NOAEL Studies Cosmetic Ingredient

2,4-Diaminophenoxyethanol HCl NOAEL Studies

INCI: 2,4-DIAMINOPHENOXYETHANOL HCL

CAS: 66422-95-5

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

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COSMOS_DB 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS_DB LOAEL 20 mg/kg bw/day rat oral 90 day Subchronic SCCS; G. Chevalier. 2,4 diaminophenoxyethanol HCl (A042): 13-Week Toxicity Study by oralRoute (Gavage) in Rats followed by a 4-Week Treatment-free Period. CIT StudyNo. 26892 TCR, 2005
COSMOS_DB LOAEL 125 mg/kg bw/day rat oral 6-19 Gestation day Developmental SCCS; W. Gaoua. 2,4 diaminophenoxyethanol HCl (A042): prenatal developmental ToxicityStudy by oral Route (Gavage) in Rats. CIT Study No. 26891 RSR, 2005
COSMOS_DB NOAEL 4 mg/kg bw/day rat oral 90 day Subchronic SCCS; G. Chevalier. 2,4 diaminophenoxyethanol HCl (A042): 13-Week Toxicity Study by oralRoute (Gavage) in Rats followed by a 4-Week Treatment-free Period. CIT StudyNo. 26892 TCR, 2005
COSMOS_DB NOAEL 20 mg/kg bw/day rat oral 6-19 Gestation day Developmental SCCS; W. Gaoua. 2,4 diaminophenoxyethanol HCl (A042): prenatal developmental ToxicityStudy by oral Route (Gavage) in Rats. CIT Study No. 26891 RSR, 2005
NTP_ICE_skin_sensitization 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_skin_sensitization EC3 5.5 % Mouse Dermal - In Vivo; LLNAdb2013; LLNA sheet=Data_invivo; excel_row=13080; Record_ID=skin_sensitization_invivo_3075; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID3070462; Assay=LLNA; Endpoint=EC3; Response=5.5; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Kern et al. 2010; 20137736; Not available; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID3070462
SCCS_vision_codex 12 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =20 mg/kg/day - - 4-week NOAEL study {"dose":"Deposition of brownish pigment in the thyroids and an augmented degree of spleen hemosiderosis were also observed for most animals given 100 mg/kg/day on completion of treatment and treatment-free periods.","effect":"d for males. Presence of urinary bilirubin, nitrites, glucose and coloured urine in both males and females was observed at the end of the treatment period. After a 4-week treatment-free period, all the above-mentioned changes were no longer noted. Deposition of brownish pigment in the thyroids and an augmented degree of spleen hemosiderosis were also observed for most animals given 100 mg/kg/day on completion of treatment and treatment-free periods. Consequently, under the experimental conditions of the study, the No Observed Adverse Effect Level (NOAEL) is 20 mg/kg/day. Ref.: 7","page":15,"pdf":"sccp_o_042.pdf","row_type":"noael_study","study_id":"sccp_o_042_noael_001"}
SCCS_vision_codex NOAEL =0.051 mg/kg rat oral 13 week developmental toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,4-Diaminophenoxyethanol HCl) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.33 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.031 mg Typical body weight of human = 60 kg Systemic...","effect":"salts ____________________________________________________________________________________________ 24 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,4-Diaminophenoxyethanol HCl) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.33 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.031 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.051 mg/kg No observed adverse effect level (mg/kg) NOAEL = 20 mg/kg (rat, 13 week, oral) Margin of Safety NOAEL / SED = 392 3.3.14. Discussion Physico-chemical specification The stability of 2,4-diaminophenoxyethanol HCl in marketed products is not reported. No data are reported on the physico-chemical characterisation/properties of 2,4-diamino-phenoxyethanol sulphate. General toxicity The LD50 of the test item was close to 1000 mg/kg bw. The NOAEL was set at 20 mg/kg bw/day in a rat 13-week toxicity study and in a rat prenatal development toxicity","page":24,"pdf":"sccp_o_042.pdf","row_type":"noael_study","study_id":"sccp_o_042_noael_004"}
