NOAEL Studies Cosmetic Ingredient

Glyoxal NOAEL Studies

INCI: GLYOXAL

CAS: 107-22-2

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 >300 mg/kg/day rabbit oral - developmental toxicity {"citation":"300; 150; 200, 800","dose":"of the high-dose group.","effect":"of the high-dose group. Maternal body weight gain was decreased in dams of the 300 mg/kg/day group compared to control dams. Rooting behavior was noted in animals of the 150 and 300 mg/kg/day groups but decreased after the dosing period was completed. At necropsy, no dose-related effects were noted on maternal liver weight. No differences were noted between treated and control animals in the frequency of postimplanta- tion loss, mean fetal body weight per litter, or external, visceral, or skeletal malformations. A no-observable-adverse-effect level (NOAEL) of >300 mg/kg/day was established. At that dose mild maternal toxicity was indicated by reduced maternal body weight and feed consumption (NTP 1994). In a pilot study using pregnant New Zealand white rabbits, Glyoxal Trimeric Dihydrate, at doses of 200, 800, 1000, 1200, and 1500 mg/kg/day, was administered by gavage on GD 6 to 19. Maternal mortality was 100% at doses >800 mg/kg/day. Ma- ternal weight gain and corrected weight gain were below values for controls, but the differences were not statistically significant. One of seve...","page":7,"pdf":"pr269.pdf","row_type":"noael_study","study_id":"pr269_noael_001"}
CIR_vision_codex NOAEL <50 mg/kg/day rat oral - developmental toxicity {"citation":"30; 6; 9","dose":"The NOAEL for maternal effects was <50 mg/kg/day and the level for developmental tox- icity was 50 mg/kg/day (NTP 1993).","effect":"o severe toxicity observed at larger doses (unpublished data). Rabbits were killed on GD 30. A re- duction in feed consumption and body weight gain was noted during the dosing period. The reduction in body weight gain was significant on GD 6 to 9. No treatment-related effect on maternal liver weight was noted at necropsy. No differences were noted between treated and control animals in the frequency of postim- plantation loss, mean fetal body weight per litter, or external, visceral, or skeletal malformations. The NOAEL for maternal effects was <50 mg/kg/day and the level for developmental tox- icity was 50 mg/kg/day (NTP 1993). GENOTOXICITY Glyoxal is reported to be a mutagen in renaturation assays, unscheduled DNA synthesis (UDS) assays, the Ames assay, the Escherichia coli SOS chromotest, the Bacillus subtilis liquid rec-assay, the rat hepatocyte primary DNA repair test (single strand breaks found, but no DNA cross-linking), sister chromatid exchange assays, Chinese hamster ovary (CHO) and Chinese hamster V79 chromosome aberration assays, the CHO/HGPRT gene mutation assay (only...","page":7,"pdf":"pr269.pdf","row_type":"noael_study","study_id":"pr269_noael_002"}
CIR_vision_codex NOAEL =100 mg/kg/day rat oral 28-day oral toxicity {"citation":"28; 100; 300","dose":"A 28-day drinking water study noted significantly suppressed water intake and significantly reduced terminal body weight in rats which received > 100 mg/kg/day and >300 mg/kg/day, respectively.","effect":"species), dimer, and trimer. Residual chemicals that may be found in commercial solutions of Glyoxal include formaldehyde, glycolaldehyde, acetic acid, and a trace of ethylene glycol. A wide range of oral, dermal and intraperitoneal LDsn val- ues have been reported. A 28-day drinking water study noted significantly suppressed water intake and significantly reduced terminal body weight in rats which received > 100 mg/kg/day and >300 mg/kg/day, respectively. Three-month feeding stud- ies on rats and dogs reported a no-effect level of approximately 100 mg/kg/day. Ocular irritation studies conducted with Glyoxal solutions (30% and 40%) produced slight to moderate injury. Results are conflicting for Glyoxal powder; one study suggested severe dam- age whereas another found only slight damage. In dermal studies, Glyoxal powder was not an irritant whereas 40% Glyoxal solution produced negative to moderate irritation. In a guinea pig study using the Magnusson-Kligman protocol, a trade mixture containing 1.3% Glyoxal (tested at 0.00065%) induced sensitization. A guinea pig study using the R...","page":12,"pdf":"pr269.pdf","row_type":"noael_study","study_id":"pr269_noael_003"}
CIR_vision_codex NOAEL >300 mg/kg/day rabbit oral - developmental toxicity {"citation":"300; 150; 200, 800","dose":"of the high-dose group.","effect":"of the high-dose group. Maternal body weight gain was decreased in dams of the 300 mg/kg/day group compared to control dams. Rooting behavior was noted in animals of the 150 and 300 mg/kg/day groups but decreased after the dosing period was completed. At necropsy, no dose-related effects were noted on maternal liver weight. No differences were noted between treated and control animals in the frequency of postimplanta- tion loss, mean fetal body weight per litter, or external, visceral, or skeletal malformations. A no-observable-adverse-effect level (NOAEL) of >300 mg/kg/day was established. At that dose mild maternal toxicity was indicated by reduced maternal body weight and feed consumption (NTP 1994). In a pilot study using pregnant New Zealand white rabbits, Glyoxal Trimeric Dihydrate, at doses of 200, 800, 1000, 1200, and 1500 mg/kg/day, was administered by gavage on GD 6 to 19. Maternal mortality was 100% at doses >800 mg/kg/day. Ma- ternal weight gain and corrected weight gain were below values for controls, but the differences were not statistically significant. One of seve...","page":7,"pdf":"pr269.pdf","row_type":"noael_study","study_id":"pr269_noael_001"}
CIR_vision_codex NOAEL <50 mg/kg/day rat oral - developmental toxicity {"citation":"30; 6; 9","dose":"The NOAEL for maternal effects was <50 mg/kg/day and the level for developmental tox- icity was 50 mg/kg/day (NTP 1993).","effect":"o severe toxicity observed at larger doses (unpublished data). Rabbits were killed on GD 30. A re- duction in feed consumption and body weight gain was noted during the dosing period. The reduction in body weight gain was significant on GD 6 to 9. No treatment-related effect on maternal liver weight was noted at necropsy. No differences were noted between treated and control animals in the frequency of postim- plantation loss, mean fetal body weight per litter, or external, visceral, or skeletal malformations. The NOAEL for maternal effects was <50 mg/kg/day and the level for developmental tox- icity was 50 mg/kg/day (NTP 1993). GENOTOXICITY Glyoxal is reported to be a mutagen in renaturation assays, unscheduled DNA synthesis (UDS) assays, the Ames assay, the Escherichia coli SOS chromotest, the Bacillus subtilis liquid rec-assay, the rat hepatocyte primary DNA repair test (single strand breaks found, but no DNA cross-linking), sister chromatid exchange assays, Chinese hamster ovary (CHO) and Chinese hamster V79 chromosome aberration assays, the CHO/HGPRT gene mutation assay (only...","page":7,"pdf":"pr269.pdf","row_type":"noael_study","study_id":"pr269_noael_002"}
CIR_vision_codex NOAEL =100 mg/kg/day rat oral 28-day oral toxicity {"citation":"28; 100; 300","dose":"A 28-day drinking water study noted significantly suppressed water intake and significantly reduced terminal body weight in rats which received > 100 mg/kg/day and >300 mg/kg/day, respectively.","effect":"species), dimer, and trimer. Residual chemicals that may be found in commercial solutions of Glyoxal include formaldehyde, glycolaldehyde, acetic acid, and a trace of ethylene glycol. A wide range of oral, dermal and intraperitoneal LDsn val- ues have been reported. A 28-day drinking water study noted significantly suppressed water intake and significantly reduced terminal body weight in rats which received > 100 mg/kg/day and >300 mg/kg/day, respectively. Three-month feeding stud- ies on rats and dogs reported a no-effect level of approximately 100 mg/kg/day. Ocular irritation studies conducted with Glyoxal solutions (30% and 40%) produced slight to moderate injury. Results are conflicting for Glyoxal powder; one study suggested severe dam- age whereas another found only slight damage. In dermal studies, Glyoxal powder was not an irritant whereas 40% Glyoxal solution produced negative to moderate irritation. In a guinea pig study using the Magnusson-Kligman protocol, a trade mixture containing 1.3% Glyoxal (tested at 0.00065%) induced sensitization. A guinea pig study using the R...","page":12,"pdf":"pr269.pdf","row_type":"noael_study","study_id":"pr269_noael_003"}
CIR_vision_codex NOAEL >300 mg/kg/day rabbit oral - developmental toxicity {"citation":"300; 150; 200, 800","dose":"of the high-dose group.","effect":"of the high-dose group. Maternal body weight gain was decreased in dams of the 300 mg/kg/day group compared to control dams. Rooting behavior was noted in animals of the 150 and 300 mg/kg/day groups but decreased after the dosing period was completed. At necropsy, no dose-related effects were noted on maternal liver weight. No differences were noted between treated and control animals in the frequency of postimplanta- tion loss, mean fetal body weight per litter, or external, visceral, or skeletal malformations. A no-observable-adverse-effect level (NOAEL) of >300 mg/kg/day was established. At that dose mild maternal toxicity was indicated by reduced maternal body weight and feed consumption (NTP 1994). In a pilot study using pregnant New Zealand white rabbits, Glyoxal Trimeric Dihydrate, at doses of 200, 800, 1000, 1200, and 1500 mg/kg/day, was administered by gavage on GD 6 to 19. Maternal mortality was 100% at doses >800 mg/kg/day. Ma- ternal weight gain and corrected weight gain were below values for controls, but the differences were not statistically significant. One of seve...","page":7,"pdf":"pr269.pdf","row_type":"noael_study","study_id":"pr269_noael_001"}
CIR_vision_codex NOAEL <50 mg/kg/day rat oral - developmental toxicity {"citation":"30; 6; 9","dose":"The NOAEL for maternal effects was <50 mg/kg/day and the level for developmental tox- icity was 50 mg/kg/day (NTP 1993).","effect":"o severe toxicity observed at larger doses (unpublished data). Rabbits were killed on GD 30. A re- duction in feed consumption and body weight gain was noted during the dosing period. The reduction in body weight gain was significant on GD 6 to 9. No treatment-related effect on maternal liver weight was noted at necropsy. No differences were noted between treated and control animals in the frequency of postim- plantation loss, mean fetal body weight per litter, or external, visceral, or skeletal malformations. The NOAEL for maternal effects was <50 mg/kg/day and the level for developmental tox- icity was 50 mg/kg/day (NTP 1993). GENOTOXICITY Glyoxal is reported to be a mutagen in renaturation assays, unscheduled DNA synthesis (UDS) assays, the Ames assay, the Escherichia coli SOS chromotest, the Bacillus subtilis liquid rec-assay, the rat hepatocyte primary DNA repair test (single strand breaks found, but no DNA cross-linking), sister chromatid exchange assays, Chinese hamster ovary (CHO) and Chinese hamster V79 chromosome aberration assays, the CHO/HGPRT gene mutation assay (only...","page":7,"pdf":"pr269.pdf","row_type":"noael_study","study_id":"pr269_noael_002"}
CIR_vision_codex NOAEL =100 mg/kg/day rat oral 28-day oral toxicity {"citation":"28; 100; 300","dose":"A 28-day drinking water study noted significantly suppressed water intake and significantly reduced terminal body weight in rats which received > 100 mg/kg/day and >300 mg/kg/day, respectively.","effect":"species), dimer, and trimer. Residual chemicals that may be found in commercial solutions of Glyoxal include formaldehyde, glycolaldehyde, acetic acid, and a trace of ethylene glycol. A wide range of oral, dermal and intraperitoneal LDsn val- ues have been reported. A 28-day drinking water study noted significantly suppressed water intake and significantly reduced terminal body weight in rats which received > 100 mg/kg/day and >300 mg/kg/day, respectively. Three-month feeding stud- ies on rats and dogs reported a no-effect level of approximately 100 mg/kg/day. Ocular irritation studies conducted with Glyoxal solutions (30% and 40%) produced slight to moderate injury. Results are conflicting for Glyoxal powder; one study suggested severe dam- age whereas another found only slight damage. In dermal studies, Glyoxal powder was not an irritant whereas 40% Glyoxal solution produced negative to moderate irritation. In a guinea pig study using the Magnusson-Kligman protocol, a trade mixture containing 1.3% Glyoxal (tested at 0.00065%) induced sensitization. A guinea pig study using the R...","page":12,"pdf":"pr269.pdf","row_type":"noael_study","study_id":"pr269_noael_003"}
CIR_vision_codex NOAEL >300 mg/kg/day rabbit oral - developmental toxicity {"citation":"300; 150; 200, 800","dose":"of the high-dose group.","effect":"of the high-dose group. Maternal body weight gain was decreased in dams of the 300 mg/kg/day group compared to control dams. Rooting behavior was noted in animals of the 150 and 300 mg/kg/day groups but decreased after the dosing period was completed. At necropsy, no dose-related effects were noted on maternal liver weight. No differences were noted between treated and control animals in the frequency of postimplanta- tion loss, mean fetal body weight per litter, or external, visceral, or skeletal malformations. A no-observable-adverse-effect level (NOAEL) of >300 mg/kg/day was established. At that dose mild maternal toxicity was indicated by reduced maternal body weight and feed consumption (NTP 1994). In a pilot study using pregnant New Zealand white rabbits, Glyoxal Trimeric Dihydrate, at doses of 200, 800, 1000, 1200, and 1500 mg/kg/day, was administered by gavage on GD 6 to 19. Maternal mortality was 100% at doses >800 mg/kg/day. Ma- ternal weight gain and corrected weight gain were below values for controls, but the differences were not statistically significant. One of seve...","page":7,"pdf":"pr269.pdf","row_type":"noael_study","study_id":"pr269_noael_001"}
CIR_vision_codex NOAEL <50 mg/kg/day rat oral - developmental toxicity {"citation":"30; 6; 9","dose":"The NOAEL for maternal effects was <50 mg/kg/day and the level for developmental tox- icity was 50 mg/kg/day (NTP 1993).","effect":"o severe toxicity observed at larger doses (unpublished data). Rabbits were killed on GD 30. A re- duction in feed consumption and body weight gain was noted during the dosing period. The reduction in body weight gain was significant on GD 6 to 9. No treatment-related effect on maternal liver weight was noted at necropsy. No differences were noted between treated and control animals in the frequency of postim- plantation loss, mean fetal body weight per litter, or external, visceral, or skeletal malformations. The NOAEL for maternal effects was <50 mg/kg/day and the level for developmental tox- icity was 50 mg/kg/day (NTP 1993). GENOTOXICITY Glyoxal is reported to be a mutagen in renaturation assays, unscheduled DNA synthesis (UDS) assays, the Ames assay, the Escherichia coli SOS chromotest, the Bacillus subtilis liquid rec-assay, the rat hepatocyte primary DNA repair test (single strand breaks found, but no DNA cross-linking), sister chromatid exchange assays, Chinese hamster ovary (CHO) and Chinese hamster V79 chromosome aberration assays, the CHO/HGPRT gene mutation assay (only...","page":7,"pdf":"pr269.pdf","row_type":"noael_study","study_id":"pr269_noael_002"}
CIR_vision_codex NOAEL =100 mg/kg/day rat oral 28-day oral toxicity {"citation":"28; 100; 300","dose":"A 28-day drinking water study noted significantly suppressed water intake and significantly reduced terminal body weight in rats which received > 100 mg/kg/day and >300 mg/kg/day, respectively.","effect":"species), dimer, and trimer. Residual chemicals that may be found in commercial solutions of Glyoxal include formaldehyde, glycolaldehyde, acetic acid, and a trace of ethylene glycol. A wide range of oral, dermal and intraperitoneal LDsn val- ues have been reported. A 28-day drinking water study noted significantly suppressed water intake and significantly reduced terminal body weight in rats which received > 100 mg/kg/day and >300 mg/kg/day, respectively. Three-month feeding stud- ies on rats and dogs reported a no-effect level of approximately 100 mg/kg/day. Ocular irritation studies conducted with Glyoxal solutions (30% and 40%) produced slight to moderate injury. Results are conflicting for Glyoxal powder; one study suggested severe dam- age whereas another found only slight damage. In dermal studies, Glyoxal powder was not an irritant whereas 40% Glyoxal solution produced negative to moderate irritation. In a guinea pig study using the Magnusson-Kligman protocol, a trade mixture containing 1.3% Glyoxal (tested at 0.00065%) induced sensitization. A guinea pig study using the R...","page":12,"pdf":"pr269.pdf","row_type":"noael_study","study_id":"pr269_noael_003"}
INCHEM_WHO_cicads_cicads_cicad57 20 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
INCHEM_WHO_cicads_cicads_cicad57 LOAEL =107 mg/kg bw/day Rat oral 90-day Subchronic toxicity document_id=cicads_cicads_cicad57; title=Glyoxal (Cicads 57, 2004); path=mirror/documents/cicads/cicads/cicad57.htm; row_hash=fb285543b88d62dc; raw_unit=mg/kg body weight per day; context=In a 90-day drinking-water study in rats examining more sensitive end-points, the lowest tested dosage of 107 mg/kg body weight per day (99% glyoxal) was given as the LOAEL for serum clinical parameters (Ueno et al., 1991a).
INCHEM_WHO_cicads_cicads_cicad57 LOAEL =107 mg/kg bw/day Rat oral 90-day Subchronic toxicity document_id=cicads_cicads_cicad57; title=Glyoxal (Cicads 57, 2004); path=mirror/documents/cicads/cicads/cicad57.htm; row_hash=fb285543b88d62dc; raw_unit=mg/kg body weight per day; context=In a 90-day drinking-water study in rats examining more sensitive end-points, the lowest tested dosage of 107 mg/kg body weight per day (99% glyoxal) was given as the LOAEL for serum clinical parameters (Ueno et al., 1991a).
INCHEM_WHO_cicads_cicads_cicad57 NOAEL =125 mg/kg bw/day Rat oral 90-day Subchronic toxicity document_id=cicads_cicads_cicad57; title=Glyoxal (Cicads 57, 2004); path=mirror/documents/cicads/cicads/cicad57.htm; row_hash=8e0704ed31771dee; raw_unit=mg/kg body weight per day; context=The 90-day feeding of glyoxal to rats resulted in a NOAEL of 125 mg/kg body weight per day (dosage corresponding to 100% glyoxal).
INCHEM_WHO_cicads_cicads_cicad57 NOAEL ~40 mg/kg bw Rat oral 90-day Subchronic toxicity document_id=cicads_cicads_cicad57; title=Glyoxal (Cicads 57, 2004); path=mirror/documents/cicads/cicads/cicad57.htm; row_hash=38d9aca49db1e4eb; raw_unit=mg/kg body weight; context=If not, the NOAEL would be about 40 mg/kg body weight adjusted to 100% glyoxal.) 8.3 Medium-term exposure In a 90-day feeding study, Wistar rats (10 males and 10 females per dose group) were exposed to glyoxal (40% preparation).
INCHEM_WHO_cicads_cicads_cicad57 NOAEL ~100 mg/kg bw/day - oral - Toxicology study document_id=cicads_cicads_cicad57; title=Glyoxal (Cicads 57, 2004); path=mirror/documents/cicads/cicads/cicad57.htm; row_hash=84419a8e6baf9cb5; raw_unit=mg/kg body weight per day; context=From studies on oral exposure, the NOAEL seems to be about 100 mg/kg body weight per day (adjusted to 100% glyoxal).
INCHEM_WHO_cicads_cicads_cicad57 NOAEL =25 mg/kg bw - - lifetime Chronic toxicity document_id=cicads_cicads_cicad57; title=Glyoxal (Cicads 57, 2004); path=mirror/documents/cicads/cicads/cicad57.htm; row_hash=f55d03ff8950e4a7; raw_unit=mg/kg body weight; context=The use of the lifetime extrapolation uncertainty factor (factor of 5) is also justified on the basis of the 125 mg/kg body weight LOAEL with wide dose spacing to a NOAEL of 25 mg/kg body weight (BASF & Clariant, 2000).
INCHEM_WHO_cicads_cicads_cicad57 NOAEL =125 mg/kg bw Rat - - Toxicology study document_id=cicads_cicads_cicad57; title=Glyoxal (Cicads 57, 2004); path=mirror/documents/cicads/cicads/cicad57.htm; row_hash=9ede73a4cd303453; raw_unit=mg/kg; context=Pour d'autres rats qui en avaient reçu pendant 90 jours dans leur alimentation, la NOAEL s'est révélée égale à 125 mg/kg de poids corporel par jour (dose correspondant à 100 % de glyoxal).
INCHEM_WHO_cicads_cicads_cicad57 NOAEL ~40 mg/kg bw Rat oral 90-day Subchronic toxicity document_id=cicads_cicads_cicad57; title=Glyoxal (Cicads 57, 2004); path=mirror/documents/cicads/cicads/cicad57.htm; row_hash=38d9aca49db1e4eb; raw_unit=mg/kg body weight; context=If not, the NOAEL would be about 40 mg/kg body weight adjusted to 100% glyoxal.) 8.3 Medium-term exposure In a 90-day feeding study, Wistar rats (10 males and 10 females per dose group) were exposed to glyoxal (40% preparation).
INCHEM_WHO_cicads_cicads_cicad57 NOAEL ~100 mg/kg bw/day - oral - Toxicology study document_id=cicads_cicads_cicad57; title=Glyoxal (Cicads 57, 2004); path=mirror/documents/cicads/cicads/cicad57.htm; row_hash=84419a8e6baf9cb5; raw_unit=mg/kg body weight per day; context=From studies on oral exposure, the NOAEL seems to be about 100 mg/kg body weight per day (adjusted to 100% glyoxal).
INCHEM_WHO_cicads_cicads_cicad57 NOAEL =25 mg/kg bw - - lifetime Chronic toxicity document_id=cicads_cicads_cicad57; title=Glyoxal (Cicads 57, 2004); path=mirror/documents/cicads/cicads/cicad57.htm; row_hash=f55d03ff8950e4a7; raw_unit=mg/kg body weight; context=The use of the lifetime extrapolation uncertainty factor (factor of 5) is also justified on the basis of the 125 mg/kg body weight LOAEL with wide dose spacing to a NOAEL of 25 mg/kg body weight (BASF & Clariant, 2000).
INCHEM_WHO_cicads_cicads_cicad57 NOAEL =125 mg/kg bw Rat - - Toxicology study document_id=cicads_cicads_cicad57; title=Glyoxal (Cicads 57, 2004); path=mirror/documents/cicads/cicads/cicad57.htm; row_hash=9ede73a4cd303453; raw_unit=mg/kg; context=Pour d'autres rats qui en avaient reçu pendant 90 jours dans leur alimentation, la NOAEL s'est révélée égale à 125 mg/kg de poids corporel par jour (dose correspondant à 100 % de glyoxal).
INCHEM_WHO_cicads_cicads_cicad57 NOEL >8.9 mg/m3 Rat inhalation 29-day Inhalation toxicity document_id=cicads_cicads_cicad57; title=Glyoxal (Cicads 57, 2004); path=mirror/documents/cicads/cicads/cicad57.htm; row_hash=7b72322d14d89674; raw_unit=mg/m 3; context=29-day) inhalation exposure of rats to glyoxal showed a no-observed-effect level (NOEL) of 0.6 mg/m 3 (nominal concentration was 0.4 mg/m 3 ) for local effects in the larynx and a NOEL of >8.9 mg/m 3 (nominal concentration was 10 mg/m 3 ) for systemic effects (examination of body weight, haematological and biochemical parameters, urine analysis, macroscopic and histological examination).
INCHEM_WHO_cicads_cicads_cicad57 NOEL =0.6 mg/m3 Rat inhalation 29-day Inhalation toxicity document_id=cicads_cicads_cicad57; title=Glyoxal (Cicads 57, 2004); path=mirror/documents/cicads/cicads/cicad57.htm; row_hash=16ad53bb58358bfc; raw_unit=mg/m 3; context=Taking the 29-day inhalation study in rats exposed to glyoxal, which showed a NOEL of 0.6 mg/m 3 for local effects in the larynx, and using uncertainty factors of 10 for interspecies differences and 10 for interindividual differences, a tolerable concentration of 6 ug/m 3 for local effects in the larynx for short-term exposure was estimated.
INCHEM_WHO_cicads_cicads_cicad57 NOEL >115 mg/kg bw/day Dog oral 90-day Subchronic toxicity document_id=cicads_cicads_cicad57; title=Glyoxal (Cicads 57, 2004); path=mirror/documents/cicads/cicads/cicad57.htm; row_hash=a1850408a020af8c; raw_unit=mg/kg body weight per day; context=The NOEL for 90-day feeding of glyoxal to dogs was >115 mg/kg body weight per day (dosage corresponding to 100% glyoxal) (Mellon Institute, 1966).
INCHEM_WHO_cicads_cicads_cicad57 NOEL =6 mg/m3 Human; Rat - - Toxicology study document_id=cicads_cicads_cicad57; title=Glyoxal (Cicads 57, 2004); path=mirror/documents/cicads/cicads/cicad57.htm; row_hash=820e25519f9fffa5; raw_unit=mg/m 3; context=Des études au cours desquelles on a fait inhaler du glyoxal à des rats pendant une courte période (29 jours), montrent que la dose sans effet observable au niveau du larynx (NOEL) est de 0,6 mg/m 3 (concentration nominale égale à 0,4 mg/m 3 ), la dose sans effets généraux observables (contrôle du poids corporel, des paramètres hématologiques et biochimiques, analyse d'urine, examen macroscopique et histologique) étant supérieure à 8.9 mg/m 3 (concentrat
INCHEM_WHO_cicads_cicads_cicad57 NOEL =9 mg/m3 Human - - Toxicology study document_id=cicads_cicads_cicad57; title=Glyoxal (Cicads 57, 2004); path=mirror/documents/cicads/cicads/cicad57.htm; row_hash=9a6acd6607a276a1; raw_unit=mg/m 3; context=ción se puso de manifiesto una concentración sin efectos observados (NOEL) de 0,6 mg/m 3 (la concentración nominal fue de 0,4 mg/m 3 ) para los efectos locales en la laringe y una NOEL de >8,9 mg/m 3 (la concentración nominal fue de 10 mg/m 3 ) para los efectos sistémicos (examen del peso corporal, parámetros hematológicos y bioquímicos, análisis de orina, examen macroscópico e histológico).
