NOAEL Studies Cosmetic Ingredient

ACETALDEHYDE NOAEL Studies

CAS: 75-07-0

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 7 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS_DB LOAEL 675 mg/kg bw/day rat oral 31 day Short Term Toxicity PAFA;SCCS; FOOD CHEM TOXICOL 26:447-452,
COSMOS_DB NOAEL 10 mg/kg bw/day guinea pig oral 113 day Subchronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 675 mg/kg bw/day rat oral 28 day Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 400 mg/kg bw/day rat oral 10 day Developmental US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 240 mg/kg bw/day rat oral 42 day Reproductive US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 324 mg/kg bw/day rat oral 240 day Chronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 125 mg/kg bw/day rat oral 1085 day Carcinogenicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
California Proposition 65 6 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
California Proposition 65 California Proposition 65 NSRL SQEinhalation=90 ug/day - - 1988-04-01 No significant risk level {"cancer_reproductive":"cancer","listed_date":"1988-04-01","listing_mechanism":"SQE","madl":null,"nsrl":"inhalation=90","row_type":"nsrl","source_table":"prop65_listings"}
California Proposition 65 California Proposition 65 NSRL SQEinhalation=90 ug/day - - 1988-04-01 No significant risk level {"cancer_reproductive":"cancer","listed_date":"1988-04-01","listing_mechanism":"SQE","madl":null,"nsrl":"inhalation=90","row_type":"nsrl","source_table":"prop65_listings"}
California Proposition 65 California Proposition 65 NSRL SQEinhalation=90 ug/day - - 1988-04-01 No significant risk level {"cancer_reproductive":"cancer","listed_date":"1988-04-01","listing_mechanism":"SQE","madl":null,"nsrl":"inhalation=90","row_type":"nsrl","source_table":"prop65_listings"}
California Proposition 65 California Proposition 65 listing SQEcancer listing type - - 1988-04-01 California Proposition 65 listing {"cancer_reproductive":"cancer","listed_date":"1988-04-01","listing_mechanism":"SQE","madl":null,"nsrl":"inhalation=90","source_table":"prop65_listings"}
California Proposition 65 California Proposition 65 listing SQEcancer listing type - - 1988-04-01 California Proposition 65 listing {"cancer_reproductive":"cancer","listed_date":"1988-04-01","listing_mechanism":"SQE","madl":null,"nsrl":"inhalation=90","source_table":"prop65_listings"}
California Proposition 65 California Proposition 65 listing SQEcancer listing type - - 1988-04-01 California Proposition 65 listing {"cancer_reproductive":"cancer","listed_date":"1988-04-01","listing_mechanism":"SQE","madl":null,"nsrl":"inhalation=90","source_table":"prop65_listings"}
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx NOAEL =120 mg/kg bw/day Rat oral: drinking water 77 days subchronic EFSA FEEDAP - 2013 - OutputID 2209 - other - hepatotoxicity - Scientific Opinion on the safety and efficacy of straight-chain primary aliphatic alcohols/aldehydes/acids, acetals and esters with esters containing saturated alcohols and acetals containing saturated aldehydes (chemical group 1) when used as flavourings for all animal species - doi:10.2903/j.efsa.2013.3169
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx NOEL =125 mg/kg bw/day Rat - 28 days short-term toxicity EFSA CEF - 2010 - OutputID 2042 - Scientific Opinion on Flavouring Group Evaluation 91 (FGE.91): Consideration of simple aliphatic and aromatic sulphides and thiols evaluated by JECFA (53rd and 68th meetings) structurally related to aliphatic and alicyclic mono-, di-, tri-, and polysulphides with or without additional oxygenated functional groups evaluated by EFSA in FGE.08Rev1 (2009). EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) - doi:10.2903/j.efsa.2010.1337
EPA_IRIS_iris_rfc_systems.csv 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
EPA_IRIS_iris_rfc_systems.csv NOAEL (HEC) =8.7 mg/m^3 - inhalation chronic IRIS chronic inhalation RfC system PoD row_hash=10400ab902b567d1; file=iris_rfc_systems.csv; kind=point_of_departure; raw_column=point_of_departure; raw_value=NOAEL (HEC): 8.7 mg/m^3; system=Nervous, Respiratory; basis=Degeneration of olfactory epithelium; point_of_departure=NOAEL (HEC): 8.7 mg/m^3; composite_uf=1000; confidence=Low; dtxsid=DTXSID5039224; detail_url=https://iris.epa.gov/ChemicalLanding/&substance_nmbr=290; rfc_last_updated=10/01/1991; rfc_pdf_url=https://iris.epa.gov/static/pdfs/0290_summary.pdf
EPA_IRIS_iris_rfc_systems.csv RfC =0.009 mg/m^3 - inhalation chronic IRIS chronic inhalation RfC system row_hash=e05b1d336cfea136; file=iris_rfc_systems.csv; kind=reference_value; raw_column=rfc_mg_per_m3; raw_value=9e-3; system=Nervous, Respiratory; basis=Degeneration of olfactory epithelium; point_of_departure=NOAEL (HEC): 8.7 mg/m^3; composite_uf=1000; confidence=Low; dtxsid=DTXSID5039224; detail_url=https://iris.epa.gov/ChemicalLanding/&substance_nmbr=290; rfc_last_updated=10/01/1991; rfc_pdf_url=https://iris.epa.gov/static/pdfs/0290_summary.pdf
Health Canada Drug Product Database 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
Health Canada Drug Product Database Health Canada DPD product listing 2233545 DIN Human - 2025-03-22 Health Canada Drug Product Database {"ai_group_number":"0123453004","class":"Human","company_name":"BIO ACTIVE CANADA LTD.","descriptor":null,"din":"02233545","drug_code":"53633","drug_name":"ACETALDEHYDE","last_update_date":"2025-03-22","number_of_active_ingredients":1,"schedule":null,"source_file":"C:\\BENDA_PROJECT\\DOWNLOADS_NEW\\health_canada_dpd_sample.json","source_record_index":23570,"source_table":"health_canada_drugs"}
Health Canada Drug Product Database Health Canada DPD product listing 2233545 DIN Human - 2025-03-22 Health Canada Drug Product Database {"ai_group_number":"0123453004","class":"Human","company_name":"BIO ACTIVE CANADA LTD.","descriptor":null,"din":"02233545","drug_code":"53633","drug_name":"ACETALDEHYDE","last_update_date":"2025-03-22","number_of_active_ingredients":1,"schedule":null,"source_file":"C:\\BENDA_PROJECT\\DOWNLOADS_NEW\\health_canada_dpd_sample.json","source_record_index":23570,"source_table":"health_canada_drugs"}
Health Canada Drug Product Database Health Canada DPD product listing 2233545 DIN Human - 2025-03-22 Health Canada Drug Product Database {"ai_group_number":"0123453004","class":"Human","company_name":"BIO ACTIVE CANADA LTD.","descriptor":null,"din":"02233545","drug_code":"53633","drug_name":"ACETALDEHYDE","last_update_date":"2025-03-22","number_of_active_ingredients":1,"schedule":null,"source_file":"C:\\BENDA_PROJECT\\DOWNLOADS_NEW\\health_canada_dpd_sample.json","source_record_index":23570,"source_table":"health_canada_drugs"}
IARC Monographs 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
IARC Monographs IARC carcinogenicity classification 2B IARC group - - 1998 IARC Monographs {"additional_info":"volume_publication_year=1999","evaluation_year":1998,"source_table":"iarc_classifications","volume":"36, Sup 7, 71"}
IARC Monographs IARC carcinogenicity classification 1 IARC group - - 2009 IARC Monographs {"additional_info":"volume_publication_year=2012","evaluation_year":2009,"source_table":"iarc_classifications","volume":"100E"}
INCHEM_WHO_ehc_ehc_ehc167 10 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
INCHEM_WHO_ehc_ehc_ehc167 LOEL =675 mg/kg bw - - - Toxicology study document_id=ehc_ehc_ehc167; title=Acetaldehyde (EHC 167, 1995); path=mirror/documents/ehc/ehc/ehc167.htm; row_hash=01f9a88f66886fe5; raw_unit=mg/kg; context=The no-observed-effect level (NOEL) was 125 mg/kg, the lowest-observed-effect level (LOEL) was 675 mg/kg (Til et al., 1988).
INCHEM_WHO_ehc_ehc_ehc167 LOEL =675 mg/kg bw - - - Toxicology study document_id=ehc_ehc_ehc167; title=Acetaldehyde (EHC 167, 1995); path=mirror/documents/ehc/ehc/ehc167.htm; row_hash=01f9a88f66886fe5; raw_unit=mg/kg; context=The no-observed-effect level (NOEL) was 125 mg/kg, the lowest-observed-effect level (LOEL) was 675 mg/kg (Til et al., 1988).
INCHEM_WHO_ehc_ehc_ehc167 NOEL =255 mg/m3 - - - Toxicology study document_id=ehc_ehc_ehc167; title=Acetaldehyde (EHC 167, 1995); path=mirror/documents/ehc/ehc/ehc167.htm; row_hash=9c45cd03a505be41; raw_unit=mg/m 3; context=The NOEL was 255 mg/m 3 , 6-h TWA (LOEL = 1050 mg/m 3 , 6-h time weighted average) (Appelman et al., 1986).
INCHEM_WHO_ehc_ehc_ehc167 NOEL =700 mg/m3 - - - Toxicology study document_id=ehc_ehc_ehc167; title=Acetaldehyde (EHC 167, 1995); path=mirror/documents/ehc/ehc/ehc167.htm; row_hash=95a544f0ee8f95b0; raw_unit=mg/m 3; context=At 700 mg/m 3 , no significant effects were observed (NOEL:
INCHEM_WHO_ehc_ehc_ehc167 NOEL =275 mg/m3 Rat - 4-week Carcinogenicity document_id=ehc_ehc_ehc167; title=Acetaldehyde (EHC 167, 1995); path=mirror/documents/ehc/ehc/ehc167.htm; row_hash=780be76dc3136233; raw_unit=mg/m 3; context=275 mg/m 3 was the NOEL for irritation in rats in a 4-week study (Appelman et al., 1986) and 1000 is the uncertainty factor (×10 for interspecies variation, ×10 for intraspecies variation and ×10 for a less than long-term study and severity of effect, i.e., carcinogenicity associate
INCHEM_WHO_ehc_ehc_ehc167 NOEL =125 mg/kg bw - - - Toxicology study document_id=ehc_ehc_ehc167; title=Acetaldehyde (EHC 167, 1995); path=mirror/documents/ehc/ehc/ehc167.htm; row_hash=36b9647358fda2e5; raw_unit=mg/kg; context=En un estudio de 28 días en el que se administró a ratas con el agua de beber acetaldehído a razón de 675 mg/kg de peso corporal (nivel sin efecto observado (NOEL) = 125 mg/kg de peso corporal) los efectos se limitaron a una ligera hiperqueratosis focal en la parte anterior del estómago.
INCHEM_WHO_ehc_ehc_ehc167 NOEL =255 mg/m3 - - - Toxicology study document_id=ehc_ehc_ehc167; title=Acetaldehyde (EHC 167, 1995); path=mirror/documents/ehc/ehc/ehc167.htm; row_hash=9c45cd03a505be41; raw_unit=mg/m 3; context=The NOEL was 255 mg/m 3 , 6-h TWA (LOEL = 1050 mg/m 3 , 6-h time weighted average) (Appelman et al., 1986).
