NOAEL Studies
Cosmetic Ingredient
Acid Red 18 NOAEL Studies
INCI: CI 16255
CAS: 2611-82-7
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx | NOAEL | =70 | mg/kg bw/day | Mouse | oral: feed | 574 days | chronic/long term toxicity | EFSA ANS - 2009 - OutputID 392 - neurology - nephrotoxicity - Scientific Opinion on the re-evaluation of Ponceau 4R (E 124) as a food additive - doi:10.2903/j.efsa.2009.1328 |
| EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx | NOAEL | =70 | mg/kg bw/day | Mouse | oral: feed | 574 days | chronic/long term toxicity | EFSA ANS - 2009 - OutputID 392 - neurology - nephrotoxicity - Scientific Opinion on the re-evaluation of Ponceau 4R (E 124) as a food additive - doi:10.2903/j.efsa.2009.1328 |
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx | ADI | =0.7 | mg/kg bw/day | Consumers | - | - | ADI | EFSA ANS - 2009 - OutputID 392 - Consumers - Scientific Opinion on the re-evaluation of Ponceau 4R (E 124) as a food additive - doi:10.2903/j.efsa.2009.1328 |
| EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx | ADI | =0.7 | mg/kg bw/day | Consumers | - | - | ADI | EFSA ANS - 2009 - OutputID 392 - Consumers - Scientific Opinion on the re-evaluation of Ponceau 4R (E 124) as a food additive - doi:10.2903/j.efsa.2009.1328 |
NTP_ICE_acute_oral 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_acute_oral | LD50 | >8000 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | record_id=acute_oral_4786; row=15377; data_type=In Vivo; mixture=Chemical; chemical_name=SX purple; preferred_name=C.I. Acid Red 18, trisodium salt; dtxsid=DTXSID9021213; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9021213; source_file=acute_oral.xlsx |
SCCNFP_vision_codex 24 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCNFP_vision_codex | NOAEL | =500 | mg/kg bw/day | rat | oral | 90 days | repeated dose toxicity | {"citation":"Ref.: 4 At higher doses (> 1250 mg/kg bw/day) administered in other rat studies, effects were noted in the liver, heart, adrenal gland, caecum, brain arteries, testes and bodyweight deve","dose":"Repeated dose oral toxicity No data 2.3.5 Repeated dose dermal toxicity In rats, given up to 2% Acid Red 18 (approximately 1000 mg/kg bw/day) in diet, the main treatment-related effects were increased serum transaminase in both sexes and decreased haematological indices (depressed red cell counts, decreased haemoglobin concentration and haematoc...","effect":"ata 2.3.4. Repeated dose oral toxicity No data 2.3.5 Repeated dose dermal toxicity In rats, given up to 2% Acid Red 18 (approximately 1000 mg/kg bw/day) in diet, the main treatment-related effects were increased serum transaminase in both sexes and decreased haematological indices (depressed red cell counts, decreased haemoglobin concentration and haematocrit value) mainly in females. Based on the increased transaminase levels (suggesting potential liver injury) and blood parameters in the high dose group, the NOEL was considered to be 500 mg/kg bw/day (1 % Acid Red 18 in the diet). Ref.: 4 At higher doses (> 1250 mg/kg bw/day) administered in other rat studies, effects were noted in the liver, heart, adrenal gland, caecum, brain arteries, testes and bodyweight development. Ref.: 2 Mild and transient anaemia (reduced haemoglobin, haematocrit and red blood cell number) was seen in male pigs given 900 mg/kg bw/day in the diet for 90 days. A NOEL of 300 mg/kg bw/day was derived from this study. Ref.: 2, 3 2.3.6. Repeated d","page":6,"pdf":"out265_en.pdf","row_type":"noael_study","study_id":"out265_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =300 | mg/kg bw/day | rat | oral | 90 days | repeated dose toxicity | {"citation":"Ref.: 4 At higher doses (> 1250 mg/kg bw/day) administered in other rat studies, effects were noted in the liver, heart, adrenal gland, caecum, brain arteries, testes and bodyweight deve","dose":"sting potential liver injury) and blood parameters in the high dose group, the NOEL was considered to be 500 mg/kg bw/day (1 % Acid Red 18 in the diet).","effect":"sting potential liver injury) and blood parameters in the high dose group, the NOEL was considered to be 500 mg/kg bw/day (1 % Acid Red 18 in the diet). Ref.: 4 At higher doses (> 1250 mg/kg bw/day) administered in other rat studies, effects were noted in the liver, heart, adrenal gland, caecum, brain arteries, testes and bodyweight development. Ref.: 2 Mild and transient anaemia (reduced haemoglobin, haematocrit and red blood cell number) was seen in male pigs given 900 mg/kg bw/day in the diet for 90 days. A NOEL of 300 mg/kg bw/day was derived from this study. Ref.: 2, 3 2.3.6. Repeated dose inhalation toxicity No data 2.3.7. Subchronic oral toxicity No data","page":6,"pdf":"out265_en.pdf","row_type":"noael_study","study_id":"out265_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | >1 | % | rat | oral | - | reproductive toxicity | {"citation":"Ref.: 9 In other studies, particularly a 3-generation feeding study in rats, there were no indications of toxicity to the developing foetuses up to the highest dose, 1250 mg/kg bw","dose":"No effects were noted on bodyweight development, except in the high dose group where there were significantly higher values for survival rate and lactation index.","effect":"oups. There were no treatment related effects with regard to litter size, foetal mortality, foetal bodyweight or external malformations. Similarly, no treatment-related skeletal effects were noted. The postnatal development was not affected by Acid Red 18. No effects were noted on bodyweight development, except in the high dose group where there were significantly higher values for survival rate and lactation index. No adverse effect was noted with regard to the general and sexual development of the offspring. A NOEL of > 1 % in the diet, approximately 1200 mg/kg bw/day was derived from this study. Ref.: 9 In other studies, particularly a 3-generation feeding study in rats, there were no indications of toxicity to the developing foetuses up to the highest dose, 1250 mg/kg bw. Animals in all dose groups showed a pink coloration of the fur and soft faeces in the two highest dose groups. No treatment-related effects were noted with regard to the observed mortalities, food intake and bodyweight development. Neither fertility no","page":10,"pdf":"out265_en.pdf","row_type":"noael_study","study_id":"out265_en_noael_004"} |
| SCCNFP_vision_codex | NOAEL | =1250 | mg/kg bw/day | rat | - | - | dermal absorption | {"citation":"Ref.: 10 2","dose":"The weight of the caecum (full or empty) showed a dose related increase for both the absolute and the relative weight in almost all generations and is most likely linked to the observed enlarged caecum.","effect":"ions. The weight of the caecum (full or empty) showed a dose related increase for both the absolute and the relative weight in almost all generations and is most likely linked to the observed enlarged caecum. This effect is noted in older animals, but in young animals it was similar to controls. There were no further dose- related changes in organ weights or were only seen in one generation. No treatment related effects were seen histologically. Based on the findings in this 3-generation study with Acid Red 18, A NOAEL of 1250 mg/kg bw/day was derived for dams, the unborn, pups, neonates and young adult rats. Ref.: 10 2.7. Toxicokinetics (including Percutaneous Absorption) Percutaneous absorption in vitro Guideline : OECD 428 (2000) Test system : split thickness pig skin (300-400 µm), 5-6 samples / experiment Contact time : 30 minutes under occlusion (donor chamber covered with parafilm) Test substance : Exp. I : CI 16255, Red 102 WR 23087, dissolved in acetone/water 1:1 (20 mg/ml) Exp. II : CI 16255, Red 102 WR 230","page":11,"pdf":"out265_en.pdf","row_type":"noael_study","study_id":"out265_en_noael_005"} |