INCHEM_WHO_cicads_cicads_cicad57 NOEL =0.6 mg/m3 Rat inhalation 29-day Inhalation toxicity document_id=cicads_cicads_cicad57; title=Glyoxal (Cicads 57, 2004); path=mirror/documents/cicads/cicads/cicad57.htm; row_hash=16ad53bb58358bfc; raw_unit=mg/m 3; context=Taking the 29-day inhalation study in rats exposed to glyoxal, which showed a NOEL of 0.6 mg/m 3 for local effects in the larynx, and using uncertainty factors of 10 for interspecies differences and 10 for interindividual differences, a tolerable concentration of 6 ug/m 3 for local effects in the larynx for short-term exposure was estimated.
INCHEM_WHO_cicads_cicads_cicad57 NOEL >115 mg/kg bw/day Dog oral 90-day Subchronic toxicity document_id=cicads_cicads_cicad57; title=Glyoxal (Cicads 57, 2004); path=mirror/documents/cicads/cicads/cicad57.htm; row_hash=a1850408a020af8c; raw_unit=mg/kg body weight per day; context=The NOEL for 90-day feeding of glyoxal to dogs was >115 mg/kg body weight per day (dosage corresponding to 100% glyoxal) (Mellon Institute, 1966).
INCHEM_WHO_cicads_cicads_cicad57 NOEL =6 mg/m3 Human; Rat - - Toxicology study document_id=cicads_cicads_cicad57; title=Glyoxal (Cicads 57, 2004); path=mirror/documents/cicads/cicads/cicad57.htm; row_hash=820e25519f9fffa5; raw_unit=mg/m 3; context=Des études au cours desquelles on a fait inhaler du glyoxal à des rats pendant une courte période (29 jours), montrent que la dose sans effet observable au niveau du larynx (NOEL) est de 0,6 mg/m 3 (concentration nominale égale à 0,4 mg/m 3 ), la dose sans effets généraux observables (contrôle du poids corporel, des paramètres hématologiques et biochimiques, analyse d'urine, examen macroscopique et histologique) étant supérieure à 8.9 mg/m 3 (concentrat
INCHEM_WHO_cicads_cicads_cicad57 NOEL =9 mg/m3 Human - - Toxicology study document_id=cicads_cicads_cicad57; title=Glyoxal (Cicads 57, 2004); path=mirror/documents/cicads/cicads/cicad57.htm; row_hash=9a6acd6607a276a1; raw_unit=mg/m 3; context=ción se puso de manifiesto una concentración sin efectos observados (NOEL) de 0,6 mg/m 3 (la concentración nominal fue de 0,4 mg/m 3 ) para los efectos locales en la laringe y una NOEL de >8,9 mg/m 3 (la concentración nominal fue de 10 mg/m 3 ) para los efectos sistémicos (examen del peso corporal, parámetros hematológicos y bioquímicos, análisis de orina, examen macroscópico e histológico).
NTP_ICE_acute_inhalation 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_acute_inhalation LC50 2.44 mg/L - Inhalation Duration=4 hr In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity sheet=Data; excel_row=2904; Record_ID=acute_inhalation_532; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response=2.44; Response_Unit=mg/L; Reference=REACH; URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/16112/7/3/3/?documentUUID=850f84ca-6a81-47d6-8559-881943a66d05; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_acute_inhalation LC50 2.47 mg/L - Inhalation Duration=4 hr In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity sheet=Data; excel_row=2905; Record_ID=acute_inhalation_533; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response=2.47; Response_Unit=mg/L; Reference=REACH; URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/16112/7/3/3/?documentUUID=850f84ca-6a81-47d6-8559-881943a66d05; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_acute_inhalation LC50 >11.56 mg/L - Inhalation Duration=7 hr In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity sheet=Data; excel_row=2906; Record_ID=acute_inhalation_534; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response_Modifier=>; Response=11.56; Response_Unit=mg/L; Reference=REACH; URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/16112/7/3/3/?documentUUID=aad62e23-9cea-42dc-b275-bc394f7707f0; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_acute_inhalation LC50 2.41 mg/L - Inhalation Duration=4 hr In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity sheet=Data; excel_row=2907; Record_ID=acute_inhalation_2748; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response=2.41; Response_Unit=mg/L; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_acute_oral 7 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_acute_oral LD50 =4290 mg/kg bw Rat oral acute Rat Acute Oral Toxicity NLM ChemIDplus TEST (undated); record_id=acute_oral_1292; row=8882; data_type=In Vivo; mixture=Chemical; chemical_name=Glyoxal; preferred_name=Glyoxal; dtxsid=DTXSID5025364; url=https://chem.nlm.nih.gov/chemidplus/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID5025364; source_file=acute_oral.xlsx
NTP_ICE_acute_oral LD50 =7070 mg/kg bw Rat oral acute Rat Acute Oral Toxicity NLM Hazardous Substances Data Bank (undated); record_id=acute_oral_1294; row=8883; data_type=In Vivo; mixture=Chemical; chemical_name=Glyoxal; preferred_name=Glyoxal; dtxsid=DTXSID5025364; url=https://pubchem.ncbi.nlm.nih.gov/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID5025364; source_file=acute_oral.xlsx
NTP_ICE_acute_oral LD50 =200 mg/kg bw Rat oral acute Rat Acute Oral Toxicity NLM ChemIDplus TEST (undated); record_id=acute_oral_1282; row=8884; data_type=In Vivo; mixture=Chemical; chemical_name=Glyoxal; preferred_name=Glyoxal; dtxsid=DTXSID5025364; url=https://chem.nlm.nih.gov/chemidplus/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID5025364; source_file=acute_oral.xlsx
NTP_ICE_acute_oral LD50 =762 mg/kg bw Rat oral acute Rat Acute Oral Toxicity NLM Hazardous Substances Data Bank (undated); record_id=acute_oral_1285; row=8885; data_type=In Vivo; mixture=Chemical; chemical_name=Glyoxal; preferred_name=Glyoxal; dtxsid=DTXSID5025364; url=https://pubchem.ncbi.nlm.nih.gov/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID5025364; source_file=acute_oral.xlsx
NTP_ICE_acute_oral LD50 =1400 mg/kg bw Rat oral acute Rat Acute Oral Toxicity NLM Hazardous Substances Data Bank (undated); record_id=acute_oral_1287; row=8886; data_type=In Vivo; mixture=Chemical; chemical_name=Glyoxal; preferred_name=Glyoxal; dtxsid=DTXSID5025364; url=https://pubchem.ncbi.nlm.nih.gov/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID5025364; source_file=acute_oral.xlsx
NTP_ICE_acute_oral LD50 =2000 mg/kg bw Rat oral acute Rat Acute Oral Toxicity record_id=acute_oral_1289; row=8887; data_type=In Vivo; mixture=Chemical; chemical_name=Glyoxal; preferred_name=Glyoxal; dtxsid=DTXSID5025364; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID5025364; source_file=acute_oral.xlsx
NTP_ICE_acute_oral LD50 =2960 mg/kg bw Rat oral acute Rat Acute Oral Toxicity NLM ChemIDplus TEST (undated); record_id=acute_oral_1290; row=8888; data_type=In Vivo; mixture=Chemical; chemical_name=Glyoxal; preferred_name=Glyoxal; dtxsid=DTXSID5025364; url=https://chem.nlm.nih.gov/chemidplus/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID5025364; source_file=acute_oral.xlsx
NTP_ICE_skin_sensitization 93 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_skin_sensitization CD54, EC200 286.7 ug/mL - Dermal - In Vitro; CE_hCLAT2018; h-CLAT sheet=Data_invitro; excel_row=2029; Record_ID=skin_sensitization_invitro_509; Data_Type=In Vitro; Internal_Data_Source=CE_hCLAT2018; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=h-CLAT; Endpoint=CD54, EC200; Reported_Response=286.7; Reported_Response_Unit=ug/mL; Response=286.7; Response_Unit=ug/mL; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization CD86, EC150 27.998 ug/mL - Dermal - In Vitro; Urbisch_SkinSensitization2020; U-SENS sheet=Data_invitro; excel_row=8269; Record_ID=skin_sensitization_invitro_2292; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=U-SENS; Endpoint=CD86, EC150; Reported_Response=482.4259132; Reported_Response_Unit=uM; Conversion_Factor_Value=58.036; Conversion_Factor_Source=EPA Dashboard; Converted_Response=27.998; Converted_Response_Unit=ug/mL; Response=27.998; Response_Unit=ug/mL; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization CD86, EC150 32.63 ug/mL - Dermal - In Vitro; CE_USENSE2018; U-SENS sheet=Data_invitro; excel_row=8534; Record_ID=skin_sensitization_invitro_2354; Data_Type=In Vitro; Internal_Data_Source=CE_USENSE2018; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=U-SENS; Endpoint=CD86, EC150; Reported_Response=32.63; Reported_Response_Unit=ug/mL; Response=32.63; Response_Unit=ug/mL; Reference=Piroird et al. 2015; 25820135; 10.1016/j.tiv.2015.03.009; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization CV70 92.79 ug/mL - Dermal - In Vitro; CE_USENSE2018; U-SENS sheet=Data_invitro; excel_row=8536; Record_ID=skin_sensitization_invitro_2354; Data_Type=In Vitro; Internal_Data_Source=CE_USENSE2018; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=U-SENS; Endpoint=CV70; Reported_Response=92.79; Reported_Response_Unit=ug/mL; Response=92.79; Response_Unit=ug/mL; Reference=Piroird et al. 2015; 25820135; 10.1016/j.tiv.2015.03.009; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization CV75 396 ug/mL - Dermal - In Vitro; CE_hCLAT2018; h-CLAT sheet=Data_invitro; excel_row=2031; Record_ID=skin_sensitization_invitro_509; Data_Type=In Vitro; Internal_Data_Source=CE_hCLAT2018; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=h-CLAT; Endpoint=CV75; Reported_Response=396; Reported_Response_Unit=ug/mL; Response=396; Response_Unit=ug/mL; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization Concentration, 5% incidence of positive responses 0.5 % Human Dermal - In Vivo; HPPT2020WIP; Human Maximization Test sheet=Data_invivo; excel_row=3229; Record_ID=skin_sensitization_invivo_821; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=10.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=Human Maximization Test; Endpoint=Concentration, 5% incidence of positive responses; Response=0.5; Response_Unit=%; Species=Human; Route=Dermal; Reference=Kligman 1966; 5924294; 10.1038/jid.1966.160|Basketter et al. 1994; 8045461; 10.1016/0278-6915(94)90112-0|Basketter et al. 1999; 10654593; 10.1016/S0278-6915(99)00112-x|Gerberick et al. 2000; 10684384; 10.1053/ajcd.2000.0003|Akkan et al. 2003; Not available; Not available|Schneider and Akkan 2004; 15135206; 10.1016/j.yrtph.2004.02.002; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization Concentration, one positive response 0.4167 % Human Dermal - In Vivo; HPPT2020WIP; Human Maximization Test sheet=Data_invivo; excel_row=3225; Record_ID=skin_sensitization_invivo_821; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=10.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=Human Maximization Test; Endpoint=Concentration, one positive response; Response=0.4167; Response_Unit=%; Species=Human; Route=Dermal; Reference=Kligman 1966; 5924294; 10.1038/jid.1966.160|Basketter et al. 1994; 8045461; 10.1016/0278-6915(94)90112-0|Basketter et al. 1999; 10654593; 10.1016/S0278-6915(99)00112-x|Gerberick et al. 2000; 10684384; 10.1053/ajcd.2000.0003|Akkan et al. 2003; Not available; Not available|Schneider and Akkan 2004; 15135206; 10.1016/j.yrtph.2004.02.002; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization Depletion Cys 56.5 % - Dermal - In Vitro; DPRA2015; DPRA sheet=Data_invitro; excel_row=1084; Record_ID=skin_sensitization_invitro_295; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=DPRA; Endpoint=Depletion Cys; Reported_Response=56.5; Reported_Response_Unit=%; Response=56.5; Response_Unit=%; Reference=Gerberick et al. 2007; 17400584; 10.1093/toxsci/kfm064|Natsch et al. 2013; 23576290; 10.1002/jat.2868; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization Depletion Cys 68.2 % - Dermal - In Vitro; DPRA2015; DPRA sheet=Data_invitro; excel_row=1091; Record_ID=skin_sensitization_invitro_296; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=DPRA; Endpoint=Depletion Cys; Reported_Response=68.2; Reported_Response_Unit=%; Response=68.2; Response_Unit=%; Reference=Nukada personal communication (undated); URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization Depletion Lys 67.8 % - Dermal - In Vitro; DPRA2015; DPRA sheet=Data_invitro; excel_row=1082; Record_ID=skin_sensitization_invitro_295; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=DPRA; Endpoint=Depletion Lys; Reported_Response=67.8; Reported_Response_Unit=%; Response=67.8; Response_Unit=%; Reference=Gerberick et al. 2007; 17400584; 10.1093/toxsci/kfm064|Natsch et al. 2013; 23576290; 10.1002/jat.2868; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization Depletion Lys 26.7 % - Dermal - In Vitro; DPRA2015; DPRA sheet=Data_invitro; excel_row=1089; Record_ID=skin_sensitization_invitro_296; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=DPRA; Endpoint=Depletion Lys; Reported_Response=26.7; Reported_Response_Unit=%; Response=26.7; Response_Unit=%; Reference=Nukada personal communication (undated); URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization Depletion Lys + Cys 62.15 % - Dermal - In Vitro; DPRA2015; DPRA sheet=Data_invitro; excel_row=1086; Record_ID=skin_sensitization_invitro_295; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=DPRA; Endpoint=Depletion Lys + Cys; Reported_Response=62.15; Reported_Response_Unit=%; Response=62.15; Response_Unit=%; Reference=Gerberick et al. 2007; 17400584; 10.1093/toxsci/kfm064|Natsch et al. 2013; 23576290; 10.1002/jat.2868; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization Depletion Lys + Cys 47 % - Dermal - In Vitro; DPRA2015; DPRA sheet=Data_invitro; excel_row=1093; Record_ID=skin_sensitization_invitro_296; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=DPRA; Endpoint=Depletion Lys + Cys; Reported_Response=47; Reported_Response_Unit=%; Response=47; Response_Unit=%; Reference=Nukada personal communication (undated); URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization EC1.5 87 uM - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4467; Record_ID=skin_sensitization_invitro_1030; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=EC1.5; Reported_Response=87; Reported_Response_Unit=uM; Response=87; Response_Unit=uM; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization EC1.5 88.6 uM - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4468; Record_ID=skin_sensitization_invitro_1031; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=EC1.5; Reported_Response=88.6; Reported_Response_Unit=uM; Response=88.6; Response_Unit=uM; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization EC1.5 89.1 uM - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4469; Record_ID=skin_sensitization_invitro_1032; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=EC1.5; Reported_Response=89.1; Reported_Response_Unit=uM; Response=89.1; Response_Unit=uM; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization EC1.5 89.12 uM - Dermal - In Vitro; CE_KeratinoSense2018; KeratinoSens sheet=Data_invitro; excel_row=4470; Record_ID=skin_sensitization_invitro_1025; Data_Type=In Vitro; Internal_Data_Source=CE_KeratinoSense2018; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=EC1.5; Reported_Response=89.12; Reported_Response_Unit=uM; Response=89.12; Response_Unit=uM; Reference=Natsch et al. 2013; 23576290; 10.1002/jat.2868|Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization EC1.5 91.7 uM - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4471; Record_ID=skin_sensitization_invitro_1033; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=EC1.5; Reported_Response=91.7; Reported_Response_Unit=uM; Response=91.7; Response_Unit=uM; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization EC1.5 95.6 uM - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4472; Record_ID=skin_sensitization_invitro_1029; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=EC1.5; Reported_Response=95.6; Reported_Response_Unit=uM; Response=95.6; Response_Unit=uM; Reference=Natsch et al. 2011; 22023385; 10.1021/tx2003678; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization EC1.5 100.92 uM - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4540; Record_ID=skin_sensitization_invitro_1046; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=EC1.5; Reported_Response=100.92; Reported_Response_Unit=uM; Response=100.92; Response_Unit=uM; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization EC1.5 107.53 uM - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4541; Record_ID=skin_sensitization_invitro_1047; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=EC1.5; Reported_Response=107.53; Reported_Response_Unit=uM; Response=107.53; Response_Unit=uM; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization EC1.5 115.89 uM - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4543; Record_ID=skin_sensitization_invitro_1045; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=EC1.5; Reported_Response=115.89; Reported_Response_Unit=uM; Response=115.89; Response_Unit=uM; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization EC1.5 116.87 uM - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4545; Record_ID=skin_sensitization_invitro_1041; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=EC1.5; Reported_Response=116.87; Reported_Response_Unit=uM; Response=116.87; Response_Unit=uM; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization EC1.5 120 uM - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4547; Record_ID=skin_sensitization_invitro_1028; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=EC1.5; Reported_Response=120; Reported_Response_Unit=uM; Response=120; Response_Unit=uM; Reference=Natsch et al. 2011; 22023385; 10.1021/tx2003678; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization EC1.5 123.92 uM - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4549; Record_ID=skin_sensitization_invitro_1042; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=EC1.5; Reported_Response=123.92; Reported_Response_Unit=uM; Response=123.92; Response_Unit=uM; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization EC1.5 127.41 uM - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4551; Record_ID=skin_sensitization_invitro_1035; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=EC1.5; Reported_Response=127.41; Reported_Response_Unit=uM; Response=127.41; Response_Unit=uM; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization EC1.5 127.64 uM - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4553; Record_ID=skin_sensitization_invitro_1040; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=EC1.5; Reported_Response=127.64; Reported_Response_Unit=uM; Response=127.64; Response_Unit=uM; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization EC1.5 130.5 uM - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4555; Record_ID=skin_sensitization_invitro_1037; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=EC1.5; Reported_Response=130.5; Reported_Response_Unit=uM; Response=130.5; Response_Unit=uM; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization EC1.5 131.2 uM - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4557; Record_ID=skin_sensitization_invitro_1038; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=EC1.5; Reported_Response=131.19999999999999; Reported_Response_Unit=uM; Response=131.2; Response_Unit=uM; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization EC1.5 134.1 uM - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4559; Record_ID=skin_sensitization_invitro_1026; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=EC1.5; Reported_Response=134.1; Reported_Response_Unit=uM; Response=134.1; Response_Unit=uM; Reference=Natsch et al. 2011; 22023385; 10.1021/tx2003678; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization EC1.5 140.8 uM - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4561; Record_ID=skin_sensitization_invitro_1036; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=EC1.5; Reported_Response=140.80000000000001; Reported_Response_Unit=uM; Response=140.8; Response_Unit=uM; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization EC1.5 146.06 uM - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4563; Record_ID=skin_sensitization_invitro_1039; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=EC1.5; Reported_Response=146.06; Reported_Response_Unit=uM; Response=146.06; Response_Unit=uM; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization EC1.5 169.1 uM - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4565; Record_ID=skin_sensitization_invitro_1043; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=EC1.5; Reported_Response=169.1; Reported_Response_Unit=uM; Response=169.1; Response_Unit=uM; Reference=Natsch et al. 2011; 22023385; 10.1021/tx2003678; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization EC1.5 175.14 uM - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4567; Record_ID=skin_sensitization_invitro_1044; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=EC1.5; Reported_Response=175.14; Reported_Response_Unit=uM; Response=175.14; Response_Unit=uM; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization EC1.5 228.98 uM - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4570; Record_ID=skin_sensitization_invitro_1049; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=EC1.5; Reported_Response=228.98; Reported_Response_Unit=uM; Response=228.98; Response_Unit=uM; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization EC1.5 24.58 uM - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4572; Record_ID=skin_sensitization_invitro_1034; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=EC1.5; Reported_Response=24.58; Reported_Response_Unit=uM; Response=24.58; Response_Unit=uM; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization EC1.5 77 uM - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4574; Record_ID=skin_sensitization_invitro_1027; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=EC1.5; Reported_Response=77; Reported_Response_Unit=uM; Response=77; Response_Unit=uM; Reference=Natsch et al. 2011; 22023385; 10.1021/tx2003678; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization EC1.5 80.41 uM - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4576; Record_ID=skin_sensitization_invitro_1048; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=EC1.5; Reported_Response=80.41; Reported_Response_Unit=uM; Response=80.41; Response_Unit=uM; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization EC1.5 <180.84 uM - Dermal - In Vitro; Urbisch_SkinSensitization2020; LuSens sheet=Data_invitro; excel_row=7604; Record_ID=skin_sensitization_invitro_1843; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=LuSens; Endpoint=EC1.5; Response_Modifier=<; Reported_Response_Modifier=<; Reported_Response=180.84; Reported_Response_Unit=uM; Response=180.84; Response_Unit=uM; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization EC3 307.8 uM - Dermal - In Vitro; CE_KeratinoSense2018; KeratinoSens sheet=Data_invitro; excel_row=4473; Record_ID=skin_sensitization_invitro_1025; Data_Type=In Vitro; Internal_Data_Source=CE_KeratinoSense2018; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=EC3; Reported_Response=307.80500000000001; Reported_Response_Unit=uM; Response=307.8; Response_Unit=uM; Reference=Natsch et al. 2013; 23576290; 10.1002/jat.2868|Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization EC3 1.4 % Mouse Dermal - In Vivo; LLNAdb2013; LLNA sheet=Data_invivo; excel_row=13285; Record_ID=skin_sensitization_invivo_3380; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=LLNA; Endpoint=EC3; Response=1.4; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Gerberick et al. 2005; 16536334; Not available; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization EC3 1.4 % Mouse Dermal - In Vivo; LLNAdb2013; LLNA sheet=Data_invivo; excel_row=13285; Record_ID=skin_sensitization_invivo_3380; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=LLNA; Endpoint=EC3; Response=1.4; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Gerberick et al. 2005; 16536334; Not available; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization EC3 1.4 % Mouse Dermal - In Vivo; LLNAdb2013; LLNA sheet=Data_invivo; excel_row=13285; Record_ID=skin_sensitization_invivo_3380; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=LLNA; Endpoint=EC3; Response=1.4; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Gerberick et al. 2005; 16536334; Not available; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization EC3 1.4 % Mouse Dermal - In Vivo; LLNAdb2013; LLNA sheet=Data_invivo; excel_row=13285; Record_ID=skin_sensitization_invivo_3380; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=LLNA; Endpoint=EC3; Response=1.4; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Gerberick et al. 2005; 16536334; Not available; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization IC50 364.57 uM - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4474; Record_ID=skin_sensitization_invitro_1034; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=IC50; Reported_Response=364.57; Reported_Response_Unit=uM; Response=364.57; Response_Unit=uM; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization IC50 523.2 uM - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4475; Record_ID=skin_sensitization_invitro_1027; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=IC50; Reported_Response=523.20000000000005; Reported_Response_Unit=uM; Response=523.2; Response_Unit=uM; Reference=Natsch et al. 2011; 22023385; 10.1021/tx2003678; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization IC50 573.8 uM - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4476; Record_ID=skin_sensitization_invitro_1035; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=IC50; Reported_Response=573.82000000000005; Reported_Response_Unit=uM; Response=573.8; Response_Unit=uM; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization IC50 594.7 uM - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4477; Record_ID=skin_sensitization_invitro_1036; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=IC50; Reported_Response=594.66999999999996; Reported_Response_Unit=uM; Response=594.7; Response_Unit=uM; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization IC50 607.13 uM - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4478; Record_ID=skin_sensitization_invitro_1037; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=IC50; Reported_Response=607.13; Reported_Response_Unit=uM; Response=607.13; Response_Unit=uM; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization IC50 610.5 uM - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4479; Record_ID=skin_sensitization_invitro_1026; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=IC50; Reported_Response=610.5; Reported_Response_Unit=uM; Response=610.5; Response_Unit=uM; Reference=Natsch et al. 2011; 22023385; 10.1021/tx2003678; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization IC50 630.2 uM - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4480; Record_ID=skin_sensitization_invitro_1038; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=IC50; Reported_Response=630.17999999999995; Reported_Response_Unit=uM; Response=630.2; Response_Unit=uM; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization IC50 677.86 uM - Dermal - In Vitro; CE_KeratinoSense2018; KeratinoSens sheet=Data_invitro; excel_row=4481; Record_ID=skin_sensitization_invitro_1025; Data_Type=In Vitro; Internal_Data_Source=CE_KeratinoSense2018; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=IC50; Reported_Response=677.86; Reported_Response_Unit=uM; Response=677.86; Response_Unit=uM; Reference=Natsch et al. 2013; 23576290; 10.1002/jat.2868|Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization IC50 684.61 uM - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4482; Record_ID=skin_sensitization_invitro_1039; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=IC50; Reported_Response=684.61; Reported_Response_Unit=uM; Response=684.61; Response_Unit=uM; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization IC50 689.79 uM - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4483; Record_ID=skin_sensitization_invitro_1040; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=IC50; Reported_Response=689.79; Reported_Response_Unit=uM; Response=689.79; Response_Unit=uM; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization IC50 693.99 uM - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4484; Record_ID=skin_sensitization_invitro_1041; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=IC50; Reported_Response=693.99; Reported_Response_Unit=uM; Response=693.99; Response_Unit=uM; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization IC50 696.02 uM - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4485; Record_ID=skin_sensitization_invitro_1042; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=IC50; Reported_Response=696.02; Reported_Response_Unit=uM; Response=696.02; Response_Unit=uM; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization IC50 700.4 uM - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4486; Record_ID=skin_sensitization_invitro_1043; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=IC50; Reported_Response=700.4; Reported_Response_Unit=uM; Response=700.4; Response_Unit=uM; Reference=Natsch et al. 2011; 22023385; 10.1021/tx2003678; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization IC50 704.8 uM - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4487; Record_ID=skin_sensitization_invitro_1044; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=IC50; Reported_Response=704.8; Reported_Response_Unit=uM; Response=704.8; Response_Unit=uM; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization IC50 721.9 uM - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4488; Record_ID=skin_sensitization_invitro_1028; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=IC50; Reported_Response=721.9; Reported_Response_Unit=uM; Response=721.9; Response_Unit=uM; Reference=Natsch et al. 2011; 22023385; 10.1021/tx2003678; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization IC50 785.71 uM - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4489; Record_ID=skin_sensitization_invitro_1045; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=IC50; Reported_Response=785.71; Reported_Response_Unit=uM; Response=785.71; Response_Unit=uM; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization IC50 >800 uM - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4490; Record_ID=skin_sensitization_invitro_1029; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=IC50; Response_Modifier=>; Reported_Response_Modifier=>; Reported_Response=800; Reported_Response_Unit=uM; Response=800; Response_Unit=uM; Reference=Natsch et al. 2011; 22023385; 10.1021/tx2003678; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization IC50 >450 uM - Dermal - In Vitro; Urbisch_SkinSensitization2020; LuSens sheet=Data_invitro; excel_row=7674; Record_ID=skin_sensitization_invitro_1843; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=LuSens; Endpoint=IC50; Response_Modifier=>; Reported_Response_Modifier=>; Reported_Response=450; Reported_Response_Unit=uM; Response=450; Response_Unit=uM; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization Imax 10.93 ratio - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4495; Record_ID=skin_sensitization_invitro_1034; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=10.93; Reported_Response_Unit=Unitless; Response=10.93; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization Imax 100.866 ratio - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4496; Record_ID=skin_sensitization_invitro_1036; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=100.866; Reported_Response_Unit=Unitless; Response=100.866; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization Imax 116.078 ratio - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4497; Record_ID=skin_sensitization_invitro_1049; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=116.078; Reported_Response_Unit=Unitless; Response=116.078; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization Imax 132.82 ratio - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4498; Record_ID=skin_sensitization_invitro_1046; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=132.82; Reported_Response_Unit=Unitless; Response=132.82; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization Imax 14.5 ratio - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4499; Record_ID=skin_sensitization_invitro_1027; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=14.5; Reported_Response_Unit=Unitless; Response=14.5; Response_Unit=Ratio; Reference=Natsch et al. 2011; 22023385; 10.1021/tx2003678; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization Imax 14.67 ratio - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4500; Record_ID=skin_sensitization_invitro_1035; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=14.667999999999999; Reported_Response_Unit=Unitless; Response=14.67; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization Imax 17.881 ratio - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4501; Record_ID=skin_sensitization_invitro_1039; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=17.881; Reported_Response_Unit=Unitless; Response=17.881; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization Imax 176.768 ratio - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4504; Record_ID=skin_sensitization_invitro_1048; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=176.768; Reported_Response_Unit=Unitless; Response=176.768; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization Imax 195 ratio - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4506; Record_ID=skin_sensitization_invitro_1029; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=195; Reported_Response_Unit=Unitless; Response=195; Response_Unit=Ratio; Reference=Natsch et al. 2011; 22023385; 10.1021/tx2003678; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization Imax 21.802 ratio - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4508; Record_ID=skin_sensitization_invitro_1038; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=21.802; Reported_Response_Unit=Unitless; Response=21.802; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization Imax 23.63 ratio - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4510; Record_ID=skin_sensitization_invitro_1030; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=23.632000000000001; Reported_Response_Unit=Unitless; Response=23.63; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization Imax 26.343 ratio - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4512; Record_ID=skin_sensitization_invitro_1042; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=26.343; Reported_Response_Unit=Unitless; Response=26.343; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization Imax 275.5 ratio - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4514; Record_ID=skin_sensitization_invitro_1047; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=275.46199999999999; Reported_Response_Unit=Unitless; Response=275.5; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization Imax 28.19 ratio - Dermal - In Vitro; CE_KeratinoSense2018; KeratinoSens sheet=Data_invitro; excel_row=4516; Record_ID=skin_sensitization_invitro_1025; Data_Type=In Vitro; Internal_Data_Source=CE_KeratinoSense2018; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=28.19; Reported_Response_Unit=Unitless; Response=28.19; Response_Unit=Ratio; Reference=Natsch et al. 2013; 23576290; 10.1002/jat.2868|Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization Imax 3.521 ratio - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4518; Record_ID=skin_sensitization_invitro_1032; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=3.5209999999999999; Reported_Response_Unit=Unitless; Response=3.521; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization Imax 31.384 ratio - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4520; Record_ID=skin_sensitization_invitro_1045; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=31.384; Reported_Response_Unit=Unitless; Response=31.384; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization Imax 4.27 ratio - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4522; Record_ID=skin_sensitization_invitro_1031; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=4.2699999999999996; Reported_Response_Unit=Unitless; Response=4.27; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization Imax 58.3 ratio - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4524; Record_ID=skin_sensitization_invitro_1028; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=58.3; Reported_Response_Unit=Unitless; Response=58.3; Response_Unit=Ratio; Reference=Natsch et al. 2011; 22023385; 10.1021/tx2003678; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization Imax 64.68 ratio - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4526; Record_ID=skin_sensitization_invitro_1040; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=64.685000000000002; Reported_Response_Unit=Unitless; Response=64.68; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization Imax 66.67 ratio - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4528; Record_ID=skin_sensitization_invitro_1044; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=66.665000000000006; Reported_Response_Unit=Unitless; Response=66.67; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization Imax 67.1 ratio - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4530; Record_ID=skin_sensitization_invitro_1026; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=67.099999999999994; Reported_Response_Unit=Unitless; Response=67.1; Response_Unit=Ratio; Reference=Natsch et al. 2011; 22023385; 10.1021/tx2003678; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization Imax 69.7 ratio - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4532; Record_ID=skin_sensitization_invitro_1043; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=69.7; Reported_Response_Unit=Unitless; Response=69.7; Response_Unit=Ratio; Reference=Natsch et al. 2011; 22023385; 10.1021/tx2003678; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization Imax 78.65 ratio - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4534; Record_ID=skin_sensitization_invitro_1037; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=78.650999999999996; Reported_Response_Unit=Unitless; Response=78.65; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization Imax 78.82 ratio - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4536; Record_ID=skin_sensitization_invitro_1041; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=78.820999999999998; Reported_Response_Unit=Unitless; Response=78.82; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization Imax 81.32 ratio - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4539; Record_ID=skin_sensitization_invitro_1033; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=81.322999999999993; Reported_Response_Unit=Unitless; Response=81.32; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization Imax 4.643 ratio - Dermal - In Vitro; Urbisch_SkinSensitization2020; LuSens sheet=Data_invitro; excel_row=7577; Record_ID=skin_sensitization_invitro_1843; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=LuSens; Endpoint=Imax; Reported_Response=4.6432523; Reported_Response_Unit=Unitless; Response=4.643; Response_Unit=Ratio; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization Incidence of positive responses 100 % Human Dermal - In Vivo; HPPT2020WIP; Human Maximization Test sheet=Data_invivo; excel_row=3189; Record_ID=skin_sensitization_invivo_821; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=10.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=Human Maximization Test; Endpoint=Incidence of positive responses; Response=100; Response_Unit=%; Species=Human; Route=Dermal; Reference=Kligman 1966; 5924294; 10.1038/jid.1966.160|Basketter et al. 1994; 8045461; 10.1016/0278-6915(94)90112-0|Basketter et al. 1999; 10654593; 10.1016/S0278-6915(99)00112-x|Gerberick et al. 2000; 10684384; 10.1053/ajcd.2000.0003|Akkan et al. 2003; Not available; Not available|Schneider and Akkan 2004; 15135206; 10.1016/j.yrtph.2004.02.002; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization Induction dose per skin area 6207 ug/cm2 Human Dermal - In Vivo; HPPT2020WIP; Human Maximization Test sheet=Data_invivo; excel_row=3188; Record_ID=skin_sensitization_invivo_821; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=10.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=Human Maximization Test; Endpoint=Induction dose per skin area; Response=6207; Response_Unit=ug/cm2; Species=Human; Route=Dermal; Reference=Kligman 1966; 5924294; 10.1038/jid.1966.160|Basketter et al. 1994; 8045461; 10.1016/0278-6915(94)90112-0|Basketter et al. 1999; 10654593; 10.1016/S0278-6915(99)00112-x|Gerberick et al. 2000; 10684384; 10.1053/ajcd.2000.0003|Akkan et al. 2003; Not available; Not available|Schneider and Akkan 2004; 15135206; 10.1016/j.yrtph.2004.02.002; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization Induction dose per skin area, 5% incidence of positive responses 310.3 ug/cm2 Human Dermal - In Vivo; HPPT2020WIP; Human Maximization Test sheet=Data_invivo; excel_row=3231; Record_ID=skin_sensitization_invivo_821; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=10.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=Human Maximization Test; Endpoint=Induction dose per skin area, 5% incidence of positive responses; Response=310.3; Response_Unit=ug/cm2; Species=Human; Route=Dermal; Reference=Kligman 1966; 5924294; 10.1038/jid.1966.160|Basketter et al. 1994; 8045461; 10.1016/0278-6915(94)90112-0|Basketter et al. 1999; 10654593; 10.1016/S0278-6915(99)00112-x|Gerberick et al. 2000; 10684384; 10.1053/ajcd.2000.0003|Akkan et al. 2003; Not available; Not available|Schneider and Akkan 2004; 15135206; 10.1016/j.yrtph.2004.02.002; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization Induction dose per skin area, one positive response 258.6 ug/cm2 Human Dermal - In Vivo; HPPT2020WIP; Human Maximization Test sheet=Data_invivo; excel_row=3227; Record_ID=skin_sensitization_invivo_821; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=10.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=Human Maximization Test; Endpoint=Induction dose per skin area, one positive response; Response=258.6; Response_Unit=ug/cm2; Species=Human; Route=Dermal; Reference=Kligman 1966; 5924294; 10.1038/jid.1966.160|Basketter et al. 1994; 8045461; 10.1016/0278-6915(94)90112-0|Basketter et al. 1999; 10654593; 10.1016/S0278-6915(99)00112-x|Gerberick et al. 2000; 10684384; 10.1053/ajcd.2000.0003|Akkan et al. 2003; Not available; Not available|Schneider and Akkan 2004; 15135206; 10.1016/j.yrtph.2004.02.002; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
NTP_ICE_skin_sensitization Relative reliability score 1 unitless Human Dermal - In Vivo; HPPT2020WIP; Human Maximization Test sheet=Data_invivo; excel_row=3233; Record_ID=skin_sensitization_invivo_821; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=10.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID5025364; Assay=Human Maximization Test; Endpoint=Relative reliability score; Response=1; Response_Unit=Unitless; Species=Human; Route=Dermal; Reference=Kligman 1966; 5924294; 10.1038/jid.1966.160|Basketter et al. 1994; 8045461; 10.1016/0278-6915(94)90112-0|Basketter et al. 1999; 10654593; 10.1016/S0278-6915(99)00112-x|Gerberick et al. 2000; 10684384; 10.1053/ajcd.2000.0003|Akkan et al. 2003; Not available; Not available|Schneider and Akkan 2004; 15135206; 10.1016/j.yrtph.2004.02.002; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5025364; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5025364
SCCS_vision_codex 60 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =100 mg/kg bw/day - - - NOAEL study {"citation":"Ref.: 149","dose":"The effect on the various organ weights in the high dose group was attributed to the reduced body weight.","effect":"n. The effect on the various organ weights in the high dose group was attributed to the reduced body weight. Moreover, in none of the dose groups a substance-related effect on haematological and biochemical parameters and of the urinary status was seen. During necropsy no substance-related macroscopic findings were recorded and histopathology revealed no findings in any organ at any dose group. Based on these findings and mainly on the dose related decrease of the water and food consumption and body weight gain, a NOEL of 100 mg/kg bw/day was established for glyoxal 40% (corresponding to about 40 mg/kg bw pure active ingredient). Ref.: 149","page":20,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_001"}
SCCS_vision_codex NOAEL =107 mg/kg bw - - - NOAEL study {"citation":"Ref.: Ueno et al","dose":"f the intermediate and high dose groups as well as the glyoxalase I activity in the kidneys in the animals of the high dose group.","effect":"f the intermediate and high dose groups as well as the glyoxalase I activity in the kidneys in the animals of the high dose group. In contrast, no substance-related effect on the enzymatic activity of glyoxalase I and II was detectable for the longer exposure periods. Neither the glutathione level nor the synthesis of 2-thiobarbituric acid-active substances was affected in the liver, kidney or erythrocytes. Substance-related macroscopic or histopathological organ changes were not found. According to the authors, a no observed adverse effect level could not be determined due to the reduced serum protein levels in the lowest dose group (lowest observed effect level of 107 mg/kg bw pure active ingredient). Ref.: Ueno et al., 1991a","page":22,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_002"}
SCCS_vision_codex NOAEL =115 mg/kg bw rat oral 90-day repeated dose toxicity {"citation":"Reference: 123) carried out in rats, which obtained a LOEL of 107 mg/kg bw related to pure glyoxal","dose":"A no effect level of 100 mg/kg bw was established for glyoxal 40% (i.e.","effect":"inking water study in rats since this study was performed according to a valid and internationally accepted testing guideline as well as under GLP conditions. A no effect level of 100 mg/kg bw was established for glyoxal 40% (i.e. 40 mg/kg bw related to the active ingredient). This value is supported by the published drinking water studies of Ueno et al. (1991a) (Reference: 123) carried out in rats, which obtained a LOEL of 107 mg/kg bw related to pure glyoxal. Moreover, also the 90-day study in dogs resulted in a NOEL of 115 mg/kg bw related to pure glyoxal. In a subacute inhalation study on rats for 29 days, a NOEL of 0.4 mg/m³ was derived for local effects and of > 10 mg/m³ for the systemic toxicity (40% glyoxal). An overview of NOAEL values from repeated dose toxicity studies is given in Table 3.3.3. Table 3.3.3. Overview of NOAEL values from repeated dose toxicity studies Exposure period Route/Species Dosage NOAEL Ref. 28 days Oral (drinking water) Rat 0, 100, 300, 1000 mg/kg bw (Glyoxal 40%) 100 mg/kg bw (40 mg/kg bw","page":24,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_003"}
SCCS_vision_codex NOAEL =40 % rat oral 90-day repeated dose toxicity {"citation":"Reference: 123) carried out in rats, which obtained a LOEL of 107 mg/kg bw related to pure glyoxal","dose":"40 mg/kg bw related to the active ingredient).","effect":"0% (i.e. 40 mg/kg bw related to the active ingredient). This value is supported by the published drinking water studies of Ueno et al. (1991a) (Reference: 123) carried out in rats, which obtained a LOEL of 107 mg/kg bw related to pure glyoxal. Moreover, also the 90-day study in dogs resulted in a NOEL of 115 mg/kg bw related to pure glyoxal. In a subacute inhalation study on rats for 29 days, a NOEL of 0.4 mg/m³ was derived for local effects and of > 10 mg/m³ for the systemic toxicity (40% glyoxal). An overview of NOAEL values from repeated dose toxicity studies is given in Table 3.3.3. Table 3.3.3. Overview of NOAEL values from repeated dose toxicity studies Exposure period Route/Species Dosage NOAEL Ref. 28 days Oral (drinking water) Rat 0, 100, 300, 1000 mg/kg bw (Glyoxal 40%) 100 mg/kg bw (40 mg/kg bw related to active ingredient) 142 30, 60, 90 days Oral (drinking water) Rat 0, 2000, 4000, 6000 mg/l (Glyoxal 100%) LOAEL 107 mg/kg bw (related to active ingredient) Ueno et al., 1991a 90 days Oral (drinking water) Rat and","page":24,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_005"}
SCCS_vision_codex NOAEL =1000 mg/kg bw rat oral 90-day repeated dose toxicity {"dose":"tained a LOEL of 107 mg/kg bw related to pure glyoxal.","effect":"tained a LOEL of 107 mg/kg bw related to pure glyoxal. Moreover, also the 90-day study in dogs resulted in a NOEL of 115 mg/kg bw related to pure glyoxal. In a subacute inhalation study on rats for 29 days, a NOEL of 0.4 mg/m³ was derived for local effects and of > 10 mg/m³ for the systemic toxicity (40% glyoxal). An overview of NOAEL values from repeated dose toxicity studies is given in Table 3.3.3. Table 3.3.3. Overview of NOAEL values from repeated dose toxicity studies Exposure period Route/Species Dosage NOAEL Ref. 28 days Oral (drinking water) Rat 0, 100, 300, 1000 mg/kg bw (Glyoxal 40%) 100 mg/kg bw (40 mg/kg bw related to active ingredient) 142 30, 60, 90 days Oral (drinking water) Rat 0, 2000, 4000, 6000 mg/l (Glyoxal 100%) LOAEL 107 mg/kg bw (related to active ingredient) Ueno et al., 1991a 90 days Oral (drinking water) Rat and mice 0, 1000, 2000, 4000, 8000, 16000 mg/l (Glyoxal, unknown content) Not derived 45 90 days Oral (diet) Rat 0, 32.7, 63.2, 132, 253 mg kg for males; 0; 32, 63.2, 127, 271 mg for females 12","page":24,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_007"}
SCCS_vision_codex NOAEL =5 mg/kg bw rat oral - NOAEL study {"citation":"Ref.: 40, 41 Another group examined the potential of glyoxal to induce UDS in male Fischer 344 rats","dose":"SCCP/0881/05 Opinion on glyoxal 38 Glyoxal induced DNA damage in the pyloric mucosa of the rat stomach after oral application of dose levels in the range of 50 – 550 mg/kg bw.","effect":"SCCP/0881/05 Opinion on glyoxal 38 Glyoxal induced DNA damage in the pyloric mucosa of the rat stomach after oral application of dose levels in the range of 50 – 550 mg/kg bw. No damage was noted at 5 mg/kg bw, indicating that this dose level can be considered as a “NOAEL” for local DNA damage. Ref.: 40, 41 Another group examined the potential of glyoxal to induce UDS in male Fischer 344 rats. Groups of 5 rats received a single oral application of the test substance (content not specified) in distilled water at dose levels of 0, 120, 240, 300, 360, 400 mg/kg in an application volume of 0.5 ml. A homogenate of the pyloric mucosa of the stomach was prepared at 2, 5 and 16 h after dosing and assayed unscheduled DNA synthesis. Significant and dose-related induction of UDS was apparent","page":38,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_009"}
SCCS_vision_codex NOAEL =881 - rabbit oral Developmental developmental toxicity {"dose":"SCCP/0881/05 Opinion on glyoxal 44 observed at 200 mg glyoxal dihydrate/kg body weight per day in the preliminary study or at the highest dose in the main study.","effect":"SCCP/0881/05 Opinion on glyoxal 44 observed at 200 mg glyoxal dihydrate/kg body weight per day in the preliminary study or at the highest dose in the main study. Developmental toxicity range-finding studies in New Zealand White rabbits administered glyoxal by gavage yielded a NOEL of 200 mg glyoxal trimeric dihydrate/kg body weight per day, corresponding to 123 mg glyoxal/kg body weight per day (NTP, 1991d), and a LOEL of 400 mg glyoxal dihydrate/kg body weight per day, corresponding to 247 mg glyoxal/kg body weight per day (NTP, 1992), for both maternal toxicity and embryotoxicity. Maternal signs of systemic toxicity and decreases of weight parameters were accompanied by reduced fetal weight (NTP, 1992). The application of doses in the range of 200 mg glyoxal dihydrate/kg body weight per d","page":44,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_011"}
SCCS_vision_codex NOAEL =125 mg/kg bw - - prenatal repeated dose toxicity {"citation":"Ref.: 17 Overall results No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of appro","dose":"No signs of prenatal developmental toxicity, especially no signs of teratogenicity, were seen at any dose level including the highest dose tested at 125 mg/kg bw.","effect":"SCCP/0881/05 Opinion on glyoxal 46 No substance-related influence on gestational parameters was seen. No signs of prenatal developmental toxicity, especially no signs of teratogenicity, were seen at any dose level including the highest dose tested at 125 mg/kg bw. In this study, the NOAEL for maternal toxicity is 25 mg/kg bw; the NOAEL for prenatal developmental toxicity is 125 mg/kg bw, each correspond to the pure active ingredient, respectively. Ref.: 17 Overall results No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of approx. 250 mg/kg bw (related to pure active ingredient). A prenatal developmental toxicity study performed according to current testing guidelines and under GLP conditions s","page":46,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_013"}