INCHEM_WHO_ehc_ehc_ehc167 NOEL =700 mg/m3 - - - Toxicology study document_id=ehc_ehc_ehc167; title=Acetaldehyde (EHC 167, 1995); path=mirror/documents/ehc/ehc/ehc167.htm; row_hash=95a544f0ee8f95b0; raw_unit=mg/m 3; context=At 700 mg/m 3 , no significant effects were observed (NOEL:
INCHEM_WHO_ehc_ehc_ehc167 NOEL =275 mg/m3 Rat - 4-week Carcinogenicity document_id=ehc_ehc_ehc167; title=Acetaldehyde (EHC 167, 1995); path=mirror/documents/ehc/ehc/ehc167.htm; row_hash=780be76dc3136233; raw_unit=mg/m 3; context=275 mg/m 3 was the NOEL for irritation in rats in a 4-week study (Appelman et al., 1986) and 1000 is the uncertainty factor (×10 for interspecies variation, ×10 for intraspecies variation and ×10 for a less than long-term study and severity of effect, i.e., carcinogenicity associate
INCHEM_WHO_ehc_ehc_ehc167 NOEL =125 mg/kg bw - - - Toxicology study document_id=ehc_ehc_ehc167; title=Acetaldehyde (EHC 167, 1995); path=mirror/documents/ehc/ehc/ehc167.htm; row_hash=36b9647358fda2e5; raw_unit=mg/kg; context=En un estudio de 28 días en el que se administró a ratas con el agua de beber acetaldehído a razón de 675 mg/kg de peso corporal (nivel sin efecto observado (NOEL) = 125 mg/kg de peso corporal) los efectos se limitaron a una ligera hiperqueratosis focal en la parte anterior del estómago.
NTP_ICE_acute_inhalation 5 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_acute_inhalation LC50 24 mg/L - Inhalation Duration=4 hr In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity sheet=Data; excel_row=3178; Record_ID=acute_inhalation_2331; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID5039224; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response=24; Response_Unit=mg/L; Reference=AEGL; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5039224; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5039224
NTP_ICE_acute_inhalation LC50 23.9485 mg/L - Inhalation Duration=4 hr In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity sheet=Data; excel_row=3179; Record_ID=acute_inhalation_2789; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID5039224; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response=23.9485; Response_Unit=mg/L; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5039224; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5039224
NTP_ICE_acute_inhalation LC50 25 mg/L - Inhalation - In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity sheet=Data; excel_row=3180; Record_ID=acute_inhalation_1703; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID5039224; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response=25; Response_Unit=mg/L; Reference=NIOSH; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5039224; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5039224
NTP_ICE_acute_inhalation LC50 37 mg/L - Inhalation Duration=0.5 hr In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity sheet=Data; excel_row=3181; Record_ID=acute_inhalation_2327; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID5039224; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response=37; Response_Unit=mg/L; Reference=AEGL; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5039224; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5039224
NTP_ICE_acute_inhalation LC50 37.3092 mg/L - Inhalation Duration=0.5 hr In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity sheet=Data; excel_row=3182; Record_ID=acute_inhalation_2329; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID5039224; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response=37.3092; Response_Unit=mg/L; Reference=AEGL; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5039224; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5039224
NTP_ICE_acute_oral 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_acute_oral LD50 =661 mg/kg bw Rat oral acute Rat Acute Oral Toxicity NLM Hazardous Substances Data Bank (undated); record_id=acute_oral_10002; row=9276; data_type=In Vivo; mixture=Chemical; chemical_name=Acetaldehyde; preferred_name=Acetaldehyde; dtxsid=DTXSID5039224; url=https://pubchem.ncbi.nlm.nih.gov/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5039224; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID5039224; source_file=acute_oral.xlsx
NTP_ICE_acute_oral LD50 =1930 mg/kg bw Rat oral acute Rat Acute Oral Toxicity NLM Hazardous Substances Data Bank (undated); record_id=acute_oral_10004; row=9277; data_type=In Vivo; mixture=Chemical; chemical_name=Acetaldehyde; preferred_name=Acetaldehyde; dtxsid=DTXSID5039224; url=https://pubchem.ncbi.nlm.nih.gov/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5039224; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID5039224; source_file=acute_oral.xlsx
NTP_ICE_cancer 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_cancer IARC group 2 unitless - - - WOE; IARC Carcinogenicity sheet=Data; excel_row=6207; Record_ID=cancer_3673; Data_Type=WOE; Formulation_Name=Acetaldehyde; Mixture=Chemical; DTXSID=DTXSID5039224; Assay=IARC Carcinogenicity; Endpoint=IARC group; Response=2B; Response_Unit=Unitless; URL=http://publications.iarc.fr/54; http://publications.iarc.fr/139; http://publications.iarc.fr/89; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5039224; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5039224
NTP_ICE_cancer Inhalation risk unit 0.0000022 ug/m3 - Inhalation - WOE; IRIS Carcinogenicity sheet=Data; excel_row=6210; Record_ID=cancer_3675; Data_Type=WOE; Formulation_Name=Acetaldehyde; Mixture=Chemical; DTXSID=DTXSID5039224; Assay=IRIS Carcinogenicity; Endpoint=Inhalation risk unit; Response=2.2000000000000001E-6; Response_Unit=ug/m3; Route=Inhalation; URL=https://cfpub.epa.gov/ncea/iris/iris_documents/documents/subst/0290_summary.pdf; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5039224; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5039224
SCCS_vision_codex 24 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =125 mg/kg bw/d - inhalation 28 days repeated dose toxicity {"citation":"Ref.: 10 Comment A NOAEL of 125 mg/kg bw/d can be derived from the study","dose":"In the high-dose group, the relative kidney weights were slightly increased in males, and urinary production was decreased.","effect":"/10 females). In the control group, very slight or slight focal hyperkeratosis of the forestomach was noted in 6/20 females and 4/20 males. In the high-dose group, the relative kidney weights were slightly increased in males, and urinary production was decreased. The effects and reported variations in serum biochemistry, were generally attributed to reduced water intake. Acetaldehyde exposure did not affect indices of liver function and produced no evidence of histological change in this organ. Ref.: 10 Comment A NOAEL of 125 mg/kg bw/d can be derived from the study. 3.3.5.2 Repeated Dose (28 days) inhalation toxicity Several studies investigating toxicity of acetaldehyde by inhalation have been published but most of them are not recent ones and did not followed standardized procedures. Two short- term studies conducted by the same research group are considered as the most reliable and informative and then are the principal studies used for risk assessment of acetaldehyde by inhalation. In a first 28 days study, Appelman et a","page":11,"pdf":"sccs_o_104.pdf","row_type":"noael_study","study_id":"sccs_o_104_noael_001"}
SCCS_vision_codex NOAEL =400 ppm rat inhalation 28 days NOAEL study {"citation":"Ref: 40 Comment This study does not follow OECD/GLP guidelines","dose":"n acetaldehyde ___________________________________________________________________________________________ 12 epithelium, and only at 2200 ppm, minimal epithelial changes in the larynx and trachea.","effect":"n acetaldehyde ___________________________________________________________________________________________ 12 epithelium, and only at 2200 ppm, minimal epithelial changes in the larynx and trachea. The only change observed at the 400 ppm level that could be attributed to acetaldehyde was slight degeneration of the nasal olfactory epithelium seen as loss of microvilli and thinning and disarrangement of the layer of epithelial cells. Ref: 40 Comment This study does not follow OECD/GLP guidelines. No NOAEL can be derived from this study and, based on the slight degeneration of the nasal olfactory epithelium, 400 ppm could be considered as a LOAEL. In a second 28 days study, Appelman et al (1986) have studied the effect of short-term increases and interruption in exposure on the inhalation toxicity of acetaldehyde during 28 days in male Wistar rats. Male rats were exposed to 110, 150 and 500 ppm for 6 h per day/5 days per week. One group of animals was exposed without interruption, the exposure of a second group was","page":12,"pdf":"sccs_o_104.pdf","row_type":"noael_study","study_id":"sccs_o_104_noael_002"}
SCCS_vision_codex NOAEL =150 ppm rat oral 5 days repeated dose toxicity {"citation":"Ref: 41 Comment This study does not follow OECD/GLP guidelines","dose":"effects were seen in rats interruptedly or uninterruptedly exposed to 150 ppm acetaldehyde or interruptedly exposed to 110 ppm with peak loads of 660 ppm.","effect":"effects were seen in rats interruptedly or uninterruptedly exposed to 150 ppm acetaldehyde or interruptedly exposed to 110 ppm with peak loads of 660 ppm. As a consequence 150 ppm acetaldehyde can be considered a 'no-toxic-effect level' in male rats exposed for 6 h/day, 5 days/week, during a 4-week period. Ref: 41 Comment This study does not follow OECD/GLP guidelines. Based on the degeneration of the nasal olfactory epithelium observed at 500 ppm, which could be considered as a LOAEL and 150 ppm (273 mg/m³) as a NOAEL. The NOAEL, based on continuous exposure, would then be (273 x 5/7 x 6/24) 49 mg/m³. This value will be used in the safety assessment for non-cancer effects by inhalation. 3.3.5.3 Sub-chronic (90 days) oral toxicity In a group of rats exposed to 0.05% acetaldehyde in the drinking water (estimated to be about 40 mg/kg bw for 6 months, an increase in collagen synthesis in the liver was reported. Since no other indices of toxicity were reported, the significance of this finding is unknown. Ref.: 11 Guideline: / Sp","page":12,"pdf":"sccs_o_104.pdf","row_type":"noael_study","study_id":"sccs_o_104_noael_003"}
SCCS_vision_codex NOAEL =500 mg/kg bw/day rat - 6 months NOAEL study {"citation":"Ref.: 37 Comment Based on the accumulation of fat and inflammatory changes in the liver of the male rats receiving 500 mg/kg bw/day, a NOAEL of 120 mg/kg bw/day for acetaldehyde can be d","dose":"both in the periportal and in the pericentral areas of the hepatic acinus in the livers of rats receiving the high dose acetaldehyde.","effect":"both in the periportal and in the pericentral areas of the hepatic acinus in the livers of rats receiving the high dose acetaldehyde. In rats receiving a high dose of acetaldehyde, some foci of inflammatory cells were found in the liver specimens of seven out of ten rats. No inflammatory changes were found either in the rats receiving a low dose of acetaldehyde or in the controls. Ref.: 37 Comment Based on the accumulation of fat and inflammatory changes in the liver of the male rats receiving 500 mg/kg bw/day, a NOAEL of 120 mg/kg bw/day for acetaldehyde can be derived. The potential toxicity of acetaldehyde administered perorally in aqueous solution to white rats and guinea pigs at dose levels of 0.5, 10, or 100 mg/kg bw/d for periods of 5-6 months was studied. In guinea pigs, indices monitored at every dose level, with the exception of the high-dose level, included peripheral blood cholinesterase and leukocyte phagocytic activity, as well as the ratio of protein fractions in blood serum. In rats, conditional reflex activity","page":13,"pdf":"sccs_o_104.pdf","row_type":"noael_study","study_id":"sccs_o_104_noael_005"}
