NOAEL Studies
Emollient
Eucalyptus Oil (Eucalyptus Globulus Leaf Oil) Return st NOAEL Studies
INCI: EUCALYPTUS GLOBULUS LEAF OIL
CAS: 8000-48-4
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
CIR_vision_codex 12 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| CIR_vision_codex | NOAEL | =1000 | mg/kg | rat | oral | 2 weeks | oral toxicity | {"citation":"300; 10; (100, 300","dose":"There were no microscopic correlates for decrease in spleen weight and increase in adrenal weight of high-dose females.","effect":"n livers of males and an increase in glycogenic vacuolation in livers of females, which was considered an adaptive change likely associated with microsomal enzyme induction. A slight increase in incidence and severity of glycogenic vacuolation in livers of treated female compared with controls may be partially responsible for liver weight increase. Liver changes were not considered to be adverse. There were no microscopic correlates for decrease in spleen weight and increase in adrenal weight of high-dose females. NOAEL for males was 1000 mg/kg based on hyaline droplet nephropathy at all dose levels; however this response is considered to be rat specific and to have no counterpart in humans. NOAEL for females was 300 mg/kg based on effects on body weight and feed consumption 10 Eucalyptus globulus leaf oil (100, 300, or 1000 mg/ kg/day in corn oil) Crl:CD (SD) rats (3/sex) Administered for 2 weeks There were no mortalities. Clinical signs were salivation in isolated females in 300 and 1000 mg/kg/day groups, which authors considered minor and did not indicate an association with te...","page":18,"pdf":"PRS754.pdf","row_type":"noael_study","study_id":"PRS754_noael_001"} |
| CIR_vision_codex | NOAEL | =300 | mg/kg | rat | oral | 2 weeks | oral toxicity | {"citation":"300; 10; (100, 300","dose":"There were no microscopic correlates for decrease in spleen weight and increase in adrenal weight of high-dose females.","effect":"t increase in incidence and severity of glycogenic vacuolation in livers of treated female compared with controls may be partially responsible for liver weight increase. Liver changes were not considered to be adverse. There were no microscopic correlates for decrease in spleen weight and increase in adrenal weight of high-dose females. NOAEL for males was 1000 mg/kg based on hyaline droplet nephropathy at all dose levels; however this response is considered to be rat specific and to have no counterpart in humans. NOAEL for females was 300 mg/kg based on effects on body weight and feed consumption 10 Eucalyptus globulus leaf oil (100, 300, or 1000 mg/ kg/day in corn oil) Crl:CD (SD) rats (3/sex) Administered for 2 weeks There were no mortalities. Clinical signs were salivation in isolated females in 300 and 1000 mg/kg/day groups, which authors considered minor and did not indicate an association with test material. Other signs were transient body weight loss and low feed consumption in males in 1000 mg/kg/day group during days 1 to 5. Necropsy showed that liver and kidney weights...","page":18,"pdf":"PRS754.pdf","row_type":"noael_study","study_id":"PRS754_noael_002"} |
| CIR_vision_codex | NOAEL | =100 | mg/kg bw/day | rat | - | - | NOAEL study | {"citation":"2; 1; 300","dose":"weights were only observed in females in 1000 mg/kg/day group.","effect":"weights were only observed in females in 1000 mg/kg/day group. Thickening of mammary tissue was observed in 2 and 1 males in 300 and 1000 mg/kg/day groups, respectively, and 1 female in the 1000 mg/kg/day group. Under test conditions, LOAEL and NOAEL in female rats could be considered as 300 and 100 mg/kg/day, respectively, based on clinical signs at 300 and 1000 mg/kg/day and increased liver weight at 1000 mg/kg/day. Since dose-related increases in liver and kidney weights were observed in males at all doses, no NOAEL could be identified for male rats in this study. The LOAEL in male rats could be considered as 100 mg/kg bw/day 10 (continued) 74S International Journal of Toxicology 42(Supplement 1)","page":18,"pdf":"PRS754.pdf","row_type":"noael_study","study_id":"PRS754_noael_004"} |