SCCS_vision_codex NOAEL =20 mg/kg rat oral 13 week developmental toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,4-Diaminophenoxyethanol HCl) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.33 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.031 mg Typical body weight of human = 60 kg Systemic...","effect":"__________________________________________________________ 24 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,4-Diaminophenoxyethanol HCl) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.33 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.031 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.051 mg/kg No observed adverse effect level (mg/kg) NOAEL = 20 mg/kg (rat, 13 week, oral) Margin of Safety NOAEL / SED = 392 3.3.14. Discussion Physico-chemical specification The stability of 2,4-diaminophenoxyethanol HCl in marketed products is not reported. No data are reported on the physico-chemical characterisation/properties of 2,4-diamino-phenoxyethanol sulphate. General toxicity The LD50 of the test item was close to 1000 mg/kg bw. The NOAEL was set at 20 mg/kg bw/day in a rat 13-week toxicity study and in a rat prenatal development toxicity study. Irrit","page":24,"pdf":"sccp_o_042.pdf","row_type":"noael_study","study_id":"sccp_o_042_noael_005"}
SCCS_vision_codex NOAEL =20 mg/kg/day - - 4-week NOAEL study {"dose":"Deposition of brownish pigment in the thyroids and an augmented degree of spleen hemosiderosis were also observed for most animals given 100 mg/kg/day on completion of treatment and treatment-free periods.","effect":"d for males. Presence of urinary bilirubin, nitrites, glucose and coloured urine in both males and females was observed at the end of the treatment period. After a 4-week treatment-free period, all the above-mentioned changes were no longer noted. Deposition of brownish pigment in the thyroids and an augmented degree of spleen hemosiderosis were also observed for most animals given 100 mg/kg/day on completion of treatment and treatment-free periods. Consequently, under the experimental conditions of the study, the No Observed Adverse Effect Level (NOAEL) is 20 mg/kg/day. Ref.: 7","page":15,"pdf":"sccp_o_042.pdf","row_type":"noael_study","study_id":"sccp_o_042_noael_001"}
SCCS_vision_codex NOAEL =0.051 mg/kg rat oral 13 week developmental toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,4-Diaminophenoxyethanol HCl) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.33 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.031 mg Typical body weight of human = 60 kg Systemic...","effect":"salts ____________________________________________________________________________________________ 24 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,4-Diaminophenoxyethanol HCl) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.33 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.031 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.051 mg/kg No observed adverse effect level (mg/kg) NOAEL = 20 mg/kg (rat, 13 week, oral) Margin of Safety NOAEL / SED = 392 3.3.14. Discussion Physico-chemical specification The stability of 2,4-diaminophenoxyethanol HCl in marketed products is not reported. No data are reported on the physico-chemical characterisation/properties of 2,4-diamino-phenoxyethanol sulphate. General toxicity The LD50 of the test item was close to 1000 mg/kg bw. The NOAEL was set at 20 mg/kg bw/day in a rat 13-week toxicity study and in a rat prenatal development toxicity","page":24,"pdf":"sccp_o_042.pdf","row_type":"noael_study","study_id":"sccp_o_042_noael_004"}
SCCS_vision_codex NOAEL =20 mg/kg rat oral 13 week developmental toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,4-Diaminophenoxyethanol HCl) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.33 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.031 mg Typical body weight of human = 60 kg Systemic...","effect":"__________________________________________________________ 24 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,4-Diaminophenoxyethanol HCl) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.33 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.031 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.051 mg/kg No observed adverse effect level (mg/kg) NOAEL = 20 mg/kg (rat, 13 week, oral) Margin of Safety NOAEL / SED = 392 3.3.14. Discussion Physico-chemical specification The stability of 2,4-diaminophenoxyethanol HCl in marketed products is not reported. No data are reported on the physico-chemical characterisation/properties of 2,4-diamino-phenoxyethanol sulphate. General toxicity The LD50 of the test item was close to 1000 mg/kg bw. The NOAEL was set at 20 mg/kg bw/day in a rat 13-week toxicity study and in a rat prenatal development toxicity study. Irrit","page":24,"pdf":"sccp_o_042.pdf","row_type":"noael_study","study_id":"sccp_o_042_noael_005"}