SCCS_vision_codex NOAEL =0.5 mg/kg bw/d rat dermal 3 month carcinogenicity {"citation":"Ref.: 12 Comment No documentation for the above study was available to SCCS for evaluation","dose":"Compound-related effects reported in guinea pigs were limited to a statistically significant reduction in eosinophil count in groups treated at 10 mg/kg bw/d.","effect":"SCCS-rejected applicant NOAEL: nditioned reflex activity also was reported in rats receiving 10 mg acetaldehyde/kg bw/d at the 2 and 3 month of treatment. Compound-related effects reported in guinea pigs were limited to a statistically significant reduction in eosinophil count in groups treated at 10 mg/kg bw/d. No apparent adverse effects were reported in groups of animals administered 0.5 mg/kg bw/d. Ref.: 12 Comment No documentation for the above study was available to SCCS for evaluation. The study is not suitable for the estimation of the NOAEL/LOAEL. No dermal study with acetaldehyde has been found. 3.3.5.4 Chronic (> 12 months) toxicity See Section 3.3.7 Carcinogenicity 3.3.6 Mutagenicity / Genotoxicity This section is based on IARC, 1999, 2011, 2012 (Ref.: 13, 14, and 15)","page":13,"pdf":"sccs_o_104.pdf","row_type":"noael_study","study_id":"sccs_o_104_noael_006"}
SCCS_vision_codex NOAEL =5 ppm rat inhalation 28 day NOAEL study {"dose":"n cosmetics is up to 25 ppm acetaldehyde in fragrance compounds.","effect":"n cosmetics is up to 25 ppm acetaldehyde in fragrance compounds. Acetaldehyde should otherwise only be found in cosmetic products in the form of unavoidable traces originating mainly through plant extracts and botanical ingredients and ethanol. The probability of cancer risk for a lifetime exposure to 100 ppm from all cosmetic products is 2 x 10-4. It can be derived from the above calculation that a safe concentration with a LCR of 10-5 would be 5 ppm in all cosmetic products. In the case of non-cancer effects, a NOAEL of 49 mg/m³ has been derived from a 28 day inhalation study in rats. As a worse case approach, complete evaporation of acetaldehyde present in all cosmetic products (total exposure of 1.74 mg/d) in a small room (10 m³) without ventilation would result in a concentration of 0.174 mg/m³. In this worst case scenario, the Margin of Exposure would be much higher than 100.","page":27,"pdf":"sccs_o_104.pdf","row_type":"noael_study","study_id":"sccs_o_104_noael_007"}
SCCS_vision_codex NOAEL =125 mg/kg bw/d - inhalation 28 days repeated dose toxicity {"citation":"Ref.: 10 Comment A NOAEL of 125 mg/kg bw/d can be derived from the study","dose":"In the high-dose group, the relative kidney weights were slightly increased in males, and urinary production was decreased.","effect":"/10 females). In the control group, very slight or slight focal hyperkeratosis of the forestomach was noted in 6/20 females and 4/20 males. In the high-dose group, the relative kidney weights were slightly increased in males, and urinary production was decreased. The effects and reported variations in serum biochemistry, were generally attributed to reduced water intake. Acetaldehyde exposure did not affect indices of liver function and produced no evidence of histological change in this organ. Ref.: 10 Comment A NOAEL of 125 mg/kg bw/d can be derived from the study. 3.3.5.2 Repeated Dose (28 days) inhalation toxicity Several studies investigating toxicity of acetaldehyde by inhalation have been published but most of them are not recent ones and did not followed standardized procedures. Two short- term studies conducted by the same research group are considered as the most reliable and informative and then are the principal studies used for risk assessment of acetaldehyde by inhalation. In a first 28 days study, Appelman et a","page":11,"pdf":"sccs_o_104.pdf","row_type":"noael_study","study_id":"sccs_o_104_noael_001"}
SCCS_vision_codex NOAEL =400 ppm rat inhalation 28 days NOAEL study {"citation":"Ref: 40 Comment This study does not follow OECD/GLP guidelines","dose":"n acetaldehyde ___________________________________________________________________________________________ 12 epithelium, and only at 2200 ppm, minimal epithelial changes in the larynx and trachea.","effect":"n acetaldehyde ___________________________________________________________________________________________ 12 epithelium, and only at 2200 ppm, minimal epithelial changes in the larynx and trachea. The only change observed at the 400 ppm level that could be attributed to acetaldehyde was slight degeneration of the nasal olfactory epithelium seen as loss of microvilli and thinning and disarrangement of the layer of epithelial cells. Ref: 40 Comment This study does not follow OECD/GLP guidelines. No NOAEL can be derived from this study and, based on the slight degeneration of the nasal olfactory epithelium, 400 ppm could be considered as a LOAEL. In a second 28 days study, Appelman et al (1986) have studied the effect of short-term increases and interruption in exposure on the inhalation toxicity of acetaldehyde during 28 days in male Wistar rats. Male rats were exposed to 110, 150 and 500 ppm for 6 h per day/5 days per week. One group of animals was exposed without interruption, the exposure of a second group was","page":12,"pdf":"sccs_o_104.pdf","row_type":"noael_study","study_id":"sccs_o_104_noael_002"}
SCCS_vision_codex NOAEL =150 ppm rat oral 5 days repeated dose toxicity {"citation":"Ref: 41 Comment This study does not follow OECD/GLP guidelines","dose":"effects were seen in rats interruptedly or uninterruptedly exposed to 150 ppm acetaldehyde or interruptedly exposed to 110 ppm with peak loads of 660 ppm.","effect":"effects were seen in rats interruptedly or uninterruptedly exposed to 150 ppm acetaldehyde or interruptedly exposed to 110 ppm with peak loads of 660 ppm. As a consequence 150 ppm acetaldehyde can be considered a 'no-toxic-effect level' in male rats exposed for 6 h/day, 5 days/week, during a 4-week period. Ref: 41 Comment This study does not follow OECD/GLP guidelines. Based on the degeneration of the nasal olfactory epithelium observed at 500 ppm, which could be considered as a LOAEL and 150 ppm (273 mg/m³) as a NOAEL. The NOAEL, based on continuous exposure, would then be (273 x 5/7 x 6/24) 49 mg/m³. This value will be used in the safety assessment for non-cancer effects by inhalation. 3.3.5.3 Sub-chronic (90 days) oral toxicity In a group of rats exposed to 0.05% acetaldehyde in the drinking water (estimated to be about 40 mg/kg bw for 6 months, an increase in collagen synthesis in the liver was reported. Since no other indices of toxicity were reported, the significance of this finding is unknown. Ref.: 11 Guideline: / Sp","page":12,"pdf":"sccs_o_104.pdf","row_type":"noael_study","study_id":"sccs_o_104_noael_003"}
SCCS_vision_codex NOAEL =500 mg/kg bw/day rat - 6 months NOAEL study {"citation":"Ref.: 37 Comment Based on the accumulation of fat and inflammatory changes in the liver of the male rats receiving 500 mg/kg bw/day, a NOAEL of 120 mg/kg bw/day for acetaldehyde can be d","dose":"both in the periportal and in the pericentral areas of the hepatic acinus in the livers of rats receiving the high dose acetaldehyde.","effect":"both in the periportal and in the pericentral areas of the hepatic acinus in the livers of rats receiving the high dose acetaldehyde. In rats receiving a high dose of acetaldehyde, some foci of inflammatory cells were found in the liver specimens of seven out of ten rats. No inflammatory changes were found either in the rats receiving a low dose of acetaldehyde or in the controls. Ref.: 37 Comment Based on the accumulation of fat and inflammatory changes in the liver of the male rats receiving 500 mg/kg bw/day, a NOAEL of 120 mg/kg bw/day for acetaldehyde can be derived. The potential toxicity of acetaldehyde administered perorally in aqueous solution to white rats and guinea pigs at dose levels of 0.5, 10, or 100 mg/kg bw/d for periods of 5-6 months was studied. In guinea pigs, indices monitored at every dose level, with the exception of the high-dose level, included peripheral blood cholinesterase and leukocyte phagocytic activity, as well as the ratio of protein fractions in blood serum. In rats, conditional reflex activity","page":13,"pdf":"sccs_o_104.pdf","row_type":"noael_study","study_id":"sccs_o_104_noael_005"}
SCCS_vision_codex NOAEL =0.5 mg/kg bw/d rat dermal 3 month carcinogenicity {"citation":"Ref.: 12 Comment No documentation for the above study was available to SCCS for evaluation","dose":"Compound-related effects reported in guinea pigs were limited to a statistically significant reduction in eosinophil count in groups treated at 10 mg/kg bw/d.","effect":"SCCS-rejected applicant NOAEL: nditioned reflex activity also was reported in rats receiving 10 mg acetaldehyde/kg bw/d at the 2 and 3 month of treatment. Compound-related effects reported in guinea pigs were limited to a statistically significant reduction in eosinophil count in groups treated at 10 mg/kg bw/d. No apparent adverse effects were reported in groups of animals administered 0.5 mg/kg bw/d. Ref.: 12 Comment No documentation for the above study was available to SCCS for evaluation. The study is not suitable for the estimation of the NOAEL/LOAEL. No dermal study with acetaldehyde has been found. 3.3.5.4 Chronic (> 12 months) toxicity See Section 3.3.7 Carcinogenicity 3.3.6 Mutagenicity / Genotoxicity This section is based on IARC, 1999, 2011, 2012 (Ref.: 13, 14, and 15)","page":13,"pdf":"sccs_o_104.pdf","row_type":"noael_study","study_id":"sccs_o_104_noael_006"}
SCCS_vision_codex NOAEL =5 ppm rat inhalation 28 day NOAEL study {"dose":"n cosmetics is up to 25 ppm acetaldehyde in fragrance compounds.","effect":"n cosmetics is up to 25 ppm acetaldehyde in fragrance compounds. Acetaldehyde should otherwise only be found in cosmetic products in the form of unavoidable traces originating mainly through plant extracts and botanical ingredients and ethanol. The probability of cancer risk for a lifetime exposure to 100 ppm from all cosmetic products is 2 x 10-4. It can be derived from the above calculation that a safe concentration with a LCR of 10-5 would be 5 ppm in all cosmetic products. In the case of non-cancer effects, a NOAEL of 49 mg/m³ has been derived from a 28 day inhalation study in rats. As a worse case approach, complete evaporation of acetaldehyde present in all cosmetic products (total exposure of 1.74 mg/d) in a small room (10 m³) without ventilation would result in a concentration of 0.174 mg/m³. In this worst case scenario, the Margin of Exposure would be much higher than 100.","page":27,"pdf":"sccs_o_104.pdf","row_type":"noael_study","study_id":"sccs_o_104_noael_007"}
SCCS_vision_codex NOAEL =125 mg/kg bw/d - inhalation 28 days repeated dose toxicity {"citation":"Ref.: 10 Comment A NOAEL of 125 mg/kg bw/d can be derived from the study","dose":"In the high-dose group, the relative kidney weights were slightly increased in males, and urinary production was decreased.","effect":"/10 females). In the control group, very slight or slight focal hyperkeratosis of the forestomach was noted in 6/20 females and 4/20 males. In the high-dose group, the relative kidney weights were slightly increased in males, and urinary production was decreased. The effects and reported variations in serum biochemistry, were generally attributed to reduced water intake. Acetaldehyde exposure did not affect indices of liver function and produced no evidence of histological change in this organ. Ref.: 10 Comment A NOAEL of 125 mg/kg bw/d can be derived from the study. 3.3.5.2 Repeated Dose (28 days) inhalation toxicity Several studies investigating toxicity of acetaldehyde by inhalation have been published but most of them are not recent ones and did not followed standardized procedures. Two short- term studies conducted by the same research group are considered as the most reliable and informative and then are the principal studies used for risk assessment of acetaldehyde by inhalation. In a first 28 days study, Appelman et a","page":11,"pdf":"sccs_o_104.pdf","row_type":"noael_study","study_id":"sccs_o_104_noael_001"}