| SCCNFP_vision_codex | NOAEL | >8000 | mg/kg bw | rat | oral | - | irritation | {"dose":"SCCNFP/0792/04 Evaluation and opinion on Acid Red 18 _____________________________________________________________________________________________ 15 Concentration of dye in the formulation = 0.5 % Systemic exposure dose (SED) = 0.29 mg/kg/day No observed effect level (mg/kg) NOAEL = 1000 mg/kg Margin of Safety NOAEL / SED = 3429 2.12.","effect":"SCCNFP/0792/04 Evaluation and opinion on Acid Red 18 _____________________________________________________________________________________________ 15 Concentration of dye in the formulation = 0.5 % Systemic exposure dose (SED) = 0.29 mg/kg/day No observed effect level (mg/kg) NOAEL = 1000 mg/kg Margin of Safety NOAEL / SED = 3429 2.12. Conclusions Acid Red 18 has low toxicity. In rats fed Acid Red 18, the LD50 is >8000 mg/kg bw. A NOEL was considered to be 500 mg/kg bw/day (1 % Acid Red 18 in the diet) in rats. Acid Red 18 was not considered maternotoxic or foetotoxic. No data on skin irritation. 1% aqueous solution of Acid Red 18, assessed for eye irritation potential with HET-CAM and Neutral-Red Uptake in vitro assays, was slightly irritating in a HET-CAM and non irritant in the","page":15,"pdf":"out265_en.pdf","row_type":"noael_study","study_id":"out265_en_noael_006"} |
| SCCNFP_vision_codex | NOAEL | =1000 | mg/kg | - | - | - | NOAEL study | {"dose":"No observed effect level (mg/kg) | NOAEL | = | 1000 mg/kg","effect":"Absolute worst case calculation continuation / Margin of Safety: No observed effect level (mg/kg) | NOAEL | = | 1000 mg/kg","page":15,"pdf":"out265_en.pdf","row_type":"noael_study","study_id":"out265_en_noael_008"} |
| SCCNFP_vision_codex | NOAEL | =500 | mg/kg bw/day | rat | oral | 90 days | repeated dose toxicity | {"citation":"Ref.: 4 At higher doses (> 1250 mg/kg bw/day) administered in other rat studies, effects were noted in the liver, heart, adrenal gland, caecum, brain arteries, testes and bodyweight deve","dose":"Repeated dose oral toxicity No data 2.3.5 Repeated dose dermal toxicity In rats, given up to 2% Acid Red 18 (approximately 1000 mg/kg bw/day) in diet, the main treatment-related effects were increased serum transaminase in both sexes and decreased haematological indices (depressed red cell counts, decreased haemoglobin concentration and haematoc...","effect":"ata 2.3.4. Repeated dose oral toxicity No data 2.3.5 Repeated dose dermal toxicity In rats, given up to 2% Acid Red 18 (approximately 1000 mg/kg bw/day) in diet, the main treatment-related effects were increased serum transaminase in both sexes and decreased haematological indices (depressed red cell counts, decreased haemoglobin concentration and haematocrit value) mainly in females. Based on the increased transaminase levels (suggesting potential liver injury) and blood parameters in the high dose group, the NOEL was considered to be 500 mg/kg bw/day (1 % Acid Red 18 in the diet). Ref.: 4 At higher doses (> 1250 mg/kg bw/day) administered in other rat studies, effects were noted in the liver, heart, adrenal gland, caecum, brain arteries, testes and bodyweight development. Ref.: 2 Mild and transient anaemia (reduced haemoglobin, haematocrit and red blood cell number) was seen in male pigs given 900 mg/kg bw/day in the diet for 90 days. A NOEL of 300 mg/kg bw/day was derived from this study. Ref.: 2, 3 2.3.6. Repeated d","page":6,"pdf":"out265_en.pdf","row_type":"noael_study","study_id":"out265_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =300 | mg/kg bw/day | rat | oral | 90 days | repeated dose toxicity | {"citation":"Ref.: 4 At higher doses (> 1250 mg/kg bw/day) administered in other rat studies, effects were noted in the liver, heart, adrenal gland, caecum, brain arteries, testes and bodyweight deve","dose":"sting potential liver injury) and blood parameters in the high dose group, the NOEL was considered to be 500 mg/kg bw/day (1 % Acid Red 18 in the diet).","effect":"sting potential liver injury) and blood parameters in the high dose group, the NOEL was considered to be 500 mg/kg bw/day (1 % Acid Red 18 in the diet). Ref.: 4 At higher doses (> 1250 mg/kg bw/day) administered in other rat studies, effects were noted in the liver, heart, adrenal gland, caecum, brain arteries, testes and bodyweight development. Ref.: 2 Mild and transient anaemia (reduced haemoglobin, haematocrit and red blood cell number) was seen in male pigs given 900 mg/kg bw/day in the diet for 90 days. A NOEL of 300 mg/kg bw/day was derived from this study. Ref.: 2, 3 2.3.6. Repeated dose inhalation toxicity No data 2.3.7. Subchronic oral toxicity No data","page":6,"pdf":"out265_en.pdf","row_type":"noael_study","study_id":"out265_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | >1 | % | rat | oral | - | reproductive toxicity | {"citation":"Ref.: 9 In other studies, particularly a 3-generation feeding study in rats, there were no indications of toxicity to the developing foetuses up to the highest dose, 1250 mg/kg bw","dose":"No effects were noted on bodyweight development, except in the high dose group where there were significantly higher values for survival rate and lactation index.","effect":"oups. There were no treatment related effects with regard to litter size, foetal mortality, foetal bodyweight or external malformations. Similarly, no treatment-related skeletal effects were noted. The postnatal development was not affected by Acid Red 18. No effects were noted on bodyweight development, except in the high dose group where there were significantly higher values for survival rate and lactation index. No adverse effect was noted with regard to the general and sexual development of the offspring. A NOEL of > 1 % in the diet, approximately 1200 mg/kg bw/day was derived from this study. Ref.: 9 In other studies, particularly a 3-generation feeding study in rats, there were no indications of toxicity to the developing foetuses up to the highest dose, 1250 mg/kg bw. Animals in all dose groups showed a pink coloration of the fur and soft faeces in the two highest dose groups. No treatment-related effects were noted with regard to the observed mortalities, food intake and bodyweight development. Neither fertility no","page":10,"pdf":"out265_en.pdf","row_type":"noael_study","study_id":"out265_en_noael_004"} |
| SCCNFP_vision_codex | NOAEL | =1250 | mg/kg bw/day | rat | - | - | dermal absorption | {"citation":"Ref.: 10 2","dose":"The weight of the caecum (full or empty) showed a dose related increase for both the absolute and the relative weight in almost all generations and is most likely linked to the observed enlarged caecum.","effect":"ions. The weight of the caecum (full or empty) showed a dose related increase for both the absolute and the relative weight in almost all generations and is most likely linked to the observed enlarged caecum. This effect is noted in older animals, but in young animals it was similar to controls. There were no further dose- related changes in organ weights or were only seen in one generation. No treatment related effects were seen histologically. Based on the findings in this 3-generation study with Acid Red 18, A NOAEL of 1250 mg/kg bw/day was derived for dams, the unborn, pups, neonates and young adult rats. Ref.: 10 2.7. Toxicokinetics (including Percutaneous Absorption) Percutaneous absorption in vitro Guideline : OECD 428 (2000) Test system : split thickness pig skin (300-400 µm), 5-6 samples / experiment Contact time : 30 minutes under occlusion (donor chamber covered with parafilm) Test substance : Exp. I : CI 16255, Red 102 WR 23087, dissolved in acetone/water 1:1 (20 mg/ml) Exp. II : CI 16255, Red 102 WR 230","page":11,"pdf":"out265_en.pdf","row_type":"noael_study","study_id":"out265_en_noael_005"} |