SCCS_vision_codex NOAEL =25 mg/kg bw - - prenatal repeated dose toxicity {"citation":"Ref.: 17 Overall results No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of appro","dose":"No signs of prenatal developmental toxicity, especially no signs of teratogenicity, were seen at any dose level including the highest dose tested at 125 mg/kg bw.","effect":"SCCP/0881/05 Opinion on glyoxal 46 No substance-related influence on gestational parameters was seen. No signs of prenatal developmental toxicity, especially no signs of teratogenicity, were seen at any dose level including the highest dose tested at 125 mg/kg bw. In this study, the NOAEL for maternal toxicity is 25 mg/kg bw; the NOAEL for prenatal developmental toxicity is 125 mg/kg bw, each correspond to the pure active ingredient, respectively. Ref.: 17 Overall results No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of approx. 250 mg/kg bw (related to pure active ingredient). A prenatal developmental toxicity study performed according to current testing guidelines and under GLP conditions showed a NOAEL of 125 mg/kg bw for prenatal devel","page":46,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_014"}
SCCS_vision_codex NOAEL =100 mg/kg bw rat oral 28 day NOAEL study {"dose":"This is slightly less than the tolerable intake of about 0.2 mg/kg body weight per day for lifetime oral exposure to glyoxal (based on a NOAEL of 100 mg/kg bw./day and an uncertainty factor of 100 and a factor of 5 for less-than- lifetime exposure) (Cicads 57, 2004).","effect":"unication, 2003). People can therefore be exposed to glyoxal during its use as a household cleaner. Examples of exposure from non-cosmetic products General population: An exposure scenario has been compiled as a hypothesized worst case. Using the daily intake of, maximally, 10 mg glyoxal via food, an estimated intake of 0.16 mg glyoxal/kg body weight per day can be calculated. This is slightly less than the tolerable intake of about 0.2 mg/kg body weight per day for lifetime oral exposure to glyoxal (based on a NOAEL of 100 mg/kg bw./day and an uncertainty factor of 100 and a factor of 5 for less-than- lifetime exposure) (Cicads 57, 2004). (The above NOAEL is based on reduced body weight gain in a 28 day rat study (149). It is not clear from the report if the actual glyoxal dose was 40 mg/kg bw./day). A LOAEL of 107 mg/kg bw./day was obtained in a 90 day rat study based on reduced serum protein levels (Ueno et al., 1991a)) A nurse or hospital cleaner or consumer using disinfectant: A typical brand of disinfectant (7.5 g in 10","page":49,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_017"}
SCCS_vision_codex NOAEL =40 mg/kg bw/day rat oral 28-day NOAEL study {"dose":"A 28-day study in which glyoxal was administered to rats in drinking-water resulted in a no- observed-adverse-effect level (NOAEL) of 100 mg glyoxal/kg body weight per day (It is not clear from the report if the actual glyoxal dose was calculated as 40% glyoxal.","effect":"o tumour initiating effect after the dermal administration to mice. Oral administration of glyoxal after initiation with MNNG was associated with increased incidences of adenocarcinomas and hyperplasias in both pylorus and fundus of rat stomach. A 28-day study in which glyoxal was administered to rats in drinking-water resulted in a no- observed-adverse-effect level (NOAEL) of 100 mg glyoxal/kg body weight per day (It is not clear from the report if the actual glyoxal dose was calculated as 40% glyoxal. Thus, the NOAEL could be 40 mg/kg bw/day). The 90-day feeding of glyoxal to rats resulted in a NOAEL of 127 mg/kg bw/day (dosage corresponding to 100% glyoxal). Effects stated at higher dosages in the two studies above were retardation of body weight gain. In a study examining more sensitive end-points (serum clinical biochemistry), the lowest tested dosage of 107 mg/kg bw/day (99% glyoxal) corresponded to the lowest-observed-adverse-effect level (LOAEL) for a 90-day exposure of rats via drinking-water. No dose-dependent effects","page":52,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_020"}
SCCS_vision_codex NOAEL =127 mg/kg bw/day rat - 28-day repeated dose toxicity {"dose":"A 28-day study in which glyoxal was administered to rats in drinking-water resulted in a no- observed-adverse-effect level (NOAEL) of 100 mg glyoxal/kg body weight per day (It is not clear from the report if the actual glyoxal dose was calculated as 40% glyoxal.","effect":"on of glyoxal after initiation with MNNG was associated with increased incidences of adenocarcinomas and hyperplasias in both pylorus and fundus of rat stomach. A 28-day study in which glyoxal was administered to rats in drinking-water resulted in a no- observed-adverse-effect level (NOAEL) of 100 mg glyoxal/kg body weight per day (It is not clear from the report if the actual glyoxal dose was calculated as 40% glyoxal. Thus, the NOAEL could be 40 mg/kg bw/day). The 90-day feeding of glyoxal to rats resulted in a NOAEL of 127 mg/kg bw/day (dosage corresponding to 100% glyoxal). Effects stated at higher dosages in the two studies above were retardation of body weight gain. In a study examining more sensitive end-points (serum clinical biochemistry), the lowest tested dosage of 107 mg/kg bw/day (99% glyoxal) corresponded to the lowest-observed-adverse-effect level (LOAEL) for a 90-day exposure of rats via drinking-water. No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a","page":52,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_021"}
SCCS_vision_codex NOAEL =24 - - - - NOAEL study {"effect":"Unlabeled table on page 24: Exposure period Route/Species | Dosage | NOAEL | Ref.","page":24,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_029"}
SCCS_vision_codex NOAEL =132 mg/kg bw rat oral 90 days NOAEL study {"dose":"90 days Oral (diet) Rat | 0, 32.7, 63.2, 132, 253 mg kg for males;","effect":"Unlabeled table on page 24: 90 days Oral (diet) Rat | 0, 32.7, 63.2, 132, 253 mg kg for males; 0; 32, 63.2, 127, 271 mg for females | 127/132 mg/kg bw for females/males (related to active ingredient) | 142","page":24,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_033"}
SCCS_vision_codex NOAEL =0.4 - rat inhalation 29 days NOAEL study {"effect":"Unlabeled table on page 24: 29 days Inhalation Rat | 0, 0.4, 2.0, 10 mg/m³ | NOEL Local effects: 0.4 mg/m³ Systemic effects:>10 mg/m³ (pure active ingredient) | 73","page":24,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_035"}
SCCS_vision_codex NOAEL =100 mg/kg bw/day - - - NOAEL study {"citation":"Ref.: 149","dose":"The effect on the various organ weights in the high dose group was attributed to the reduced body weight.","effect":"n. The effect on the various organ weights in the high dose group was attributed to the reduced body weight. Moreover, in none of the dose groups a substance-related effect on haematological and biochemical parameters and of the urinary status was seen. During necropsy no substance-related macroscopic findings were recorded and histopathology revealed no findings in any organ at any dose group. Based on these findings and mainly on the dose related decrease of the water and food consumption and body weight gain, a NOEL of 100 mg/kg bw/day was established for glyoxal 40% (corresponding to about 40 mg/kg bw pure active ingredient). Ref.: 149","page":20,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_001"}
SCCS_vision_codex NOAEL =107 mg/kg bw - - - NOAEL study {"citation":"Ref.: Ueno et al","dose":"f the intermediate and high dose groups as well as the glyoxalase I activity in the kidneys in the animals of the high dose group.","effect":"f the intermediate and high dose groups as well as the glyoxalase I activity in the kidneys in the animals of the high dose group. In contrast, no substance-related effect on the enzymatic activity of glyoxalase I and II was detectable for the longer exposure periods. Neither the glutathione level nor the synthesis of 2-thiobarbituric acid-active substances was affected in the liver, kidney or erythrocytes. Substance-related macroscopic or histopathological organ changes were not found. According to the authors, a no observed adverse effect level could not be determined due to the reduced serum protein levels in the lowest dose group (lowest observed effect level of 107 mg/kg bw pure active ingredient). Ref.: Ueno et al., 1991a","page":22,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_002"}
SCCS_vision_codex NOAEL =115 mg/kg bw rat oral 90-day repeated dose toxicity {"citation":"Reference: 123) carried out in rats, which obtained a LOEL of 107 mg/kg bw related to pure glyoxal","dose":"A no effect level of 100 mg/kg bw was established for glyoxal 40% (i.e.","effect":"inking water study in rats since this study was performed according to a valid and internationally accepted testing guideline as well as under GLP conditions. A no effect level of 100 mg/kg bw was established for glyoxal 40% (i.e. 40 mg/kg bw related to the active ingredient). This value is supported by the published drinking water studies of Ueno et al. (1991a) (Reference: 123) carried out in rats, which obtained a LOEL of 107 mg/kg bw related to pure glyoxal. Moreover, also the 90-day study in dogs resulted in a NOEL of 115 mg/kg bw related to pure glyoxal. In a subacute inhalation study on rats for 29 days, a NOEL of 0.4 mg/m³ was derived for local effects and of > 10 mg/m³ for the systemic toxicity (40% glyoxal). An overview of NOAEL values from repeated dose toxicity studies is given in Table 3.3.3. Table 3.3.3. Overview of NOAEL values from repeated dose toxicity studies Exposure period Route/Species Dosage NOAEL Ref. 28 days Oral (drinking water) Rat 0, 100, 300, 1000 mg/kg bw (Glyoxal 40%) 100 mg/kg bw (40 mg/kg bw","page":24,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_003"}
SCCS_vision_codex NOAEL =40 % rat oral 90-day repeated dose toxicity {"citation":"Reference: 123) carried out in rats, which obtained a LOEL of 107 mg/kg bw related to pure glyoxal","dose":"40 mg/kg bw related to the active ingredient).","effect":"0% (i.e. 40 mg/kg bw related to the active ingredient). This value is supported by the published drinking water studies of Ueno et al. (1991a) (Reference: 123) carried out in rats, which obtained a LOEL of 107 mg/kg bw related to pure glyoxal. Moreover, also the 90-day study in dogs resulted in a NOEL of 115 mg/kg bw related to pure glyoxal. In a subacute inhalation study on rats for 29 days, a NOEL of 0.4 mg/m³ was derived for local effects and of > 10 mg/m³ for the systemic toxicity (40% glyoxal). An overview of NOAEL values from repeated dose toxicity studies is given in Table 3.3.3. Table 3.3.3. Overview of NOAEL values from repeated dose toxicity studies Exposure period Route/Species Dosage NOAEL Ref. 28 days Oral (drinking water) Rat 0, 100, 300, 1000 mg/kg bw (Glyoxal 40%) 100 mg/kg bw (40 mg/kg bw related to active ingredient) 142 30, 60, 90 days Oral (drinking water) Rat 0, 2000, 4000, 6000 mg/l (Glyoxal 100%) LOAEL 107 mg/kg bw (related to active ingredient) Ueno et al., 1991a 90 days Oral (drinking water) Rat and","page":24,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_005"}
SCCS_vision_codex NOAEL =1000 mg/kg bw rat oral 90-day repeated dose toxicity {"dose":"tained a LOEL of 107 mg/kg bw related to pure glyoxal.","effect":"tained a LOEL of 107 mg/kg bw related to pure glyoxal. Moreover, also the 90-day study in dogs resulted in a NOEL of 115 mg/kg bw related to pure glyoxal. In a subacute inhalation study on rats for 29 days, a NOEL of 0.4 mg/m³ was derived for local effects and of > 10 mg/m³ for the systemic toxicity (40% glyoxal). An overview of NOAEL values from repeated dose toxicity studies is given in Table 3.3.3. Table 3.3.3. Overview of NOAEL values from repeated dose toxicity studies Exposure period Route/Species Dosage NOAEL Ref. 28 days Oral (drinking water) Rat 0, 100, 300, 1000 mg/kg bw (Glyoxal 40%) 100 mg/kg bw (40 mg/kg bw related to active ingredient) 142 30, 60, 90 days Oral (drinking water) Rat 0, 2000, 4000, 6000 mg/l (Glyoxal 100%) LOAEL 107 mg/kg bw (related to active ingredient) Ueno et al., 1991a 90 days Oral (drinking water) Rat and mice 0, 1000, 2000, 4000, 8000, 16000 mg/l (Glyoxal, unknown content) Not derived 45 90 days Oral (diet) Rat 0, 32.7, 63.2, 132, 253 mg kg for males; 0; 32, 63.2, 127, 271 mg for females 12","page":24,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_007"}
SCCS_vision_codex NOAEL =5 mg/kg bw rat oral - NOAEL study {"citation":"Ref.: 40, 41 Another group examined the potential of glyoxal to induce UDS in male Fischer 344 rats","dose":"SCCP/0881/05 Opinion on glyoxal 38 Glyoxal induced DNA damage in the pyloric mucosa of the rat stomach after oral application of dose levels in the range of 50 – 550 mg/kg bw.","effect":"SCCP/0881/05 Opinion on glyoxal 38 Glyoxal induced DNA damage in the pyloric mucosa of the rat stomach after oral application of dose levels in the range of 50 – 550 mg/kg bw. No damage was noted at 5 mg/kg bw, indicating that this dose level can be considered as a “NOAEL” for local DNA damage. Ref.: 40, 41 Another group examined the potential of glyoxal to induce UDS in male Fischer 344 rats. Groups of 5 rats received a single oral application of the test substance (content not specified) in distilled water at dose levels of 0, 120, 240, 300, 360, 400 mg/kg in an application volume of 0.5 ml. A homogenate of the pyloric mucosa of the stomach was prepared at 2, 5 and 16 h after dosing and assayed unscheduled DNA synthesis. Significant and dose-related induction of UDS was apparent","page":38,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_009"}
SCCS_vision_codex NOAEL =881 - rabbit oral Developmental developmental toxicity {"dose":"SCCP/0881/05 Opinion on glyoxal 44 observed at 200 mg glyoxal dihydrate/kg body weight per day in the preliminary study or at the highest dose in the main study.","effect":"SCCP/0881/05 Opinion on glyoxal 44 observed at 200 mg glyoxal dihydrate/kg body weight per day in the preliminary study or at the highest dose in the main study. Developmental toxicity range-finding studies in New Zealand White rabbits administered glyoxal by gavage yielded a NOEL of 200 mg glyoxal trimeric dihydrate/kg body weight per day, corresponding to 123 mg glyoxal/kg body weight per day (NTP, 1991d), and a LOEL of 400 mg glyoxal dihydrate/kg body weight per day, corresponding to 247 mg glyoxal/kg body weight per day (NTP, 1992), for both maternal toxicity and embryotoxicity. Maternal signs of systemic toxicity and decreases of weight parameters were accompanied by reduced fetal weight (NTP, 1992). The application of doses in the range of 200 mg glyoxal dihydrate/kg body weight per d","page":44,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_011"}
SCCS_vision_codex NOAEL =125 mg/kg bw - - prenatal repeated dose toxicity {"citation":"Ref.: 17 Overall results No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of appro","dose":"No signs of prenatal developmental toxicity, especially no signs of teratogenicity, were seen at any dose level including the highest dose tested at 125 mg/kg bw.","effect":"SCCP/0881/05 Opinion on glyoxal 46 No substance-related influence on gestational parameters was seen. No signs of prenatal developmental toxicity, especially no signs of teratogenicity, were seen at any dose level including the highest dose tested at 125 mg/kg bw. In this study, the NOAEL for maternal toxicity is 25 mg/kg bw; the NOAEL for prenatal developmental toxicity is 125 mg/kg bw, each correspond to the pure active ingredient, respectively. Ref.: 17 Overall results No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of approx. 250 mg/kg bw (related to pure active ingredient). A prenatal developmental toxicity study performed according to current testing guidelines and under GLP conditions s","page":46,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_013"}
SCCS_vision_codex NOAEL =25 mg/kg bw - - prenatal repeated dose toxicity {"citation":"Ref.: 17 Overall results No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of appro","dose":"No signs of prenatal developmental toxicity, especially no signs of teratogenicity, were seen at any dose level including the highest dose tested at 125 mg/kg bw.","effect":"SCCP/0881/05 Opinion on glyoxal 46 No substance-related influence on gestational parameters was seen. No signs of prenatal developmental toxicity, especially no signs of teratogenicity, were seen at any dose level including the highest dose tested at 125 mg/kg bw. In this study, the NOAEL for maternal toxicity is 25 mg/kg bw; the NOAEL for prenatal developmental toxicity is 125 mg/kg bw, each correspond to the pure active ingredient, respectively. Ref.: 17 Overall results No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of approx. 250 mg/kg bw (related to pure active ingredient). A prenatal developmental toxicity study performed according to current testing guidelines and under GLP conditions showed a NOAEL of 125 mg/kg bw for prenatal devel","page":46,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_014"}
SCCS_vision_codex NOAEL =100 mg/kg bw rat oral 28 day NOAEL study {"dose":"This is slightly less than the tolerable intake of about 0.2 mg/kg body weight per day for lifetime oral exposure to glyoxal (based on a NOAEL of 100 mg/kg bw./day and an uncertainty factor of 100 and a factor of 5 for less-than- lifetime exposure) (Cicads 57, 2004).","effect":"unication, 2003). People can therefore be exposed to glyoxal during its use as a household cleaner. Examples of exposure from non-cosmetic products General population: An exposure scenario has been compiled as a hypothesized worst case. Using the daily intake of, maximally, 10 mg glyoxal via food, an estimated intake of 0.16 mg glyoxal/kg body weight per day can be calculated. This is slightly less than the tolerable intake of about 0.2 mg/kg body weight per day for lifetime oral exposure to glyoxal (based on a NOAEL of 100 mg/kg bw./day and an uncertainty factor of 100 and a factor of 5 for less-than- lifetime exposure) (Cicads 57, 2004). (The above NOAEL is based on reduced body weight gain in a 28 day rat study (149). It is not clear from the report if the actual glyoxal dose was 40 mg/kg bw./day). A LOAEL of 107 mg/kg bw./day was obtained in a 90 day rat study based on reduced serum protein levels (Ueno et al., 1991a)) A nurse or hospital cleaner or consumer using disinfectant: A typical brand of disinfectant (7.5 g in 10","page":49,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_017"}
SCCS_vision_codex NOAEL =40 mg/kg bw/day rat oral 28-day NOAEL study {"dose":"A 28-day study in which glyoxal was administered to rats in drinking-water resulted in a no- observed-adverse-effect level (NOAEL) of 100 mg glyoxal/kg body weight per day (It is not clear from the report if the actual glyoxal dose was calculated as 40% glyoxal.","effect":"o tumour initiating effect after the dermal administration to mice. Oral administration of glyoxal after initiation with MNNG was associated with increased incidences of adenocarcinomas and hyperplasias in both pylorus and fundus of rat stomach. A 28-day study in which glyoxal was administered to rats in drinking-water resulted in a no- observed-adverse-effect level (NOAEL) of 100 mg glyoxal/kg body weight per day (It is not clear from the report if the actual glyoxal dose was calculated as 40% glyoxal. Thus, the NOAEL could be 40 mg/kg bw/day). The 90-day feeding of glyoxal to rats resulted in a NOAEL of 127 mg/kg bw/day (dosage corresponding to 100% glyoxal). Effects stated at higher dosages in the two studies above were retardation of body weight gain. In a study examining more sensitive end-points (serum clinical biochemistry), the lowest tested dosage of 107 mg/kg bw/day (99% glyoxal) corresponded to the lowest-observed-adverse-effect level (LOAEL) for a 90-day exposure of rats via drinking-water. No dose-dependent effects","page":52,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_020"}
SCCS_vision_codex NOAEL =127 mg/kg bw/day rat - 28-day repeated dose toxicity {"dose":"A 28-day study in which glyoxal was administered to rats in drinking-water resulted in a no- observed-adverse-effect level (NOAEL) of 100 mg glyoxal/kg body weight per day (It is not clear from the report if the actual glyoxal dose was calculated as 40% glyoxal.","effect":"on of glyoxal after initiation with MNNG was associated with increased incidences of adenocarcinomas and hyperplasias in both pylorus and fundus of rat stomach. A 28-day study in which glyoxal was administered to rats in drinking-water resulted in a no- observed-adverse-effect level (NOAEL) of 100 mg glyoxal/kg body weight per day (It is not clear from the report if the actual glyoxal dose was calculated as 40% glyoxal. Thus, the NOAEL could be 40 mg/kg bw/day). The 90-day feeding of glyoxal to rats resulted in a NOAEL of 127 mg/kg bw/day (dosage corresponding to 100% glyoxal). Effects stated at higher dosages in the two studies above were retardation of body weight gain. In a study examining more sensitive end-points (serum clinical biochemistry), the lowest tested dosage of 107 mg/kg bw/day (99% glyoxal) corresponded to the lowest-observed-adverse-effect level (LOAEL) for a 90-day exposure of rats via drinking-water. No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a","page":52,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_021"}
SCCS_vision_codex NOAEL =24 - - - - NOAEL study {"effect":"Unlabeled table on page 24: Exposure period Route/Species | Dosage | NOAEL | Ref.","page":24,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_029"}
SCCS_vision_codex NOAEL =132 mg/kg bw rat oral 90 days NOAEL study {"dose":"90 days Oral (diet) Rat | 0, 32.7, 63.2, 132, 253 mg kg for males;","effect":"Unlabeled table on page 24: 90 days Oral (diet) Rat | 0, 32.7, 63.2, 132, 253 mg kg for males; 0; 32, 63.2, 127, 271 mg for females | 127/132 mg/kg bw for females/males (related to active ingredient) | 142","page":24,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_033"}
SCCS_vision_codex NOAEL =0.4 - rat inhalation 29 days NOAEL study {"effect":"Unlabeled table on page 24: 29 days Inhalation Rat | 0, 0.4, 2.0, 10 mg/m³ | NOEL Local effects: 0.4 mg/m³ Systemic effects:>10 mg/m³ (pure active ingredient) | 73","page":24,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_035"}
SCCS_vision_codex NOAEL =100 mg/kg bw/day - - - NOAEL study {"citation":"Ref.: 149","dose":"The effect on the various organ weights in the high dose group was attributed to the reduced body weight.","effect":"n. The effect on the various organ weights in the high dose group was attributed to the reduced body weight. Moreover, in none of the dose groups a substance-related effect on haematological and biochemical parameters and of the urinary status was seen. During necropsy no substance-related macroscopic findings were recorded and histopathology revealed no findings in any organ at any dose group. Based on these findings and mainly on the dose related decrease of the water and food consumption and body weight gain, a NOEL of 100 mg/kg bw/day was established for glyoxal 40% (corresponding to about 40 mg/kg bw pure active ingredient). Ref.: 149","page":20,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_001"}
SCCS_vision_codex NOAEL =107 mg/kg bw - - - NOAEL study {"citation":"Ref.: Ueno et al","dose":"f the intermediate and high dose groups as well as the glyoxalase I activity in the kidneys in the animals of the high dose group.","effect":"f the intermediate and high dose groups as well as the glyoxalase I activity in the kidneys in the animals of the high dose group. In contrast, no substance-related effect on the enzymatic activity of glyoxalase I and II was detectable for the longer exposure periods. Neither the glutathione level nor the synthesis of 2-thiobarbituric acid-active substances was affected in the liver, kidney or erythrocytes. Substance-related macroscopic or histopathological organ changes were not found. According to the authors, a no observed adverse effect level could not be determined due to the reduced serum protein levels in the lowest dose group (lowest observed effect level of 107 mg/kg bw pure active ingredient). Ref.: Ueno et al., 1991a","page":22,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_002"}
SCCS_vision_codex NOAEL =115 mg/kg bw rat oral 90-day repeated dose toxicity {"citation":"Reference: 123) carried out in rats, which obtained a LOEL of 107 mg/kg bw related to pure glyoxal","dose":"A no effect level of 100 mg/kg bw was established for glyoxal 40% (i.e.","effect":"inking water study in rats since this study was performed according to a valid and internationally accepted testing guideline as well as under GLP conditions. A no effect level of 100 mg/kg bw was established for glyoxal 40% (i.e. 40 mg/kg bw related to the active ingredient). This value is supported by the published drinking water studies of Ueno et al. (1991a) (Reference: 123) carried out in rats, which obtained a LOEL of 107 mg/kg bw related to pure glyoxal. Moreover, also the 90-day study in dogs resulted in a NOEL of 115 mg/kg bw related to pure glyoxal. In a subacute inhalation study on rats for 29 days, a NOEL of 0.4 mg/m³ was derived for local effects and of > 10 mg/m³ for the systemic toxicity (40% glyoxal). An overview of NOAEL values from repeated dose toxicity studies is given in Table 3.3.3. Table 3.3.3. Overview of NOAEL values from repeated dose toxicity studies Exposure period Route/Species Dosage NOAEL Ref. 28 days Oral (drinking water) Rat 0, 100, 300, 1000 mg/kg bw (Glyoxal 40%) 100 mg/kg bw (40 mg/kg bw","page":24,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_003"}
SCCS_vision_codex NOAEL =40 % rat oral 90-day repeated dose toxicity {"citation":"Reference: 123) carried out in rats, which obtained a LOEL of 107 mg/kg bw related to pure glyoxal","dose":"40 mg/kg bw related to the active ingredient).","effect":"0% (i.e. 40 mg/kg bw related to the active ingredient). This value is supported by the published drinking water studies of Ueno et al. (1991a) (Reference: 123) carried out in rats, which obtained a LOEL of 107 mg/kg bw related to pure glyoxal. Moreover, also the 90-day study in dogs resulted in a NOEL of 115 mg/kg bw related to pure glyoxal. In a subacute inhalation study on rats for 29 days, a NOEL of 0.4 mg/m³ was derived for local effects and of > 10 mg/m³ for the systemic toxicity (40% glyoxal). An overview of NOAEL values from repeated dose toxicity studies is given in Table 3.3.3. Table 3.3.3. Overview of NOAEL values from repeated dose toxicity studies Exposure period Route/Species Dosage NOAEL Ref. 28 days Oral (drinking water) Rat 0, 100, 300, 1000 mg/kg bw (Glyoxal 40%) 100 mg/kg bw (40 mg/kg bw related to active ingredient) 142 30, 60, 90 days Oral (drinking water) Rat 0, 2000, 4000, 6000 mg/l (Glyoxal 100%) LOAEL 107 mg/kg bw (related to active ingredient) Ueno et al., 1991a 90 days Oral (drinking water) Rat and","page":24,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_005"}