SCCS_vision_codex NOAEL =20 mg/kg/day - - 4-week NOAEL study {"dose":"Deposition of brownish pigment in the thyroids and an augmented degree of spleen hemosiderosis were also observed for most animals given 100 mg/kg/day on completion of treatment and treatment-free periods.","effect":"d for males. Presence of urinary bilirubin, nitrites, glucose and coloured urine in both males and females was observed at the end of the treatment period. After a 4-week treatment-free period, all the above-mentioned changes were no longer noted. Deposition of brownish pigment in the thyroids and an augmented degree of spleen hemosiderosis were also observed for most animals given 100 mg/kg/day on completion of treatment and treatment-free periods. Consequently, under the experimental conditions of the study, the No Observed Adverse Effect Level (NOAEL) is 20 mg/kg/day. Ref.: 7","page":15,"pdf":"sccp_o_042.pdf","row_type":"noael_study","study_id":"sccp_o_042_noael_001"}
SCCS_vision_codex NOAEL =0.051 mg/kg rat oral 13 week developmental toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,4-Diaminophenoxyethanol HCl) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.33 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.031 mg Typical body weight of human = 60 kg Systemic...","effect":"salts ____________________________________________________________________________________________ 24 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,4-Diaminophenoxyethanol HCl) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.33 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.031 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.051 mg/kg No observed adverse effect level (mg/kg) NOAEL = 20 mg/kg (rat, 13 week, oral) Margin of Safety NOAEL / SED = 392 3.3.14. Discussion Physico-chemical specification The stability of 2,4-diaminophenoxyethanol HCl in marketed products is not reported. No data are reported on the physico-chemical characterisation/properties of 2,4-diamino-phenoxyethanol sulphate. General toxicity The LD50 of the test item was close to 1000 mg/kg bw. The NOAEL was set at 20 mg/kg bw/day in a rat 13-week toxicity study and in a rat prenatal development toxicity","page":24,"pdf":"sccp_o_042.pdf","row_type":"noael_study","study_id":"sccp_o_042_noael_004"}
SCCS_vision_codex NOAEL =20 mg/kg rat oral 13 week developmental toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,4-Diaminophenoxyethanol HCl) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.33 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.031 mg Typical body weight of human = 60 kg Systemic...","effect":"__________________________________________________________ 24 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,4-Diaminophenoxyethanol HCl) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.33 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.031 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.051 mg/kg No observed adverse effect level (mg/kg) NOAEL = 20 mg/kg (rat, 13 week, oral) Margin of Safety NOAEL / SED = 392 3.3.14. Discussion Physico-chemical specification The stability of 2,4-diaminophenoxyethanol HCl in marketed products is not reported. No data are reported on the physico-chemical characterisation/properties of 2,4-diamino-phenoxyethanol sulphate. General toxicity The LD50 of the test item was close to 1000 mg/kg bw. The NOAEL was set at 20 mg/kg bw/day in a rat 13-week toxicity study and in a rat prenatal development toxicity study. Irrit","page":24,"pdf":"sccp_o_042.pdf","row_type":"noael_study","study_id":"sccp_o_042_noael_005"}
SCCS_vision_codex NOAEL =20 mg/kg/day - - 4-week NOAEL study {"dose":"Deposition of brownish pigment in the thyroids and an augmented degree of spleen hemosiderosis were also observed for most animals given 100 mg/kg/day on completion of treatment and treatment-free periods.","effect":"d for males. Presence of urinary bilirubin, nitrites, glucose and coloured urine in both males and females was observed at the end of the treatment period. After a 4-week treatment-free period, all the above-mentioned changes were no longer noted. Deposition of brownish pigment in the thyroids and an augmented degree of spleen hemosiderosis were also observed for most animals given 100 mg/kg/day on completion of treatment and treatment-free periods. Consequently, under the experimental conditions of the study, the No Observed Adverse Effect Level (NOAEL) is 20 mg/kg/day. Ref.: 7","page":15,"pdf":"sccp_o_042.pdf","row_type":"noael_study","study_id":"sccp_o_042_noael_001"}