| SCCNFP_vision_codex | NOAEL | >8000 | mg/kg bw | rat | oral | - | irritation | {"dose":"SCCNFP/0792/04 Evaluation and opinion on Acid Red 18 _____________________________________________________________________________________________ 15 Concentration of dye in the formulation = 0.5 % Systemic exposure dose (SED) = 0.29 mg/kg/day No observed effect level (mg/kg) NOAEL = 1000 mg/kg Margin of Safety NOAEL / SED = 3429 2.12.","effect":"SCCNFP/0792/04 Evaluation and opinion on Acid Red 18 _____________________________________________________________________________________________ 15 Concentration of dye in the formulation = 0.5 % Systemic exposure dose (SED) = 0.29 mg/kg/day No observed effect level (mg/kg) NOAEL = 1000 mg/kg Margin of Safety NOAEL / SED = 3429 2.12. Conclusions Acid Red 18 has low toxicity. In rats fed Acid Red 18, the LD50 is >8000 mg/kg bw. A NOEL was considered to be 500 mg/kg bw/day (1 % Acid Red 18 in the diet) in rats. Acid Red 18 was not considered maternotoxic or foetotoxic. No data on skin irritation. 1% aqueous solution of Acid Red 18, assessed for eye irritation potential with HET-CAM and Neutral-Red Uptake in vitro assays, was slightly irritating in a HET-CAM and non irritant in the","page":15,"pdf":"out265_en.pdf","row_type":"noael_study","study_id":"out265_en_noael_006"} |
| SCCNFP_vision_codex | NOAEL | =1000 | mg/kg | - | - | - | NOAEL study | {"dose":"No observed effect level (mg/kg) | NOAEL | = | 1000 mg/kg","effect":"Absolute worst case calculation continuation / Margin of Safety: No observed effect level (mg/kg) | NOAEL | = | 1000 mg/kg","page":15,"pdf":"out265_en.pdf","row_type":"noael_study","study_id":"out265_en_noael_008"} |
| SCCNFP_vision_codex | NOAEL | =500 | mg/kg bw/day | rat | oral | 90 days | repeated dose toxicity | {"citation":"Ref.: 4 At higher doses (> 1250 mg/kg bw/day) administered in other rat studies, effects were noted in the liver, heart, adrenal gland, caecum, brain arteries, testes and bodyweight deve","dose":"Repeated dose oral toxicity No data 2.3.5 Repeated dose dermal toxicity In rats, given up to 2% Acid Red 18 (approximately 1000 mg/kg bw/day) in diet, the main treatment-related effects were increased serum transaminase in both sexes and decreased haematological indices (depressed red cell counts, decreased haemoglobin concentration and haematoc...","effect":"ata 2.3.4. Repeated dose oral toxicity No data 2.3.5 Repeated dose dermal toxicity In rats, given up to 2% Acid Red 18 (approximately 1000 mg/kg bw/day) in diet, the main treatment-related effects were increased serum transaminase in both sexes and decreased haematological indices (depressed red cell counts, decreased haemoglobin concentration and haematocrit value) mainly in females. Based on the increased transaminase levels (suggesting potential liver injury) and blood parameters in the high dose group, the NOEL was considered to be 500 mg/kg bw/day (1 % Acid Red 18 in the diet). Ref.: 4 At higher doses (> 1250 mg/kg bw/day) administered in other rat studies, effects were noted in the liver, heart, adrenal gland, caecum, brain arteries, testes and bodyweight development. Ref.: 2 Mild and transient anaemia (reduced haemoglobin, haematocrit and red blood cell number) was seen in male pigs given 900 mg/kg bw/day in the diet for 90 days. A NOEL of 300 mg/kg bw/day was derived from this study. Ref.: 2, 3 2.3.6. Repeated d","page":6,"pdf":"out265_en.pdf","row_type":"noael_study","study_id":"out265_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =300 | mg/kg bw/day | rat | oral | 90 days | repeated dose toxicity | {"citation":"Ref.: 4 At higher doses (> 1250 mg/kg bw/day) administered in other rat studies, effects were noted in the liver, heart, adrenal gland, caecum, brain arteries, testes and bodyweight deve","dose":"sting potential liver injury) and blood parameters in the high dose group, the NOEL was considered to be 500 mg/kg bw/day (1 % Acid Red 18 in the diet).","effect":"sting potential liver injury) and blood parameters in the high dose group, the NOEL was considered to be 500 mg/kg bw/day (1 % Acid Red 18 in the diet). Ref.: 4 At higher doses (> 1250 mg/kg bw/day) administered in other rat studies, effects were noted in the liver, heart, adrenal gland, caecum, brain arteries, testes and bodyweight development. Ref.: 2 Mild and transient anaemia (reduced haemoglobin, haematocrit and red blood cell number) was seen in male pigs given 900 mg/kg bw/day in the diet for 90 days. A NOEL of 300 mg/kg bw/day was derived from this study. Ref.: 2, 3 2.3.6. Repeated dose inhalation toxicity No data 2.3.7. Subchronic oral toxicity No data","page":6,"pdf":"out265_en.pdf","row_type":"noael_study","study_id":"out265_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | >1 | % | rat | oral | - | reproductive toxicity | {"citation":"Ref.: 9 In other studies, particularly a 3-generation feeding study in rats, there were no indications of toxicity to the developing foetuses up to the highest dose, 1250 mg/kg bw","dose":"No effects were noted on bodyweight development, except in the high dose group where there were significantly higher values for survival rate and lactation index.","effect":"oups. There were no treatment related effects with regard to litter size, foetal mortality, foetal bodyweight or external malformations. Similarly, no treatment-related skeletal effects were noted. The postnatal development was not affected by Acid Red 18. No effects were noted on bodyweight development, except in the high dose group where there were significantly higher values for survival rate and lactation index. No adverse effect was noted with regard to the general and sexual development of the offspring. A NOEL of > 1 % in the diet, approximately 1200 mg/kg bw/day was derived from this study. Ref.: 9 In other studies, particularly a 3-generation feeding study in rats, there were no indications of toxicity to the developing foetuses up to the highest dose, 1250 mg/kg bw. Animals in all dose groups showed a pink coloration of the fur and soft faeces in the two highest dose groups. No treatment-related effects were noted with regard to the observed mortalities, food intake and bodyweight development. Neither fertility no","page":10,"pdf":"out265_en.pdf","row_type":"noael_study","study_id":"out265_en_noael_004"} |
| SCCNFP_vision_codex | NOAEL | =1250 | mg/kg bw/day | rat | - | - | dermal absorption | {"citation":"Ref.: 10 2","dose":"The weight of the caecum (full or empty) showed a dose related increase for both the absolute and the relative weight in almost all generations and is most likely linked to the observed enlarged caecum.","effect":"ions. The weight of the caecum (full or empty) showed a dose related increase for both the absolute and the relative weight in almost all generations and is most likely linked to the observed enlarged caecum. This effect is noted in older animals, but in young animals it was similar to controls. There were no further dose- related changes in organ weights or were only seen in one generation. No treatment related effects were seen histologically. Based on the findings in this 3-generation study with Acid Red 18, A NOAEL of 1250 mg/kg bw/day was derived for dams, the unborn, pups, neonates and young adult rats. Ref.: 10 2.7. Toxicokinetics (including Percutaneous Absorption) Percutaneous absorption in vitro Guideline : OECD 428 (2000) Test system : split thickness pig skin (300-400 µm), 5-6 samples / experiment Contact time : 30 minutes under occlusion (donor chamber covered with parafilm) Test substance : Exp. I : CI 16255, Red 102 WR 23087, dissolved in acetone/water 1:1 (20 mg/ml) Exp. II : CI 16255, Red 102 WR 230","page":11,"pdf":"out265_en.pdf","row_type":"noael_study","study_id":"out265_en_noael_005"} |