| CIR_vision_codex | NOAEL | =1000 | mg/kg | rat | oral | 2 weeks | oral toxicity | {"citation":"300; 10; (100, 300","dose":"There were no microscopic correlates for decrease in spleen weight and increase in adrenal weight of high-dose females.","effect":"n livers of males and an increase in glycogenic vacuolation in livers of females, which was considered an adaptive change likely associated with microsomal enzyme induction. A slight increase in incidence and severity of glycogenic vacuolation in livers of treated female compared with controls may be partially responsible for liver weight increase. Liver changes were not considered to be adverse. There were no microscopic correlates for decrease in spleen weight and increase in adrenal weight of high-dose females. NOAEL for males was 1000 mg/kg based on hyaline droplet nephropathy at all dose levels; however this response is considered to be rat specific and to have no counterpart in humans. NOAEL for females was 300 mg/kg based on effects on body weight and feed consumption 10 Eucalyptus globulus leaf oil (100, 300, or 1000 mg/ kg/day in corn oil) Crl:CD (SD) rats (3/sex) Administered for 2 weeks There were no mortalities. Clinical signs were salivation in isolated females in 300 and 1000 mg/kg/day groups, which authors considered minor and did not indicate an association with te...","page":18,"pdf":"PRS754.pdf","row_type":"noael_study","study_id":"PRS754_noael_001"} |
| CIR_vision_codex | NOAEL | =300 | mg/kg | rat | oral | 2 weeks | oral toxicity | {"citation":"300; 10; (100, 300","dose":"There were no microscopic correlates for decrease in spleen weight and increase in adrenal weight of high-dose females.","effect":"t increase in incidence and severity of glycogenic vacuolation in livers of treated female compared with controls may be partially responsible for liver weight increase. Liver changes were not considered to be adverse. There were no microscopic correlates for decrease in spleen weight and increase in adrenal weight of high-dose females. NOAEL for males was 1000 mg/kg based on hyaline droplet nephropathy at all dose levels; however this response is considered to be rat specific and to have no counterpart in humans. NOAEL for females was 300 mg/kg based on effects on body weight and feed consumption 10 Eucalyptus globulus leaf oil (100, 300, or 1000 mg/ kg/day in corn oil) Crl:CD (SD) rats (3/sex) Administered for 2 weeks There were no mortalities. Clinical signs were salivation in isolated females in 300 and 1000 mg/kg/day groups, which authors considered minor and did not indicate an association with test material. Other signs were transient body weight loss and low feed consumption in males in 1000 mg/kg/day group during days 1 to 5. Necropsy showed that liver and kidney weights...","page":18,"pdf":"PRS754.pdf","row_type":"noael_study","study_id":"PRS754_noael_002"} |
| CIR_vision_codex | NOAEL | =100 | mg/kg bw/day | rat | - | - | NOAEL study | {"citation":"2; 1; 300","dose":"weights were only observed in females in 1000 mg/kg/day group.","effect":"weights were only observed in females in 1000 mg/kg/day group. Thickening of mammary tissue was observed in 2 and 1 males in 300 and 1000 mg/kg/day groups, respectively, and 1 female in the 1000 mg/kg/day group. Under test conditions, LOAEL and NOAEL in female rats could be considered as 300 and 100 mg/kg/day, respectively, based on clinical signs at 300 and 1000 mg/kg/day and increased liver weight at 1000 mg/kg/day. Since dose-related increases in liver and kidney weights were observed in males at all doses, no NOAEL could be identified for male rats in this study. The LOAEL in male rats could be considered as 100 mg/kg bw/day 10 (continued) 74S International Journal of Toxicology 42(Supplement 1)","page":18,"pdf":"PRS754.pdf","row_type":"noael_study","study_id":"PRS754_noael_004"} |