SCCS_vision_codex NOAEL =1000 mg/kg bw rat oral 90-day repeated dose toxicity {"dose":"tained a LOEL of 107 mg/kg bw related to pure glyoxal.","effect":"tained a LOEL of 107 mg/kg bw related to pure glyoxal. Moreover, also the 90-day study in dogs resulted in a NOEL of 115 mg/kg bw related to pure glyoxal. In a subacute inhalation study on rats for 29 days, a NOEL of 0.4 mg/m³ was derived for local effects and of > 10 mg/m³ for the systemic toxicity (40% glyoxal). An overview of NOAEL values from repeated dose toxicity studies is given in Table 3.3.3. Table 3.3.3. Overview of NOAEL values from repeated dose toxicity studies Exposure period Route/Species Dosage NOAEL Ref. 28 days Oral (drinking water) Rat 0, 100, 300, 1000 mg/kg bw (Glyoxal 40%) 100 mg/kg bw (40 mg/kg bw related to active ingredient) 142 30, 60, 90 days Oral (drinking water) Rat 0, 2000, 4000, 6000 mg/l (Glyoxal 100%) LOAEL 107 mg/kg bw (related to active ingredient) Ueno et al., 1991a 90 days Oral (drinking water) Rat and mice 0, 1000, 2000, 4000, 8000, 16000 mg/l (Glyoxal, unknown content) Not derived 45 90 days Oral (diet) Rat 0, 32.7, 63.2, 132, 253 mg kg for males; 0; 32, 63.2, 127, 271 mg for females 12","page":24,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_007"}
SCCS_vision_codex NOAEL =5 mg/kg bw rat oral - NOAEL study {"citation":"Ref.: 40, 41 Another group examined the potential of glyoxal to induce UDS in male Fischer 344 rats","dose":"SCCP/0881/05 Opinion on glyoxal 38 Glyoxal induced DNA damage in the pyloric mucosa of the rat stomach after oral application of dose levels in the range of 50 – 550 mg/kg bw.","effect":"SCCP/0881/05 Opinion on glyoxal 38 Glyoxal induced DNA damage in the pyloric mucosa of the rat stomach after oral application of dose levels in the range of 50 – 550 mg/kg bw. No damage was noted at 5 mg/kg bw, indicating that this dose level can be considered as a “NOAEL” for local DNA damage. Ref.: 40, 41 Another group examined the potential of glyoxal to induce UDS in male Fischer 344 rats. Groups of 5 rats received a single oral application of the test substance (content not specified) in distilled water at dose levels of 0, 120, 240, 300, 360, 400 mg/kg in an application volume of 0.5 ml. A homogenate of the pyloric mucosa of the stomach was prepared at 2, 5 and 16 h after dosing and assayed unscheduled DNA synthesis. Significant and dose-related induction of UDS was apparent","page":38,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_009"}
SCCS_vision_codex NOAEL =881 - rabbit oral Developmental developmental toxicity {"dose":"SCCP/0881/05 Opinion on glyoxal 44 observed at 200 mg glyoxal dihydrate/kg body weight per day in the preliminary study or at the highest dose in the main study.","effect":"SCCP/0881/05 Opinion on glyoxal 44 observed at 200 mg glyoxal dihydrate/kg body weight per day in the preliminary study or at the highest dose in the main study. Developmental toxicity range-finding studies in New Zealand White rabbits administered glyoxal by gavage yielded a NOEL of 200 mg glyoxal trimeric dihydrate/kg body weight per day, corresponding to 123 mg glyoxal/kg body weight per day (NTP, 1991d), and a LOEL of 400 mg glyoxal dihydrate/kg body weight per day, corresponding to 247 mg glyoxal/kg body weight per day (NTP, 1992), for both maternal toxicity and embryotoxicity. Maternal signs of systemic toxicity and decreases of weight parameters were accompanied by reduced fetal weight (NTP, 1992). The application of doses in the range of 200 mg glyoxal dihydrate/kg body weight per d","page":44,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_011"}
SCCS_vision_codex NOAEL =125 mg/kg bw - - prenatal repeated dose toxicity {"citation":"Ref.: 17 Overall results No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of appro","dose":"No signs of prenatal developmental toxicity, especially no signs of teratogenicity, were seen at any dose level including the highest dose tested at 125 mg/kg bw.","effect":"SCCP/0881/05 Opinion on glyoxal 46 No substance-related influence on gestational parameters was seen. No signs of prenatal developmental toxicity, especially no signs of teratogenicity, were seen at any dose level including the highest dose tested at 125 mg/kg bw. In this study, the NOAEL for maternal toxicity is 25 mg/kg bw; the NOAEL for prenatal developmental toxicity is 125 mg/kg bw, each correspond to the pure active ingredient, respectively. Ref.: 17 Overall results No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of approx. 250 mg/kg bw (related to pure active ingredient). A prenatal developmental toxicity study performed according to current testing guidelines and under GLP conditions s","page":46,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_013"}
SCCS_vision_codex NOAEL =25 mg/kg bw - - prenatal repeated dose toxicity {"citation":"Ref.: 17 Overall results No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of appro","dose":"No signs of prenatal developmental toxicity, especially no signs of teratogenicity, were seen at any dose level including the highest dose tested at 125 mg/kg bw.","effect":"SCCP/0881/05 Opinion on glyoxal 46 No substance-related influence on gestational parameters was seen. No signs of prenatal developmental toxicity, especially no signs of teratogenicity, were seen at any dose level including the highest dose tested at 125 mg/kg bw. In this study, the NOAEL for maternal toxicity is 25 mg/kg bw; the NOAEL for prenatal developmental toxicity is 125 mg/kg bw, each correspond to the pure active ingredient, respectively. Ref.: 17 Overall results No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of approx. 250 mg/kg bw (related to pure active ingredient). A prenatal developmental toxicity study performed according to current testing guidelines and under GLP conditions showed a NOAEL of 125 mg/kg bw for prenatal devel","page":46,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_014"}
SCCS_vision_codex NOAEL =100 mg/kg bw rat oral 28 day NOAEL study {"dose":"This is slightly less than the tolerable intake of about 0.2 mg/kg body weight per day for lifetime oral exposure to glyoxal (based on a NOAEL of 100 mg/kg bw./day and an uncertainty factor of 100 and a factor of 5 for less-than- lifetime exposure) (Cicads 57, 2004).","effect":"unication, 2003). People can therefore be exposed to glyoxal during its use as a household cleaner. Examples of exposure from non-cosmetic products General population: An exposure scenario has been compiled as a hypothesized worst case. Using the daily intake of, maximally, 10 mg glyoxal via food, an estimated intake of 0.16 mg glyoxal/kg body weight per day can be calculated. This is slightly less than the tolerable intake of about 0.2 mg/kg body weight per day for lifetime oral exposure to glyoxal (based on a NOAEL of 100 mg/kg bw./day and an uncertainty factor of 100 and a factor of 5 for less-than- lifetime exposure) (Cicads 57, 2004). (The above NOAEL is based on reduced body weight gain in a 28 day rat study (149). It is not clear from the report if the actual glyoxal dose was 40 mg/kg bw./day). A LOAEL of 107 mg/kg bw./day was obtained in a 90 day rat study based on reduced serum protein levels (Ueno et al., 1991a)) A nurse or hospital cleaner or consumer using disinfectant: A typical brand of disinfectant (7.5 g in 10","page":49,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_017"}
SCCS_vision_codex NOAEL =40 mg/kg bw/day rat oral 28-day NOAEL study {"dose":"A 28-day study in which glyoxal was administered to rats in drinking-water resulted in a no- observed-adverse-effect level (NOAEL) of 100 mg glyoxal/kg body weight per day (It is not clear from the report if the actual glyoxal dose was calculated as 40% glyoxal.","effect":"o tumour initiating effect after the dermal administration to mice. Oral administration of glyoxal after initiation with MNNG was associated with increased incidences of adenocarcinomas and hyperplasias in both pylorus and fundus of rat stomach. A 28-day study in which glyoxal was administered to rats in drinking-water resulted in a no- observed-adverse-effect level (NOAEL) of 100 mg glyoxal/kg body weight per day (It is not clear from the report if the actual glyoxal dose was calculated as 40% glyoxal. Thus, the NOAEL could be 40 mg/kg bw/day). The 90-day feeding of glyoxal to rats resulted in a NOAEL of 127 mg/kg bw/day (dosage corresponding to 100% glyoxal). Effects stated at higher dosages in the two studies above were retardation of body weight gain. In a study examining more sensitive end-points (serum clinical biochemistry), the lowest tested dosage of 107 mg/kg bw/day (99% glyoxal) corresponded to the lowest-observed-adverse-effect level (LOAEL) for a 90-day exposure of rats via drinking-water. No dose-dependent effects","page":52,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_020"}
SCCS_vision_codex NOAEL =127 mg/kg bw/day rat - 28-day repeated dose toxicity {"dose":"A 28-day study in which glyoxal was administered to rats in drinking-water resulted in a no- observed-adverse-effect level (NOAEL) of 100 mg glyoxal/kg body weight per day (It is not clear from the report if the actual glyoxal dose was calculated as 40% glyoxal.","effect":"on of glyoxal after initiation with MNNG was associated with increased incidences of adenocarcinomas and hyperplasias in both pylorus and fundus of rat stomach. A 28-day study in which glyoxal was administered to rats in drinking-water resulted in a no- observed-adverse-effect level (NOAEL) of 100 mg glyoxal/kg body weight per day (It is not clear from the report if the actual glyoxal dose was calculated as 40% glyoxal. Thus, the NOAEL could be 40 mg/kg bw/day). The 90-day feeding of glyoxal to rats resulted in a NOAEL of 127 mg/kg bw/day (dosage corresponding to 100% glyoxal). Effects stated at higher dosages in the two studies above were retardation of body weight gain. In a study examining more sensitive end-points (serum clinical biochemistry), the lowest tested dosage of 107 mg/kg bw/day (99% glyoxal) corresponded to the lowest-observed-adverse-effect level (LOAEL) for a 90-day exposure of rats via drinking-water. No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a","page":52,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_021"}
SCCS_vision_codex NOAEL =24 - - - - NOAEL study {"effect":"Unlabeled table on page 24: Exposure period Route/Species | Dosage | NOAEL | Ref.","page":24,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_029"}
SCCS_vision_codex NOAEL =132 mg/kg bw rat oral 90 days NOAEL study {"dose":"90 days Oral (diet) Rat | 0, 32.7, 63.2, 132, 253 mg kg for males;","effect":"Unlabeled table on page 24: 90 days Oral (diet) Rat | 0, 32.7, 63.2, 132, 253 mg kg for males; 0; 32, 63.2, 127, 271 mg for females | 127/132 mg/kg bw for females/males (related to active ingredient) | 142","page":24,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_033"}
SCCS_vision_codex NOAEL =0.4 - rat inhalation 29 days NOAEL study {"effect":"Unlabeled table on page 24: 29 days Inhalation Rat | 0, 0.4, 2.0, 10 mg/m³ | NOEL Local effects: 0.4 mg/m³ Systemic effects:>10 mg/m³ (pure active ingredient) | 73","page":24,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_035"}
SCCS_vision_codex NOAEL =100 mg/kg bw/day - - - NOAEL study {"citation":"Ref.: 149","dose":"The effect on the various organ weights in the high dose group was attributed to the reduced body weight.","effect":"n. The effect on the various organ weights in the high dose group was attributed to the reduced body weight. Moreover, in none of the dose groups a substance-related effect on haematological and biochemical parameters and of the urinary status was seen. During necropsy no substance-related macroscopic findings were recorded and histopathology revealed no findings in any organ at any dose group. Based on these findings and mainly on the dose related decrease of the water and food consumption and body weight gain, a NOEL of 100 mg/kg bw/day was established for glyoxal 40% (corresponding to about 40 mg/kg bw pure active ingredient). Ref.: 149","page":20,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_001"}
SCCS_vision_codex NOAEL =107 mg/kg bw - - - NOAEL study {"citation":"Ref.: Ueno et al","dose":"f the intermediate and high dose groups as well as the glyoxalase I activity in the kidneys in the animals of the high dose group.","effect":"f the intermediate and high dose groups as well as the glyoxalase I activity in the kidneys in the animals of the high dose group. In contrast, no substance-related effect on the enzymatic activity of glyoxalase I and II was detectable for the longer exposure periods. Neither the glutathione level nor the synthesis of 2-thiobarbituric acid-active substances was affected in the liver, kidney or erythrocytes. Substance-related macroscopic or histopathological organ changes were not found. According to the authors, a no observed adverse effect level could not be determined due to the reduced serum protein levels in the lowest dose group (lowest observed effect level of 107 mg/kg bw pure active ingredient). Ref.: Ueno et al., 1991a","page":22,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_002"}
SCCS_vision_codex NOAEL =115 mg/kg bw rat oral 90-day repeated dose toxicity {"citation":"Reference: 123) carried out in rats, which obtained a LOEL of 107 mg/kg bw related to pure glyoxal","dose":"A no effect level of 100 mg/kg bw was established for glyoxal 40% (i.e.","effect":"inking water study in rats since this study was performed according to a valid and internationally accepted testing guideline as well as under GLP conditions. A no effect level of 100 mg/kg bw was established for glyoxal 40% (i.e. 40 mg/kg bw related to the active ingredient). This value is supported by the published drinking water studies of Ueno et al. (1991a) (Reference: 123) carried out in rats, which obtained a LOEL of 107 mg/kg bw related to pure glyoxal. Moreover, also the 90-day study in dogs resulted in a NOEL of 115 mg/kg bw related to pure glyoxal. In a subacute inhalation study on rats for 29 days, a NOEL of 0.4 mg/m³ was derived for local effects and of > 10 mg/m³ for the systemic toxicity (40% glyoxal). An overview of NOAEL values from repeated dose toxicity studies is given in Table 3.3.3. Table 3.3.3. Overview of NOAEL values from repeated dose toxicity studies Exposure period Route/Species Dosage NOAEL Ref. 28 days Oral (drinking water) Rat 0, 100, 300, 1000 mg/kg bw (Glyoxal 40%) 100 mg/kg bw (40 mg/kg bw","page":24,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_003"}
SCCS_vision_codex NOAEL =40 % rat oral 90-day repeated dose toxicity {"citation":"Reference: 123) carried out in rats, which obtained a LOEL of 107 mg/kg bw related to pure glyoxal","dose":"40 mg/kg bw related to the active ingredient).","effect":"0% (i.e. 40 mg/kg bw related to the active ingredient). This value is supported by the published drinking water studies of Ueno et al. (1991a) (Reference: 123) carried out in rats, which obtained a LOEL of 107 mg/kg bw related to pure glyoxal. Moreover, also the 90-day study in dogs resulted in a NOEL of 115 mg/kg bw related to pure glyoxal. In a subacute inhalation study on rats for 29 days, a NOEL of 0.4 mg/m³ was derived for local effects and of > 10 mg/m³ for the systemic toxicity (40% glyoxal). An overview of NOAEL values from repeated dose toxicity studies is given in Table 3.3.3. Table 3.3.3. Overview of NOAEL values from repeated dose toxicity studies Exposure period Route/Species Dosage NOAEL Ref. 28 days Oral (drinking water) Rat 0, 100, 300, 1000 mg/kg bw (Glyoxal 40%) 100 mg/kg bw (40 mg/kg bw related to active ingredient) 142 30, 60, 90 days Oral (drinking water) Rat 0, 2000, 4000, 6000 mg/l (Glyoxal 100%) LOAEL 107 mg/kg bw (related to active ingredient) Ueno et al., 1991a 90 days Oral (drinking water) Rat and","page":24,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_005"}
SCCS_vision_codex NOAEL =1000 mg/kg bw rat oral 90-day repeated dose toxicity {"dose":"tained a LOEL of 107 mg/kg bw related to pure glyoxal.","effect":"tained a LOEL of 107 mg/kg bw related to pure glyoxal. Moreover, also the 90-day study in dogs resulted in a NOEL of 115 mg/kg bw related to pure glyoxal. In a subacute inhalation study on rats for 29 days, a NOEL of 0.4 mg/m³ was derived for local effects and of > 10 mg/m³ for the systemic toxicity (40% glyoxal). An overview of NOAEL values from repeated dose toxicity studies is given in Table 3.3.3. Table 3.3.3. Overview of NOAEL values from repeated dose toxicity studies Exposure period Route/Species Dosage NOAEL Ref. 28 days Oral (drinking water) Rat 0, 100, 300, 1000 mg/kg bw (Glyoxal 40%) 100 mg/kg bw (40 mg/kg bw related to active ingredient) 142 30, 60, 90 days Oral (drinking water) Rat 0, 2000, 4000, 6000 mg/l (Glyoxal 100%) LOAEL 107 mg/kg bw (related to active ingredient) Ueno et al., 1991a 90 days Oral (drinking water) Rat and mice 0, 1000, 2000, 4000, 8000, 16000 mg/l (Glyoxal, unknown content) Not derived 45 90 days Oral (diet) Rat 0, 32.7, 63.2, 132, 253 mg kg for males; 0; 32, 63.2, 127, 271 mg for females 12","page":24,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_007"}
SCCS_vision_codex NOAEL =5 mg/kg bw rat oral - NOAEL study {"citation":"Ref.: 40, 41 Another group examined the potential of glyoxal to induce UDS in male Fischer 344 rats","dose":"SCCP/0881/05 Opinion on glyoxal 38 Glyoxal induced DNA damage in the pyloric mucosa of the rat stomach after oral application of dose levels in the range of 50 – 550 mg/kg bw.","effect":"SCCP/0881/05 Opinion on glyoxal 38 Glyoxal induced DNA damage in the pyloric mucosa of the rat stomach after oral application of dose levels in the range of 50 – 550 mg/kg bw. No damage was noted at 5 mg/kg bw, indicating that this dose level can be considered as a “NOAEL” for local DNA damage. Ref.: 40, 41 Another group examined the potential of glyoxal to induce UDS in male Fischer 344 rats. Groups of 5 rats received a single oral application of the test substance (content not specified) in distilled water at dose levels of 0, 120, 240, 300, 360, 400 mg/kg in an application volume of 0.5 ml. A homogenate of the pyloric mucosa of the stomach was prepared at 2, 5 and 16 h after dosing and assayed unscheduled DNA synthesis. Significant and dose-related induction of UDS was apparent","page":38,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_009"}
SCCS_vision_codex NOAEL =881 - rabbit oral Developmental developmental toxicity {"dose":"SCCP/0881/05 Opinion on glyoxal 44 observed at 200 mg glyoxal dihydrate/kg body weight per day in the preliminary study or at the highest dose in the main study.","effect":"SCCP/0881/05 Opinion on glyoxal 44 observed at 200 mg glyoxal dihydrate/kg body weight per day in the preliminary study or at the highest dose in the main study. Developmental toxicity range-finding studies in New Zealand White rabbits administered glyoxal by gavage yielded a NOEL of 200 mg glyoxal trimeric dihydrate/kg body weight per day, corresponding to 123 mg glyoxal/kg body weight per day (NTP, 1991d), and a LOEL of 400 mg glyoxal dihydrate/kg body weight per day, corresponding to 247 mg glyoxal/kg body weight per day (NTP, 1992), for both maternal toxicity and embryotoxicity. Maternal signs of systemic toxicity and decreases of weight parameters were accompanied by reduced fetal weight (NTP, 1992). The application of doses in the range of 200 mg glyoxal dihydrate/kg body weight per d","page":44,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_011"}
SCCS_vision_codex NOAEL =125 mg/kg bw - - prenatal repeated dose toxicity {"citation":"Ref.: 17 Overall results No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of appro","dose":"No signs of prenatal developmental toxicity, especially no signs of teratogenicity, were seen at any dose level including the highest dose tested at 125 mg/kg bw.","effect":"SCCP/0881/05 Opinion on glyoxal 46 No substance-related influence on gestational parameters was seen. No signs of prenatal developmental toxicity, especially no signs of teratogenicity, were seen at any dose level including the highest dose tested at 125 mg/kg bw. In this study, the NOAEL for maternal toxicity is 25 mg/kg bw; the NOAEL for prenatal developmental toxicity is 125 mg/kg bw, each correspond to the pure active ingredient, respectively. Ref.: 17 Overall results No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of approx. 250 mg/kg bw (related to pure active ingredient). A prenatal developmental toxicity study performed according to current testing guidelines and under GLP conditions s","page":46,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_013"}
SCCS_vision_codex NOAEL =25 mg/kg bw - - prenatal repeated dose toxicity {"citation":"Ref.: 17 Overall results No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of appro","dose":"No signs of prenatal developmental toxicity, especially no signs of teratogenicity, were seen at any dose level including the highest dose tested at 125 mg/kg bw.","effect":"SCCP/0881/05 Opinion on glyoxal 46 No substance-related influence on gestational parameters was seen. No signs of prenatal developmental toxicity, especially no signs of teratogenicity, were seen at any dose level including the highest dose tested at 125 mg/kg bw. In this study, the NOAEL for maternal toxicity is 25 mg/kg bw; the NOAEL for prenatal developmental toxicity is 125 mg/kg bw, each correspond to the pure active ingredient, respectively. Ref.: 17 Overall results No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of approx. 250 mg/kg bw (related to pure active ingredient). A prenatal developmental toxicity study performed according to current testing guidelines and under GLP conditions showed a NOAEL of 125 mg/kg bw for prenatal devel","page":46,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_014"}
SCCS_vision_codex NOAEL =100 mg/kg bw rat oral 28 day NOAEL study {"dose":"This is slightly less than the tolerable intake of about 0.2 mg/kg body weight per day for lifetime oral exposure to glyoxal (based on a NOAEL of 100 mg/kg bw./day and an uncertainty factor of 100 and a factor of 5 for less-than- lifetime exposure) (Cicads 57, 2004).","effect":"unication, 2003). People can therefore be exposed to glyoxal during its use as a household cleaner. Examples of exposure from non-cosmetic products General population: An exposure scenario has been compiled as a hypothesized worst case. Using the daily intake of, maximally, 10 mg glyoxal via food, an estimated intake of 0.16 mg glyoxal/kg body weight per day can be calculated. This is slightly less than the tolerable intake of about 0.2 mg/kg body weight per day for lifetime oral exposure to glyoxal (based on a NOAEL of 100 mg/kg bw./day and an uncertainty factor of 100 and a factor of 5 for less-than- lifetime exposure) (Cicads 57, 2004). (The above NOAEL is based on reduced body weight gain in a 28 day rat study (149). It is not clear from the report if the actual glyoxal dose was 40 mg/kg bw./day). A LOAEL of 107 mg/kg bw./day was obtained in a 90 day rat study based on reduced serum protein levels (Ueno et al., 1991a)) A nurse or hospital cleaner or consumer using disinfectant: A typical brand of disinfectant (7.5 g in 10","page":49,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_017"}
SCCS_vision_codex NOAEL =40 mg/kg bw/day rat oral 28-day NOAEL study {"dose":"A 28-day study in which glyoxal was administered to rats in drinking-water resulted in a no- observed-adverse-effect level (NOAEL) of 100 mg glyoxal/kg body weight per day (It is not clear from the report if the actual glyoxal dose was calculated as 40% glyoxal.","effect":"o tumour initiating effect after the dermal administration to mice. Oral administration of glyoxal after initiation with MNNG was associated with increased incidences of adenocarcinomas and hyperplasias in both pylorus and fundus of rat stomach. A 28-day study in which glyoxal was administered to rats in drinking-water resulted in a no- observed-adverse-effect level (NOAEL) of 100 mg glyoxal/kg body weight per day (It is not clear from the report if the actual glyoxal dose was calculated as 40% glyoxal. Thus, the NOAEL could be 40 mg/kg bw/day). The 90-day feeding of glyoxal to rats resulted in a NOAEL of 127 mg/kg bw/day (dosage corresponding to 100% glyoxal). Effects stated at higher dosages in the two studies above were retardation of body weight gain. In a study examining more sensitive end-points (serum clinical biochemistry), the lowest tested dosage of 107 mg/kg bw/day (99% glyoxal) corresponded to the lowest-observed-adverse-effect level (LOAEL) for a 90-day exposure of rats via drinking-water. No dose-dependent effects","page":52,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_020"}
SCCS_vision_codex NOAEL =127 mg/kg bw/day rat - 28-day repeated dose toxicity {"dose":"A 28-day study in which glyoxal was administered to rats in drinking-water resulted in a no- observed-adverse-effect level (NOAEL) of 100 mg glyoxal/kg body weight per day (It is not clear from the report if the actual glyoxal dose was calculated as 40% glyoxal.","effect":"on of glyoxal after initiation with MNNG was associated with increased incidences of adenocarcinomas and hyperplasias in both pylorus and fundus of rat stomach. A 28-day study in which glyoxal was administered to rats in drinking-water resulted in a no- observed-adverse-effect level (NOAEL) of 100 mg glyoxal/kg body weight per day (It is not clear from the report if the actual glyoxal dose was calculated as 40% glyoxal. Thus, the NOAEL could be 40 mg/kg bw/day). The 90-day feeding of glyoxal to rats resulted in a NOAEL of 127 mg/kg bw/day (dosage corresponding to 100% glyoxal). Effects stated at higher dosages in the two studies above were retardation of body weight gain. In a study examining more sensitive end-points (serum clinical biochemistry), the lowest tested dosage of 107 mg/kg bw/day (99% glyoxal) corresponded to the lowest-observed-adverse-effect level (LOAEL) for a 90-day exposure of rats via drinking-water. No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a","page":52,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_021"}
SCCS_vision_codex NOAEL =24 - - - - NOAEL study {"effect":"Unlabeled table on page 24: Exposure period Route/Species | Dosage | NOAEL | Ref.","page":24,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_029"}
SCCS_vision_codex NOAEL =132 mg/kg bw rat oral 90 days NOAEL study {"dose":"90 days Oral (diet) Rat | 0, 32.7, 63.2, 132, 253 mg kg for males;","effect":"Unlabeled table on page 24: 90 days Oral (diet) Rat | 0, 32.7, 63.2, 132, 253 mg kg for males; 0; 32, 63.2, 127, 271 mg for females | 127/132 mg/kg bw for females/males (related to active ingredient) | 142","page":24,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_033"}