SCCS_vision_codex NOAEL =400 ppm rat inhalation 28 days NOAEL study {"citation":"Ref: 40 Comment This study does not follow OECD/GLP guidelines","dose":"n acetaldehyde ___________________________________________________________________________________________ 12 epithelium, and only at 2200 ppm, minimal epithelial changes in the larynx and trachea.","effect":"n acetaldehyde ___________________________________________________________________________________________ 12 epithelium, and only at 2200 ppm, minimal epithelial changes in the larynx and trachea. The only change observed at the 400 ppm level that could be attributed to acetaldehyde was slight degeneration of the nasal olfactory epithelium seen as loss of microvilli and thinning and disarrangement of the layer of epithelial cells. Ref: 40 Comment This study does not follow OECD/GLP guidelines. No NOAEL can be derived from this study and, based on the slight degeneration of the nasal olfactory epithelium, 400 ppm could be considered as a LOAEL. In a second 28 days study, Appelman et al (1986) have studied the effect of short-term increases and interruption in exposure on the inhalation toxicity of acetaldehyde during 28 days in male Wistar rats. Male rats were exposed to 110, 150 and 500 ppm for 6 h per day/5 days per week. One group of animals was exposed without interruption, the exposure of a second group was","page":12,"pdf":"sccs_o_104.pdf","row_type":"noael_study","study_id":"sccs_o_104_noael_002"}
SCCS_vision_codex NOAEL =150 ppm rat oral 5 days repeated dose toxicity {"citation":"Ref: 41 Comment This study does not follow OECD/GLP guidelines","dose":"effects were seen in rats interruptedly or uninterruptedly exposed to 150 ppm acetaldehyde or interruptedly exposed to 110 ppm with peak loads of 660 ppm.","effect":"effects were seen in rats interruptedly or uninterruptedly exposed to 150 ppm acetaldehyde or interruptedly exposed to 110 ppm with peak loads of 660 ppm. As a consequence 150 ppm acetaldehyde can be considered a 'no-toxic-effect level' in male rats exposed for 6 h/day, 5 days/week, during a 4-week period. Ref: 41 Comment This study does not follow OECD/GLP guidelines. Based on the degeneration of the nasal olfactory epithelium observed at 500 ppm, which could be considered as a LOAEL and 150 ppm (273 mg/m³) as a NOAEL. The NOAEL, based on continuous exposure, would then be (273 x 5/7 x 6/24) 49 mg/m³. This value will be used in the safety assessment for non-cancer effects by inhalation. 3.3.5.3 Sub-chronic (90 days) oral toxicity In a group of rats exposed to 0.05% acetaldehyde in the drinking water (estimated to be about 40 mg/kg bw for 6 months, an increase in collagen synthesis in the liver was reported. Since no other indices of toxicity were reported, the significance of this finding is unknown. Ref.: 11 Guideline: / Sp","page":12,"pdf":"sccs_o_104.pdf","row_type":"noael_study","study_id":"sccs_o_104_noael_003"}
SCCS_vision_codex NOAEL =500 mg/kg bw/day rat - 6 months NOAEL study {"citation":"Ref.: 37 Comment Based on the accumulation of fat and inflammatory changes in the liver of the male rats receiving 500 mg/kg bw/day, a NOAEL of 120 mg/kg bw/day for acetaldehyde can be d","dose":"both in the periportal and in the pericentral areas of the hepatic acinus in the livers of rats receiving the high dose acetaldehyde.","effect":"both in the periportal and in the pericentral areas of the hepatic acinus in the livers of rats receiving the high dose acetaldehyde. In rats receiving a high dose of acetaldehyde, some foci of inflammatory cells were found in the liver specimens of seven out of ten rats. No inflammatory changes were found either in the rats receiving a low dose of acetaldehyde or in the controls. Ref.: 37 Comment Based on the accumulation of fat and inflammatory changes in the liver of the male rats receiving 500 mg/kg bw/day, a NOAEL of 120 mg/kg bw/day for acetaldehyde can be derived. The potential toxicity of acetaldehyde administered perorally in aqueous solution to white rats and guinea pigs at dose levels of 0.5, 10, or 100 mg/kg bw/d for periods of 5-6 months was studied. In guinea pigs, indices monitored at every dose level, with the exception of the high-dose level, included peripheral blood cholinesterase and leukocyte phagocytic activity, as well as the ratio of protein fractions in blood serum. In rats, conditional reflex activity","page":13,"pdf":"sccs_o_104.pdf","row_type":"noael_study","study_id":"sccs_o_104_noael_005"}
SCCS_vision_codex NOAEL =0.5 mg/kg bw/d rat dermal 3 month carcinogenicity {"citation":"Ref.: 12 Comment No documentation for the above study was available to SCCS for evaluation","dose":"Compound-related effects reported in guinea pigs were limited to a statistically significant reduction in eosinophil count in groups treated at 10 mg/kg bw/d.","effect":"SCCS-rejected applicant NOAEL: nditioned reflex activity also was reported in rats receiving 10 mg acetaldehyde/kg bw/d at the 2 and 3 month of treatment. Compound-related effects reported in guinea pigs were limited to a statistically significant reduction in eosinophil count in groups treated at 10 mg/kg bw/d. No apparent adverse effects were reported in groups of animals administered 0.5 mg/kg bw/d. Ref.: 12 Comment No documentation for the above study was available to SCCS for evaluation. The study is not suitable for the estimation of the NOAEL/LOAEL. No dermal study with acetaldehyde has been found. 3.3.5.4 Chronic (> 12 months) toxicity See Section 3.3.7 Carcinogenicity 3.3.6 Mutagenicity / Genotoxicity This section is based on IARC, 1999, 2011, 2012 (Ref.: 13, 14, and 15)","page":13,"pdf":"sccs_o_104.pdf","row_type":"noael_study","study_id":"sccs_o_104_noael_006"}
SCCS_vision_codex NOAEL =5 ppm rat inhalation 28 day NOAEL study {"dose":"n cosmetics is up to 25 ppm acetaldehyde in fragrance compounds.","effect":"n cosmetics is up to 25 ppm acetaldehyde in fragrance compounds. Acetaldehyde should otherwise only be found in cosmetic products in the form of unavoidable traces originating mainly through plant extracts and botanical ingredients and ethanol. The probability of cancer risk for a lifetime exposure to 100 ppm from all cosmetic products is 2 x 10-4. It can be derived from the above calculation that a safe concentration with a LCR of 10-5 would be 5 ppm in all cosmetic products. In the case of non-cancer effects, a NOAEL of 49 mg/m³ has been derived from a 28 day inhalation study in rats. As a worse case approach, complete evaporation of acetaldehyde present in all cosmetic products (total exposure of 1.74 mg/d) in a small room (10 m³) without ventilation would result in a concentration of 0.174 mg/m³. In this worst case scenario, the Margin of Exposure would be much higher than 100.","page":27,"pdf":"sccs_o_104.pdf","row_type":"noael_study","study_id":"sccs_o_104_noael_007"}
SCCS_vision_codex NOAEL =125 mg/kg bw/d - inhalation 28 days repeated dose toxicity {"citation":"Ref.: 10 Comment A NOAEL of 125 mg/kg bw/d can be derived from the study","dose":"In the high-dose group, the relative kidney weights were slightly increased in males, and urinary production was decreased.","effect":"/10 females). In the control group, very slight or slight focal hyperkeratosis of the forestomach was noted in 6/20 females and 4/20 males. In the high-dose group, the relative kidney weights were slightly increased in males, and urinary production was decreased. The effects and reported variations in serum biochemistry, were generally attributed to reduced water intake. Acetaldehyde exposure did not affect indices of liver function and produced no evidence of histological change in this organ. Ref.: 10 Comment A NOAEL of 125 mg/kg bw/d can be derived from the study. 3.3.5.2 Repeated Dose (28 days) inhalation toxicity Several studies investigating toxicity of acetaldehyde by inhalation have been published but most of them are not recent ones and did not followed standardized procedures. Two short- term studies conducted by the same research group are considered as the most reliable and informative and then are the principal studies used for risk assessment of acetaldehyde by inhalation. In a first 28 days study, Appelman et a","page":11,"pdf":"sccs_o_104.pdf","row_type":"noael_study","study_id":"sccs_o_104_noael_001"}
SCCS_vision_codex NOAEL =400 ppm rat inhalation 28 days NOAEL study {"citation":"Ref: 40 Comment This study does not follow OECD/GLP guidelines","dose":"n acetaldehyde ___________________________________________________________________________________________ 12 epithelium, and only at 2200 ppm, minimal epithelial changes in the larynx and trachea.","effect":"n acetaldehyde ___________________________________________________________________________________________ 12 epithelium, and only at 2200 ppm, minimal epithelial changes in the larynx and trachea. The only change observed at the 400 ppm level that could be attributed to acetaldehyde was slight degeneration of the nasal olfactory epithelium seen as loss of microvilli and thinning and disarrangement of the layer of epithelial cells. Ref: 40 Comment This study does not follow OECD/GLP guidelines. No NOAEL can be derived from this study and, based on the slight degeneration of the nasal olfactory epithelium, 400 ppm could be considered as a LOAEL. In a second 28 days study, Appelman et al (1986) have studied the effect of short-term increases and interruption in exposure on the inhalation toxicity of acetaldehyde during 28 days in male Wistar rats. Male rats were exposed to 110, 150 and 500 ppm for 6 h per day/5 days per week. One group of animals was exposed without interruption, the exposure of a second group was","page":12,"pdf":"sccs_o_104.pdf","row_type":"noael_study","study_id":"sccs_o_104_noael_002"}
SCCS_vision_codex NOAEL =150 ppm rat oral 5 days repeated dose toxicity {"citation":"Ref: 41 Comment This study does not follow OECD/GLP guidelines","dose":"effects were seen in rats interruptedly or uninterruptedly exposed to 150 ppm acetaldehyde or interruptedly exposed to 110 ppm with peak loads of 660 ppm.","effect":"effects were seen in rats interruptedly or uninterruptedly exposed to 150 ppm acetaldehyde or interruptedly exposed to 110 ppm with peak loads of 660 ppm. As a consequence 150 ppm acetaldehyde can be considered a 'no-toxic-effect level' in male rats exposed for 6 h/day, 5 days/week, during a 4-week period. Ref: 41 Comment This study does not follow OECD/GLP guidelines. Based on the degeneration of the nasal olfactory epithelium observed at 500 ppm, which could be considered as a LOAEL and 150 ppm (273 mg/m³) as a NOAEL. The NOAEL, based on continuous exposure, would then be (273 x 5/7 x 6/24) 49 mg/m³. This value will be used in the safety assessment for non-cancer effects by inhalation. 3.3.5.3 Sub-chronic (90 days) oral toxicity In a group of rats exposed to 0.05% acetaldehyde in the drinking water (estimated to be about 40 mg/kg bw for 6 months, an increase in collagen synthesis in the liver was reported. Since no other indices of toxicity were reported, the significance of this finding is unknown. Ref.: 11 Guideline: / Sp","page":12,"pdf":"sccs_o_104.pdf","row_type":"noael_study","study_id":"sccs_o_104_noael_003"}