| SCCNFP_vision_codex | NOAEL | >8000 | mg/kg bw | rat | oral | - | irritation | {"dose":"SCCNFP/0792/04 Evaluation and opinion on Acid Red 18 _____________________________________________________________________________________________ 15 Concentration of dye in the formulation = 0.5 % Systemic exposure dose (SED) = 0.29 mg/kg/day No observed effect level (mg/kg) NOAEL = 1000 mg/kg Margin of Safety NOAEL / SED = 3429 2.12.","effect":"SCCNFP/0792/04 Evaluation and opinion on Acid Red 18 _____________________________________________________________________________________________ 15 Concentration of dye in the formulation = 0.5 % Systemic exposure dose (SED) = 0.29 mg/kg/day No observed effect level (mg/kg) NOAEL = 1000 mg/kg Margin of Safety NOAEL / SED = 3429 2.12. Conclusions Acid Red 18 has low toxicity. In rats fed Acid Red 18, the LD50 is >8000 mg/kg bw. A NOEL was considered to be 500 mg/kg bw/day (1 % Acid Red 18 in the diet) in rats. Acid Red 18 was not considered maternotoxic or foetotoxic. No data on skin irritation. 1% aqueous solution of Acid Red 18, assessed for eye irritation potential with HET-CAM and Neutral-Red Uptake in vitro assays, was slightly irritating in a HET-CAM and non irritant in the","page":15,"pdf":"out265_en.pdf","row_type":"noael_study","study_id":"out265_en_noael_006"} |
| SCCNFP_vision_codex | NOAEL | =1000 | mg/kg | - | - | - | NOAEL study | {"dose":"No observed effect level (mg/kg) | NOAEL | = | 1000 mg/kg","effect":"Absolute worst case calculation continuation / Margin of Safety: No observed effect level (mg/kg) | NOAEL | = | 1000 mg/kg","page":15,"pdf":"out265_en.pdf","row_type":"noael_study","study_id":"out265_en_noael_008"} |
| SCCNFP_vision_codex | NOAEL | =500 | mg/kg bw/day | rat | oral | 90 days | repeated dose toxicity | {"citation":"Ref.: 4 At higher doses (> 1250 mg/kg bw/day) administered in other rat studies, effects were noted in the liver, heart, adrenal gland, caecum, brain arteries, testes and bodyweight deve","dose":"Repeated dose oral toxicity No data 2.3.5 Repeated dose dermal toxicity In rats, given up to 2% Acid Red 18 (approximately 1000 mg/kg bw/day) in diet, the main treatment-related effects were increased serum transaminase in both sexes and decreased haematological indices (depressed red cell counts, decreased haemoglobin concentration and haematoc...","effect":"ata 2.3.4. Repeated dose oral toxicity No data 2.3.5 Repeated dose dermal toxicity In rats, given up to 2% Acid Red 18 (approximately 1000 mg/kg bw/day) in diet, the main treatment-related effects were increased serum transaminase in both sexes and decreased haematological indices (depressed red cell counts, decreased haemoglobin concentration and haematocrit value) mainly in females. Based on the increased transaminase levels (suggesting potential liver injury) and blood parameters in the high dose group, the NOEL was considered to be 500 mg/kg bw/day (1 % Acid Red 18 in the diet). Ref.: 4 At higher doses (> 1250 mg/kg bw/day) administered in other rat studies, effects were noted in the liver, heart, adrenal gland, caecum, brain arteries, testes and bodyweight development. Ref.: 2 Mild and transient anaemia (reduced haemoglobin, haematocrit and red blood cell number) was seen in male pigs given 900 mg/kg bw/day in the diet for 90 days. A NOEL of 300 mg/kg bw/day was derived from this study. Ref.: 2, 3 2.3.6. Repeated d","page":6,"pdf":"out265_en.pdf","row_type":"noael_study","study_id":"out265_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =300 | mg/kg bw/day | rat | oral | 90 days | repeated dose toxicity | {"citation":"Ref.: 4 At higher doses (> 1250 mg/kg bw/day) administered in other rat studies, effects were noted in the liver, heart, adrenal gland, caecum, brain arteries, testes and bodyweight deve","dose":"sting potential liver injury) and blood parameters in the high dose group, the NOEL was considered to be 500 mg/kg bw/day (1 % Acid Red 18 in the diet).","effect":"sting potential liver injury) and blood parameters in the high dose group, the NOEL was considered to be 500 mg/kg bw/day (1 % Acid Red 18 in the diet). Ref.: 4 At higher doses (> 1250 mg/kg bw/day) administered in other rat studies, effects were noted in the liver, heart, adrenal gland, caecum, brain arteries, testes and bodyweight development. Ref.: 2 Mild and transient anaemia (reduced haemoglobin, haematocrit and red blood cell number) was seen in male pigs given 900 mg/kg bw/day in the diet for 90 days. A NOEL of 300 mg/kg bw/day was derived from this study. Ref.: 2, 3 2.3.6. Repeated dose inhalation toxicity No data 2.3.7. Subchronic oral toxicity No data","page":6,"pdf":"out265_en.pdf","row_type":"noael_study","study_id":"out265_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | >1 | % | rat | oral | - | reproductive toxicity | {"citation":"Ref.: 9 In other studies, particularly a 3-generation feeding study in rats, there were no indications of toxicity to the developing foetuses up to the highest dose, 1250 mg/kg bw","dose":"No effects were noted on bodyweight development, except in the high dose group where there were significantly higher values for survival rate and lactation index.","effect":"oups. There were no treatment related effects with regard to litter size, foetal mortality, foetal bodyweight or external malformations. Similarly, no treatment-related skeletal effects were noted. The postnatal development was not affected by Acid Red 18. No effects were noted on bodyweight development, except in the high dose group where there were significantly higher values for survival rate and lactation index. No adverse effect was noted with regard to the general and sexual development of the offspring. A NOEL of > 1 % in the diet, approximately 1200 mg/kg bw/day was derived from this study. Ref.: 9 In other studies, particularly a 3-generation feeding study in rats, there were no indications of toxicity to the developing foetuses up to the highest dose, 1250 mg/kg bw. Animals in all dose groups showed a pink coloration of the fur and soft faeces in the two highest dose groups. No treatment-related effects were noted with regard to the observed mortalities, food intake and bodyweight development. Neither fertility no","page":10,"pdf":"out265_en.pdf","row_type":"noael_study","study_id":"out265_en_noael_004"} |
| SCCNFP_vision_codex | NOAEL | =1250 | mg/kg bw/day | rat | - | - | dermal absorption | {"citation":"Ref.: 10 2","dose":"The weight of the caecum (full or empty) showed a dose related increase for both the absolute and the relative weight in almost all generations and is most likely linked to the observed enlarged caecum.","effect":"ions. The weight of the caecum (full or empty) showed a dose related increase for both the absolute and the relative weight in almost all generations and is most likely linked to the observed enlarged caecum. This effect is noted in older animals, but in young animals it was similar to controls. There were no further dose- related changes in organ weights or were only seen in one generation. No treatment related effects were seen histologically. Based on the findings in this 3-generation study with Acid Red 18, A NOAEL of 1250 mg/kg bw/day was derived for dams, the unborn, pups, neonates and young adult rats. Ref.: 10 2.7. Toxicokinetics (including Percutaneous Absorption) Percutaneous absorption in vitro Guideline : OECD 428 (2000) Test system : split thickness pig skin (300-400 µm), 5-6 samples / experiment Contact time : 30 minutes under occlusion (donor chamber covered with parafilm) Test substance : Exp. I : CI 16255, Red 102 WR 23087, dissolved in acetone/water 1:1 (20 mg/ml) Exp. II : CI 16255, Red 102 WR 230","page":11,"pdf":"out265_en.pdf","row_type":"noael_study","study_id":"out265_en_noael_005"} |