| CIR_vision_codex | NOAEL | =1000 | mg/kg | rat | oral | 2 weeks | oral toxicity | {"citation":"300; 10; (100, 300","dose":"There were no microscopic correlates for decrease in spleen weight and increase in adrenal weight of high-dose females.","effect":"n livers of males and an increase in glycogenic vacuolation in livers of females, which was considered an adaptive change likely associated with microsomal enzyme induction. A slight increase in incidence and severity of glycogenic vacuolation in livers of treated female compared with controls may be partially responsible for liver weight increase. Liver changes were not considered to be adverse. There were no microscopic correlates for decrease in spleen weight and increase in adrenal weight of high-dose females. NOAEL for males was 1000 mg/kg based on hyaline droplet nephropathy at all dose levels; however this response is considered to be rat specific and to have no counterpart in humans. NOAEL for females was 300 mg/kg based on effects on body weight and feed consumption 10 Eucalyptus globulus leaf oil (100, 300, or 1000 mg/ kg/day in corn oil) Crl:CD (SD) rats (3/sex) Administered for 2 weeks There were no mortalities. Clinical signs were salivation in isolated females in 300 and 1000 mg/kg/day groups, which authors considered minor and did not indicate an association with te...","page":18,"pdf":"PRS754.pdf","row_type":"noael_study","study_id":"PRS754_noael_001"} |
| CIR_vision_codex | NOAEL | =300 | mg/kg | rat | oral | 2 weeks | oral toxicity | {"citation":"300; 10; (100, 300","dose":"There were no microscopic correlates for decrease in spleen weight and increase in adrenal weight of high-dose females.","effect":"t increase in incidence and severity of glycogenic vacuolation in livers of treated female compared with controls may be partially responsible for liver weight increase. Liver changes were not considered to be adverse. There were no microscopic correlates for decrease in spleen weight and increase in adrenal weight of high-dose females. NOAEL for males was 1000 mg/kg based on hyaline droplet nephropathy at all dose levels; however this response is considered to be rat specific and to have no counterpart in humans. NOAEL for females was 300 mg/kg based on effects on body weight and feed consumption 10 Eucalyptus globulus leaf oil (100, 300, or 1000 mg/ kg/day in corn oil) Crl:CD (SD) rats (3/sex) Administered for 2 weeks There were no mortalities. Clinical signs were salivation in isolated females in 300 and 1000 mg/kg/day groups, which authors considered minor and did not indicate an association with test material. Other signs were transient body weight loss and low feed consumption in males in 1000 mg/kg/day group during days 1 to 5. Necropsy showed that liver and kidney weights...","page":18,"pdf":"PRS754.pdf","row_type":"noael_study","study_id":"PRS754_noael_002"} |
| CIR_vision_codex | NOAEL | =100 | mg/kg bw/day | rat | - | - | NOAEL study | {"citation":"2; 1; 300","dose":"weights were only observed in females in 1000 mg/kg/day group.","effect":"weights were only observed in females in 1000 mg/kg/day group. Thickening of mammary tissue was observed in 2 and 1 males in 300 and 1000 mg/kg/day groups, respectively, and 1 female in the 1000 mg/kg/day group. Under test conditions, LOAEL and NOAEL in female rats could be considered as 300 and 100 mg/kg/day, respectively, based on clinical signs at 300 and 1000 mg/kg/day and increased liver weight at 1000 mg/kg/day. Since dose-related increases in liver and kidney weights were observed in males at all doses, no NOAEL could be identified for male rats in this study. The LOAEL in male rats could be considered as 100 mg/kg bw/day 10 (continued) 74S International Journal of Toxicology 42(Supplement 1)","page":18,"pdf":"PRS754.pdf","row_type":"noael_study","study_id":"PRS754_noael_004"} |