SCCS_vision_codex NOAEL =0.051 mg/kg rat oral 13 week developmental toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,4-Diaminophenoxyethanol HCl) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.33 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.031 mg Typical body weight of human = 60 kg Systemic...","effect":"salts ____________________________________________________________________________________________ 24 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,4-Diaminophenoxyethanol HCl) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.33 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.031 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.051 mg/kg No observed adverse effect level (mg/kg) NOAEL = 20 mg/kg (rat, 13 week, oral) Margin of Safety NOAEL / SED = 392 3.3.14. Discussion Physico-chemical specification The stability of 2,4-diaminophenoxyethanol HCl in marketed products is not reported. No data are reported on the physico-chemical characterisation/properties of 2,4-diamino-phenoxyethanol sulphate. General toxicity The LD50 of the test item was close to 1000 mg/kg bw. The NOAEL was set at 20 mg/kg bw/day in a rat 13-week toxicity study and in a rat prenatal development toxicity","page":24,"pdf":"sccp_o_042.pdf","row_type":"noael_study","study_id":"sccp_o_042_noael_004"}
SCCS_vision_codex NOAEL =20 mg/kg rat oral 13 week developmental toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,4-Diaminophenoxyethanol HCl) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.33 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.031 mg Typical body weight of human = 60 kg Systemic...","effect":"__________________________________________________________ 24 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,4-Diaminophenoxyethanol HCl) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.33 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.031 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.051 mg/kg No observed adverse effect level (mg/kg) NOAEL = 20 mg/kg (rat, 13 week, oral) Margin of Safety NOAEL / SED = 392 3.3.14. Discussion Physico-chemical specification The stability of 2,4-diaminophenoxyethanol HCl in marketed products is not reported. No data are reported on the physico-chemical characterisation/properties of 2,4-diamino-phenoxyethanol sulphate. General toxicity The LD50 of the test item was close to 1000 mg/kg bw. The NOAEL was set at 20 mg/kg bw/day in a rat 13-week toxicity study and in a rat prenatal development toxicity study. Irrit","page":24,"pdf":"sccp_o_042.pdf","row_type":"noael_study","study_id":"sccp_o_042_noael_005"}
ToxValDB_ECHA_IUCLID 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_ECHA_IUCLID NOAEL =20 mg/kg bw/day Rat oral subchronic; 13 weeks subchronic QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eae98e4b0a7c65d1ca155; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/10194/7/6/2?documentUUID=c0dfd8ed-26ea-4cf5-b089-b03309603654; YEAR=1998; ORIGINAL_YEAR=1998; TOXICOLOGICAL_EFFECT=body weight and weight gain|gross pathology|urinalysis; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|gross pathology|urinalysis; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15834528_15841006: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_dc56a34ac8693bda3c6937e626b5dfff
ToxValDB_ECHA_IUCLID NOEL =20 mg/kg bw/day Rat oral - developmental QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac4ae4b0a7c65d1be5dc; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/10194/7/9/3?documentUUID=c0dfd8ed-26ea-4cf5-b089-b03309603654; YEAR=1998; ORIGINAL_YEAR=1998; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15820582_15821849:M/F:-fetal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_32e4b0d468601fbda78d86d4db9f2324
ToxValDB_GESTIS_DNEL 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_GESTIS_DNEL DNEL systemic =0.7 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:15630976:-:--; 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_9db025a652da4daa69bdb90d84554190
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 7 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 20 mg/kg/day - - 4-week - SOURCE_SUBDIR=sccp_o_042; REPORT_TITLE=Opinion on 2,4-Diaminophenoxyethanol and its salts COLIPA N° A42; OPINION_NUMBER=SCCP/0979/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT=20; DOSE=Deposition of brownish pigment in the thyroids and an augmented degree of spleen hemosiderosis were also observed for most animals given 100 mg/kg/day on completion of treatment and treatment-free periods.; EFFECT=d for males. Presence of urinary bilirubin, nitrites, glucose and coloured urine in both males and females was observed at the end of the treatment period. After a 4-week treatment-free period, all the