| SCCNFP_vision_codex | NOAEL | >8000 | mg/kg bw | rat | oral | - | irritation | {"dose":"SCCNFP/0792/04 Evaluation and opinion on Acid Red 18 _____________________________________________________________________________________________ 15 Concentration of dye in the formulation = 0.5 % Systemic exposure dose (SED) = 0.29 mg/kg/day No observed effect level (mg/kg) NOAEL = 1000 mg/kg Margin of Safety NOAEL / SED = 3429 2.12.","effect":"SCCNFP/0792/04 Evaluation and opinion on Acid Red 18 _____________________________________________________________________________________________ 15 Concentration of dye in the formulation = 0.5 % Systemic exposure dose (SED) = 0.29 mg/kg/day No observed effect level (mg/kg) NOAEL = 1000 mg/kg Margin of Safety NOAEL / SED = 3429 2.12. Conclusions Acid Red 18 has low toxicity. In rats fed Acid Red 18, the LD50 is >8000 mg/kg bw. A NOEL was considered to be 500 mg/kg bw/day (1 % Acid Red 18 in the diet) in rats. Acid Red 18 was not considered maternotoxic or foetotoxic. No data on skin irritation. 1% aqueous solution of Acid Red 18, assessed for eye irritation potential with HET-CAM and Neutral-Red Uptake in vitro assays, was slightly irritating in a HET-CAM and non irritant in the","page":15,"pdf":"out265_en.pdf","row_type":"noael_study","study_id":"out265_en_noael_006"} |
| SCCNFP_vision_codex | NOAEL | =1000 | mg/kg | - | - | - | NOAEL study | {"dose":"No observed effect level (mg/kg) | NOAEL | = | 1000 mg/kg","effect":"Absolute worst case calculation continuation / Margin of Safety: No observed effect level (mg/kg) | NOAEL | = | 1000 mg/kg","page":15,"pdf":"out265_en.pdf","row_type":"noael_study","study_id":"out265_en_noael_008"} |
ToxValDB_ECHA_IUCLID 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECHA_IUCLID | NOAEL | =1250 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaadfe4b0a7c65d1b7cf5; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/10401/7/9/2?documentUUID=0558263c-ce95-4c77-abea-8f5ed1a7ce72; YEAR=2013; ORIGINAL_YEAR=2013; TOXICOLOGICAL_EFFECT=P0: reproductive performance; TOXICOLOGICAL_EFFECT_CATEGORY=reproduction; STUDY_GROUP=ECHA IUCLID:15857041: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_c66fbe524894935bba53770a6f1024b9 |
ToxValDB_ECOTOX 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECOTOX | LOEL | =10 | mg/kg bw/day | Mouse | oral | acute; 1 days | acute | LONG_REF=Mutat. Res.519(1/2): 103-119 Sasaki,Y.F., S. Kawaguchi, A. Kamaya, M. Ohshita, K. Kabasawa, K. Iwama, K. Taniguchi, and S. Tsuda The Comet Assay with 8 Mouse Organs: Results with 39 Currently Used Food Additives 2002; TITLE=The Comet Assay with 8 Mouse Organs: Results with 39 Currently Used Food Additives; AUTHOR=Sasaki,Y.F., S. Kawaguchi, A. Kamaya, M. Ohshita, K. Kabasawa, K. Iwama, K. Taniguchi, and S. Tsuda; DOI=10.1016/s1383-5718(02)00128-6; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=75840; 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=2002; ORIGINAL_YEAR=2002; TOXICOLOGICAL_EFFECT=Genetics: Damage; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=ECOTOX_dup_EPA ORD_15609031_15609032:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=c61bcccdae024ba16d0de474716385b4 |
| ToxValDB_ECOTOX | NOEL | =1 | mg/kg bw/day | Mouse | oral | acute; 1 days | acute | LONG_REF=Mutat. Res.519(1/2): 103-119 Sasaki,Y.F., S. Kawaguchi, A. Kamaya, M. Ohshita, K. Kabasawa, K. Iwama, K. Taniguchi, and S. Tsuda The Comet Assay with 8 Mouse Organs: Results with 39 Currently Used Food Additives 2002; TITLE=The Comet Assay with 8 Mouse Organs: Results with 39 Currently Used Food Additives; AUTHOR=Sasaki,Y.F., S. Kawaguchi, A. Kamaya, M. Ohshita, K. Kabasawa, K. Iwama, K. Taniguchi, and S. Tsuda; DOI=10.1016/s1383-5718(02)00128-6; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=75840; 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=2002; ORIGINAL_YEAR=2002; TOXICOLOGICAL_EFFECT=Genetics: Damage; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=ECOTOX_dup_EPA ORD_15609031_15609032:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=d088d90d109ded5656a6faa056a91e7b |
ToxValDB_EFSA 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_EFSA | NOAEL | =70 | mg/kg bw/day | Mouse | oral | chronic; 82 weeks | chronic | LONG_REF=EFSA ANS (2009). Scientific Opinion on the re-evaluation of Ponceau 4R (E 124) as a food additive. doi:10.2903/j.efsa.2009.1328.; TITLE=Scientific Opinion on the re-evaluation of Ponceau 4R (E 124) as a food additive; AUTHOR=EFSA ANS; DOI=doi:10.2903/j.efsa.2009.1328; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2009; ORIGINAL_YEAR=2009; TOXICOLOGICAL_EFFECT=neurology; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=EFSA_dup_-_15614320_15614321: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_1074035a4a921898fec2148a5e00931d |
ToxValDB_GESTIS_DNEL 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_GESTIS_DNEL | DNEL systemic | =24.7 | mg/m3 | Human | inhalation | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6543dd69e4b045b9ff7cd87e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.dguv.de/ifa/gestis/gestis-dnel-liste/index-2.jsp; STUDY_GROUP=GESTIS DNEL:15635583:-:--; 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_28b96c649302208c4a70f18633ca7cef |
ToxValDB_WHO_JECFA_ADI 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_WHO_JECFA_ADI | ADI | <=4 | mg/kg | Human | oral | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/650afcb9e4b0d99f5a87cc88; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://apps.who.int/food-additives-contaminants-jecfa-database/; SUBSOURCE_URL=https://apps.who.int/food-additives-contaminants-jecfa-database/Home/Chemical/393; YEAR=2011; ORIGINAL_YEAR=2011; STUDY_GROUP=WHO JECFA ADI:15715367:-:--; 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_9b11c5940bff80e98494d48b4f5c7bd6 |
UnifiedCodex:SCCNFP:beta.noael_studies 8 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCNFP:beta.noael_studies | - | 500 | mg/kg bw/day | - | - | - | - | SOURCE_SUBDIR=out265_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID RED 18 COLIPA n° C175; OPINION_NUMBER=SCCNFP/0792/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=500; DOSE=50 mg/kg bw/day (being statistically different to control) in males.; EFFECT=50 mg/kg bw/day (being statistically different to control) in males. Taken together with the increase in proteinuria in high dose females, this finding indicates that there might be some effect on the kidney at 1250 mg/kg bw/day of Acid Red 18. No other dose-related effects were noted with regard to organ weights. Other than increased renal pelvic calculi at 1250 mg/kg bw/day in both sexes and 500 mg/kg/ bw in males, the authors of the paper considered there were no clear treatment related effects and concluded a NOEL of 500 mg/kg bw/day from this study. They considered other pathological findings as small and restricted to one sex. In 1983, the SCF and the JECFA used this study to derive an ADI of 4 mg/kg bw/day for Acid Red 18. The final rationale for this decision is not known. The committees may have based this on the figures for food consumption and bodyweight given in the original report or used a slightly higher Safety Factor of 125 instead of 100.