| CIR_vision_codex | NOAEL | =1000 | mg/kg | rat | oral | 2 weeks | oral toxicity | {"citation":"300; 10; (100, 300","dose":"There were no microscopic correlates for decrease in spleen weight and increase in adrenal weight of high-dose females.","effect":"n livers of males and an increase in glycogenic vacuolation in livers of females, which was considered an adaptive change likely associated with microsomal enzyme induction. A slight increase in incidence and severity of glycogenic vacuolation in livers of treated female compared with controls may be partially responsible for liver weight increase. Liver changes were not considered to be adverse. There were no microscopic correlates for decrease in spleen weight and increase in adrenal weight of high-dose females. NOAEL for males was 1000 mg/kg based on hyaline droplet nephropathy at all dose levels; however this response is considered to be rat specific and to have no counterpart in humans. NOAEL for females was 300 mg/kg based on effects on body weight and feed consumption 10 Eucalyptus globulus leaf oil (100, 300, or 1000 mg/ kg/day in corn oil) Crl:CD (SD) rats (3/sex) Administered for 2 weeks There were no mortalities. Clinical signs were salivation in isolated females in 300 and 1000 mg/kg/day groups, which authors considered minor and did not indicate an association with te...","page":18,"pdf":"PRS754.pdf","row_type":"noael_study","study_id":"PRS754_noael_001"} |
| CIR_vision_codex | NOAEL | =300 | mg/kg | rat | oral | 2 weeks | oral toxicity | {"citation":"300; 10; (100, 300","dose":"There were no microscopic correlates for decrease in spleen weight and increase in adrenal weight of high-dose females.","effect":"t increase in incidence and severity of glycogenic vacuolation in livers of treated female compared with controls may be partially responsible for liver weight increase. Liver changes were not considered to be adverse. There were no microscopic correlates for decrease in spleen weight and increase in adrenal weight of high-dose females. NOAEL for males was 1000 mg/kg based on hyaline droplet nephropathy at all dose levels; however this response is considered to be rat specific and to have no counterpart in humans. NOAEL for females was 300 mg/kg based on effects on body weight and feed consumption 10 Eucalyptus globulus leaf oil (100, 300, or 1000 mg/ kg/day in corn oil) Crl:CD (SD) rats (3/sex) Administered for 2 weeks There were no mortalities. Clinical signs were salivation in isolated females in 300 and 1000 mg/kg/day groups, which authors considered minor and did not indicate an association with test material. Other signs were transient body weight loss and low feed consumption in males in 1000 mg/kg/day group during days 1 to 5. Necropsy showed that liver and kidney weights...","page":18,"pdf":"PRS754.pdf","row_type":"noael_study","study_id":"PRS754_noael_002"} |
| CIR_vision_codex | NOAEL | =100 | mg/kg bw/day | rat | - | - | NOAEL study | {"citation":"2; 1; 300","dose":"weights were only observed in females in 1000 mg/kg/day group.","effect":"weights were only observed in females in 1000 mg/kg/day group. Thickening of mammary tissue was observed in 2 and 1 males in 300 and 1000 mg/kg/day groups, respectively, and 1 female in the 1000 mg/kg/day group. Under test conditions, LOAEL and NOAEL in female rats could be considered as 300 and 100 mg/kg/day, respectively, based on clinical signs at 300 and 1000 mg/kg/day and increased liver weight at 1000 mg/kg/day. Since dose-related increases in liver and kidney weights were observed in males at all doses, no NOAEL could be identified for male rats in this study. The LOAEL in male rats could be considered as 100 mg/kg bw/day 10 (continued) 74S International Journal of Toxicology 42(Supplement 1)","page":18,"pdf":"PRS754.pdf","row_type":"noael_study","study_id":"PRS754_noael_004"} |