SCCS_vision_codex NOAEL =500 mg/kg bw/day rat - 6 months NOAEL study {"citation":"Ref.: 37 Comment Based on the accumulation of fat and inflammatory changes in the liver of the male rats receiving 500 mg/kg bw/day, a NOAEL of 120 mg/kg bw/day for acetaldehyde can be d","dose":"both in the periportal and in the pericentral areas of the hepatic acinus in the livers of rats receiving the high dose acetaldehyde.","effect":"both in the periportal and in the pericentral areas of the hepatic acinus in the livers of rats receiving the high dose acetaldehyde. In rats receiving a high dose of acetaldehyde, some foci of inflammatory cells were found in the liver specimens of seven out of ten rats. No inflammatory changes were found either in the rats receiving a low dose of acetaldehyde or in the controls. Ref.: 37 Comment Based on the accumulation of fat and inflammatory changes in the liver of the male rats receiving 500 mg/kg bw/day, a NOAEL of 120 mg/kg bw/day for acetaldehyde can be derived. The potential toxicity of acetaldehyde administered perorally in aqueous solution to white rats and guinea pigs at dose levels of 0.5, 10, or 100 mg/kg bw/d for periods of 5-6 months was studied. In guinea pigs, indices monitored at every dose level, with the exception of the high-dose level, included peripheral blood cholinesterase and leukocyte phagocytic activity, as well as the ratio of protein fractions in blood serum. In rats, conditional reflex activity","page":13,"pdf":"sccs_o_104.pdf","row_type":"noael_study","study_id":"sccs_o_104_noael_005"}
SCCS_vision_codex NOAEL =0.5 mg/kg bw/d rat dermal 3 month carcinogenicity {"citation":"Ref.: 12 Comment No documentation for the above study was available to SCCS for evaluation","dose":"Compound-related effects reported in guinea pigs were limited to a statistically significant reduction in eosinophil count in groups treated at 10 mg/kg bw/d.","effect":"SCCS-rejected applicant NOAEL: nditioned reflex activity also was reported in rats receiving 10 mg acetaldehyde/kg bw/d at the 2 and 3 month of treatment. Compound-related effects reported in guinea pigs were limited to a statistically significant reduction in eosinophil count in groups treated at 10 mg/kg bw/d. No apparent adverse effects were reported in groups of animals administered 0.5 mg/kg bw/d. Ref.: 12 Comment No documentation for the above study was available to SCCS for evaluation. The study is not suitable for the estimation of the NOAEL/LOAEL. No dermal study with acetaldehyde has been found. 3.3.5.4 Chronic (> 12 months) toxicity See Section 3.3.7 Carcinogenicity 3.3.6 Mutagenicity / Genotoxicity This section is based on IARC, 1999, 2011, 2012 (Ref.: 13, 14, and 15)","page":13,"pdf":"sccs_o_104.pdf","row_type":"noael_study","study_id":"sccs_o_104_noael_006"}
SCCS_vision_codex NOAEL =5 ppm rat inhalation 28 day NOAEL study {"dose":"n cosmetics is up to 25 ppm acetaldehyde in fragrance compounds.","effect":"n cosmetics is up to 25 ppm acetaldehyde in fragrance compounds. Acetaldehyde should otherwise only be found in cosmetic products in the form of unavoidable traces originating mainly through plant extracts and botanical ingredients and ethanol. The probability of cancer risk for a lifetime exposure to 100 ppm from all cosmetic products is 2 x 10-4. It can be derived from the above calculation that a safe concentration with a LCR of 10-5 would be 5 ppm in all cosmetic products. In the case of non-cancer effects, a NOAEL of 49 mg/m³ has been derived from a 28 day inhalation study in rats. As a worse case approach, complete evaporation of acetaldehyde present in all cosmetic products (total exposure of 1.74 mg/d) in a small room (10 m³) without ventilation would result in a concentration of 0.174 mg/m³. In this worst case scenario, the Margin of Exposure would be much higher than 100.","page":27,"pdf":"sccs_o_104.pdf","row_type":"noael_study","study_id":"sccs_o_104_noael_007"}
ToxValDB_Cal_OEHHA_REL_derivations 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_Cal_OEHHA_REL_derivations BMC (05) =178 mg/m3 Rat inhalation short-term; 4 weeks short-term LONG_REF=Appelman LM, Woutersen RA and Feron VJ (1982). Inhalation toxicity of acetaldehyde in rats. I. Acute and subacute studies. Toxicology 23(4): 293-307. Appelman LM, Woutersen RA, Feron VJ, Hooftman RN and Notten WR (1986). Effect of variable versus fixed exposure levels on the toxicity of acetaldehyde in rats. J Appl Toxicol 6(5): 331-336.; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/68c97043e4b02565fc7d32df; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://oehha.ca.gov/; SUBSOURCE_URL=https://oehha.ca.gov/sites/default/files/media/downloads/crnr/appendixd1final.pdf; YEAR=2008; ORIGINAL_YEAR=2008; TOXICOLOGICAL_EFFECT=degeneration of olfactory epithelium; STUDY_GROUP=Cal OEHHA REL derivations:15951852:-:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_c2a50eb65f47256cc07d371e42cc2ed0
ToxValDB_Cal_OEHHA_REL_derivations LOAEL =142 mg/m3 Human inhalation acute; 6 minutes clinical LONG_REF=Prieto L, Sanchez-Toril F, Brotons B, Soriano S, Casan R and Belenguer JL (2000). Airway responsiveness to acetaldehyde in patients with asthma: Relationship to methacholine responsiveness and peak expiratory flow variation. Clin Exp Allergy 30(1): 71-78; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/68c97043e4b02565fc7d32df; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://oehha.ca.gov/; SUBSOURCE_URL=https://oehha.ca.gov/sites/default/files/media/downloads/crnr/appendixd1final.pdf; YEAR=2008; ORIGINAL_YEAR=2008; TOXICOLOGICAL_EFFECT=Bronchoconstriction, PC20 >20% drop in FEV1; STUDY_GROUP=Cal OEHHA REL derivations:15951850:-:-asthmatic volunteers; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_a52a5decc6a28f51fa371db8f3310849
ToxValDB_DOE_Protective_Action_Criteria 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_DOE_Protective_Action_Criteria LEL =72070.7 mg/m3 Human inhalation - acute LONG_REF=U.S. Department of Energy (DOE) Protective Action Criteria (PAC). 2023. PAC Chemical Database. Updated 11 October 2023. Available: https://edms3.energy.gov/pac/ (Accessed November 16, 2023); TITLE=U.S. Department of Energy (DOE) Protective Action Criteria (PAC) Chemical Database; AUTHOR=U.S. Department of Energy; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65428efee4b045b9ff7cc432; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://edms3.energy.gov/pac/TeelDocs; YEAR=2006; ORIGINAL_YEAR=2006; STUDY_GROUP=DOE Protective Action Criteria:15511749:-:--; 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_4fbdec93ab8ab61aeb4f1b70302332e2
ToxValDB_ECHA_IUCLID 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_ECHA_IUCLID LEL =125 mg/kg bw/day Rat oral - acute QUALITY=2 (reliable with restrictions); 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/33836/7/3/2?documentUUID=886c3edc-944b-48cd-a56c-965049ac8387; YEAR=1981; ORIGINAL_YEAR=1981; STUDY_GROUP=ECHA IUCLID_dup_Acute Toxicity Oral_15807032_15807033: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_21f80b308fcb7ca5846996ca6e347e1a
ToxValDB_ECHA_IUCLID LEL =675 mg/kg bw/day Rat oral - acute QUALITY=2 (reliable with restrictions); 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/33836/7/3/2?documentUUID=886c3edc-944b-48cd-a56c-965049ac8387; YEAR=1981; ORIGINAL_YEAR=1981; STUDY_GROUP=ECHA IUCLID_dup_Acute Toxicity Oral_15807032_15807033: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_56e7042f3d916007966c15507d5e3c1e
ToxValDB_ECHA_IUCLID NOAEL =12000 ppm Rat oral short-term; 3 weeks short-term QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7cbc8e4b0a7c65d227874; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/33836?documentUUID=5e85f61d-206b-406e-978b-494f531da7ba; YEAR=2013; ORIGINAL_YEAR=2013; TOXICOLOGICAL_EFFECT=histopathology: nonneoplastic; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=ECHA IUCLID:15829739: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_8796f2fb0827305c6af91c5f83364f45
ToxValDB_ECHA_IUCLID NOAEL =6000 ppm Rat oral - reproduction developmental QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7c93ee4b0a7c65d21c2bc; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/33836?documentUUID=5e85f61d-206b-406e-978b-494f531da7ba; YEAR=2013; ORIGINAL_YEAR=2013; TOXICOLOGICAL_EFFECT=P0: reproductive performance; TOXICOLOGICAL_EFFECT_CATEGORY=reproduction; STUDY_GROUP=ECHA IUCLID:15857717:M/F:P0-; 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_ee2769907b3cb71f1949e8de475f25a8
ToxValDB_ECOTOX 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_ECOTOX LOEL =50 mg/100 mL Mouse environmental short-term; 3 days developmental LONG_REF=Experientia45(5): 484-487 Kalmus,G.W., and C.C. Buckenmaier III Effects of Ethanol and Acetaldehyde on Cultured Pre-Implantation Mouse Embryos 1989; TITLE=Effects of Ethanol and Acetaldehyde on Cultured Pre-Implantation Mouse Embryos; AUTHOR=Kalmus,G.W., and C.C. Buckenmaier III; DOI=10.1007/BF01952040; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=112963; 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=Development: Stage; TOXICOLOGICAL_EFFECT_CATEGORY=development; STUDY_GROUP=ECOTOX_dup_EPA ORD_15604985_15604986:unknown:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=9941f142c819b70ea026f332cb639b16
ToxValDB_ECOTOX NOEL =10 mg/100 mL Mouse environmental short-term; 3 days developmental LONG_REF=Experientia45(5): 484-487 Kalmus,G.W., and C.C. Buckenmaier III Effects of Ethanol and Acetaldehyde on Cultured Pre-Implantation Mouse Embryos 1989; TITLE=Effects of Ethanol and Acetaldehyde on Cultured Pre-Implantation Mouse Embryos; AUTHOR=Kalmus,G.W., and C.C. Buckenmaier III; DOI=10.1007/BF01952040; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=112963; 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=Development: Stage; TOXICOLOGICAL_EFFECT_CATEGORY=development; STUDY_GROUP=ECOTOX_dup_EPA ORD_15604985_15604986:unknown:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=947ebb690875bbe57079bbbc123f92d5
ToxValDB_EFSA 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_EFSA NOAEL =120 mg/kg bw/day Rat oral subchronic; 11 weeks subchronic LONG_REF=EFSA FEEDAP (2013). Scientific Opinion on the safety and efficacy of straight-chain primary aliphatic alcohols/aldehydes/acids, acetals and esters with esters containing saturated alcohols and acetals containing saturated aldehydes (chemical group 1) when used as flavourings for all animal species. doi:10.2903/j.efsa.2013.3169.; TITLE=Scientific Opinion on the safety and efficacy of straight-chain primary aliphatic alcohols/aldehydes/acids, acetals and esters with esters containing saturated alcohols and acetals containing saturated aldehydes (chemical group 1) when used as flavourings for all animal species; AUTHOR=EFSA FEEDAP; DOI=doi:10.2903/j.efsa.2013.3169; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2013; ORIGINAL_YEAR=2013; TOXICOLOGICAL_EFFECT=other; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=EFSA:15621824:-:--; 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_c90b4b76f2b0fcefcc90656c4b54782e