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2611-82-7","citation":"","dose":"50 mg/kg bw/day (being statistically different to control) in males.","duration":"","effect":"50 mg/kg bw/day (being statistically different to control) in males. Taken together with the increase in proteinuria in high dose females, this finding indicates that there might be some effect on the kidney at 1250 mg/kg bw/day of Acid Red 18. No other dose-related effects were noted with regard to organ weights. Other than increased renal pelvic calculi at 1250 mg/kg bw/day in both sexes and 500 mg/kg/ bw in males, the authors of the paper considered there were no clear treatment related effects and concluded a NOEL of 500 mg/kg bw/day from this study. They considered other pathological findings as small and restricted to one sex. In 1983, the SCF and the JECFA used this study to derive an ADI of 4 mg/kg bw/day for Acid Red 18. The final rationale for this decision is not known. The committees may have based this on the figures for food consumption and bodyweight given in the original report or used a slightly higher Safety Factor of 125 instead of 100.","endpoint":"","ingredient":"Trisodium 7-hydroxy-8-[(E)-(4-sulfonato-1-naphthyl)-diazenyl)]-1,3","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"500","page":7,"route":"","species":"","study_id":"out265_en_noael_003"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | - | 1000 | mg/kg | - | - | - | - | SOURCE_SUBDIR=out265_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID RED 18 COLIPA n° C175; OPINION_NUMBER=SCCNFP/0792/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=1000; DOSE=No observed effect level (mg/kg) | NOAEL | = | 1000 mg/kg; EFFECT=Absolute worst case calculation continuation / Margin of Safety: No observed effect level (mg/kg) | NOAEL | = | 1000 mg/kg; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2611-82-7","citation":"","dose":"No observed effect level (mg/kg) | NOAEL | = | 1000 mg/kg","duration":"","effect":"Absolute worst case calculation continuation / Margin of Safety: No observed effect level (mg/kg) | NOAEL | = | 1000 mg/kg","endpoint":"","ingredient":"Trisodium 7-hydroxy-8-[(E)-(4-sulfonato-1-naphthyl)-diazenyl)]-1,3","loael_value":"","noael_unit":"mg/kg","noael_value":"1000","page":15,"route":"","species":"","study_id":"out265_en_noael_008"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | dermal absorption | 1250 | mg/kg bw/day | rat | - | - | dermal absorption | SOURCE_SUBDIR=out265_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID RED 18 COLIPA n° C175; OPINION_NUMBER=SCCNFP/0792/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=1250; DOSE=The weight of the caecum (full or empty) showed a dose related increase for both the absolute and the relative weight in almost all generations and is most likely linked to the observed enlarged caecum.; EFFECT=ions. The weight of the caecum (full or empty) showed a dose related increase for both the absolute and the relative weight in almost all generations and is most likely linked to the observed enlarged caecum. This effect is noted in older animals, but in young animals it was similar to controls. There were no further dose- related changes in organ weights or were only seen in one generation. No treatment related effects were seen histologically. Based on the findings in this 3-generation study with Acid Red 18, A NOAEL of 1250 mg/kg bw/day was derived for dams, the unborn, pups, neonates and young adult rats. Ref.: 10 2.7. Toxicokinetics (including Percutaneous Absorption) Percutaneous absorption in vitro Guideline : OECD 428 (2000) Test system : split thickness pig skin (300-400 µm), 5-6 samples / experiment Contact time : 30 minutes under occlusion (donor chamber covered with parafilm) Test substance : Exp. I : CI 16255, Red 102 WR 23087, dissolved in acetone/water 1:1 (20 mg/ml) Exp. II : CI 16255, Red 102 WR 230; CITATION=Ref.: 10 2; CITATION_NUMBERS=[10,2]; REFERENCE=Ref.: 10 2; DETAILS_JSON={"cas_number":"2611-82-7","citation":"Ref.: 10 2","dose":"The weight of the caecum (full or empty) showed a dose related increase for both the absolute and the relative weight in almost all generations and is most likely linked to the observed enlarged caecum.","duration":"","effect":"ions. The weight of the caecum (full or empty) showed a dose related increase for both the absolute and the relative weight in almost all generations and is most likely linked to the observed enlarged caecum. This effect is noted in older animals, but in young animals it was similar to controls. There were no further dose- related changes in organ weights or were only seen in one generation. No treatment related effects were seen histologically. Based on the findings in this 3-generation study with Acid Red 18, A NOAEL of 1250 mg/kg bw/day was derived for dams, the unborn, pups, neonates and young adult rats. Ref.: 10 2.7. Toxicokinetics (including Percutaneous Absorption) Percutaneous absorption in vitro Guideline : OECD 428 (2000) Test system : split thickness pig skin (300-400 µm), 5-6 samples / experiment Contact time : 30 minutes under occlusion (donor chamber covered with parafilm) Test substance : Exp. I : CI 16255, Red 102 WR 23087, dissolved in acetone/water 1:1 (20 mg/ml) Exp. II : CI 16255, Red 102 WR 230","endpoint":"dermal absorption","ingredient":"Trisodium 7-hydroxy-8-[(E)-(4-sulfonato-1-naphthyl)-diazenyl)]-1,3","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1250","page":11,"route":"","species":"rat","study_id":"out265_en_noael_005"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | irritation | >8000 | mg/kg bw | rat | oral | - | irritation | SOURCE_SUBDIR=out265_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID RED 18 COLIPA n° C175; OPINION_NUMBER=SCCNFP/0792/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=>8000; DOSE=SCCNFP/0792/04 Evaluation and opinion on Acid Red 18 _____________________________________________________________________________________________ 15 Concentration of dye in the formulation = 0.5 % Systemic exposure dose (SED) = 0.29 mg/kg/day No observed effect level (mg/kg) NOAEL = 1000 mg/kg Margin of Safety NOAEL / SED = 3429 2.12.; EFFECT=SCCNFP/0792/04 Evaluation and opinion on Acid Red 18 _____________________________________________________________________________________________ 15 Concentration of dye in the formulation = 0.5 % Systemic exposure dose (SED) = 0.29 mg/kg/day No observed effect level (mg/kg) NOAEL = 1000 mg/kg Margin of Safety NOAEL / SED = 3429 2.12. Conclusions Acid Red 18 has low toxicity. In rats fed Acid Red 18, the LD50 is >8000 mg/kg bw. A NOEL was considered to be 500 mg/kg bw/day (1 % Acid Red 18 in the diet) in rats. Acid Red 18 was not considered maternotoxic or foetotoxic. No data on skin irritation. 1% aqueous solution of Acid Red 18, assessed for eye irritation potential with HET-CAM and Neutral-Red Uptake in vitro assays, was slightly irritating in a HET-CAM and non irritant in the; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2611-82-7","citation":"","dose":"SCCNFP/0792/04 Evaluation and opinion on Acid Red 18 _____________________________________________________________________________________________ 15 Concentration of dye in the formulation = 0.5 % Systemic exposure dose (SED) = 0.29 mg/kg/day No observed effect level (mg/kg) NOAEL = 1000 mg/kg Margin of Safety NOAEL / SED = 3429 2.12.","duration":"","effect":"SCCNFP/0792/04 Evaluation and opinion on Acid Red 18 _____________________________________________________________________________________________ 15 Concentration of dye in the formulation = 0.5 % Systemic exposure dose (SED) = 0.29 mg/kg/day No observed effect level (mg/kg) NOAEL = 1000 mg/kg Margin of Safety NOAEL / SED = 3429 2.12. Conclusions Acid Red 18 has low toxicity. In rats fed Acid Red 18, the LD50 is >8000 mg/kg bw. A NOEL was considered to be 500 mg/kg bw/day (1 % Acid Red 18 in the diet) in rats. Acid Red 18 was not considered maternotoxic or foetotoxic. No data on skin irritation. 