NTP_ICE_skin_sensitization 3 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_skin_sensitization | Incidence of positive responses | 0 | % | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Maximization Test | sheet=Data_invivo; excel_row=12447; Record_ID=skin_sensitization_invivo_2713; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Formulation_ID=MIX1031; Formulation_Name=Eucalyptus oil; Concentration=10.0; Concentration_Units=%; Mixture=Mixture; DTXSID=DTXSID9034781; Assay=Human Maximization Test; Endpoint=Incidence of positive responses; Response=0; Response_Unit=%; Species=Human; Route=Dermal; Reference=Kligman 1973: report to RlFM|Opdyke 1975; Not available; 10.1016/S0015-6264(75)80165-9; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9034781 |
| NTP_ICE_skin_sensitization | Induction dose per skin area | 6480 | ug/cm2 | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Maximization Test | sheet=Data_invivo; excel_row=12445; Record_ID=skin_sensitization_invivo_2713; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Formulation_ID=MIX1031; Formulation_Name=Eucalyptus oil; Concentration=10.0; Concentration_Units=%; Mixture=Mixture; DTXSID=DTXSID9034781; Assay=Human Maximization Test; Endpoint=Induction dose per skin area; Response=6480; Response_Unit=ug/cm2; Species=Human; Route=Dermal; Reference=Kligman 1973: report to RlFM|Opdyke 1975; Not available; 10.1016/S0015-6264(75)80165-9; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9034781 |
| NTP_ICE_skin_sensitization | Relative reliability score | 3 | unitless | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Maximization Test | sheet=Data_invivo; excel_row=12451; Record_ID=skin_sensitization_invivo_2713; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Formulation_ID=MIX1031; Formulation_Name=Eucalyptus oil; Concentration=10.0; Concentration_Units=%; Mixture=Mixture; DTXSID=DTXSID9034781; Assay=Human Maximization Test; Endpoint=Relative reliability score; Response=3; Response_Unit=Unitless; Species=Human; Route=Dermal; Reference=Kligman 1973: report to RlFM|Opdyke 1975; Not available; 10.1016/S0015-6264(75)80165-9; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9034781 |
UnifiedCodex:CIR:beta.noael_studies 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:CIR:beta.noael_studies | - | 100 | mg/kg bw/day | rat | - | - | - | SOURCE_SUBDIR=PRS754; REPORT_TITLE=Safety Assessment of Eucalyptus globulus (Eucalyptus)-Derived Ingredients as Used in Cosmetics Lillian C. Becker*, Alice Akinsulie*, Wilma F. Bergfeld**, Donald V. Belsito**, Ronald A. Hill***, Curtis D. Klaassen**, Daniel C. Liebler***, J; OPINION_NUMBER=PRS754; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=Toxicology 2023; VALUE_TEXT=100; DOSE=weights were only observed in females in 1000 mg/kg/day group.; LOAEL_VALUE=100 mg/kg/day; EFFECT=weights were only observed in females in 1000 mg/kg/day group. Thickening of mammary tissue was observed in 2 and 1 males in 300 and 1000 mg/kg/day groups, respectively, and 1 female in the 1000 mg/kg/day group. Under test conditions, LOAEL and NOAEL in female rats could be considered as 300 and 100 mg/kg/day, respectively, based on clinical signs at 300 and 1000 mg/kg/day and increased liver weight at 1000 mg/kg/day. Since dose-related increases in liver and kidney weights were observed in males at all doses, no NOAEL could be identified for male rats in this study. The LOAEL in male rats could be considered as 100 mg/kg bw/day 10 (continued) 74S International Journal of Toxicology 42(Supplement 1); CITATION=2; 1; 300; CITATION_NUMBERS=[2,1,300]; REFERENCE=2; 1; 300; DETAILS_JSON={"cas_number":"8000-48-4","citation":"2; 1; 300","dose":"weights were only observed in females in 1000 mg/kg/day