ToxValDB_EFSA NOEL =125 mg/kg bw/day Rat oral short-term; 28 days short-term LONG_REF=EFSA CEF (2010). Scientific Opinion on Flavouring Group Evaluation 91 (FGE.91): Consideration of simple aliphatic and aromatic sulphides and thiols evaluated by JECFA (53rd and 68th meetings) structurally related to aliphatic and alicyclic mono-, di-, tri-, and polysulphides with or without additional oxygenated functional groups evaluated by EFSA in FGE.08Rev1 (2009). EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF). doi:10.2903/j.efsa.2010.1337.; TITLE=Scientific Opinion on Flavouring Group Evaluation 91 (FGE.91): Consideration of simple aliphatic and aromatic sulphides and thiols evaluated by JECFA (53rd and 68th meetings) structurally related to aliphatic and alicyclic mono-, di-, tri-, and polysulphides with or without additional oxygenated functional groups evaluated by EFSA in FGE.08Rev1 (2009). EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF); AUTHOR=EFSA CEF; DOI=doi:10.2903/j.efsa.2010.1337; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2010; ORIGINAL_YEAR=2010; STUDY_GROUP=EFSA:15621823:-:--; 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_e73d9649700b4ad55e05a053a822a39e
ToxValDB_IRIS 7 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_IRIS LOAEL =728 mg/m3 Rat inhalation short-term; 4 weeks short-term LONG_REF=Appleman, L.M., R.A. Woutersen, V.J. Feron, R.N. Hooftman and W.R.F. Notten. 1986. Effect of variable versus fixed exposure levels on the toxicity of acetaldehyde in rats. J. Appl. Toxicol. 6(5): 331-336. ; Appleman, L.M., R.A. Woutersen, and V.J. Feron. 1982. Inhalation toxicity of acetaldehyde in rats. I. Acute and subacute studies. Toxicology. 23: 293-297.; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/652e8a35e4b045b9ff7a545f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.epa.gov/iris; SUBSOURCE_URL=https://iris.epa.gov/ChemicalLanding/&substance_nmbr=290; TOXICOLOGICAL_EFFECT=degeneration of olfactory epithelium; STUDY_GROUP=IRIS_dup_IRIS Summary_15644188_15644189_15644190_15644191_15644192_15644193:M/F:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_4f6c78dec2aae8e9a3e4d457f37ea4b2
ToxValDB_IRIS LOAEL (ADJ) =130 mg/m3 Rat inhalation short-term; 4 weeks short-term LONG_REF=Appleman, L.M., R.A. Woutersen, V.J. Feron, R.N. Hooftman and W.R.F. Notten. 1986. Effect of variable versus fixed exposure levels on the toxicity of acetaldehyde in rats. J. Appl. Toxicol. 6(5): 331-336. ; Appleman, L.M., R.A. Woutersen, and V.J. Feron. 1982. Inhalation toxicity of acetaldehyde in rats. I. Acute and subacute studies. Toxicology. 23: 293-297.; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/652e8a35e4b045b9ff7a545f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.epa.gov/iris; SUBSOURCE_URL=https://iris.epa.gov/ChemicalLanding/&substance_nmbr=290; TOXICOLOGICAL_EFFECT=degeneration of olfactory epithelium; STUDY_GROUP=IRIS_dup_IRIS Summary_15644188_15644189_15644190_15644191_15644192_15644193:M/F:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_11acbcc93ec1185b183bbca1adb6ea75
ToxValDB_IRIS LOAEL (HEC) =16.9 mg/m3 Rat inhalation short-term; 4 weeks short-term LONG_REF=Appleman, L.M., R.A. Woutersen, V.J. Feron, R.N. Hooftman and W.R.F. Notten. 1986. Effect of variable versus fixed exposure levels on the toxicity of acetaldehyde in rats. J. Appl. Toxicol. 6(5): 331-336. ; Appleman, L.M., R.A. Woutersen, and V.J. Feron. 1982. Inhalation toxicity of acetaldehyde in rats. I. Acute and subacute studies. Toxicology. 23: 293-297.; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/652e8a35e4b045b9ff7a545f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.epa.gov/iris; SUBSOURCE_URL=https://iris.epa.gov/ChemicalLanding/&substance_nmbr=290; TOXICOLOGICAL_EFFECT=degeneration of olfactory epithelium; STUDY_GROUP=IRIS_dup_IRIS Summary_15644188_15644189_15644190_15644191_15644192_15644193:M/F:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_29f6729b6bb791c35e9027092fdecfc1
ToxValDB_IRIS NOAEL =273 mg/m3 Rat inhalation short-term; 4 weeks short-term LONG_REF=Appleman, L.M., R.A. Woutersen, V.J. Feron, R.N. Hooftman and W.R.F. Notten. 1986. Effect of variable versus fixed exposure levels on the toxicity of acetaldehyde in rats. J. Appl. Toxicol. 6(5): 331-336. ; Appleman, L.M., R.A. Woutersen, and V.J. Feron. 1982. Inhalation toxicity of acetaldehyde in rats. I. Acute and subacute studies. Toxicology. 23: 293-297.; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/652e8a35e4b045b9ff7a545f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.epa.gov/iris; SUBSOURCE_URL=https://iris.epa.gov/ChemicalLanding/&substance_nmbr=290; TOXICOLOGICAL_EFFECT=degeneration of olfactory epithelium; STUDY_GROUP=IRIS_dup_IRIS Summary_15644188_15644189_15644190_15644191_15644192_15644193:M/F:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_05d40dd1d7f69633a6d072cef8676c32
ToxValDB_IRIS NOAEL (ADJ) =48.75 mg/m3 Rat inhalation short-term; 4 weeks short-term LONG_REF=Appleman, L.M., R.A. Woutersen, V.J. Feron, R.N. Hooftman and W.R.F. Notten. 1986. Effect of variable versus fixed exposure levels on the toxicity of acetaldehyde in rats. J. Appl. Toxicol. 6(5): 331-336. ; Appleman, L.M., R.A. Woutersen, and V.J. Feron. 1982. Inhalation toxicity of acetaldehyde in rats. I. Acute and subacute studies. Toxicology. 23: 293-297.; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/652e8a35e4b045b9ff7a545f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.epa.gov/iris; SUBSOURCE_URL=https://iris.epa.gov/ChemicalLanding/&substance_nmbr=290; TOXICOLOGICAL_EFFECT=degeneration of olfactory epithelium; STUDY_GROUP=IRIS_dup_IRIS Summary_15644188_15644189_15644190_15644191_15644192_15644193:M/F:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_6c2823bf6944db829ef400f27e6742c0
ToxValDB_IRIS NOAEL (HEC) =8.7 mg/m3 Rat inhalation short-term; 4 weeks short-term LONG_REF=Appleman, L.M., R.A. Woutersen, V.J. Feron, R.N. Hooftman and W.R.F. Notten. 1986. Effect of variable versus fixed exposure levels on the toxicity of acetaldehyde in rats. J. Appl. Toxicol. 6(5): 331-336. ; Appleman, L.M., R.A. Woutersen, and V.J. Feron. 1982. Inhalation toxicity of acetaldehyde in rats. I. Acute and subacute studies. Toxicology. 23: 293-297.; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/652e8a35e4b045b9ff7a545f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.epa.gov/iris; SUBSOURCE_URL=https://iris.epa.gov/ChemicalLanding/&substance_nmbr=290; TOXICOLOGICAL_EFFECT=degeneration of olfactory epithelium; STUDY_GROUP=IRIS_dup_IRIS Summary_15644188_15644189_15644190_15644191_15644192_15644193:M/F:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_a1b245daf7de39d5df16fb287db090b3
ToxValDB_IRIS RfC =0.009 mg/m3 Human inhalation - Toxicity Value LONG_REF=Appleman, L.M., R.A. Woutersen, V.J. Feron, R.N. Hooftman and W.R.F. Notten. 1986. Effect of variable versus fixed exposure levels on the toxicity of acetaldehyde in rats. J. Appl. Toxicol. 6(5): 331-336. ; Appleman, L.M., R.A. Woutersen, and V.J. Feron. 1982. Inhalation toxicity of acetaldehyde in rats. I. Acute and subacute studies. Toxicology. 23: 293-297.; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/652e8a35e4b045b9ff7a545f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.epa.gov/iris; SUBSOURCE_URL=https://iris.epa.gov/ChemicalLanding/&substance_nmbr=290; TOXICOLOGICAL_EFFECT=Degeneration of olfactory epithelium in male/female rats; STUDY_GROUP=IRIS:15644194:-:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_ffebe259d55b456ae7253fc0d1d13ca3
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 9 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 400 ppm rat inhalation 28 days - SOURCE_SUBDIR=sccs_o_104; REPORT_TITLE=OPINION ON Acetaldehyde; OPINION_NUMBER=SCCS/1468/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=400; DOSE=n acetaldehyde ___________________________________________________________________________________________ 12 epithelium, and only at 2200 ppm, minimal epithelial changes in the larynx and trachea.; EFFECT=n acetaldehyde ___________________________________________________________________________________________ 12 epithelium, and only at 2200 ppm, minimal epithelial changes in the larynx and trachea. The only change observed at the 400 ppm level that could be attributed to acetaldehyde was slight degeneration of the nasal olfactory epithelium seen as loss of microvilli and thinning and disarrangement of the layer of epithelial cells. Ref: 40 Comment This study does not follow OECD/GLP guidelines. No NOAEL can be derived from this study and, based on the slight degeneration of the nasal olfactory epithelium, 400 ppm could be considered as a LOAEL. In a second 28 days study, Appelman et al (1986) have studied the effect of short-term increases and interruption in exposure on the inhalation toxicity of acetaldehyde during 28 days in male Wistar rats. Male rats were exposed to 110, 150 and 500 ppm for 6 h per day/5 days per week. One group of animals was exposed without interruption, the exposure of a second group was; CITATION=Ref: 40 Comment This study does not follow OECD/GLP guidelines; CITATION_NUMBERS=[40]; REFERENCE=Ref: 40 Comment This study does not follow OECD/GLP guidelines; DETAILS_JSON={"cas_number":"75-07-0","citation":"Ref: 40 Comment This study does not follow OECD/GLP guidelines","dose":"n acetaldehyde ___________________________________________________________________________________________ 12 epithelium, and only at 2200 ppm, minimal epithelial changes in the larynx and trachea.","duration":"28 days","effect":"n acetaldehyde ___________________________________________________________________________________________ 12 epithelium, and only at 2200 ppm, minimal epithelial changes in the larynx and trachea. The only change observed at the 400 ppm level that could be attributed to acetaldehyde was slight degeneration of the nasal olfactory epithelium seen as loss of microvilli and thinning and disarrangement of the layer of epithelial cells. Ref: 40 Comment This study does not follow OECD/GLP guidelines. No NOAEL can be derived from this study and, based on the slight degeneration of the nasal olfactory epithelium, 400 ppm could be considered as a LOAEL. In a second 28 days study, Appelman et al (1986) have studied the effect of short-term increases and interruption in exposure on the inhalation toxicity of acetaldehyde during 28 days in male Wistar rats. Male rats were exposed to 110, 150 and 500 ppm for 6 h per day/5 days per week. One group of animals was exposed without interruption, the exposure of a second group was","endpoint":"","ingredient":"odes ..................................... 