SCCS_vision_codex NOAEL =0.4 - rat inhalation 29 days NOAEL study {"effect":"Unlabeled table on page 24: 29 days Inhalation Rat | 0, 0.4, 2.0, 10 mg/m³ | NOEL Local effects: 0.4 mg/m³ Systemic effects:>10 mg/m³ (pure active ingredient) | 73","page":24,"pdf":"sccp_o_023.pdf","row_type":"noael_study","study_id":"sccp_o_023_noael_035"}
ToxValDB_ECHA_IUCLID 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_ECHA_IUCLID LOAEL =2000 mg/L Rat oral short-term; 30 days short-term QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7cb12e4b0a7c65d224a7c; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/6904/7/6/2?documentUUID=77e2fa46-1cd2-4842-a40f-e63a46e17e8e; YEAR=1990; ORIGINAL_YEAR=1990; STUDY_GROUP=ECHA IUCLID:15833149:M:--; 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_5ab57b0aeee4e5251c7e811ba0a70a00
ToxValDB_ECHA_IUCLID LOAEL =250 mg/kg bw/day Rat oral subchronic; 3 months subchronic QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eae07e4b0a7c65d1c7372; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/6904/7/6/2?documentUUID=77e2fa46-1cd2-4842-a40f-e63a46e17e8e; YEAR=1990; ORIGINAL_YEAR=1990; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15847674_15847781: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_4e156e3338ee0840815eee0d876fe837
ToxValDB_ECHA_IUCLID NOAEL =115 mg/kg bw/day Dog oral subchronic; 3 months subchronic QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eae07e4b0a7c65d1c7366; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/6904/7/6/2?documentUUID=77e2fa46-1cd2-4842-a40f-e63a46e17e8e; YEAR=1990; ORIGINAL_YEAR=1990; STUDY_GROUP=ECHA IUCLID:15836993: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_b598407e42c1a8164549ebe3619c0299
ToxValDB_ECHA_IUCLID NOAEL =125 mg/kg bw/day Rat oral subchronic; 3 months subchronic QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eae07e4b0a7c65d1c7372; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/6904/7/6/2?documentUUID=77e2fa46-1cd2-4842-a40f-e63a46e17e8e; YEAR=1990; ORIGINAL_YEAR=1990; TOXICOLOGICAL_EFFECT=body weight and weight gain|organ weights and organ / body weight ratios; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|organ weight; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15847674_15847781: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_3fa889d724726de22bd6c1e90d4e1e9d
ToxValDB_GESTIS_DNEL 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_GESTIS_DNEL DNEL local =0.04 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_dup_-_15632420_15632421:-:--; 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_1813c5facde93a5c1b3ce6d8c1fffa3f
ToxValDB_GESTIS_DNEL DNEL systemic =2.96 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_dup_-_15632420_15632421:-:--; 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_ccea26cddf67b4b1c548311529c49303
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 35 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 100 mg/kg bw/day - - - - SOURCE_SUBDIR=sccp_o_023; REPORT_TITLE=Opinion on Glyoxal; OPINION_NUMBER=SCCP/0881/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=100; DOSE=The effect on the various organ weights in the high dose group was attributed to the reduced body weight.; EFFECT=n. The effect on the various organ weights in the high dose group was attributed to the reduced body weight. Moreover, in none of the dose groups a substance-related effect on haematological and biochemical parameters and of the urinary status was seen. During necropsy no substance-related macroscopic findings were recorded and histopathology revealed no findings in any organ at any dose group. Based on these findings and mainly on the dose related decrease of the water and food consumption and body weight gain, a NOEL of 100 mg/kg bw/day was established for glyoxal 40% (corresponding to about 40 mg/kg bw pure active ingredient). Ref.: 149; CITATION=Ref.: 149; CITATION_NUMBERS=[149]; REFERENCE=Ref.: 149; DETAILS_JSON={"cas_number":"107-22-2","citation":"Ref.: 149","dose":"The effect on the various organ weights in the high dose group was attributed to the reduced body weight.","duration":"","effect":"n. The effect on the various organ weights in the high dose group was attributed to the reduced body weight. Moreover, in none of the dose groups a substance-related effect on haematological and biochemical parameters and of the urinary status was seen. During necropsy no substance-related macroscopic findings were recorded and histopathology revealed no findings in any organ at any dose group. Based on these findings and mainly on the dose related decrease of the water and food consumption and body weight gain, a NOEL of 100 mg/kg bw/day was established for glyoxal 40% (corresponding to about 40 mg/kg bw pure active ingredient). Ref.: 149","endpoint":"","ingredient":"Glyoxal (INCI name)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":20,"route":"","species":"","study_id":"sccp_o_023_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 107 mg/kg bw - - - - SOURCE_SUBDIR=sccp_o_023; REPORT_TITLE=Opinion on Glyoxal; OPINION_NUMBER=SCCP/0881/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=107; DOSE=f the intermediate and high dose groups as well as the glyoxalase I activity in the kidneys in the animals of the high dose group.; EFFECT=f the intermediate and high dose groups as well as the glyoxalase I activity in the kidneys in the animals of the high dose group. In contrast, no substance-related effect on the enzymatic activity of glyoxalase I and II was detectable for the longer exposure periods. Neither the glutathione level nor the synthesis of 2-thiobarbituric acid-active substances was affected in the liver, kidney or erythrocytes. Substance-related macroscopic or histopathological organ changes were not found. According to the authors, a no observed adverse effect level could not be determined due to the reduced serum protein levels in the lowest dose group (lowest observed effect level of 107 mg/kg bw pure active ingredient). Ref.: Ueno et al., 1991a; CITATION=Ref.: Ueno et al; CITATION_NUMBERS=[]; REFERENCE=Ref.: Ueno et al; DETAILS_JSON={"cas_number":"107-22-2","citation":"Ref.: Ueno et al","dose":"f the intermediate and high dose groups as well as the glyoxalase I activity in the kidneys in the animals of the high dose group.","duration":"","effect":"f the intermediate and high dose groups as well as the glyoxalase I activity in the kidneys in the animals of the high dose group. In contrast, no substance-related effect on the enzymatic activity of glyoxalase I and II was detectable for the longer exposure periods. Neither the glutathione level nor the synthesis of 2-thiobarbituric acid-active substances was affected in the liver, kidney or erythrocytes. Substance-related macroscopic or histopathological organ changes were not found. According to the authors, a no observed adverse effect level could not be determined due to the reduced serum protein levels in the lowest dose group (lowest observed effect level of 107 mg/kg bw pure active ingredient). Ref.: Ueno et al., 1991a","endpoint":"","ingredient":"Glyoxal (INCI name)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"107","page":22,"route":"","species":"","study_id":"sccp_o_023_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 115 mg/kg bw rat oral 90 days - SOURCE_SUBDIR=sccp_o_023; REPORT_TITLE=Opinion on Glyoxal; OPINION_NUMBER=SCCP/0881/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=115; DOSE=(Glyoxal 100%) LOAEL 107 mg/kg bw (related to active ingredient) Ueno et al., 1991a 90 days Oral (drinking water) Rat and mice 0, 1000, 2000, 4000, 8000, 16000 mg/l (Glyoxal, unknown content) Not derived 45 90 days Oral (diet) Rat 0, 32.7, 63.2, 132, 253 mg kg for males;; LOAEL_VALUE=107 mg/kg bw; EFFECT=(Glyoxal 100%) LOAEL 107 mg/kg bw (related to active ingredient) Ueno et al., 1991a 90 days Oral (drinking water) Rat and mice 0, 1000, 2000, 4000, 8000, 16000 mg/l (Glyoxal, unknown content) Not derived 45 90 days Oral (diet) Rat 0, 32.7, 63.2, 132, 253 mg kg for males; 0; 32, 63.2, 127, 271 mg for females 127/132 mg/kg bw for females/males (related to active ingredient) 142 90 days Oral (diet) Dog 0, 31, 65, 115 mg/kg bw 115 mg/kg bw (related to active ingredient) 142 29 days Inhalation Rat 0, 0.4, 2.0, 10 mg/m³ NOEL Local effects: 0.4 mg/m³ Systemic effects:>10 mg/m³ (pure active ingredient) 73; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"107-22-2","citation":"","dose":"(Glyoxal 100%) LOAEL 107 mg/kg bw (related to active ingredient) Ueno et al., 1991a 90 days Oral (drinking water) Rat and mice 0, 1000, 2000, 4000, 8000, 16000 mg/l (Glyoxal, unknown content) Not derived 45 90 days Oral (diet) Rat 0, 32.7, 63.2, 132, 253 mg kg for males;","duration":"90 days","effect":"(Glyoxal 100%) LOAEL 107 mg/kg bw (related to active ingredient) Ueno et al., 1991a 90 days Oral (drinking water) Rat and mice 0, 1000, 2000, 4000, 8000, 16000 mg/l (Glyoxal, unknown content) Not derived 45 90 days Oral (diet) Rat 0, 32.7, 63.2, 132, 253 mg kg for males; 0; 32, 63.2, 127, 271 mg for females 127/132 mg/kg bw for females/males (related to active ingredient) 142 90 days Oral (diet) Dog 0, 31, 65, 115 mg/kg bw 115 mg/kg bw (related to active ingredient) 142 29 days Inhalation Rat 0, 0.4, 2.0, 10 mg/m³ NOEL Local effects: 0.4 mg/m³ Systemic effects:>10 mg/m³ (pure active ingredient) 73","endpoint":"","ingredient":"Glyoxal (INCI name)","loael_value":"107 mg/kg bw","noael_unit":"mg/kg bw","noael_value":"115","page":24,"route":"oral","species":"rat","study_id":"sccp_o_023_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 5 mg/kg bw rat oral - - SOURCE_SUBDIR=sccp_o_023; REPORT_TITLE=Opinion on Glyoxal; OPINION_NUMBER=SCCP/0881/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=5; DOSE=SCCP/0881/05 Opinion on glyoxal 38 Glyoxal induced DNA damage in the pyloric mucosa of the rat stomach after oral application of dose levels in the range of 50 – 550 mg/kg bw.; EFFECT=SCCP/0881/05 Opinion on glyoxal 38 Glyoxal induced DNA damage in the pyloric mucosa of the rat stomach after oral application of dose levels in the range of 50 – 550 mg/kg bw. No damage was noted at 5 mg/kg bw, indicating that this dose level can be considered as a “NOAEL” for local DNA damage. Ref.: 40, 41 Another group examined the potential of glyoxal to induce UDS in male Fischer 344 rats. Groups of 5 rats received a single oral application of the test substance (content not specified) in distilled water at dose levels of 0, 120, 240, 300, 360, 400 mg/kg in an application volume of 0.5 ml. A homogenate of the pyloric mucosa of the stomach was prepared at 2, 5 and 16 h after dosing and assayed unscheduled DNA synthesis. Significant and dose-related induction of UDS was apparent; CITATION=Ref.: 40, 41 Another group examined the potential of glyoxal to induce UDS in male Fischer 344 rats; CITATION_NUMBERS=[40,41,344]; REFERENCE=Ref.: 40, 41 Another group examined the potential of glyoxal to induce UDS in male Fischer 344 rats; DETAILS_JSON={"cas_number":"107-22-2","citation":"Ref.: 40, 41 Another group examined the potential of glyoxal to induce UDS in male Fischer 344 rats","dose":"SCCP/0881/05 Opinion on glyoxal 38 Glyoxal induced DNA damage in the pyloric mucosa of the rat stomach after oral application of dose levels in the range of 50 – 550 mg/kg bw.","duration":"","effect":"SCCP/0881/05 Opinion on glyoxal 38 Glyoxal induced DNA damage in the pyloric mucosa of the rat stomach after oral application of dose levels in the range of 50 – 550 mg/kg bw. No damage was noted at 5 mg/kg bw, indicating that this dose level can be considered as a “NOAEL” for local DNA damage. Ref.: 40, 41 Another group examined the potential of glyoxal to induce UDS in male Fischer 344 rats. Groups of 5 rats received a single oral application of the test substance (content not specified) in distilled water at dose levels of 0, 120, 240, 300, 360, 400 mg/kg in an application volume of 0.5 ml. A homogenate of the pyloric mucosa of the stomach was prepared at 2, 5 and 16 h after dosing and assayed unscheduled DNA synthesis. Significant and dose-related induction of UDS was apparent","endpoint":"","ingredient":"Glyoxal (INCI name)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"5","page":38,"route":"oral","species":"rat","study_id":"sccp_o_023_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 100 mg/kg bw rat oral 28 day - SOURCE_SUBDIR=sccp_o_023; REPORT_TITLE=Opinion on Glyoxal; OPINION_NUMBER=SCCP/0881/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=100; DOSE=This is slightly less than the tolerable intake of about 0.2 mg/kg body weight per day for lifetime oral exposure to glyoxal (based on a NOAEL of 100 mg/kg bw./day and an uncertainty factor of 100 and a factor of 5 for less-than- lifetime exposure) (Cicads 57, 2004).; LOAEL_VALUE=107 mg/kg bw; EFFECT=unication, 2003). People can therefore be exposed to glyoxal during its use as a household cleaner. Examples of exposure from non-cosmetic products General population: An exposure scenario has been compiled as a hypothesized worst case. Using the daily intake of, maximally, 10 mg glyoxal via food, an estimated intake of 0.16 mg glyoxal/kg body weight per day can be calculated. This is slightly less than the tolerable intake of about 0.2 mg/kg body weight per day for lifetime oral exposure to glyoxal (based on a NOAEL of 100 mg/kg bw./day and an uncertainty factor of 100 and a factor of 5 for less-than- lifetime exposure) (Cicads 57, 2004). (The above NOAEL is based on reduced body weight gain in a 28 day rat study (149). It is not clear from the report if the actual glyoxal dose was 40 mg/kg bw./day). A LOAEL of 107 mg/kg bw./day was obtained in a 90 day rat study based on reduced serum protein levels (Ueno et al., 1991a)) A nurse or hospital cleaner or consumer using disinfectant: A typical brand of disinfectant (7.5 g in 10; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"107-22-2","citation":"","dose":"This is slightly less than the tolerable intake of about 0.2 mg/kg body weight per day for lifetime oral exposure to glyoxal (based on a NOAEL of 100 mg/kg bw./day and an uncertainty factor of 100 and a factor of 5 for less-than- lifetime exposure) (Cicads 57, 2004).","duration":"28 day","effect":"unication, 2003). People can therefore be exposed to glyoxal during its use as a household cleaner. Examples of exposure from non-cosmetic products General population: An exposure scenario has been compiled as a hypothesized worst case. Using the daily intake of, maximally, 10 mg glyoxal via food, an estimated intake of 0.16 mg glyoxal/kg body weight per day can be calculated. This is slightly less than the tolerable intake of about 0.2 mg/kg body weight per day for lifetime oral exposure to glyoxal (based on a NOAEL of 100 mg/kg bw./day and an uncertainty factor of 100 and a factor of 5 for less-than- lifetime exposure) (Cicads 57, 2004). (The above NOAEL is based on reduced body weight gain in a 28 day rat study (149). It is not clear from the report if the actual glyoxal dose was 40 mg/kg bw./day). A LOAEL of 107 mg/kg bw./day was obtained in a 90 day rat study based on reduced serum protein levels (Ueno et al., 1991a)) A nurse or hospital cleaner or consumer using disinfectant: A typical brand of disinfectant (7.5 g in 10","endpoint":"","ingredient":"Glyoxal (INCI name)","loael_value":"107 mg/kg bw","noael_unit":"mg/kg bw","noael_value":"100","page":49,"route":"oral","species":"rat","study_id":"sccp_o_023_noael_017"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 100 mg/kg bw rat oral 28 day - SOURCE_SUBDIR=sccp_o_023; REPORT_TITLE=Opinion on Glyoxal; OPINION_NUMBER=SCCP/0881/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=100; DOSE=This is slightly less than the tolerable intake of about 0.2 mg/kg body weight per day for lifetime oral exposure to glyoxal (based on a NOAEL of 100 mg/kg bw./day and an uncertainty factor of 100 and a factor of 5 for less-than- lifetime exposure) (Cicads 57, 2004).; LOAEL_VALUE=107 mg/kg bw; EFFECT=roducts General population: An exposure scenario has been compiled as a hypothesized worst case. Using the daily intake of, maximally, 10 mg glyoxal via food, an estimated intake of 0.16 mg glyoxal/kg body weight per day can be calculated. This is slightly less than the tolerable intake of about 0.2 mg/kg body weight per day for lifetime oral exposure to glyoxal (based on a NOAEL of 100 mg/kg bw./day and an uncertainty factor of 100 and a factor of 5 for less-than- lifetime exposure) (Cicads 57, 2004). (The above NOAEL is based on reduced body weight gain in a 28 day rat study (149). It is not clear from the report if the actual glyoxal dose was 40 mg/kg bw./day). A LOAEL of 107 mg/kg bw./day was obtained in a 90 day rat study based on reduced serum protein levels (Ueno et al., 1991a)) A nurse or hospital cleaner or consumer using disinfectant: A typical brand of disinfectant (7.5 g in 100 g = 7.5% glyoxal) is used at a dilution of 1% for disinfection and cleaning of surfaces (i.e., 0.075% glyoxal). Using a rounded-up 0.1% glyo; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"107-22-2","citation":"","dose":"This is slightly less than the tolerable intake of about 0.2 mg/kg body weight per day for lifetime oral exposure to glyoxal (based on a NOAEL of 100 mg/kg bw./day and an uncertainty factor of 100 and a factor of 5 for less-than- lifetime exposure) (Cicads 57, 2004).","duration":"28 day","effect":"roducts General population: An exposure scenario has been compiled as a hypothesized worst case. Using the daily intake of, maximally, 10 mg glyoxal via food, an estimated intake of 0.16 mg glyoxal/kg body weight per day can be calculated. This is slightly less than the tolerable intake of about 0.2 mg/kg body weight per day for lifetime oral exposure to glyoxal (based on a NOAEL of 100 mg/kg bw./day and an uncertainty factor of 100 and a factor of 5 for less-than- lifetime exposure) (Cicads 57, 2004). (The above NOAEL is based on reduced body weight gain in a 28 day rat study (149). It is not clear from the report if the actual glyoxal dose was 40 mg/kg bw./day). A LOAEL of 107 mg/kg bw./day was obtained in a 90 day rat study based on reduced serum protein levels (Ueno et al., 1991a)) A nurse or hospital cleaner or consumer using disinfectant: A typical brand of disinfectant (7.5 g in 100 g = 7.5% glyoxal) is used at a dilution of 1% for disinfection and cleaning of surfaces (i.e., 0.075% glyoxal). Using a rounded-up 0.1% glyo","endpoint":"","ingredient":"Glyoxal (INCI name)","loael_value":"107 mg/kg bw","noael_unit":"mg/kg bw","noael_value":"100","page":49,"route":"oral","species":"rat","study_id":"sccp_o_023_noael_018"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 40 mg/kg bw/day rat oral 28-day - SOURCE_SUBDIR=sccp_o_023; REPORT_TITLE=Opinion on Glyoxal; OPINION_NUMBER=SCCP/0881/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=40; DOSE=A 28-day study in which glyoxal was administered to rats in drinking-water resulted in a no- observed-adverse-effect level (NOAEL) of 100 mg glyoxal/kg body weight per day (It is not clear from the report if the actual glyoxal dose was calculated as 40% glyoxal.; EFFECT=o tumour initiating effect after the dermal administration to mice. Oral administration of glyoxal after initiation with MNNG was associated with increased incidences of adenocarcinomas and hyperplasias in both pylorus and fundus of rat stomach. A 28-day study in which glyoxal was administered to rats in drinking-water resulted in a no- observed-adverse-effect level (NOAEL) of 100 mg glyoxal/kg body weight per day (It is not clear from the report if the actual glyoxal dose was calculated as 40% glyoxal. Thus, the NOAEL could be 40 mg/kg bw/day). The 90-day feeding of glyoxal to rats resulted in a NOAEL of 127 mg/kg bw/day (dosage corresponding to 100% glyoxal). Effects stated at higher dosages in the two studies above were retardation of body weight gain. In a study examining more sensitive end-points (serum clinical biochemistry), the lowest tested dosage of 107 mg/kg bw/day (99% glyoxal) corresponded to the lowest-observed-adverse-effect level (LOAEL) for a 90-day exposure of rats via drinking-water. No dose-dependent effects; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"107-22-2","citation":"","dose":"A 28-day study in which glyoxal was administered to rats in drinking-water resulted in a no- observed-adverse-effect level (NOAEL) of 100 mg glyoxal/kg body weight per day (It is not clear from the report if the actual glyoxal dose was calculated as 40% glyoxal.","duration":"28-day","effect":"o tumour initiating effect after the dermal administration to mice. Oral administration of glyoxal after initiation with MNNG was associated with increased incidences of adenocarcinomas and hyperplasias in both pylorus and fundus of rat stomach. A 28-day study in which glyoxal was administered to rats in drinking-water resulted in a no- observed-adverse-effect level (NOAEL) of 100 mg glyoxal/kg body weight per day (It is not clear from the report if the actual glyoxal dose was calculated as 40% glyoxal. Thus, the NOAEL could be 40 mg/kg bw/day). The 90-day feeding of glyoxal to rats resulted in a NOAEL of 127 mg/kg bw/day (dosage corresponding to 100% glyoxal). Effects stated at higher dosages in the two studies above were retardation of body weight gain. In a study examining more sensitive end-points (serum clinical biochemistry), the lowest tested dosage of 107 mg/kg bw/day (99% glyoxal) corresponded to the lowest-observed-adverse-effect level (LOAEL) for a 90-day exposure of rats via drinking-water. No dose-dependent effects","endpoint":"","ingredient":"Glyoxal (INCI name)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"40","page":52,"route":"oral","species":"rat","study_id":"sccp_o_023_noael_020"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 40 % rat - 28-day - SOURCE_SUBDIR=sccp_o_023; REPORT_TITLE=Opinion on Glyoxal; OPINION_NUMBER=SCCP/0881/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=40; DOSE=A 28-day study in which glyoxal was administered to rats in drinking-water resulted in a no- observed-adverse-effect level (NOAEL) of 100 mg glyoxal/kg body weight per day (It is not clear from the report if the actual glyoxal dose was calculated as 40% glyoxal, Thus, the NOAEL could be 40 mg/kg bw/day).; EFFECT=prominent target organs, pancreas and kidney, the toxic action of glyoxal leads to severe degenerative changes resembling those induced during diabetes. In animal studies, 30% and 40% aqueous glyoxal caused slight to definite skin irritations, depending on the application time. Glyoxal is irritating to mucous membranes and acts as a skin sensitising agent in humans and experimental animals. A 28-day study in which glyoxal was administered to rats in drinking-water resulted in a no- observed-adverse-effect level (NOAEL) of 100 mg glyoxal/kg body weight per day (It is not clear from the report if the actual glyoxal dose was calculated as 40% glyoxal, Thus, the NOAEL could be 40 mg/kg bw/day). The 90-day feeding of glyoxal to rats resulted in a NOAEL of 127 mg/kg bw/day (dosage corresponding to 100% glyoxal). Effects stated at higher dosages in the two studies above were retardation of body weight gain. In a study examining more sensitive end-points (serum clinical biochemistry), the lowest tested dosage of 107 mg/kg bw/day (99% g; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"107-22-2","citation":"","dose":"A 28-day study in which glyoxal was administered to rats in drinking-water resulted in a no- observed-adverse-effect level (NOAEL) of 100 mg glyoxal/kg body weight per day (It is not clear from the report if the actual glyoxal dose was calculated as 40% glyoxal, Thus, the NOAEL could be 40 mg/kg bw/day).","duration":"28-day","effect":"prominent target organs, pancreas and kidney, the toxic action of glyoxal leads to severe degenerative changes resembling those induced during diabetes. In animal studies, 30% and 40% aqueous glyoxal caused slight to definite skin irritations, depending on the application time. Glyoxal is irritating to mucous membranes and acts as a skin sensitising agent in humans and experimental animals. A 28-day study in which glyoxal was administered to rats in drinking-water resulted in a no- observed-adverse-effect level (NOAEL) of 100 mg glyoxal/kg body weight per day (It is not clear from the report if the actual glyoxal dose was calculated as 40% glyoxal, Thus, the NOAEL could be 40 mg/kg bw/day). The 90-day feeding of glyoxal to rats resulted in a NOAEL of 127 mg/kg bw/day (dosage corresponding to 100% glyoxal). Effects stated at higher dosages in the two studies above were retardation of body weight gain. In a study examining more sensitive end-points (serum clinical biochemistry), the lowest tested dosage of 107 mg/kg bw/day (99% g","endpoint":"","ingredient":"Glyoxal (INCI name)","loael_value":"","noael_unit":"%","noael_value":"40","page":55,"route":"","species":"rat","study_id":"sccp_o_023_noael_024"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 40 mg/kg bw/day rat - 28-day - SOURCE_SUBDIR=sccp_o_023; REPORT_TITLE=Opinion on Glyoxal; OPINION_NUMBER=SCCP/0881/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=40; DOSE=A 28-day study in which glyoxal was administered to rats in drinking-water resulted in a no- observed-adverse-effect level (NOAEL) of 100 mg glyoxal/kg body weight per day (It is not clear from the report if the actual glyoxal dose was calculated as 40% glyoxal, Thus, the NOAEL could be 40 mg/kg bw/day).; EFFECT=es. In animal studies, 30% and 40% aqueous glyoxal caused slight to definite skin irritations, depending on the application time. Glyoxal is irritating to mucous membranes and acts as a skin sensitising agent in humans and experimental animals. A 28-day study in which glyoxal was administered to rats in drinking-water resulted in a no- observed-adverse-effect level (NOAEL) of 100 mg glyoxal/kg body weight per day (It is not clear from the report if the actual glyoxal dose was calculated as 40% glyoxal, Thus, the NOAEL could be 40 mg/kg bw/day). The 90-day feeding of glyoxal to rats resulted in a NOAEL of 127 mg/kg bw/day (dosage corresponding to 100% glyoxal). Effects stated at higher dosages in the two studies above were retardation of body weight gain. In a study examining more sensitive end-points (serum clinical biochemistry), the lowest tested dosage of 107 mg/kg bw/day (99% glyoxal) corresponded to the lowest-observed-adverse-effect level (LOAEL) for a 90-day exposure of rats via drinking-water. No dose-dependent effects; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"107-22-2","citation":"","dose":"A 28-day study in which glyoxal was administered to rats in drinking-water resulted in a no- observed-adverse-effect level (NOAEL) of 100 mg glyoxal/kg body weight per day (It is not clear from the report if the actual glyoxal dose was calculated as 40% glyoxal, Thus, the NOAEL could be 40 mg/kg bw/day).","duration":"28-day","effect":"es. In animal studies, 30% and 40% aqueous glyoxal caused slight to definite skin irritations, depending on the application time. Glyoxal is irritating to mucous membranes and acts as a skin sensitising agent in humans and experimental animals. A 28-day study in which glyoxal was administered to rats in drinking-water resulted in a no- observed-adverse-effect level (NOAEL) of 100 mg glyoxal/kg body weight per day (It is not clear from the report if the actual glyoxal dose was calculated as 40% glyoxal, Thus, the NOAEL could be 40 mg/kg bw/day). The 90-day feeding of glyoxal to rats resulted in a NOAEL of 127 mg/kg bw/day (dosage corresponding to 100% glyoxal). Effects stated at higher dosages in the two studies above were retardation of body weight gain. In a study examining more sensitive end-points (serum clinical biochemistry), the lowest tested dosage of 107 mg/kg bw/day (99% glyoxal) corresponded to the lowest-observed-adverse-effect level (LOAEL) for a 90-day exposure of rats via drinking-water. No dose-dependent effects","endpoint":"","ingredient":"Glyoxal (INCI name)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"40","page":55,"route":"","species":"rat","study_id":"sccp_o_023_noael_025"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 24 - - - - - SOURCE_SUBDIR=sccp_o_023; REPORT_TITLE=Opinion on Glyoxal; OPINION_NUMBER=SCCP/0881/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=unclear:Unlabeled table on page 24: Exposure period Route/Species | Dosage | NOAEL | Ref.; EFFECT=Unlabeled table on page 24: Exposure period Route/Species | Dosage | NOAEL | Ref.