stomach. No gastric effects were seen in the female mice dosed at 200 mg/kg bw/day or in the other treatment groups. Exposure was accompanied by increase in white blood cell counts, the response being dose related in the female mice. However, the increases were all within historical normal limits of the laboratory. The weight gain was affected by the treatment, however the effect was not dose related. Conclusions The gastric lesions showed a sex difference, with the male mice having a NOAEL of 100 mg/kg bw/day. NOAEL for female mice was higher than the highest dose applied (200 mg/kg bw/day). Ref.: 4 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 (1981) Species/strain: Crl:CD/(SD)BR VAF/Plus rats; Group size: 15 per sex and per dose Test substance: RE1141.03 Batch: Lot n° 03 Purity: 99.7% Dose: 0, 65, 130, 400 mg/kg bw/day Route: oral, in carboxymethylcellulose 0.5% Exposure: by oral gavage GLP: in compliance Date: 20 April – 22 July 1998; CITATION=Ref.: 4 3; CITATION_NUMBERS=[4,3]; REFERENCE=Ref.: 4 3; DETAILS_JSON={"cas_number":"90-15-3","citation":"Ref.: 4 3","dose":"No gastric effects were seen in the female mice dosed at 200 mg/kg bw/day or in the other treatment groups.","duration":"Sub-chronic","effect":"cal erosion of the glandular stomach. No gastric effects were seen in the female mice dosed at 200 mg/kg bw/day or in the other treatment groups. Exposure was accompanied by increase in white blood cell counts, the response being dose related in the female mice. However, the increases were all within historical normal limits of the laboratory. The weight gain was affected by the treatment, however the effect was not dose related. Conclusions The gastric lesions showed a sex difference, with the male mice having a NOAEL of 100 mg/kg bw/day. NOAEL for female mice was higher than the highest dose applied (200 mg/kg bw/day). Ref.: 4 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 (1981) Species/strain: Crl:CD/(SD)BR VAF/Plus rats; Group size: 15 per sex and per dose Test substance: RE1141.03 Batch: Lot n° 03 Purity: 99.7% Dose: 0, 65, 130, 400 mg/kg bw/day Route: oral, in carboxymethylcellulose 0.5% Exposure: by oral gavage GLP: in compliance Date: 20 April – 22 July 1998","endpoint":"repeated dose toxicity","ingredient":"was submitted in July 1996 by COLIPA. The Scientific","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":14,"route":"oral","species":"rat","study_id":"sccp_o_125_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 100 | mg/kg bw/day | rat | oral | Sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_125; REPORT_TITLE=OPINION ON 1-Naphthol COLIPA n° A17; OPINION_NUMBER=SCCP/1123/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=100; DOSE=No gastric effects were seen in the female mice dosed at 200 mg/kg bw/day or in the other treatment groups.; EFFECT=r stomach. No gastric effects were seen in the female mice dosed at 200 mg/kg bw/day or in the other treatment groups. Exposure was accompanied by increase in white blood cell counts, the response being dose related in the female mice. However, the increases were all within historical normal limits of the laboratory. The weight gain was affected by the treatment, however the effect was not dose related. Conclusions The gastric lesions showed a sex difference, with the male mice having a NOAEL of 100 mg/kg bw/day. NOAEL for female mice was higher than the highest dose applied (200 mg/kg bw/day). Ref.: 4 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 (1981) Species/strain: Crl:CD/(SD)BR VAF/Plus rats; Group size: 15 per sex and per dose Test substance: RE1141.03 Batch: Lot n° 03 Purity: 99.7% Dose: 0, 65, 130, 400 mg/kg bw/day Route: oral, in carboxymethylcellulose 0.5% Exposure: by oral gavage GLP: in compliance Date: 20 April – 22 July 1998; CITATION=Ref.: 4 3; CITATION_NUMBERS=[4,3]; REFERENCE=Ref.: 4 3; DETAILS_JSON={"cas_number":"90-15-3","citation":"Ref.: 4 3","dose":"No gastric effects were seen in the female mice dosed at 200 mg/kg bw/day or in the other treatment groups.","duration":"Sub-chronic","effect":"r stomach. No gastric effects were seen in the female mice dosed at 200 mg/kg bw/day or in the other treatment groups. Exposure was accompanied by increase in white blood cell counts, the response being dose related in the female mice. However, the increases were all within historical normal limits of the laboratory. The weight gain was affected by the treatment, however the effect was not dose related. Conclusions The gastric lesions showed a sex difference, with the male mice having a NOAEL of 100 mg/kg bw/day. NOAEL for female mice was higher than the highest dose applied (200 mg/kg bw/day). Ref.: 4 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 (1981) Species/strain: Crl:CD/(SD)BR VAF/Plus rats; Group size: 15 per sex and per dose Test substance: RE1141.03 Batch: Lot n° 03 Purity: 99.7% Dose: 0, 65, 130, 400 mg/kg bw/day Route: oral, in carboxymethylcellulose 0.5% Exposure: by oral gavage GLP: in compliance Date: 20 April – 22 July 1998","endpoint":"repeated dose toxicity","ingredient":"was submitted in July 1996 by COLIPA. The Scientific","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":14,"route":"oral","species":"rat","study_id":"sccp_o_125_noael_003"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | 2A71EAQ389 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C10H8O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"2A71EAQ389"} |
| openFDA substances | FDA UNII substance identifier | 2A71EAQ389 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C10H8O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"2A71EAQ389"} |
| openFDA substances | FDA UNII substance identifier | 2A71EAQ389 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C10H8O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"2A71EAQ389"} |
| openFDA substances | FDA UNII substance identifier | 2A71EAQ389 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C10H8O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"2A71EAQ389"} |