above-mentioned changes were no longer noted. Deposition of brownish pigment in the thyroids and an augmented degree of spleen hemosiderosis were also observed for most animals given 100 mg/kg/day on completion of treatment and treatment-free periods. Consequently, under the experimental conditions of the study, the No Observed Adverse Effect Level (NOAEL) is 20 mg/kg/day. Ref.: 7; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"66422-95-5","citation":"","dose":"Deposition of brownish pigment in the thyroids and an augmented degree of spleen hemosiderosis were also observed for most animals given 100 mg/kg/day on completion of treatment and treatment-free periods.","duration":"4-week","effect":"d for males. Presence of urinary bilirubin, nitrites, glucose and coloured urine in both males and females was observed at the end of the treatment period. After a 4-week treatment-free period, all the above-mentioned changes were no longer noted. Deposition of brownish pigment in the thyroids and an augmented degree of spleen hemosiderosis were also observed for most animals given 100 mg/kg/day on completion of treatment and treatment-free periods. Consequently, under the experimental conditions of the study, the No Observed Adverse Effect Level (NOAEL) is 20 mg/kg/day. Ref.: 7","endpoint":"","ingredient":"2,4-diaminophenoxy ethanol HCl (INCI)","loael_value":"","noael_unit":"mg/kg/day","noael_value":"20","page":15,"route":"","species":"","study_id":"sccp_o_042_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 20 mg/kg/day - - 4-week - SOURCE_SUBDIR=sccp_o_042; REPORT_TITLE=Opinion on 2,4-Diaminophenoxyethanol and its salts COLIPA N° A42; OPINION_NUMBER=SCCP/0979/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT=20; DOSE=Deposition of brownish pigment in the thyroids and an augmented degree of spleen hemosiderosis were also observed for most animals given 100 mg/kg/day on completion of treatment and treatment-free periods.; EFFECT=ilirubin, nitrites, glucose and coloured urine in both males and females was observed at the end of the treatment period. After a 4-week treatment-free period, all the above-mentioned changes were no longer noted. Deposition of brownish pigment in the thyroids and an augmented degree of spleen hemosiderosis were also observed for most animals given 100 mg/kg/day on completion of treatment and treatment-free periods. Consequently, under the experimental conditions of the study, the No Observed Adverse Effect Level (NOAEL) is 20 mg/kg/day. Ref.: 7; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"66422-95-5","citation":"","dose":"Deposition of brownish pigment in the thyroids and an augmented degree of spleen hemosiderosis were also observed for most animals given 100 mg/kg/day on completion of treatment and treatment-free periods.","duration":"4-week","effect":"ilirubin, nitrites, glucose and coloured urine in both males and females was observed at the end of the treatment period. After a 4-week treatment-free period, all the above-mentioned changes were no longer noted. Deposition of brownish pigment in the thyroids and an augmented degree of spleen hemosiderosis were also observed for most animals given 100 mg/kg/day on completion of treatment and treatment-free periods. Consequently, under the experimental conditions of the study, the No Observed Adverse Effect Level (NOAEL) is 20 mg/kg/day. Ref.: 7","endpoint":"","ingredient":"2,4-diaminophenoxy ethanol HCl (INCI)","loael_value":"","noael_unit":"mg/kg/day","noael_value":"20","page":15,"route":"","species":"","study_id":"sccp_o_042_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 20 mg/kg/day human - - - SOURCE_SUBDIR=sccp_o_042; REPORT_TITLE=Opinion on 2,4-Diaminophenoxyethanol and its salts COLIPA N° A42; OPINION_NUMBER=SCCP/0979/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT=20; DOSE=No clinical signs were observed in the females of the low and intermediate dose groups.; EFFECT=ughout the dosing period, when compared to controls. No clinical signs were observed in the females of the low and intermediate dose groups. Litter data There was a statistically significant reduction in the mean foetal weight (-7%, p < 0.001) at 125 mg/kg bw, associated with a statistically significantly increased incidence of foetuses showing incomplete ossification of thoracic vertebra centrum or supernumerary short 14th rib. Conclusion Under the experimental conditions, the No Observed Adverse Effect Levels (NOAEL) for maternal toxicity and embryo-foetal development are 20 mg/kg/day. Ref.: 15 