1% aqueous solution of Acid Red 18, assessed for eye irritation potential with HET-CAM and Neutral-Red Uptake in vitro assays, was slightly irritating in a HET-CAM and non irritant in the","endpoint":"irritation","ingredient":"Trisodium 7-hydroxy-8-[(E)-(4-sulfonato-1-naphthyl)-diazenyl)]-1,3","loael_value":"","noael_unit":"mg/kg bw","noael_value":">8000","page":15,"route":"oral","species":"rat","study_id":"out265_en_noael_006"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | irritation | 500 | mg/kg bw/day | rat | oral | - | irritation | SOURCE_SUBDIR=out265_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID RED 18 COLIPA n° C175; OPINION_NUMBER=SCCNFP/0792/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=500; DOSE=SCCNFP/0792/04 Evaluation and opinion on Acid Red 18 _____________________________________________________________________________________________ 15 Concentration of dye in the formulation = 0.5 % Systemic exposure dose (SED) = 0.29 mg/kg/day No observed effect level (mg/kg) NOAEL = 1000 mg/kg Margin of Safety NOAEL / SED = 3429 2.12.; EFFECT=SCCNFP/0792/04 Evaluation and opinion on Acid Red 18 _____________________________________________________________________________________________ 15 Concentration of dye in the formulation = 0.5 % Systemic exposure dose (SED) = 0.29 mg/kg/day No observed effect level (mg/kg) NOAEL = 1000 mg/kg Margin of Safety NOAEL / SED = 3429 2.12. Conclusions Acid Red 18 has low toxicity. In rats fed Acid Red 18, the LD50 is >8000 mg/kg bw. A NOEL was considered to be 500 mg/kg bw/day (1 % Acid Red 18 in the diet) in rats. Acid Red 18 was not considered maternotoxic or foetotoxic. No data on skin irritation. 1% aqueous solution of Acid Red 18, assessed for eye irritation potential with HET-CAM and Neutral-Red Uptake in vitro assays, was slightly irritating in a HET-CAM and non irritant in the NRU assays. These assays have limitations for use with coloured substances. Neither test has been validated. Acid Red 18 was classified as a non-sensitiser. The perc; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2611-82-7","citation":"","dose":"SCCNFP/0792/04 Evaluation and opinion on Acid Red 18 _____________________________________________________________________________________________ 15 Concentration of dye in the formulation = 0.5 % Systemic exposure dose (SED) = 0.29 mg/kg/day No observed effect level (mg/kg) NOAEL = 1000 mg/kg Margin of Safety NOAEL / SED = 3429 2.12.","duration":"","effect":"SCCNFP/0792/04 Evaluation and opinion on Acid Red 18 _____________________________________________________________________________________________ 15 Concentration of dye in the formulation = 0.5 % Systemic exposure dose (SED) = 0.29 mg/kg/day No observed effect level (mg/kg) NOAEL = 1000 mg/kg Margin of Safety NOAEL / SED = 3429 2.12. Conclusions Acid Red 18 has low toxicity. In rats fed Acid Red 18, the LD50 is >8000 mg/kg bw. A NOEL was considered to be 500 mg/kg bw/day (1 % Acid Red 18 in the diet) in rats. Acid Red 18 was not considered maternotoxic or foetotoxic. No data on skin irritation. 1% aqueous solution of Acid Red 18, assessed for eye irritation potential with HET-CAM and Neutral-Red Uptake in vitro assays, was slightly irritating in a HET-CAM and non irritant in the NRU assays. These assays have limitations for use with coloured substances. Neither test has been validated. Acid Red 18 was classified as a non-sensitiser. The perc","endpoint":"irritation","ingredient":"Trisodium 7-hydroxy-8-[(E)-(4-sulfonato-1-naphthyl)-diazenyl)]-1,3","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"500","page":15,"route":"oral","species":"rat","study_id":"out265_en_noael_007"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 500 | mg/kg bw/day | rat | oral | 90 days | repeated dose toxicity | SOURCE_SUBDIR=out265_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID RED 18 COLIPA n° C175; OPINION_NUMBER=SCCNFP/0792/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=500; DOSE=Repeated dose oral toxicity No data 2.3.5 Repeated dose dermal toxicity In rats, given up to 2% Acid Red 18 (approximately 1000 mg/kg bw/day) in diet, the main treatment-related effects were increased serum transaminase in both sexes and decreased haematological indices (depressed red cell counts, decreased haemoglobin concentration and haematoc...; EFFECT=ata 2.3.4. Repeated dose oral toxicity No data 2.3.5 Repeated dose dermal toxicity In rats, given up to 2% Acid Red 18 (approximately 1000 mg/kg bw/day) in diet, the main treatment-related effects were increased serum transaminase in both sexes and decreased haematological indices (depressed red cell counts, decreased haemoglobin concentration and haematocrit value) mainly in females. Based on the increased transaminase levels (suggesting potential liver injury) and blood parameters in the high dose group, the NOEL was considered to be 500 mg/kg bw/day (1 % Acid Red 18 in the diet). Ref.: 4 At higher doses (> 1250 mg/kg bw/day) administered in other rat studies, effects were noted in the liver, heart, adrenal gland, caecum, brain arteries, testes and bodyweight development. Ref.: 2 Mild and transient anaemia (reduced haemoglobin, haematocrit and red blood cell number) was seen in male pigs given 900 mg/kg bw/day in the diet for 90 days. A NOEL of 300 mg/kg bw/day was derived from this study. Ref.: 2, 3 2.3.6. Repeated d; CITATION=Ref.: 4 At higher doses (> 1250 mg/kg bw/day) administered in other rat studies, effects were noted in the liver, heart, adrenal gland, caecum, brain arteries, testes and bodyweight deve; CITATION_NUMBERS=[4,1250]; REFERENCE=Ref.: 4 At higher doses (> 1250 mg/kg bw/day) administered in other rat studies, effects were noted in the liver, heart, adrenal gland, caecum, brain arteries, testes and bodyweight deve; DETAILS_JSON={"cas_number":"2611-82-7","citation":"Ref.: 4 At higher doses (> 1250 mg/kg bw/day) administered in other rat studies, effects were noted in the liver, heart, adrenal gland, caecum, brain arteries, testes and bodyweight deve","dose":"Repeated dose oral toxicity No data 2.3.5 Repeated dose dermal toxicity In rats, given up to 2% Acid Red 18 (approximately 1000 mg/kg bw/day) in diet, the main treatment-related effects were increased serum transaminase in both sexes and decreased haematological indices (depressed red cell counts, decreased haemoglobin concentration and haematoc...","duration":"90 days","effect":"ata 2.3.4. Repeated dose oral toxicity No data 2.3.5 Repeated dose dermal toxicity In rats, given up to 2% Acid Red 18 (approximately 1000 mg/kg bw/day) in diet, the main treatment-related effects were increased serum transaminase in both sexes and decreased haematological indices (depressed red cell counts, decreased haemoglobin concentration and haematocrit value) mainly in females. Based on the increased transaminase levels (suggesting potential liver injury) and blood parameters in the high dose group, the NOEL was considered to be 500 mg/kg bw/day (1 % Acid Red 18 in the diet). Ref.: 4 At higher doses (> 1250 mg/kg bw/day) administered in other rat studies, effects were noted in the liver, heart, adrenal gland, caecum, brain arteries, testes and bodyweight development. Ref.: 2 Mild and transient anaemia (reduced haemoglobin, haematocrit and red blood cell number) was seen in male pigs given 900 mg/kg bw/day in the diet for 90 days. A NOEL of 300 