6","loael_value":"","noael_unit":"ppm","noael_value":"400","page":12,"route":"inhalation","species":"rat","study_id":"sccs_o_104_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 500 mg/kg bw/day rat - 6 months - SOURCE_SUBDIR=sccs_o_104; REPORT_TITLE=OPINION ON Acetaldehyde; OPINION_NUMBER=SCCS/1468/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=500; DOSE=both in the periportal and in the pericentral areas of the hepatic acinus in the livers of rats receiving the high dose acetaldehyde.; EFFECT=both in the periportal and in the pericentral areas of the hepatic acinus in the livers of rats receiving the high dose acetaldehyde. In rats receiving a high dose of acetaldehyde, some foci of inflammatory cells were found in the liver specimens of seven out of ten rats. No inflammatory changes were found either in the rats receiving a low dose of acetaldehyde or in the controls. Ref.: 37 Comment Based on the accumulation of fat and inflammatory changes in the liver of the male rats receiving 500 mg/kg bw/day, a NOAEL of 120 mg/kg bw/day for acetaldehyde can be derived. The potential toxicity of acetaldehyde administered perorally in aqueous solution to white rats and guinea pigs at dose levels of 0.5, 10, or 100 mg/kg bw/d for periods of 5-6 months was studied. In guinea pigs, indices monitored at every dose level, with the exception of the high-dose level, included peripheral blood cholinesterase and leukocyte phagocytic activity, as well as the ratio of protein fractions in blood serum. In rats, conditional reflex activity; CITATION=Ref.: 37 Comment Based on the accumulation of fat and inflammatory changes in the liver of the male rats receiving 500 mg/kg bw/day, a NOAEL of 120 mg/kg bw/day for acetaldehyde can be d; CITATION_NUMBERS=[37,500,120]; REFERENCE=Ref.: 37 Comment Based on the accumulation of fat and inflammatory changes in the liver of the male rats receiving 500 mg/kg bw/day, a NOAEL of 120 mg/kg bw/day for acetaldehyde can be d; DETAILS_JSON={"cas_number":"75-07-0","citation":"Ref.: 37 Comment Based on the accumulation of fat and inflammatory changes in the liver of the male rats receiving 500 mg/kg bw/day, a NOAEL of 120 mg/kg bw/day for acetaldehyde can be d","dose":"both in the periportal and in the pericentral areas of the hepatic acinus in the livers of rats receiving the high dose acetaldehyde.","duration":"6 months","effect":"both in the periportal and in the pericentral areas of the hepatic acinus in the livers of rats receiving the high dose acetaldehyde. In rats receiving a high dose of acetaldehyde, some foci of inflammatory cells were found in the liver specimens of seven out of ten rats. No inflammatory changes were found either in the rats receiving a low dose of acetaldehyde or in the controls. Ref.: 37 Comment Based on the accumulation of fat and inflammatory changes in the liver of the male rats receiving 500 mg/kg bw/day, a NOAEL of 120 mg/kg bw/day for acetaldehyde can be derived. The potential toxicity of acetaldehyde administered perorally in aqueous solution to white rats and guinea pigs at dose levels of 0.5, 10, or 100 mg/kg bw/d for periods of 5-6 months was studied. In guinea pigs, indices monitored at every dose level, with the exception of the high-dose level, included peripheral blood cholinesterase and leukocyte phagocytic activity, as well as the ratio of protein fractions in blood serum. In rats, conditional reflex activity","endpoint":"","ingredient":"odes ..................................... 6","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"500","page":13,"route":"","species":"rat","study_id":"sccs_o_104_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 5 ppm rat inhalation 28 day - SOURCE_SUBDIR=sccs_o_104; REPORT_TITLE=OPINION ON Acetaldehyde; OPINION_NUMBER=SCCS/1468/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=5; DOSE=n cosmetics is up to 25 ppm acetaldehyde in fragrance compounds.; EFFECT=n cosmetics is up to 25 ppm acetaldehyde in fragrance compounds. Acetaldehyde should otherwise only be found in cosmetic products in the form of unavoidable traces originating mainly through plant extracts and botanical ingredients and ethanol. The probability of cancer risk for a lifetime exposure to 100 ppm from all cosmetic products is 2 x 10-4. It can be derived from the above calculation that a safe concentration with a LCR of 10-5 would be 5 ppm in all cosmetic products. In the case of non-cancer effects, a NOAEL of 49 mg/m³ has been derived from a 28 day inhalation study in rats. As a worse case approach, complete evaporation of acetaldehyde present in all cosmetic products (total exposure of 1.74 mg/d) in a small room (10 m³) without ventilation would result in a concentration of 0.174 mg/m³. In this worst case scenario, the Margin of Exposure would be much higher than 100.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"75-07-0","citation":"","dose":"n cosmetics is up to 25 ppm acetaldehyde in fragrance compounds.","duration":"28 day","effect":"n cosmetics is up to 25 ppm acetaldehyde in fragrance compounds. Acetaldehyde should otherwise only be found in cosmetic products in the form of unavoidable traces originating mainly through plant extracts and botanical ingredients and ethanol. The probability of cancer risk for a lifetime exposure to 100 ppm from all cosmetic products is 2 x 10-4. It can be derived from the above calculation that a safe concentration with a LCR of 10-5 would be 5 ppm in all cosmetic products. In the case of non-cancer effects, a NOAEL of 49 mg/m³ has been derived from a 28 day inhalation study in rats. As a worse case approach, complete evaporation of acetaldehyde present in all cosmetic products (total exposure of 1.74 mg/d) in a small room (10 m³) without ventilation would result in a concentration of 0.174 mg/m³. In this worst case scenario, the Margin of Exposure would be much higher than 100.","endpoint":"","ingredient":"odes ..................................... 6","loael_value":"","noael_unit":"ppm","noael_value":"5","page":27,"route":"inhalation","species":"rat","study_id":"sccs_o_104_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies carcinogenicity 0.5 mg/kg bw/d rat dermal 3 month carcinogenicity SOURCE_SUBDIR=sccs_o_104; REPORT_TITLE=OPINION ON Acetaldehyde; OPINION_NUMBER=SCCS/1468/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=0.5; DOSE=Compound-related effects reported in guinea pigs were limited to a statistically significant reduction in eosinophil count in groups treated at 10 mg/kg bw/d.; EFFECT=SCCS-rejected applicant NOAEL: nditioned reflex activity also was reported in rats receiving 10 mg acetaldehyde/kg bw/d at the 2 and 3 month of treatment. Compound-related effects reported in guinea pigs were limited to a statistically significant reduction in eosinophil count in groups treated at 10 mg/kg bw/d. No apparent adverse effects were reported in groups of animals administered 0.5 mg/kg bw/d. Ref.: 12 Comment No documentation for the above study was available to SCCS for evaluation. The study is not suitable for the estimation of the NOAEL/LOAEL. No dermal study with acetaldehyde has been found. 3.3.5.4 Chronic (> 12 months) toxicity See Section 3.3.7 Carcinogenicity 3.3.6 Mutagenicity / Genotoxicity This section is based on IARC, 1999, 2011, 2012 (Ref.: 13, 14, and 15); CITATION=Ref.: 12 Comment No documentation for the above study was available to SCCS for evaluation; CITATION_NUMBERS=[12]; REFERENCE=Ref.: 12 Comment No documentation for the above study was available to SCCS for evaluation; DETAILS_JSON={"cas_number":"75-07-0","citation":"Ref.: 12 Comment No documentation for the above study was available to SCCS for evaluation","dose":"Compound-related effects reported in guinea pigs were limited to a statistically significant reduction in eosinophil count in groups treated at 10 mg/kg bw/d.","duration":"3 month","effect":"SCCS-rejected applicant NOAEL: nditioned reflex activity also was reported in rats receiving 10 mg acetaldehyde/kg bw/d at the 2 and 3 month of treatment. Compound-related effects reported in guinea pigs were limited to a statistically significant reduction in eosinophil count in groups treated at 10 mg/kg bw/d. No apparent adverse effects were reported in groups of animals administered 0.5 mg/kg bw/d. Ref.: 12 Comment No documentation for the above study was available to SCCS for evaluation. The study is not suitable for the estimation of the NOAEL/LOAEL. No dermal study with acetaldehyde has been found. 3.3.5.4 Chronic (> 12 months) toxicity See Section 3.3.7 Carcinogenicity 3.3.6 Mutagenicity / Genotoxicity This section is based on IARC, 1999, 2011, 2012 (Ref.: 13, 14, and 15)","endpoint":"carcinogenicity","ingredient":"odes ..................................... 6","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"0.5","page":13,"route":"dermal","species":"rat","study_id":"sccs_o_104_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 125 mg/kg bw/d rat dermal 4 week genotoxicity SOURCE_SUBDIR=sccs_o_104; REPORT_TITLE=OPINION ON Acetaldehyde; OPINION_NUMBER=SCCS/1468/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=125; DOSE=A NOAEL of 125 mg/kg bw/d was found in a 4 week study based on relative increase in kidney weight and focal hyperkeratosis of the forestomach.; EFFECT=rritant. There is limited evidence for skin sensitisation. Respiratory sensitisation has not been investigated to date. Dermal absorption Some studies are available concerning increase in blood acetaldehyde after dermal exposure to ethanol. However, no quantitative conclusions can be drawn from these studies regarding skin absorption of acetaldehyde. A dermal absorption of 100% is used in the risk characterization. General toxicity No toxicity studies have been performed according to present day requirements. A NOAEL of 125 mg/kg bw/d was found in a 4 week study based on relative increase in kidney weight and focal hyperkeratosis of the forestomach. In a 28-day inhalation study with rats, a NOAEL of 49 mg/m³ based on the degeneration of the nasal olfactory epithelium was established. Mutagenicity In vitro and without exogenous metabolic activation, acetaldehyde induced gene mutations in mouse lymphoma L5178T cells, sister chromatid exchanges in Chinese hamster ovary cells and aneuploidy in embryonic Chinese hamster diploid; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"75-07-0","citation":"","dose":"A NOAEL of 125 mg/kg bw/d was found in a 4 week study based on relative increase in kidney weight and focal hyperkeratosis of the forestomach.","duration":"4 week","effect":"rritant. There is limited evidence for skin sensitisation. Respiratory sensitisation has not been investigated to date. Dermal absorption Some studies are available concerning increase in blood acetaldehyde after dermal exposure to ethanol. However, no quantitative conclusions can be drawn from these studies regarding skin absorption of acetaldehyde. A dermal absorption of 100% is used in the risk characterization. General toxicity No toxicity studies have been performed according to present day requirements. A NOAEL of 125 mg/kg bw/d was found in a 4 week study based on relative increase in kidney weight and focal hyperkeratosis of the forestomach. In a 28-day inhalation study with rats, a NOAEL of 49 mg/m³ based on the degeneration of the nasal olfactory epithelium was established. Mutagenicity In vitro and without exogenous metabolic activation, acetaldehyde induced gene mutations in mouse lymphoma L5178T cells, sister chromatid exchanges in Chinese hamster ovary cells and aneuploidy in embryonic Chinese hamster diploid","endpoint":"genotoxicity","ingredient":"odes ..................................... 6","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"125","page":28,"route":"dermal","species":"rat","study_id":"sccs_o_104_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 125 mg/kg bw/d rat dermal 4 week genotoxicity SOURCE_SUBDIR=sccs_o_104; REPORT_TITLE=OPINION ON Acetaldehyde; OPINION_NUMBER=SCCS/1468/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=125; DOSE=A NOAEL of 125 mg/kg bw/d was found in a 4 week study based on relative increase in kidney weight and focal hyperkeratosis of the forestomach.; EFFECT=se in blood acetaldehyde after dermal exposure to ethanol. However, no quantitative conclusions can be drawn from these studies regarding skin absorption of acetaldehyde. A dermal absorption of 100% is used in the risk characterization. General toxicity No toxicity studies have been performed according to present day requirements. A NOAEL of 125 mg/kg bw/d was found in a 4 week study based on relative increase in kidney weight and focal hyperkeratosis of the forestomach. In a 28-day inhalation study with rats, a NOAEL of 49 mg/m³ based on the degeneration of the nasal olfactory epithelium was established. Mutagenicity In vitro and without exogenous metabolic activation, acetaldehyde induced gene mutations in mouse lymphoma L5178T cells, sister chromatid exchanges in Chinese hamster ovary cells and aneuploidy in embryonic Chinese hamster diploid fibroblasts. Increased frequency of acetaldehyde DNA adducts in humans has been found in relation to alcohol use.