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted; CITATION=Ref.: 15 3; CITATION_NUMBERS=[15,3]; REFERENCE=Ref.: 15 3; DETAILS_JSON={"cas_number":"66422-95-5","citation":"Ref.: 15 3","dose":"No clinical signs were observed in the females of the low and intermediate dose groups.","duration":"","effect":"ughout the dosing period, when compared to controls. No clinical signs were observed in the females of the low and intermediate dose groups. Litter data There was a statistically significant reduction in the mean foetal weight (-7%, p < 0.001) at 125 mg/kg bw, associated with a statistically significantly increased incidence of foetuses showing incomplete ossification of thoracic vertebra centrum or supernumerary short 14th rib. Conclusion Under the experimental conditions, the No Observed Adverse Effect Levels (NOAEL) for maternal toxicity and embryo-foetal development are 20 mg/kg/day. Ref.: 15 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted","endpoint":"","ingredient":"2,4-diaminophenoxy ethanol HCl (INCI)","loael_value":"","noael_unit":"mg/kg/day","noael_value":"20","page":23,"route":"","species":"human","study_id":"sccp_o_042_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity =0.051 mg/kg rat oral 13 week developmental toxicity SOURCE_SUBDIR=sccp_o_042; REPORT_TITLE=Opinion on 2,4-Diaminophenoxyethanol and its salts COLIPA N° A42; OPINION_NUMBER=SCCP/0979/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT== 0.051; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,4-Diaminophenoxyethanol HCl) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.33 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.031 mg Typical body weight of human = 60 kg Systemic...; EFFECT=salts ____________________________________________________________________________________________ 24 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,4-Diaminophenoxyethanol HCl) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.33 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.031 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.051 mg/kg No observed adverse effect level (mg/kg) NOAEL = 20 mg/kg (rat, 13 week, oral) Margin of Safety NOAEL / SED = 392 3.3.14. Discussion Physico-chemical specification The stability of 2,4-diaminophenoxyethanol HCl in marketed products is not reported. No data are reported on the physico-chemical characterisation/properties of 2,4-diamino-phenoxyethanol sulphate. General toxicity The LD50 of the test item was close to 1000 mg/kg bw. The NOAEL was set at 20 mg/kg bw/day in a rat 13-week toxicity study and in a rat prenatal development toxicity; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"66422-95-5","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,4-Diaminophenoxyethanol HCl) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.33 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.031 mg Typical body weight of human = 60 kg Systemic...","duration":"13 week","effect":"salts ____________________________________________________________________________________________ 24 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,4-Diaminophenoxyethanol HCl) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.33 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.031 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.051 mg/kg No observed adverse effect level (mg/kg) NOAEL = 20 mg/kg (rat, 13 week, oral) Margin of Safety NOAEL / SED = 392 3.3.14. Discussion Physico-chemical specification The stability of 2,4-diaminophenoxyethanol HCl in marketed products is not reported. No data are reported on the physico-chemical characterisation/properties of 2,4-diamino-phenoxyethanol sulphate. General toxicity The LD50 of the test item was close to 1000 mg/kg bw. The NOAEL was set at 20 mg/kg bw/day in a rat 13-week toxicity study and in a rat prenatal development toxicity","endpoint":"developmental toxicity","ingredient":"2,4-diaminophenoxy ethanol HCl (INCI)","loael_value":"","noael_unit":"mg/kg","noael_value":"= 0.051","page":24,"route":"oral","species":"rat","study_id":"sccp_o_042_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity =20 mg/kg rat oral 13 week developmental toxicity SOURCE_SUBDIR=sccp_o_042; REPORT_TITLE=Opinion on 2,4-Diaminophenoxyethanol and its salts COLIPA N° A42; OPINION_NUMBER=SCCP/0979/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT== 20; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,4-Diaminophenoxyethanol HCl) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.33 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.031 mg Typical body