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"107-22-2","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 24: Exposure period Route/Species | Dosage | NOAEL | Ref.","endpoint":"","ingredient":"Glyoxal (INCI name)","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 24: Exposure period Route/Species | Dosage | NOAEL | Ref.","page":24,"route":"","species":"","study_id":"sccp_o_023_noael_029"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 24 - rat inhalation 29 days - SOURCE_SUBDIR=sccp_o_023; REPORT_TITLE=Opinion on Glyoxal; OPINION_NUMBER=SCCP/0881/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=unclear:Unlabeled table on page 24: 29 days Inhalation Rat | 0, 0.4, 2.0, 10 mg/m³ | NOEL Local effects: 0.4 mg/m³ Systemic effects:>10 mg/m³ (pure active ingredient) | 73; EFFECT=Unlabeled table on page 24: 29 days Inhalation Rat | 0, 0.4, 2.0, 10 mg/m³ | NOEL Local effects: 0.4 mg/m³ Systemic effects:>10 mg/m³ (pure active ingredient) | 73; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"107-22-2","citation":"","dose":"","duration":"29 days","effect":"Unlabeled table on page 24: 29 days Inhalation Rat | 0, 0.4, 2.0, 10 mg/m³ | NOEL Local effects: 0.4 mg/m³ Systemic effects:>10 mg/m³ (pure active ingredient) | 73","endpoint":"","ingredient":"Glyoxal (INCI name)","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 24: 29 days Inhalation Rat | 0, 0.4, 2.0, 10 mg/m³ | NOEL Local effects: 0.4 mg/m³ Systemic effects:>10 mg/m³ (pure active ingredient) | 73","page":24,"route":"inhalation","species":"rat","study_id":"sccp_o_023_noael_030"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 100 mg/kg bw rat oral 28 days - SOURCE_SUBDIR=sccp_o_023; REPORT_TITLE=Opinion on Glyoxal; OPINION_NUMBER=SCCP/0881/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=100; DOSE=28 days Oral (drinking water) Rat | 0, 100, 300, 1000 mg/kg bw (Glyoxal 40%) | 100 mg/kg bw (40 mg/kg bw related to active ingredient) | 142; EFFECT=Unlabeled table on page 24: 28 days Oral (drinking water) Rat | 0, 100, 300, 1000 mg/kg bw (Glyoxal 40%) | 100 mg/kg bw (40 mg/kg bw related to active ingredient) | 142; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"107-22-2","citation":"","dose":"28 days Oral (drinking water) Rat | 0, 100, 300, 1000 mg/kg bw (Glyoxal 40%) | 100 mg/kg bw (40 mg/kg bw related to active ingredient) | 142","duration":"28 days","effect":"Unlabeled table on page 24: 28 days Oral (drinking water) Rat | 0, 100, 300, 1000 mg/kg bw (Glyoxal 40%) | 100 mg/kg bw (40 mg/kg bw related to active ingredient) | 142","endpoint":"","ingredient":"Glyoxal (INCI name)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"100","page":24,"route":"oral","species":"rat","study_id":"sccp_o_023_noael_031"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 107 mg/kg bw rat oral 90 days - SOURCE_SUBDIR=sccp_o_023; REPORT_TITLE=Opinion on Glyoxal; OPINION_NUMBER=SCCP/0881/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=107; DOSE=30, 60, 90 days Oral (drinking water) Rat | 0, 2000, 4000, 6000 mg/l (Glyoxal 100%) | LOAEL 107 mg/kg bw (related to active ingredient) | Ueno et al., 1991a; LOAEL_VALUE=107 mg/kg bw; EFFECT=Unlabeled table on page 24: 30, 60, 90 days Oral (drinking water) Rat | 0, 2000, 4000, 6000 mg/l (Glyoxal 100%) | LOAEL 107 mg/kg bw (related to active ingredient) | Ueno et al., 1991a; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"107-22-2","citation":"","dose":"30, 60, 90 days Oral (drinking water) Rat | 0, 2000, 4000, 6000 mg/l (Glyoxal 100%) | LOAEL 107 mg/kg bw (related to active ingredient) | Ueno et al., 1991a","duration":"90 days","effect":"Unlabeled table on page 24: 30, 60, 90 days Oral (drinking water) Rat | 0, 2000, 4000, 6000 mg/l (Glyoxal 100%) | LOAEL 107 mg/kg bw (related to active ingredient) | Ueno et al., 1991a","endpoint":"","ingredient":"Glyoxal (INCI name)","loael_value":"107 mg/kg bw","noael_unit":"mg/kg bw","noael_value":"107","page":24,"route":"oral","species":"rat","study_id":"sccp_o_023_noael_032"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 132 mg/kg bw rat oral 90 days - SOURCE_SUBDIR=sccp_o_023; REPORT_TITLE=Opinion on Glyoxal; OPINION_NUMBER=SCCP/0881/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=132; DOSE=90 days Oral (diet) Rat | 0, 32.7, 63.2, 132, 253 mg kg for males;; EFFECT=Unlabeled table on page 24: 90 days Oral (diet) Rat | 0, 32.7, 63.2, 132, 253 mg kg for males; 0; 32, 63.2, 127, 271 mg for females | 127/132 mg/kg bw for females/males (related to active ingredient) | 142; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"107-22-2","citation":"","dose":"90 days Oral (diet) Rat | 0, 32.7, 63.2, 132, 253 mg kg for males;","duration":"90 days","effect":"Unlabeled table on page 24: 90 days Oral (diet) Rat | 0, 32.7, 63.2, 132, 253 mg kg for males; 0; 32, 63.2, 127, 271 mg for females | 127/132 mg/kg bw for females/males (related to active ingredient) | 142","endpoint":"","ingredient":"Glyoxal (INCI name)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"132","page":24,"route":"oral","species":"rat","study_id":"sccp_o_023_noael_033"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 115 mg/kg bw dog oral 90 days - SOURCE_SUBDIR=sccp_o_023; REPORT_TITLE=Opinion on Glyoxal; OPINION_NUMBER=SCCP/0881/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=115; DOSE=90 days Oral (diet) Dog | 0, 31, 65, 115 mg/kg bw | 115 mg/kg bw (related to active ingredient) | 142; EFFECT=Unlabeled table on page 24: 90 days Oral (diet) Dog | 0, 31, 65, 115 mg/kg bw | 115 mg/kg bw (related to active ingredient) | 142; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"107-22-2","citation":"","dose":"90 days Oral (diet) Dog | 0, 31, 65, 115 mg/kg bw | 115 mg/kg bw (related to active ingredient) | 142","duration":"90 days","effect":"Unlabeled table on page 24: 90 days Oral (diet) Dog | 0, 31, 65, 115 mg/kg bw | 115 mg/kg bw (related to active ingredient) | 142","endpoint":"","ingredient":"Glyoxal (INCI name)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"115","page":24,"route":"oral","species":"dog","study_id":"sccp_o_023_noael_034"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 0.4 - rat inhalation 29 days - SOURCE_SUBDIR=sccp_o_023; REPORT_TITLE=Opinion on Glyoxal; OPINION_NUMBER=SCCP/0881/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=NOEL Local effects: 0.4 mg/m³ Systemic effects:>10 mg/m³ (pure active ingredient); EFFECT=Unlabeled table on page 24: 29 days Inhalation Rat | 0, 0.4, 2.0, 10 mg/m³ | NOEL Local effects: 0.4 mg/m³ Systemic effects:>10 mg/m³ (pure active ingredient) | 73; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"107-22-2","citation":"","dose":"","duration":"29 days","effect":"Unlabeled table on page 24: 29 days Inhalation Rat | 0, 0.4, 2.0, 10 mg/m³ | NOEL Local effects: 0.4 mg/m³ Systemic effects:>10 mg/m³ (pure active ingredient) | 73","endpoint":"","ingredient":"Glyoxal (INCI name)","loael_value":"","noael_unit":"","noael_value":"NOEL Local effects: 0.4 mg/m³ Systemic effects:>10 mg/m³ (pure active ingredient)","page":24,"route":"inhalation","species":"rat","study_id":"sccp_o_023_noael_035"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies carcinogenicity 40 % rat oral 28-day carcinogenicity SOURCE_SUBDIR=sccp_o_023; REPORT_TITLE=Opinion on Glyoxal; OPINION_NUMBER=SCCP/0881/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=40; DOSE=A 28-day study in which glyoxal was administered to rats in drinking-water resulted in a no- observed-adverse-effect level (NOAEL) of 100 mg glyoxal/kg body weight per day (It is not clear from the report if the actual glyoxal dose was calculated as 40% glyoxal.; EFFECT=5 Opinion on glyoxal 52 No carcinogenic effect is detected in mice after dermal application of glyoxal over the entire life span. Glyoxal possesses no tumour initiating effect after the dermal administration to mice. Oral administration of glyoxal after initiation with MNNG was associated with increased incidences of adenocarcinomas and hyperplasias in both pylorus and fundus of rat stomach. A 28-day study in which glyoxal was administered to rats in drinking-water resulted in a no- observed-adverse-effect level (NOAEL) of 100 mg glyoxal/kg body weight per day (It is not clear from the report if the actual glyoxal dose was calculated as 40% glyoxal. Thus, the NOAEL could be 40 mg/kg bw/day). The 90-day feeding of glyoxal to rats resulted in a NOAEL of 127 mg/kg bw/day (dosage corresponding to 100% glyoxal). Effects stated at higher dosages in the two studies above were retardation of body weight gain. In a study examining more sensitive end-points (serum clinical biochemistry), the lowest tested dosage of 107 mg/kg bw/day (99% g; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"107-22-2","citation":"","dose":"A 28-day study in which glyoxal was administered to rats in drinking-water resulted in a no- observed-adverse-effect level (NOAEL) of 100 mg glyoxal/kg body weight per day (It is not clear from the report if the actual glyoxal dose was calculated as 40% glyoxal.","duration":"28-day","effect":"5 Opinion on glyoxal 52 No carcinogenic effect is detected in mice after dermal application of glyoxal over the entire life span. Glyoxal possesses no tumour initiating effect after the dermal administration to mice. Oral administration of glyoxal after initiation with MNNG was associated with increased incidences of adenocarcinomas and hyperplasias in both pylorus and fundus of rat stomach. A 28-day study in which glyoxal was administered to rats in drinking-water resulted in a no- observed-adverse-effect level (NOAEL) of 100 mg glyoxal/kg body weight per day (It is not clear from the report if the actual glyoxal dose was calculated as 40% glyoxal. Thus, the NOAEL could be 40 mg/kg bw/day). The 90-day feeding of glyoxal to rats resulted in a NOAEL of 127 mg/kg bw/day (dosage corresponding to 100% glyoxal). Effects stated at higher dosages in the two studies above were retardation of body weight gain. In a study examining more sensitive end-points (serum clinical biochemistry), the lowest tested dosage of 107 mg/kg bw/day (99% g","endpoint":"carcinogenicity","ingredient":"Glyoxal (INCI name)","loael_value":"","noael_unit":"%","noael_value":"40","page":52,"route":"oral","species":"rat","study_id":"sccp_o_023_noael_019"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 881 - rabbit oral Developmental developmental toxicity SOURCE_SUBDIR=sccp_o_023; REPORT_TITLE=Opinion on Glyoxal; OPINION_NUMBER=SCCP/0881/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=unclear:SCCP/0881/05 Opinion on glyoxal 44 observed at 200 mg glyoxal dihydrate/kg body weight per day in the preliminary study or at the highest dose in the main study. Developmental toxicity range-finding studies in New Zealand White rabbits administered glyoxal by gavage yielded a NOEL of 200 mg glyoxal trimeric dihydrate/kg body weight per day, corresponding to 123 mg glyoxal/kg body weight per day (NTP, 1991d), and a LOEL of 400 mg glyoxal dihydrate/kg body weight per day, corresponding to 247 mg glyoxal/kg body weight per day (NTP, 1992), for both maternal toxicity and embryotoxicity. Maternal signs of systemic toxicity and decreases of weight parameters were accompanied by reduced fetal weight (NTP, 1992). The application of doses in the range of 200 mg glyoxal dihydrate/kg body weight per d; DOSE=SCCP/0881/05 Opinion on glyoxal 44 observed at 200 mg glyoxal dihydrate/kg body weight per day in the preliminary study or at the highest dose in the main study.; EFFECT=SCCP/0881/05 Opinion on glyoxal 44 observed at 200 mg glyoxal dihydrate/kg body weight per day in the preliminary study or at the highest dose in the main study. Developmental toxicity range-finding studies in New Zealand White rabbits administered glyoxal by gavage yielded a NOEL of 200 mg glyoxal trimeric dihydrate/kg body weight per day, corresponding to 123 mg glyoxal/kg body weight per day (NTP, 1991d), and a LOEL of 400 mg glyoxal dihydrate/kg body weight per day, corresponding to 247 mg glyoxal/kg body weight per day (NTP, 1992), for both maternal toxicity and embryotoxicity. Maternal signs of systemic toxicity and decreases of weight parameters were accompanied by reduced fetal weight (NTP, 1992). The application of doses in the range of 200 mg glyoxal dihydrate/kg body weight per d; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"107-22-2","citation":"","dose":"SCCP/0881/05 Opinion on glyoxal 44 observed at 200 mg glyoxal dihydrate/kg body weight per day in the preliminary study or at the highest dose in the main study.","duration":"Developmental","effect":"SCCP/0881/05 Opinion on glyoxal 44 observed at 200 mg glyoxal dihydrate/kg body weight per day in the preliminary study or at the highest dose in the main study. Developmental toxicity range-finding studies in New Zealand White rabbits administered glyoxal by gavage yielded a NOEL of 200 mg glyoxal trimeric dihydrate/kg body weight per day, corresponding to 123 mg glyoxal/kg body weight per day (NTP, 1991d), and a LOEL of 400 mg glyoxal dihydrate/kg body weight per day, corresponding to 247 mg glyoxal/kg body weight per day (NTP, 1992), for both maternal toxicity and embryotoxicity. Maternal signs of systemic toxicity and decreases of weight parameters were accompanied by reduced fetal weight (NTP, 1992). The application of doses in the range of 200 mg glyoxal dihydrate/kg body weight per d","endpoint":"developmental toxicity","ingredient":"Glyoxal (INCI name)","loael_value":"","noael_unit":"","noael_value":"unclear:SCCP/0881/05 Opinion on glyoxal 44 observed at 200 mg glyoxal dihydrate/kg body weight per day in the preliminary study or at the highest dose in the main study. Developmental toxicity range-finding studies in New Zealand White rabbits administered glyoxal by gavage yielded a NOEL of 200 mg glyoxal trimeric dihydrate/kg body weight per day, corresponding to 123 mg glyoxal/kg body weight per day (NTP, 1991d), and a LOEL of 400 mg glyoxal dihydrate/kg body weight per day, corresponding to 247 mg glyoxal/kg body weight per day (NTP, 1992), for both maternal toxicity and embryotoxicity. Maternal signs of systemic toxicity and decreases of weight parameters were accompanied by reduced fetal weight (NTP, 1992). The application of doses in the range of 200 mg glyoxal dihydrate/kg body weight per d","page":44,"route":"oral","species":"rabbit","study_id":"sccp_o_023_noael_011"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 40 % rat oral developmental developmental toxicity SOURCE_SUBDIR=sccp_o_023; REPORT_TITLE=Opinion on Glyoxal; OPINION_NUMBER=SCCP/0881/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=40; DOSE=In a subsequent study with a single dose level of 50 mg glyoxal dihydrate/kg body weight per day, corresponding to 31 mg glyoxal/kg body weight per day, there was no maternal mortality or persistent signs of toxicity, although minimal reductions in body weight gain and food consumption were noted.; EFFECT=tions cited in NTP, 1993). In a subsequent study with a single dose level of 50 mg glyoxal dihydrate/kg body weight per day, corresponding to 31 mg glyoxal/kg body weight per day, there was no maternal mortality or persistent signs of toxicity, although minimal reductions in body weight gain and food consumption were noted. Glyoxal exposure did not significantly alter post-implantation loss and had no effect on foetal body weight or the incidence of external, visceral, or skeletal malformations. The authors gave a NOAEL for developmental toxicity for rabbits of 50 mg glyoxal dihydrate/kg body weight per day, corresponding to 31 mg glyoxal/kg body weight per day (NTP, 1993). Guidelines : OECD 414 (Draft 1999), Commission Directive 87/302/EEC (1988), US EPA OPPTS 870.3700 (1988) Species/strain : Wistar rat, Chbb:THOM (SPF) Group size : 25 mated female rats Test substance : Glyoxal 40% Batch no : B 61 (produced March 1999) Dose level : 0, 5, 25, 125 mg/kg bw corresponding to pure active ingredient Route : oral (gavage) Exposure p; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"107-22-2","citation":"","dose":"In a subsequent study with a single dose level of 50 mg glyoxal dihydrate/kg body weight per day, corresponding to 31 mg glyoxal/kg body weight per day, there was no maternal mortality or persistent signs of toxicity, although minimal reductions in body weight gain and food consumption were noted.","duration":"developmental","effect":"tions cited in NTP, 1993). In a subsequent study with a single dose level of 50 mg glyoxal dihydrate/kg body weight per day, corresponding to 31 mg glyoxal/kg body weight per day, there was no maternal mortality or persistent signs of toxicity, although minimal reductions in body weight gain and food consumption were noted. Glyoxal exposure did not significantly alter post-implantation loss and had no effect on foetal body weight or the incidence of external, visceral, or skeletal malformations. The authors gave a NOAEL for developmental toxicity for rabbits of 50 mg glyoxal dihydrate/kg body weight per day, corresponding to 31 mg glyoxal/kg body weight per day (NTP, 1993). Guidelines : OECD 414 (Draft 1999), Commission Directive 87/302/EEC (1988), US EPA OPPTS 870.3700 (1988) Species/strain : Wistar rat, Chbb:THOM (SPF) Group size : 25 mated female rats Test substance : Glyoxal 40% Batch no : B 61 (produced March 1999) Dose level : 0, 5, 25, 125 mg/kg bw corresponding to pure active ingredient Route : oral (gavage) Exposure p","endpoint":"developmental toxicity","ingredient":"Glyoxal (INCI name)","loael_value":"","noael_unit":"%","noael_value":"40","page":44,"route":"oral","species":"rat","study_id":"sccp_o_023_noael_012"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 5 mg/kg bw rat oral - genotoxicity SOURCE_SUBDIR=sccp_o_023; REPORT_TITLE=Opinion on Glyoxal; OPINION_NUMBER=SCCP/0881/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=5; DOSE=Glyoxal induced DNA single strand breaks in the liver with a LED of 200 mg/kg.; EFFECT=mosomes. After oral administration to the rat, a significant increase of the unscheduled DNA synthesis is found in the pyloric mucosa of the stomach. Glyoxal induced DNA single strand breaks in the liver with a LED of 200 mg/kg. Hardly any DNA lesions could be detected in the kidney, spleen, pancreas or lung. Glyoxal at dose level of 50 mg/kg bw and above induced DNA damage in the pyloric mucosa of the rat stomach, but no damage could be noted at 5 mg/kg bw, indicating that this dose level can be considered as a “NOEL” for local DNA damage. Further in vivo mutagenicity/genotoxicity studies were performed and published in the literature. They are cited shortly in the following sections and the most relevant information is provided in the overview table 3.3.5. Table 3.3.5 Mutagenicity tests in vivo Test system/species Test conditions Results/ Remarks Ref. Gene mutations Drosophila melanogaster Sex-linked recessive-lethal test 0.73 mg/ml intraabdominal injection Lethality 0.30 % compared to 0.08 % for the controls 6u Drosophil; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"107-22-2","citation":"","dose":"Glyoxal induced DNA single strand breaks in the liver with a LED of 200 mg/kg.","duration":"","effect":"mosomes. After oral administration to the rat, a significant increase of the unscheduled DNA synthesis is found in the pyloric mucosa of the stomach. Glyoxal induced DNA single strand breaks in the liver with a LED of 200 mg/kg. Hardly any DNA lesions could be detected in the kidney, spleen, pancreas or lung. Glyoxal at dose level of 50 mg/kg bw and above induced DNA damage in the pyloric mucosa of the rat stomach, but no damage could be noted at 5 mg/kg bw, indicating that this dose level can be considered as a “NOEL” for local DNA damage. Further in vivo mutagenicity/genotoxicity studies were performed and published in the literature. They are cited shortly in the following sections and the most relevant information is provided in the overview table 3.3.5. Table 3.3.5 Mutagenicity tests in vivo Test system/species Test conditions Results/ Remarks Ref. Gene mutations Drosophila melanogaster Sex-linked recessive-lethal test 0.73 mg/ml intraabdominal injection Lethality 0.30 % compared to 0.08 % for the controls 6u Drosophil","endpoint":"genotoxicity","ingredient":"Glyoxal (INCI name)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"5","page":39,"route":"oral","species":"rat","study_id":"sccp_o_023_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 115 mg/kg bw rat oral 90-day repeated dose toxicity SOURCE_SUBDIR=sccp_o_023; REPORT_TITLE=Opinion on Glyoxal; OPINION_NUMBER=SCCP/0881/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=115; DOSE=A no effect level of 100 mg/kg bw was established for glyoxal 40% (i.e.; EFFECT=inking water study in rats since this study was performed according to a valid and internationally accepted testing guideline as well as under GLP conditions. A no effect level of 100 mg/kg bw was established for glyoxal 40% (i.e. 40 mg/kg bw related to the active ingredient). This value is supported by the published drinking water studies of Ueno et al. (1991a) (Reference: 123) carried out in rats, which obtained a LOEL of 107 mg/kg bw related to pure glyoxal. Moreover, also the 90-day study in dogs resulted in a NOEL of 115 mg/kg bw related to pure glyoxal. In a subacute inhalation study on rats for 29 days, a NOEL of 0.4 mg/m³ was derived for local effects and of > 10 mg/m³ for the systemic toxicity (40% glyoxal). An overview of NOAEL values from repeated dose toxicity studies is given in Table 3.3.3. Table 3.3.3. Overview of NOAEL values from repeated dose toxicity studies Exposure period Route/Species Dosage NOAEL Ref. 28 days Oral (drinking water) Rat 0, 100, 300, 1000 mg/kg bw (Glyoxal 40%) 100 mg/kg bw (40 mg/kg bw; CITATION=Reference: 123) carried out in rats, which obtained a LOEL of 107 mg/kg bw related to pure glyoxal; CITATION_NUMBERS=[123,107]; REFERENCE=Reference: 123) carried out in rats, which obtained a LOEL of 107 mg/kg bw related to pure glyoxal; DETAILS_JSON={"cas_number":"107-22-2","citation":"Reference: 123) carried out in rats, which obtained a LOEL of 107 mg/kg bw related to pure glyoxal","dose":"A no effect level of 100 mg/kg bw was established for glyoxal 40% (i.e.","duration":"90-day","effect":"inking water study in rats since this study was performed according to a valid and internationally accepted testing guideline as well as under GLP conditions. A no effect level of 100 mg/kg bw was established for glyoxal 40% (i.e. 40 mg/kg bw related to the active ingredient). This value is supported by the published drinking water studies of Ueno et al. (1991a) (Reference: 123) carried out in rats, which obtained a LOEL of 107 mg/kg bw related to pure glyoxal. Moreover, also the 90-day study in dogs resulted in a NOEL of 115 mg/kg bw related to pure glyoxal. In a subacute inhalation study on rats for 29 days, a NOEL of 0.4 mg/m³ was derived for local effects and of > 10 mg/m³ for the systemic toxicity (40% glyoxal). An overview of NOAEL values from repeated dose toxicity studies is given in Table 3.3.3. Table 3.3.3. Overview of NOAEL values from repeated dose toxicity studies Exposure period Route/Species Dosage NOAEL Ref. 28 days Oral (drinking water) Rat 0, 100, 300, 1000 mg/kg bw (Glyoxal 40%) 100 mg/kg bw (40 mg/kg bw","endpoint":"repeated dose toxicity","ingredient":"Glyoxal (INCI name)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"115","page":24,"route":"oral","species":"rat","study_id":"sccp_o_023_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 115 mg/kg bw rat oral 90-day repeated dose toxicity SOURCE_SUBDIR=sccp_o_023; REPORT_TITLE=Opinion on Glyoxal; OPINION_NUMBER=SCCP/0881/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=115; DOSE=A no effect level of 100 mg/kg bw was established for glyoxal 40% (i.e.; EFFECT=ccepted testing guideline as well as under GLP conditions. A no effect level of 100 mg/kg bw was established for glyoxal 40% (i.e. 40 mg/kg bw related to the active ingredient). This value is supported by the published drinking water studies of Ueno et al. (1991a) (Reference: 123) carried out in rats, which obtained a LOEL of 107 mg/kg bw related to pure glyoxal. Moreover, also the 90-day study in dogs resulted in a NOEL of 115 mg/kg bw related to pure glyoxal. In a subacute inhalation study on rats for 29 days, a NOEL of 0.4 mg/m³ was derived for local effects and of > 10 mg/m³ for the systemic toxicity (40% glyoxal). An overview of NOAEL values from repeated dose toxicity studies is given in Table 3.3.3. Table 3.3.3. Overview of NOAEL values from repeated dose toxicity studies Exposure period Route/Species Dosage NOAEL Ref. 28 days Oral (drinking water) Rat 0, 100, 300, 1000 mg/kg bw (Glyoxal 40%) 100 mg/kg bw (40 mg/kg bw related to active ingredient) 142 30, 60, 90 