group.","duration":"","effect":"weights were only observed in females in 1000 mg/kg/day group. Thickening of mammary tissue was observed in 2 and 1 males in 300 and 1000 mg/kg/day groups, respectively, and 1 female in the 1000 mg/kg/day group. Under test conditions, LOAEL and NOAEL in female rats could be considered as 300 and 100 mg/kg/day, respectively, based on clinical signs at 300 and 1000 mg/kg/day and increased liver weight at 1000 mg/kg/day. Since dose-related increases in liver and kidney weights were observed in males at all doses, no NOAEL could be identified for male rats in this study. The LOAEL in male rats could be considered as 100 mg/kg bw/day 10 (continued) 74S International Journal of Toxicology 42(Supplement 1)","endpoint":"","ingredient":"Eucalyptus globulus (Eucalyptus)-Derived Ingredients","loael_value":"100 mg/kg/day","noael_unit":"mg/kg bw/day","noael_value":"100","page":18,"route":"","species":"rat","study_id":"PRS754_noael_004"} |
| UnifiedCodex:CIR:beta.noael_studies | oral toxicity | 1000 | mg/kg | rat | oral | 2 weeks | oral toxicity | SOURCE_SUBDIR=PRS754; REPORT_TITLE=Safety Assessment of Eucalyptus globulus (Eucalyptus)-Derived Ingredients as Used in Cosmetics Lillian C. Becker*, Alice Akinsulie*, Wilma F. Bergfeld**, Donald V. Belsito**, Ronald A. Hill***, Curtis D. Klaassen**, Daniel C. Liebler***, J; OPINION_NUMBER=PRS754; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=Toxicology 2023; VALUE_TEXT=1000; DOSE=There were no microscopic correlates for decrease in spleen weight and increase in adrenal weight of high-dose females.; EFFECT=n livers of males and an increase in glycogenic vacuolation in livers of females, which was considered an adaptive change likely associated with microsomal enzyme induction. A slight increase in incidence and severity of glycogenic vacuolation in livers of treated female compared with controls may be partially responsible for liver weight increase. Liver changes were not considered to be adverse. There were no microscopic correlates for decrease in spleen weight and increase in adrenal weight of high-dose females. NOAEL for males was 1000 mg/kg based on hyaline droplet nephropathy at all dose levels; however this response is considered to be rat specific and to have no counterpart in humans. NOAEL for females was 300 mg/kg based on effects on body weight and feed consumption 10 Eucalyptus globulus leaf oil (100, 300, or 1000 mg/ kg/day in corn oil) Crl:CD (SD) rats (3/sex) Administered for 2 weeks There were no mortalities. Clinical signs were salivation in isolated females in 300 and 1000 mg/kg/day groups, which authors considered minor and did not indicate an association with te...; CITATION=300; 10; (100, 300; CITATION_NUMBERS=[300,10,100]; REFERENCE=300; 10; (100, 300; DETAILS_JSON={"cas_number":"8000-48-4","citation":"300; 10; (100, 300","dose":"There were no microscopic correlates for decrease in spleen weight and increase in adrenal weight of high-dose females.","duration":"2 weeks","effect":"n livers of males and an increase in glycogenic vacuolation in livers of females, which was considered an adaptive change likely associated with microsomal enzyme induction. A slight increase in incidence and severity of glycogenic vacuolation in livers of treated female compared with controls may be partially responsible for liver weight increase. Liver changes were not considered to be adverse. There were no microscopic correlates for decrease in spleen weight and increase in adrenal weight of high-dose females. NOAEL for males was 1000 mg/kg based on hyaline droplet nephropathy at all dose levels; however this response is considered to be rat specific and to have no counterpart in humans. NOAEL for females was 300 mg/kg based on effects on body weight and feed consumption 10 Eucalyptus globulus leaf oil (100, 300, or 1000 mg/ kg/day in corn oil) Crl:CD (SD) rats (3/sex) Administered for 2 weeks There were no mortalities. Clinical signs were salivation in isolated females in 300 and 1000 mg/kg/day groups, which authors considered minor and did not indicate an association with te...","endpoint":"oral toxicity","ingredient":"Eucalyptus globulus (Eucalyptus)-Derived Ingredients","loael_value":"","noael_unit":"mg/kg","noael_value":"1000","page":18,"route":"oral","species":"rat","study_id":"PRS754_noael_001"} |