weight of human = 60 kg Systemic...; EFFECT=__________________________________________________________ 24 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,4-Diaminophenoxyethanol HCl) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.33 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.031 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.051 mg/kg No observed adverse effect level (mg/kg) NOAEL = 20 mg/kg (rat, 13 week, oral) Margin of Safety NOAEL / SED = 392 3.3.14. Discussion Physico-chemical specification The stability of 2,4-diaminophenoxyethanol HCl in marketed products is not reported. No data are reported on the physico-chemical characterisation/properties of 2,4-diamino-phenoxyethanol sulphate. General toxicity The LD50 of the test item was close to 1000 mg/kg bw. The NOAEL was set at 20 mg/kg bw/day in a rat 13-week toxicity study and in a rat prenatal development toxicity study. Irrit; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"66422-95-5","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,4-Diaminophenoxyethanol HCl) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.33 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.031 mg Typical body weight of human = 60 kg Systemic...","duration":"13 week","effect":"__________________________________________________________ 24 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,4-Diaminophenoxyethanol HCl) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.33 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.031 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.051 mg/kg No observed adverse effect level (mg/kg) NOAEL = 20 mg/kg (rat, 13 week, oral) Margin of Safety NOAEL / SED = 392 3.3.14. Discussion Physico-chemical specification The stability of 2,4-diaminophenoxyethanol HCl in marketed products is not reported. No data are reported on the physico-chemical characterisation/properties of 2,4-diamino-phenoxyethanol sulphate. General toxicity The LD50 of the test item was close to 1000 mg/kg bw. The NOAEL was set at 20 mg/kg bw/day in a rat 13-week toxicity study and in a rat prenatal development toxicity study. Irrit","endpoint":"developmental toxicity","ingredient":"2,4-diaminophenoxy ethanol HCl (INCI)","loael_value":"","noael_unit":"mg/kg","noael_value":"= 20","page":24,"route":"oral","species":"rat","study_id":"sccp_o_042_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity =20 mg/kg rat oral 13 week developmental toxicity SOURCE_SUBDIR=sccp_o_042; REPORT_TITLE=Opinion on 2,4-Diaminophenoxyethanol and its salts COLIPA N° A42; OPINION_NUMBER=SCCP/0979/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT== 20; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,4-Diaminophenoxyethanol HCl) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.33 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.031 mg Typical body weight of human = 60 kg Systemic...; EFFECT=24 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,4-Diaminophenoxyethanol HCl) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.33 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.031 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.051 mg/kg No observed adverse effect level (mg/kg) NOAEL = 20 mg/kg (rat, 13 week, oral) Margin of Safety NOAEL / SED = 392 3.3.14. Discussion Physico-chemical specification The stability of 2,4-diaminophenoxyethanol HCl in marketed products is not reported. No data are reported on the physico-chemical characterisation/properties of 2,4-diamino-phenoxyethanol sulphate. General toxicity The LD50 of the test item was close to 1000 mg/kg bw. The NOAEL was set at 20 mg/kg bw/day in a rat 13-week toxicity study and in a rat prenatal development toxicity study. Irritation / sensitisation The test substance was not irritant t; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"66422-95-5","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,4-Diaminophenoxyethanol HCl) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.33 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.031 mg Typical body weight of human = 60 kg Systemic...","duration":"13 week","effect":"24 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,4-Diaminophenoxyethanol HCl) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.33 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.031 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.051 mg/kg No observed adverse effect level (mg/kg) NOAEL = 20 mg/kg (rat, 13 week, oral) Margin of Safety NOAEL / SED = 392 3.3.14. Discussion Physico-chemical specification The stability