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"75-07-0","citation":"","dose":"A NOAEL of 125 mg/kg bw/d was found in a 4 week study based on relative increase in kidney weight and focal hyperkeratosis of the forestomach.","duration":"4 week","effect":"se in blood acetaldehyde after dermal exposure to ethanol. However, no quantitative conclusions can be drawn from these studies regarding skin absorption of acetaldehyde. A dermal absorption of 100% is used in the risk characterization. General toxicity No toxicity studies have been performed according to present day requirements. A NOAEL of 125 mg/kg bw/d was found in a 4 week study based on relative increase in kidney weight and focal hyperkeratosis of the forestomach. In a 28-day inhalation study with rats, a NOAEL of 49 mg/m³ based on the degeneration of the nasal olfactory epithelium was established. Mutagenicity In vitro and without exogenous metabolic activation, acetaldehyde induced gene mutations in mouse lymphoma L5178T cells, sister chromatid exchanges in Chinese hamster ovary cells and aneuploidy in embryonic Chinese hamster diploid fibroblasts. Increased frequency of acetaldehyde DNA adducts in humans has been found in relation to alcohol use.","endpoint":"genotoxicity","ingredient":"odes ..................................... 6","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"125","page":28,"route":"dermal","species":"rat","study_id":"sccs_o_104_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 125 mg/kg bw/d - inhalation 28 days repeated dose toxicity SOURCE_SUBDIR=sccs_o_104; REPORT_TITLE=OPINION ON Acetaldehyde; OPINION_NUMBER=SCCS/1468/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=125; DOSE=In the high-dose group, the relative kidney weights were slightly increased in males, and urinary production was decreased.; EFFECT=/10 females). In the control group, very slight or slight focal hyperkeratosis of the forestomach was noted in 6/20 females and 4/20 males. In the high-dose group, the relative kidney weights were slightly increased in males, and urinary production was decreased. The effects and reported variations in serum biochemistry, were generally attributed to reduced water intake. Acetaldehyde exposure did not affect indices of liver function and produced no evidence of histological change in this organ. Ref.: 10 Comment A NOAEL of 125 mg/kg bw/d can be derived from the study. 3.3.5.2 Repeated Dose (28 days) inhalation toxicity Several studies investigating toxicity of acetaldehyde by inhalation have been published but most of them are not recent ones and did not followed standardized procedures. Two short- term studies conducted by the same research group are considered as the most reliable and informative and then are the principal studies used for risk assessment of acetaldehyde by inhalation. In a first 28 days study, Appelman et a; CITATION=Ref.: 10 Comment A NOAEL of 125 mg/kg bw/d can be derived from the study; CITATION_NUMBERS=[10,125]; REFERENCE=Ref.: 10 Comment A NOAEL of 125 mg/kg bw/d can be derived from the study; DETAILS_JSON={"cas_number":"75-07-0","citation":"Ref.: 10 Comment A NOAEL of 125 mg/kg bw/d can be derived from the study","dose":"In the high-dose group, the relative kidney weights were slightly increased in males, and urinary production was decreased.","duration":"28 days","effect":"/10 females). In the control group, very slight or slight focal hyperkeratosis of the forestomach was noted in 6/20 females and 4/20 males. In the high-dose group, the relative kidney weights were slightly increased in males, and urinary production was decreased. The effects and reported variations in serum biochemistry, were generally attributed to reduced water intake. Acetaldehyde exposure did not affect indices of liver function and produced no evidence of histological change in this organ. Ref.: 10 Comment A NOAEL of 125 mg/kg bw/d can be derived from the study. 3.3.5.2 Repeated Dose (28 days) inhalation toxicity Several studies investigating toxicity of acetaldehyde by inhalation have been published but most of them are not recent ones and did not followed standardized procedures. Two short- term studies conducted by the same research group are considered as the most reliable and informative and then are the principal studies used for risk assessment of acetaldehyde by inhalation. In a first 28 days study, Appelman et a","endpoint":"repeated dose toxicity","ingredient":"odes ..................................... 6","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"125","page":11,"route":"inhalation","species":"","study_id":"sccs_o_104_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 150 ppm rat oral 5 days repeated dose toxicity SOURCE_SUBDIR=sccs_o_104; REPORT_TITLE=OPINION ON Acetaldehyde; OPINION_NUMBER=SCCS/1468/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=150; DOSE=effects were seen in rats interruptedly or uninterruptedly exposed to 150 ppm acetaldehyde or interruptedly exposed to 110 ppm with peak loads of 660 ppm.; EFFECT=effects were seen in rats interruptedly or uninterruptedly exposed to 150 ppm acetaldehyde or interruptedly exposed to 110 ppm with peak loads of 660 ppm. As a consequence 150 ppm acetaldehyde can be considered a 'no-toxic-effect level' in male rats exposed for 6 h/day, 5 days/week, during a 4-week period. Ref: 41 Comment This study does not follow OECD/GLP guidelines. Based on the degeneration of the nasal olfactory epithelium observed at 500 ppm, which could be considered as a LOAEL and 150 ppm (273 mg/m³) as a NOAEL. The NOAEL, based on continuous exposure, would then be (273 x 5/7 x 6/24) 49 mg/m³. This value will be used in the safety assessment for non-cancer effects by inhalation. 3.3.5.3 Sub-chronic (90 days) oral toxicity In a group of rats exposed to 0.05% acetaldehyde in the drinking water (estimated to be about 40 mg/kg bw for 6 months, an increase in collagen synthesis in the liver was reported. Since no other indices of toxicity were reported, the significance of this finding is unknown. Ref.: 11 Guideline: / Sp; CITATION=Ref: 41 Comment This study does not follow OECD/GLP guidelines; CITATION_NUMBERS=[41]; REFERENCE=Ref: 41 Comment This study does not follow OECD/GLP guidelines; DETAILS_JSON={"cas_number":"75-07-0","citation":"Ref: 41 Comment This study does not follow OECD/GLP guidelines","dose":"effects were seen in rats interruptedly or uninterruptedly exposed to 150 ppm acetaldehyde or interruptedly exposed to 110 ppm with peak loads of 660 ppm.","duration":"5 days","effect":"effects were seen in rats interruptedly or uninterruptedly exposed to 150 ppm acetaldehyde or interruptedly exposed to 110 ppm with peak loads of 660 ppm. As a consequence 150 ppm acetaldehyde can be considered a 'no-toxic-effect level' in male rats exposed for 6 h/day, 5 days/week, during a 4-week period. Ref: 41 Comment This study does not follow OECD/GLP guidelines. Based on the degeneration of the nasal olfactory epithelium observed at 500 ppm, which could be considered as a LOAEL and 150 ppm (273 mg/m³) as a NOAEL. The NOAEL, based on continuous exposure, would then be (273 x 5/7 x 6/24) 49 mg/m³. This value will be used in the safety assessment for non-cancer effects by inhalation. 3.3.5.3 Sub-chronic (90 days) oral toxicity In a group of rats exposed to 0.05% acetaldehyde in the drinking water (estimated to be about 40 mg/kg bw for 6 months, an increase in collagen synthesis in the liver was reported. Since no other indices of toxicity were reported, the significance of this finding is unknown. Ref.: 11 Guideline: / Sp","endpoint":"repeated dose toxicity","ingredient":"odes ..................................... 6","loael_value":"","noael_unit":"ppm","noael_value":"150","page":12,"route":"oral","species":"rat","study_id":"sccs_o_104_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 150 ppm rat oral 5 days repeated dose toxicity SOURCE_SUBDIR=sccs_o_104; REPORT_TITLE=OPINION ON Acetaldehyde; OPINION_NUMBER=SCCS/1468/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=150; DOSE=e seen in rats interruptedly or uninterruptedly exposed to 150 ppm acetaldehyde or interruptedly exposed to 110 ppm with peak loads of 660 ppm.; EFFECT=e seen in rats interruptedly or uninterruptedly exposed to 150 ppm acetaldehyde or interruptedly exposed to 110 ppm with peak loads of 660 ppm. As a consequence 150 ppm acetaldehyde can be considered a 'no-toxic-effect level' in male rats exposed for 6 h/day, 5 days/week, during a 4-week period. Ref: 41 Comment This study does not follow OECD/GLP guidelines. Based on the degeneration of the nasal olfactory epithelium observed at 500 ppm, which could be considered as a LOAEL and 150 ppm (273 mg/m³) as a NOAEL. The NOAEL, based on continuous exposure, would then be (273 x 5/7 x 6/24) 49 mg/m³. This value will be used in the safety assessment for non-cancer effects by inhalation. 3.3.5.3 Sub-chronic (90 days) oral toxicity In a group of rats exposed to 0.05% acetaldehyde in the drinking water (estimated to be about 40 mg/kg bw for 6 months, an increase in collagen synthesis in the liver was reported. Since no other indices of toxicity were reported, the significance of this finding is unknown. Ref.: 11 Guideline: / Species/strai; CITATION=Ref: 41 Comment This study does not follow OECD/GLP guidelines; CITATION_NUMBERS=[41]; REFERENCE=Ref: 41 Comment This study does not follow OECD/GLP guidelines; DETAILS_JSON={"cas_number":"75-07-0","citation":"Ref: 41 Comment This study does not follow OECD/GLP guidelines","dose":"e seen in rats interruptedly or uninterruptedly exposed to 150 ppm acetaldehyde or interruptedly exposed to 110 ppm with peak loads of 660 ppm.","duration":"5 days","effect":"e seen in rats interruptedly or uninterruptedly exposed to 150 ppm acetaldehyde or interruptedly exposed to 110 ppm with peak loads of 660 ppm. As a consequence 150 ppm acetaldehyde can be considered a 'no-toxic-effect level' in male rats exposed for 6 h/day, 5 days/week, during a 4-week period. Ref: 41 Comment This study does not follow OECD/GLP guidelines. Based on the degeneration of the nasal olfactory epithelium observed at 500 ppm, which could be considered as a LOAEL and 150 ppm (273 mg/m³) as a NOAEL. The NOAEL, based on continuous exposure, would then be (273 x 5/7 x 6/24) 49 mg/m³. This value will be used in the safety assessment for non-cancer effects by inhalation. 3.3.5.3 Sub-chronic (90 days) oral toxicity In a group of rats exposed to 0.05% acetaldehyde in the drinking water (estimated to be about 40 mg/kg bw for 6 months, an increase in collagen synthesis in the liver was reported. Since no other indices of toxicity were reported, the significance of this finding is unknown. Ref.: 11 Guideline: / Species/strai","endpoint":"repeated dose toxicity","ingredient":"odes ..................................... 6","loael_value":"","noael_unit":"ppm","noael_value":"150","page":12,"route":"oral","species":"rat","study_id":"sccs_o_104_noael_004"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier GO1N1ZPR3B UNII - - - chemical {"approval_status":null,"molecular_formula":"C2H4O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"GO1N1ZPR3B"}
openFDA substances FDA UNII substance identifier GO1N1ZPR3B UNII - - - chemical {"approval_status":null,"molecular_formula":"C2H4O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"GO1N1ZPR3B"}
openFDA substances FDA UNII substance identifier GO1N1ZPR3B UNII - - - chemical {"approval_status":null,"molecular_formula":"C2H4O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"GO1N1ZPR3B"}
openFDA substances FDA UNII substance identifier GO1N1ZPR3B UNII - - - chemical {"approval_status":null,"molecular_formula":"C2H4O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"GO1N1ZPR3B"}