| UnifiedCodex:CIR:beta.noael_studies | oral toxicity | 300 | mg/kg | rat | oral | 2 weeks | oral toxicity | SOURCE_SUBDIR=PRS754; REPORT_TITLE=Safety Assessment of Eucalyptus globulus (Eucalyptus)-Derived Ingredients as Used in Cosmetics Lillian C. Becker*, Alice Akinsulie*, Wilma F. Bergfeld**, Donald V. Belsito**, Ronald A. Hill***, Curtis D. Klaassen**, Daniel C. Liebler***, J; OPINION_NUMBER=PRS754; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=Toxicology 2023; VALUE_TEXT=300; DOSE=There were no microscopic correlates for decrease in spleen weight and increase in adrenal weight of high-dose females.; EFFECT=t increase in incidence and severity of glycogenic vacuolation in livers of treated female compared with controls may be partially responsible for liver weight increase. Liver changes were not considered to be adverse. There were no microscopic correlates for decrease in spleen weight and increase in adrenal weight of high-dose females. NOAEL for males was 1000 mg/kg based on hyaline droplet nephropathy at all dose levels; however this response is considered to be rat specific and to have no counterpart in humans. NOAEL for females was 300 mg/kg based on effects on body weight and feed consumption 10 Eucalyptus globulus leaf oil (100, 300, or 1000 mg/ kg/day in corn oil) Crl:CD (SD) rats (3/sex) Administered for 2 weeks There were no mortalities. Clinical signs were salivation in isolated females in 300 and 1000 mg/kg/day groups, which authors considered minor and did not indicate an association with test material. Other signs were transient body weight loss and low feed consumption in males in 1000 mg/kg/day group during days 1 to 5. Necropsy showed that liver and kidney weights...; CITATION=300; 10; (100, 300; CITATION_NUMBERS=[300,10,100]; REFERENCE=300; 10; (100, 300; DETAILS_JSON={"cas_number":"8000-48-4","citation":"300; 10; (100, 300","dose":"There were no microscopic correlates for decrease in spleen weight and increase in adrenal weight of high-dose females.","duration":"2 weeks","effect":"t increase in incidence and severity of glycogenic vacuolation in livers of treated female compared with controls may be partially responsible for liver weight increase. Liver changes were not considered to be adverse. There were no microscopic correlates for decrease in spleen weight and increase in adrenal weight of high-dose females. NOAEL for males was 1000 mg/kg based on hyaline droplet nephropathy at all dose levels; however this response is considered to be rat specific and to have no counterpart in humans. NOAEL for females was 300 mg/kg based on effects on body weight and feed consumption 10 Eucalyptus globulus leaf oil (100, 300, or 1000 mg/ kg/day in corn oil) Crl:CD (SD) rats (3/sex) Administered for 2 weeks There were no mortalities. Clinical signs were salivation in isolated females in 300 and 1000 mg/kg/day groups, which authors considered minor and did not indicate an association with test material. Other signs were transient body weight loss and low feed consumption in males in 1000 mg/kg/day group during days 1 to 5. Necropsy showed that liver and kidney weights...","endpoint":"oral toxicity","ingredient":"Eucalyptus globulus (Eucalyptus)-Derived Ingredients","loael_value":"","noael_unit":"mg/kg","noael_value":"300","page":18,"route":"oral","species":"rat","study_id":"PRS754_noael_002"} |