of 2,4-diaminophenoxyethanol HCl in marketed products is not reported. No data are reported on the physico-chemical characterisation/properties of 2,4-diamino-phenoxyethanol sulphate. General toxicity The LD50 of the test item was close to 1000 mg/kg bw. The NOAEL was set at 20 mg/kg bw/day in a rat 13-week toxicity study and in a rat prenatal development toxicity study. Irritation / sensitisation The test substance was not irritant t","endpoint":"developmental toxicity","ingredient":"2,4-diaminophenoxy ethanol HCl (INCI)","loael_value":"","noael_unit":"mg/kg","noael_value":"= 20","page":24,"route":"oral","species":"rat","study_id":"sccp_o_042_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 20 mg/kg bw/day rat oral 13 week developmental toxicity SOURCE_SUBDIR=sccp_o_042; REPORT_TITLE=Opinion on 2,4-Diaminophenoxyethanol and its salts COLIPA N° A42; OPINION_NUMBER=SCCP/0979/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT=20; DOSE=n = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.051 mg/kg No observed adverse effect level (mg/kg) NOAEL = 20 mg/kg (rat, 13 week, oral) Margin of Safety NOAEL / SED = 392 3.3.14.; EFFECT=n = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.051 mg/kg No observed adverse effect level (mg/kg) NOAEL = 20 mg/kg (rat, 13 week, oral) Margin of Safety NOAEL / SED = 392 3.3.14. Discussion Physico-chemical specification The stability of 2,4-diaminophenoxyethanol HCl in marketed products is not reported. No data are reported on the physico-chemical characterisation/properties of 2,4-diamino-phenoxyethanol sulphate. General toxicity The LD50 of the test item was close to 1000 mg/kg bw. The NOAEL was set at 20 mg/kg bw/day in a rat 13-week toxicity study and in a rat prenatal development toxicity study. Irritation / sensitisation The test substance was not irritant to rabbit skin. It was slightly irritant to rabbit eyes when tested undiluted or at 4% in water. The topical application of undiluted 2,4-diaminophenoxyethanol dihydrochoride did not produce sensitisation reactions in a Buehler test. However, it was considered to be a moderate skin sensitiser in an LLNA study. Dermal absorption The maximum der; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"66422-95-5","citation":"","dose":"n = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.051 mg/kg No observed adverse effect level (mg/kg) NOAEL = 20 mg/kg (rat, 13 week, oral) Margin of Safety NOAEL / SED = 392 3.3.14.","duration":"13 week","effect":"n = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.051 mg/kg No observed adverse effect level (mg/kg) NOAEL = 20 mg/kg (rat, 13 week, oral) Margin of Safety NOAEL / SED = 392 3.3.14. Discussion Physico-chemical specification The stability of 2,4-diaminophenoxyethanol HCl in marketed products is not reported. No data are reported on the physico-chemical characterisation/properties of 2,4-diamino-phenoxyethanol sulphate. General toxicity The LD50 of the test item was close to 1000 mg/kg bw. The NOAEL was set at 20 mg/kg bw/day in a rat 13-week toxicity study and in a rat prenatal development toxicity study. Irritation / sensitisation The test substance was not irritant to rabbit skin. It was slightly irritant to rabbit eyes when tested undiluted or at 4% in water. The topical application of undiluted 2,4-diaminophenoxyethanol dihydrochoride did not produce sensitisation reactions in a Buehler test. However, it was considered to be a moderate skin sensitiser in an LLNA study. Dermal absorption The maximum der","endpoint":"developmental toxicity","ingredient":"2,4-diaminophenoxy ethanol HCl (INCI)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"20","page":24,"route":"oral","species":"rat","study_id":"sccp_o_042_noael_007"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier Z5Y843J6KQ UNII - - - chemical {"approval_status":null,"molecular_formula":"C8H12N2O2.2ClH","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"Z5Y843J6KQ"}
openFDA substances FDA UNII substance identifier Z5Y843J6KQ UNII - - - chemical {"approval_status":null,"molecular_formula":"C8H12N2O2.2ClH","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"Z5Y843J6KQ"}
openFDA substances FDA UNII substance identifier Z5Y843J6KQ UNII - - - chemical {"approval_status":null,"molecular_formula":"C8H12N2O2.2ClH","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"Z5Y843J6KQ"}
openFDA substances FDA UNII substance identifier Z5Y843J6KQ UNII - - - chemical {"approval_status":null,"molecular_formula":"C8H12N2O2.2ClH","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"Z5Y843J6KQ"}