mg/kg bw/day was derived from this study. Ref.: 2, 3 2.3.6. Repeated d","endpoint":"repeated dose toxicity","ingredient":"Trisodium 7-hydroxy-8-[(E)-(4-sulfonato-1-naphthyl)-diazenyl)]-1,3","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"500","page":6,"route":"oral","species":"rat","study_id":"out265_en_noael_001"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 300 | mg/kg bw/day | rat | oral | 90 days | repeated dose toxicity | SOURCE_SUBDIR=out265_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID RED 18 COLIPA n° C175; OPINION_NUMBER=SCCNFP/0792/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=300; DOSE=sting potential liver injury) and blood parameters in the high dose group, the NOEL was considered to be 500 mg/kg bw/day (1 % Acid Red 18 in the diet).; EFFECT=sting potential liver injury) and blood parameters in the high dose group, the NOEL was considered to be 500 mg/kg bw/day (1 % Acid Red 18 in the diet). Ref.: 4 At higher doses (> 1250 mg/kg bw/day) administered in other rat studies, effects were noted in the liver, heart, adrenal gland, caecum, brain arteries, testes and bodyweight development. Ref.: 2 Mild and transient anaemia (reduced haemoglobin, haematocrit and red blood cell number) was seen in male pigs given 900 mg/kg bw/day in the diet for 90 days. A NOEL of 300 mg/kg bw/day was derived from this study. Ref.: 2, 3 2.3.6. Repeated dose inhalation toxicity No data 2.3.7. Subchronic oral toxicity No data; CITATION=Ref.: 4 At higher doses (> 1250 mg/kg bw/day) administered in other rat studies, effects were noted in the liver, heart, adrenal gland, caecum, brain arteries, testes and bodyweight deve; CITATION_NUMBERS=[4,1250]; REFERENCE=Ref.: 4 At higher doses (> 1250 mg/kg bw/day) administered in other rat studies, effects were noted in the liver, heart, adrenal gland, caecum, brain arteries, testes and bodyweight deve; DETAILS_JSON={"cas_number":"2611-82-7","citation":"Ref.: 4 At higher doses (> 1250 mg/kg bw/day) administered in other rat studies, effects were noted in the liver, heart, adrenal gland, caecum, brain arteries, testes and bodyweight deve","dose":"sting potential liver injury) and blood parameters in the high dose group, the NOEL was considered to be 500 mg/kg bw/day (1 % Acid Red 18 in the diet).","duration":"90 days","effect":"sting potential liver injury) and blood parameters in the high dose group, the NOEL was considered to be 500 mg/kg bw/day (1 % Acid Red 18 in the diet). Ref.: 4 At higher doses (> 1250 mg/kg bw/day) administered in other rat studies, effects were noted in the liver, heart, adrenal gland, caecum, brain arteries, testes and bodyweight development. Ref.: 2 Mild and transient anaemia (reduced haemoglobin, haematocrit and red blood cell number) was seen in male pigs given 900 mg/kg bw/day in the diet for 90 days. A NOEL of 300 mg/kg bw/day was derived from this study. Ref.: 2, 3 2.3.6. Repeated dose inhalation toxicity No data 2.3.7. Subchronic oral toxicity No data","endpoint":"repeated dose toxicity","ingredient":"Trisodium 7-hydroxy-8-[(E)-(4-sulfonato-1-naphthyl)-diazenyl)]-1,3","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"300","page":6,"route":"oral","species":"rat","study_id":"out265_en_noael_002"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | reproductive toxicity | >1 | % | rat | oral | - | reproductive toxicity | SOURCE_SUBDIR=out265_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID RED 18 COLIPA n° C175; OPINION_NUMBER=SCCNFP/0792/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=> 1; DOSE=No effects were noted on bodyweight development, except in the high dose group where there were significantly higher values for survival rate and lactation index.; EFFECT=oups. There were no treatment related effects with regard to litter size, foetal mortality, foetal bodyweight or external malformations. Similarly, no treatment-related skeletal effects were noted. The postnatal development was not affected by Acid Red 18. No effects were noted on bodyweight development, except in the high dose group where there were significantly higher values for survival rate and lactation index. No adverse effect was noted with regard to the general and sexual development of the offspring. A NOEL of > 1 % in the diet, approximately 1200 mg/kg bw/day was derived from this study. Ref.: 9 In other studies, particularly a 3-generation feeding study in rats, there were no indications of toxicity to the developing foetuses up to the highest dose, 1250 mg/kg bw. Animals in all dose groups showed a pink coloration of the fur and soft faeces in the two highest dose groups. No treatment-related effects were noted with regard to the observed mortalities, food intake and bodyweight development. Neither fertility no; CITATION=Ref.: 9 In other studies, particularly a 3-generation feeding study in rats, there were no indications of toxicity to the developing foetuses up to the highest dose, 1250 mg/kg bw; CITATION_NUMBERS=[9,3,1250]; REFERENCE=Ref.: 9 In other studies, particularly a 3-generation feeding study in rats, there were no indications of toxicity to the developing foetuses up to the highest dose, 1250 mg/kg bw; DETAILS_JSON={"cas_number":"2611-82-7","citation":"Ref.: 9 In other studies, particularly a 3-generation feeding study in rats, there were no indications of toxicity to the developing foetuses up to the highest dose, 1250 mg/kg bw","dose":"No effects were noted on bodyweight development, except in the high dose group where there were significantly higher values for survival rate and lactation index.","duration":"","effect":"oups. There were no treatment related effects with regard to litter size, foetal mortality, foetal bodyweight or external malformations. Similarly, no treatment-related skeletal effects were noted. The postnatal development was not affected by Acid Red 18. No effects were noted on bodyweight development, except in the high dose group where there were significantly higher values for survival rate and lactation index. No adverse effect was noted with regard to the general and sexual development of the offspring. A NOEL of > 1 % in the diet, approximately 1200 mg/kg bw/day was derived from this study. Ref.: 9 In other studies, particularly a 3-generation feeding study in rats, there were no indications of toxicity to the developing foetuses up to the highest dose, 1250 mg/kg bw. Animals in all dose groups showed a pink coloration of the fur and soft faeces in the two highest dose groups. No treatment-related effects were noted with regard to the observed mortalities, food intake and bodyweight development. Neither fertility no","endpoint":"reproductive toxicity","ingredient":"Trisodium 7-hydroxy-8-[(E)-(4-sulfonato-1-naphthyl)-diazenyl)]-1,3","loael_value":"","noael_unit":"%","noael_value":"> 1","page":10,"route":"oral","species":"rat","study_id":"out265_en_noael_004"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | Z525CBK9PG | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C20H11N2O10S3.3Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"Z525CBK9PG"} |
| openFDA substances | FDA UNII substance identifier | Z525CBK9PG | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C20H11N2O10S3.3Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"Z525CBK9PG"} |
| openFDA substances | FDA UNII substance identifier | Z525CBK9PG | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C20H11N2O10S3.3Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"Z525CBK9PG"} |
| openFDA substances | FDA UNII substance identifier | Z525CBK9PG | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C20H11N2O10S3.3Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"Z525CBK9PG"} |