| UnifiedCodex:CIR:beta.noael_studies | oral toxicity | 300 | mg/kg/day | rat | oral | - | oral toxicity | SOURCE_SUBDIR=PRS754; REPORT_TITLE=Safety Assessment of Eucalyptus globulus (Eucalyptus)-Derived Ingredients as Used in Cosmetics Lillian C. Becker*, Alice Akinsulie*, Wilma F. Bergfeld**, Donald V. Belsito**, Ronald A. Hill***, Curtis D. Klaassen**, Daniel C. Liebler***, J; OPINION_NUMBER=PRS754; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=Toxicology 2023; VALUE_TEXT=300; 100; DOSE=Other signs were transient body weight loss and low feed consumption in males in 1000 mg/kg/day group during days 1 to 5.; LOAEL_VALUE=100 mg/kg/day; EFFECT=association with test material. Other signs were transient body weight loss and low feed consumption in males in 1000 mg/kg/day group during days 1 to 5. Necropsy showed that liver and kidney weights increased with increasing dose level in males; in females, increased liver weights were only observed in females in 1000 mg/kg/day group. Thickening of mammary tissue was observed in 2 and 1 males in 300 and 1000 mg/kg/day groups, respectively, and 1 female in the 1000 mg/kg/day group. Under test conditions, LOAEL and NOAEL in female rats could be considered as 300 and 100 mg/kg/day, respectively, based on clinical signs at 300 and 1000 mg/kg/day and increased liver weight at 1000 mg/kg/day. Since dose-related increases in liver and kidney weights were observed in males at all doses, no NOAEL could be identified for male rats in this study. The LOAEL in male rats could be considered as 100 mg/kg bw/day 10 (continued) 74S International Journal of Toxicology 42(Supplement 1); CITATION=1; 5; 2; CITATION_NUMBERS=[1,5,2]; REFERENCE=1; 5; 2; DETAILS_JSON={"cas_number":"8000-48-4","citation":"1; 5; 2","dose":"Other signs were transient body weight loss and low feed consumption in males in 1000 mg/kg/day group during days 1 to 5.","duration":"","effect":"association with test material. Other signs were transient body weight loss and low feed consumption in males in 1000 mg/kg/day group during days 1 to 5. Necropsy showed that liver and kidney weights increased with increasing dose level in males; in females, increased liver weights were only observed in females in 1000 mg/kg/day group. Thickening of mammary tissue was observed in 2 and 1 males in 300 and 1000 mg/kg/day groups, respectively, and 1 female in the 1000 mg/kg/day group. Under test conditions, LOAEL and NOAEL in female rats could be considered as 300 and 100 mg/kg/day, respectively, based on clinical signs at 300 and 1000 mg/kg/day and increased liver weight at 1000 mg/kg/day. Since dose-related increases in liver and kidney weights were observed in males at all doses, no NOAEL could be identified for male rats in this study. The LOAEL in male rats could be considered as 100 mg/kg bw/day 10 (continued) 74S International Journal of Toxicology 42(Supplement 1)","endpoint":"oral toxicity","ingredient":"Eucalyptus globulus (Eucalyptus)-Derived Ingredients","loael_value":"100 mg/kg/day","noael_unit":"mg/kg/day","noael_value":"300; 100","page":18,"route":"oral","species":"rat","study_id":"PRS754_noael_003"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | 2R04ONI662 | UNII | - | - | - | structurallyDiverse | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"structurallyDiverse","unii_code":"2R04ONI662"} |
| openFDA substances | FDA UNII substance identifier | 2R04ONI662 | UNII | - | - | - | structurallyDiverse | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"structurallyDiverse","unii_code":"2R04ONI662"} |
| openFDA substances | FDA UNII substance identifier | 2R04ONI662 | UNII | - | - | - | structurallyDiverse | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"structurallyDiverse","unii_code":"2R04ONI662"} |
| openFDA substances | FDA UNII substance identifier | 2R04ONI662 | UNII | - | - | - | structurallyDiverse | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"structurallyDiverse","unii_code":"2R04ONI662"} |