days Oral (drinking water) Rat 0, 2000, 4000, 6000 mg/l; CITATION=Reference: 123) carried out in rats, which obtained a LOEL of 107 mg/kg bw related to pure glyoxal; CITATION_NUMBERS=[123,107]; REFERENCE=Reference: 123) carried out in rats, which obtained a LOEL of 107 mg/kg bw related to pure glyoxal; DETAILS_JSON={"cas_number":"107-22-2","citation":"Reference: 123) carried out in rats, which obtained a LOEL of 107 mg/kg bw related to pure glyoxal","dose":"A no effect level of 100 mg/kg bw was established for glyoxal 40% (i.e.","duration":"90-day","effect":"ccepted testing guideline as well as under GLP conditions. A no effect level of 100 mg/kg bw was established for glyoxal 40% (i.e. 40 mg/kg bw related to the active ingredient). This value is supported by the published drinking water studies of Ueno et al. (1991a) (Reference: 123) carried out in rats, which obtained a LOEL of 107 mg/kg bw related to pure glyoxal. Moreover, also the 90-day study in dogs resulted in a NOEL of 115 mg/kg bw related to pure glyoxal. In a subacute inhalation study on rats for 29 days, a NOEL of 0.4 mg/m³ was derived for local effects and of > 10 mg/m³ for the systemic toxicity (40% glyoxal). An overview of NOAEL values from repeated dose toxicity studies is given in Table 3.3.3. Table 3.3.3. Overview of NOAEL values from repeated dose toxicity studies Exposure period Route/Species Dosage NOAEL Ref. 28 days Oral (drinking water) Rat 0, 100, 300, 1000 mg/kg bw (Glyoxal 40%) 100 mg/kg bw (40 mg/kg bw related to active ingredient) 142 30, 60, 90 days Oral (drinking water) Rat 0, 2000, 4000, 6000 mg/l","endpoint":"repeated dose toxicity","ingredient":"Glyoxal (INCI name)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"115","page":24,"route":"oral","species":"rat","study_id":"sccp_o_023_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 40 % rat oral 90-day repeated dose toxicity SOURCE_SUBDIR=sccp_o_023; REPORT_TITLE=Opinion on Glyoxal; OPINION_NUMBER=SCCP/0881/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=40; DOSE=40 mg/kg bw related to the active ingredient).; LOAEL_VALUE=107 mg/kg bw; EFFECT=0% (i.e. 40 mg/kg bw related to the active ingredient). This value is supported by the published drinking water studies of Ueno et al. (1991a) (Reference: 123) carried out in rats, which obtained a LOEL of 107 mg/kg bw related to pure glyoxal. Moreover, also the 90-day study in dogs resulted in a NOEL of 115 mg/kg bw related to pure glyoxal. In a subacute inhalation study on rats for 29 days, a NOEL of 0.4 mg/m³ was derived for local effects and of > 10 mg/m³ for the systemic toxicity (40% glyoxal). An overview of NOAEL values from repeated dose toxicity studies is given in Table 3.3.3. Table 3.3.3. Overview of NOAEL values from repeated dose toxicity studies Exposure period Route/Species Dosage NOAEL Ref. 28 days Oral (drinking water) Rat 0, 100, 300, 1000 mg/kg bw (Glyoxal 40%) 100 mg/kg bw (40 mg/kg bw related to active ingredient) 142 30, 60, 90 days Oral (drinking water) Rat 0, 2000, 4000, 6000 mg/l (Glyoxal 100%) LOAEL 107 mg/kg bw (related to active ingredient) Ueno et al., 1991a 90 days Oral (drinking water) Rat and; CITATION=Reference: 123) carried out in rats, which obtained a LOEL of 107 mg/kg bw related to pure glyoxal; CITATION_NUMBERS=[123,107]; REFERENCE=Reference: 123) carried out in rats, which obtained a LOEL of 107 mg/kg bw related to pure glyoxal; DETAILS_JSON={"cas_number":"107-22-2","citation":"Reference: 123) carried out in rats, which obtained a LOEL of 107 mg/kg bw related to pure glyoxal","dose":"40 mg/kg bw related to the active ingredient).","duration":"90-day","effect":"0% (i.e. 40 mg/kg bw related to the active ingredient). This value is supported by the published drinking water studies of Ueno et al. (1991a) (Reference: 123) carried out in rats, which obtained a LOEL of 107 mg/kg bw related to pure glyoxal. Moreover, also the 90-day study in dogs resulted in a NOEL of 115 mg/kg bw related to pure glyoxal. In a subacute inhalation study on rats for 29 days, a NOEL of 0.4 mg/m³ was derived for local effects and of > 10 mg/m³ for the systemic toxicity (40% glyoxal). An overview of NOAEL values from repeated dose toxicity studies is given in Table 3.3.3. Table 3.3.3. Overview of NOAEL values from repeated dose toxicity studies Exposure period Route/Species Dosage NOAEL Ref. 28 days Oral (drinking water) Rat 0, 100, 300, 1000 mg/kg bw (Glyoxal 40%) 100 mg/kg bw (40 mg/kg bw related to active ingredient) 142 30, 60, 90 days Oral (drinking water) Rat 0, 2000, 4000, 6000 mg/l (Glyoxal 100%) LOAEL 107 mg/kg bw (related to active ingredient) Ueno et al., 1991a 90 days Oral (drinking water) Rat and","endpoint":"repeated dose toxicity","ingredient":"Glyoxal (INCI name)","loael_value":"107 mg/kg bw","noael_unit":"%","noael_value":"40","page":24,"route":"oral","species":"rat","study_id":"sccp_o_023_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 40 % rat oral 90-day repeated dose toxicity SOURCE_SUBDIR=sccp_o_023; REPORT_TITLE=Opinion on Glyoxal; OPINION_NUMBER=SCCP/0881/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=40; DOSE=123) carried out in rats, which obtained a LOEL of 107 mg/kg bw related to pure glyoxal.; LOAEL_VALUE=107 mg/kg bw; EFFECT=nking water studies of Ueno et al. (1991a) (Reference: 123) carried out in rats, which obtained a LOEL of 107 mg/kg bw related to pure glyoxal. Moreover, also the 90-day study in dogs resulted in a NOEL of 115 mg/kg bw related to pure glyoxal. In a subacute inhalation study on rats for 29 days, a NOEL of 0.4 mg/m³ was derived for local effects and of > 10 mg/m³ for the systemic toxicity (40% glyoxal). An overview of NOAEL values from repeated dose toxicity studies is given in Table 3.3.3. Table 3.3.3. Overview of NOAEL values from repeated dose toxicity studies Exposure period Route/Species Dosage NOAEL Ref. 28 days Oral (drinking water) Rat 0, 100, 300, 1000 mg/kg bw (Glyoxal 40%) 100 mg/kg bw (40 mg/kg bw related to active ingredient) 142 30, 60, 90 days Oral (drinking water) Rat 0, 2000, 4000, 6000 mg/l (Glyoxal 100%) LOAEL 107 mg/kg bw (related to active ingredient) Ueno et al., 1991a 90 days Oral (drinking water) Rat and mice 0, 1000, 2000, 4000, 8000, 16000 mg/l (Glyoxal, unknown content) Not derived 45 90 days Oral (d; CITATION=Reference: 123) carried out in rats, which obtained a LOEL of 107 mg/kg bw related to pure glyoxal; CITATION_NUMBERS=[123,107]; REFERENCE=Reference: 123) carried out in rats, which obtained a LOEL of 107 mg/kg bw related to pure glyoxal; DETAILS_JSON={"cas_number":"107-22-2","citation":"Reference: 123) carried out in rats, which obtained a LOEL of 107 mg/kg bw related to pure glyoxal","dose":"123) carried out in rats, which obtained a LOEL of 107 mg/kg bw related to pure glyoxal.","duration":"90-day","effect":"nking water studies of Ueno et al. (1991a) (Reference: 123) carried out in rats, which obtained a LOEL of 107 mg/kg bw related to pure glyoxal. Moreover, also the 90-day study in dogs resulted in a NOEL of 115 mg/kg bw related to pure glyoxal. In a subacute inhalation study on rats for 29 days, a NOEL of 0.4 mg/m³ was derived for local effects and of > 10 mg/m³ for the systemic toxicity (40% glyoxal). An overview of NOAEL values from repeated dose toxicity studies is given in Table 3.3.3. Table 3.3.3. Overview of NOAEL values from repeated dose toxicity studies Exposure period Route/Species Dosage NOAEL Ref. 28 days Oral (drinking water) Rat 0, 100, 300, 1000 mg/kg bw (Glyoxal 40%) 100 mg/kg bw (40 mg/kg bw related to active ingredient) 142 30, 60, 90 days Oral (drinking water) Rat 0, 2000, 4000, 6000 mg/l (Glyoxal 100%) LOAEL 107 mg/kg bw (related to active ingredient) Ueno et al., 1991a 90 days Oral (drinking water) Rat and mice 0, 1000, 2000, 4000, 8000, 16000 mg/l (Glyoxal, unknown content) Not derived 45 90 days Oral (d","endpoint":"repeated dose toxicity","ingredient":"Glyoxal (INCI name)","loael_value":"107 mg/kg bw","noael_unit":"%","noael_value":"40","page":24,"route":"oral","species":"rat","study_id":"sccp_o_023_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 1000 mg/kg bw rat oral 90-day repeated dose toxicity SOURCE_SUBDIR=sccp_o_023; REPORT_TITLE=Opinion on Glyoxal; OPINION_NUMBER=SCCP/0881/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=1000; DOSE=tained a LOEL of 107 mg/kg bw related to pure glyoxal.; LOAEL_VALUE=107 mg/kg bw; EFFECT=tained a LOEL of 107 mg/kg bw related to pure glyoxal. Moreover, also the 90-day study in dogs resulted in a NOEL of 115 mg/kg bw related to pure glyoxal. In a subacute inhalation study on rats for 29 days, a NOEL of 0.4 mg/m³ was derived for local effects and of > 10 mg/m³ for the systemic toxicity (40% glyoxal). An overview of NOAEL values from repeated dose toxicity studies is given in Table 3.3.3. Table 3.3.3. Overview of NOAEL values from repeated dose toxicity studies Exposure period Route/Species Dosage NOAEL Ref. 28 days Oral (drinking water) Rat 0, 100, 300, 1000 mg/kg bw (Glyoxal 40%) 100 mg/kg bw (40 mg/kg bw related to active ingredient) 142 30, 60, 90 days Oral (drinking water) Rat 0, 2000, 4000, 6000 mg/l (Glyoxal 100%) LOAEL 107 mg/kg bw (related to active ingredient) Ueno et al., 1991a 90 days Oral (drinking water) Rat and mice 0, 1000, 2000, 4000, 8000, 16000 mg/l (Glyoxal, unknown content) Not derived 45 90 days Oral (diet) Rat 0, 32.7, 63.2, 132, 253 mg kg for males; 0; 32, 63.2, 127, 271 mg for females 12; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"107-22-2","citation":"","dose":"tained a LOEL of 107 mg/kg bw related to pure glyoxal.","duration":"90-day","effect":"tained a LOEL of 107 mg/kg bw related to pure glyoxal. Moreover, also the 90-day study in dogs resulted in a NOEL of 115 mg/kg bw related to pure glyoxal. In a subacute inhalation study on rats for 29 days, a NOEL of 0.4 mg/m³ was derived for local effects and of > 10 mg/m³ for the systemic toxicity (40% glyoxal). An overview of NOAEL values from repeated dose toxicity studies is given in Table 3.3.3. Table 3.3.3. Overview of NOAEL values from repeated dose toxicity studies Exposure period Route/Species Dosage NOAEL Ref. 28 days Oral (drinking water) Rat 0, 100, 300, 1000 mg/kg bw (Glyoxal 40%) 100 mg/kg bw (40 mg/kg bw related to active ingredient) 142 30, 60, 90 days Oral (drinking water) Rat 0, 2000, 4000, 6000 mg/l (Glyoxal 100%) LOAEL 107 mg/kg bw (related to active ingredient) Ueno et al., 1991a 90 days Oral (drinking water) Rat and mice 0, 1000, 2000, 4000, 8000, 16000 mg/l (Glyoxal, unknown content) Not derived 45 90 days Oral (diet) Rat 0, 32.7, 63.2, 132, 253 mg kg for males; 0; 32, 63.2, 127, 271 mg for females 12","endpoint":"repeated dose toxicity","ingredient":"Glyoxal (INCI name)","loael_value":"107 mg/kg bw","noael_unit":"mg/kg bw","noael_value":"1000","page":24,"route":"oral","species":"rat","study_id":"sccp_o_023_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 125 mg/kg bw - - prenatal repeated dose toxicity SOURCE_SUBDIR=sccp_o_023; REPORT_TITLE=Opinion on Glyoxal; OPINION_NUMBER=SCCP/0881/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=125; DOSE=No signs of prenatal developmental toxicity, especially no signs of teratogenicity, were seen at any dose level including the highest dose tested at 125 mg/kg bw.; EFFECT=SCCP/0881/05 Opinion on glyoxal 46 No substance-related influence on gestational parameters was seen. No signs of prenatal developmental toxicity, especially no signs of teratogenicity, were seen at any dose level including the highest dose tested at 125 mg/kg bw. In this study, the NOAEL for maternal toxicity is 25 mg/kg bw; the NOAEL for prenatal developmental toxicity is 125 mg/kg bw, each correspond to the pure active ingredient, respectively. Ref.: 17 Overall results No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of approx. 250 mg/kg bw (related to pure active ingredient). A prenatal developmental toxicity study performed according to current testing guidelines and under GLP conditions s; CITATION=Ref.: 17 Overall results No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of appro; CITATION_NUMBERS=[17,90]; REFERENCE=Ref.: 17 Overall results No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of appro; DETAILS_JSON={"cas_number":"107-22-2","citation":"Ref.: 17 Overall results No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of appro","dose":"No signs of prenatal developmental toxicity, especially no signs of teratogenicity, were seen at any dose level including the highest dose tested at 125 mg/kg bw.","duration":"prenatal","effect":"SCCP/0881/05 Opinion on glyoxal 46 No substance-related influence on gestational parameters was seen. No signs of prenatal developmental toxicity, especially no signs of teratogenicity, were seen at any dose level including the highest dose tested at 125 mg/kg bw. In this study, the NOAEL for maternal toxicity is 25 mg/kg bw; the NOAEL for prenatal developmental toxicity is 125 mg/kg bw, each correspond to the pure active ingredient, respectively. Ref.: 17 Overall results No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of approx. 250 mg/kg bw (related to pure active ingredient). A prenatal developmental toxicity study performed according to current testing guidelines and under GLP conditions s","endpoint":"repeated dose toxicity","ingredient":"Glyoxal (INCI name)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"125","page":46,"route":"","species":"","study_id":"sccp_o_023_noael_013"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 25 mg/kg bw - - prenatal repeated dose toxicity SOURCE_SUBDIR=sccp_o_023; REPORT_TITLE=Opinion on Glyoxal; OPINION_NUMBER=SCCP/0881/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=25; DOSE=No signs of prenatal developmental toxicity, especially no signs of teratogenicity, were seen at any dose level including the highest dose tested at 125 mg/kg bw.; EFFECT=SCCP/0881/05 Opinion on glyoxal 46 No substance-related influence on gestational parameters was seen. No signs of prenatal developmental toxicity, especially no signs of teratogenicity, were seen at any dose level including the highest dose tested at 125 mg/kg bw. In this study, the NOAEL for maternal toxicity is 25 mg/kg bw; the NOAEL for prenatal developmental toxicity is 125 mg/kg bw, each correspond to the pure active ingredient, respectively. Ref.: 17 Overall results No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of approx. 250 mg/kg bw (related to pure active ingredient). A prenatal developmental toxicity study performed according to current testing guidelines and under GLP conditions showed a NOAEL of 125 mg/kg bw for prenatal devel; CITATION=Ref.: 17 Overall results No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of appro; CITATION_NUMBERS=[17,90]; REFERENCE=Ref.: 17 Overall results No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of appro; DETAILS_JSON={"cas_number":"107-22-2","citation":"Ref.: 17 Overall results No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of appro","dose":"No signs of prenatal developmental toxicity, especially no signs of teratogenicity, were seen at any dose level including the highest dose tested at 125 mg/kg bw.","duration":"prenatal","effect":"SCCP/0881/05 Opinion on glyoxal 46 No substance-related influence on gestational parameters was seen. No signs of prenatal developmental toxicity, especially no signs of teratogenicity, were seen at any dose level including the highest dose tested at 125 mg/kg bw. In this study, the NOAEL for maternal toxicity is 25 mg/kg bw; the NOAEL for prenatal developmental toxicity is 125 mg/kg bw, each correspond to the pure active ingredient, respectively. Ref.: 17 Overall results No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of approx. 250 mg/kg bw (related to pure active ingredient). A prenatal developmental toxicity study performed according to current testing guidelines and under GLP conditions showed a NOAEL of 125 mg/kg bw for prenatal devel","endpoint":"repeated dose toxicity","ingredient":"Glyoxal (INCI name)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"25","page":46,"route":"","species":"","study_id":"sccp_o_023_noael_014"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 125 mg/kg bw - - prenatal repeated dose toxicity SOURCE_SUBDIR=sccp_o_023; REPORT_TITLE=Opinion on Glyoxal; OPINION_NUMBER=SCCP/0881/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=125; DOSE=ernal toxicity is 25 mg/kg bw; the NOAEL for prenatal developmental toxicity is 125 mg/kg bw, each correspond to the pure active ingredient, respectively.; EFFECT=ernal toxicity is 25 mg/kg bw; the NOAEL for prenatal developmental toxicity is 125 mg/kg bw, each correspond to the pure active ingredient, respectively. Ref.: 17 Overall results No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of approx. 250 mg/kg bw (related to pure active ingredient). A prenatal developmental toxicity study performed according to current testing guidelines and under GLP conditions showed a NOAEL of 125 mg/kg bw for prenatal developmental toxicity. This was the highest investigated dose level. The NOAEL for maternal toxicity was achieved at 25 mg/kg bw in this study related to pure active ingredient. 3.3.9. Toxicokinetics Glyoxal is endogenously produced during normal cellular metabolism by a multitude of enzyme- independent pathways, such as the spontaneous reaction of amino groups in proteins with reducing sugars (Maillard reaction), sugar autoxidation, DNA oxidation, peroxidation of polyunsaturated fa; CITATION=Ref.: 17 Overall results No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of appro; CITATION_NUMBERS=[17,90]; REFERENCE=Ref.: 17 Overall results No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of appro; DETAILS_JSON={"cas_number":"107-22-2","citation":"Ref.: 17 Overall results No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of appro","dose":"ernal toxicity is 25 mg/kg bw; the NOAEL for prenatal developmental toxicity is 125 mg/kg bw, each correspond to the pure active ingredient, respectively.","duration":"prenatal","effect":"ernal toxicity is 25 mg/kg bw; the NOAEL for prenatal developmental toxicity is 125 mg/kg bw, each correspond to the pure active ingredient, respectively. Ref.: 17 Overall results No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of approx. 250 mg/kg bw (related to pure active ingredient). A prenatal developmental toxicity study performed according to current testing guidelines and under GLP conditions showed a NOAEL of 125 mg/kg bw for prenatal developmental toxicity. This was the highest investigated dose level. The NOAEL for maternal toxicity was achieved at 25 mg/kg bw in this study related to pure active ingredient. 3.3.9. Toxicokinetics Glyoxal is endogenously produced during normal cellular metabolism by a multitude of enzyme- independent pathways, such as the spontaneous reaction of amino groups in proteins with reducing sugars (Maillard reaction), sugar autoxidation, DNA oxidation, peroxidation of polyunsaturated fa","endpoint":"repeated dose toxicity","ingredient":"Glyoxal (INCI name)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"125","page":46,"route":"","species":"","study_id":"sccp_o_023_noael_015"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 25 mg/kg bw - - 90 days repeated dose toxicity SOURCE_SUBDIR=sccp_o_023; REPORT_TITLE=Opinion on Glyoxal; OPINION_NUMBER=SCCP/0881/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=25; DOSE=17 Overall results No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of approx.; EFFECT=to the pure active ingredient, respectively. Ref.: 17 Overall results No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of approx. 250 mg/kg bw (related to pure active ingredient). A prenatal developmental toxicity study performed according to current testing guidelines and under GLP conditions showed a NOAEL of 125 mg/kg bw for prenatal developmental toxicity. This was the highest investigated dose level. The NOAEL for maternal toxicity was achieved at 25 mg/kg bw in this study related to pure active ingredient. 3.3.9. Toxicokinetics Glyoxal is endogenously produced during normal cellular metabolism by a multitude of enzyme- independent pathways, such as the spontaneous reaction of amino groups in proteins with reducing sugars (Maillard reaction), sugar autoxidation, DNA oxidation, peroxidation of polyunsaturated fatty acids, and UV photodamage, and in conditions of oxidative stress and depletion of GSH (Kasper & Funk, 200; CITATION=Ref.: 17 Overall results No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of appro; CITATION_NUMBERS=[17,90]; REFERENCE=Ref.: 17 Overall results No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of appro; DETAILS_JSON={"cas_number":"107-22-2","citation":"Ref.: 17 Overall results No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of appro","dose":"17 Overall results No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of approx.","duration":"90 days","effect":"to the pure active ingredient, respectively. Ref.: 17 Overall results No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of approx. 250 mg/kg bw (related to pure active ingredient). A prenatal developmental toxicity study performed according to current testing guidelines and under GLP conditions showed a NOAEL of 125 mg/kg bw for prenatal developmental toxicity. This was the highest investigated dose level. The NOAEL for maternal toxicity was achieved at 25 mg/kg bw in this study related to pure active ingredient. 3.3.9. Toxicokinetics Glyoxal is endogenously produced during normal cellular metabolism by a multitude of enzyme- independent pathways, such as the spontaneous reaction of amino groups in proteins with reducing sugars (Maillard reaction), sugar autoxidation, DNA oxidation, peroxidation of polyunsaturated fatty acids, and UV photodamage, and in conditions of oxidative stress and depletion of GSH (Kasper & Funk, 200","endpoint":"repeated dose toxicity","ingredient":"Glyoxal (INCI name)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"25","page":46,"route":"","species":"","study_id":"sccp_o_023_noael_016"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 127 mg/kg bw/day rat - 28-day repeated dose toxicity SOURCE_SUBDIR=sccp_o_023; REPORT_TITLE=Opinion on Glyoxal; OPINION_NUMBER=SCCP/0881/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=127; DOSE=A 28-day study in which glyoxal was administered to rats in drinking-water resulted in a no- observed-adverse-effect level (NOAEL) of 100 mg glyoxal/kg body weight per day (It is not clear from the report if the actual glyoxal dose was calculated as 40% glyoxal.; EFFECT=on of glyoxal after initiation with MNNG was associated with increased incidences of adenocarcinomas and hyperplasias in both pylorus and fundus of rat stomach. A 28-day study in which glyoxal was administered to rats in drinking-water resulted in a no- observed-adverse-effect level (NOAEL) of 100 mg glyoxal/kg body weight per day (It is not clear from the report if the actual glyoxal dose was calculated as 40% glyoxal. Thus, the NOAEL could be 40 mg/kg bw/day). The 90-day feeding of glyoxal to rats resulted in a NOAEL of 127 mg/kg bw/day (dosage corresponding to 100% glyoxal). Effects stated at higher dosages in the two studies above were retardation of body weight gain. In a study examining more sensitive end-points (serum clinical biochemistry), the lowest tested dosage of 107 mg/kg bw/day (99% glyoxal) corresponded to the lowest-observed-adverse-effect level (LOAEL) for a 90-day exposure of rats via drinking-water. No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"107-22-2","citation":"","dose":"A 28-day study in which glyoxal was administered to rats in drinking-water resulted in a no- observed-adverse-effect level (NOAEL) of 100 mg glyoxal/kg body weight per day (It is not clear from the report if the actual glyoxal dose was calculated as 40% glyoxal.","duration":"28-day","effect":"on of glyoxal after initiation with MNNG was associated with increased incidences of adenocarcinomas and hyperplasias in both pylorus and fundus of rat stomach. A 28-day study in which glyoxal was administered to rats in drinking-water resulted in a no- observed-adverse-effect level (NOAEL) of 100 mg glyoxal/kg body weight per day (It is not clear from the report if the actual glyoxal dose was calculated as 40% glyoxal. Thus, the NOAEL could be 40 mg/kg bw/day). The 90-day feeding of glyoxal to rats resulted in a NOAEL of 127 mg/kg bw/day (dosage corresponding to 100% glyoxal). Effects stated at higher dosages in the two studies above were retardation of body weight gain. In a study examining more sensitive end-points (serum clinical biochemistry), the lowest tested dosage of 107 mg/kg bw/day (99% glyoxal) corresponded to the lowest-observed-adverse-effect level (LOAEL) for a 90-day exposure of rats via drinking-water. No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a","endpoint":"repeated dose toxicity","ingredient":"Glyoxal (INCI name)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"127","page":52,"route":"","species":"rat","study_id":"sccp_o_023_noael_021"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 125 mg/kg bw rat - 90-day repeated dose toxicity SOURCE_SUBDIR=sccp_o_023; REPORT_TITLE=Opinion on Glyoxal; OPINION_NUMBER=SCCP/0881/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=125; DOSE=try), the lowest tested dosage of 107 mg/kg bw/day (99% glyoxal) corresponded to the lowest-observed-adverse-effect level (LOAEL) for a 90-day exposure of rats via drinking-water.; EFFECT=try), the lowest tested dosage of 107 mg/kg bw/day (99% glyoxal) corresponded to the lowest-observed-adverse-effect level (LOAEL) for a 90-day exposure of rats via drinking-water. No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of approx. 250 mg/kg bw (related to pure active ingredient). A prenatal developmental toxicity study performed according to current testing guidelines and under GLP conditions showed a NOAEL of 125 mg/kg bw for prenatal developmental toxicity. This was the highest investigated dose level. The NOAEL for maternal toxicity was achieved at 25 mg/kg bw in this study related to pure active ingredient. Glyoxal is irritating to mucous membranes and acts as a skin sensitising agent in humans and experimental animals. 3.3.13.2 EU Classification Glyoxal is listed on Annex I of Directive 67/458/EEC in the EU chemical legislation (since 26th – 28th ATP; Annex I Index# 605-016-007) with a classification as: Xn;; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"107-22-2","citation":"","dose":"try), the lowest tested dosage of 107 mg/kg bw/day (99% glyoxal) corresponded to the lowest-observed-adverse-effect level (LOAEL) for a 90-day exposure of rats via drinking-water.","duration":"90-day","effect":"try), the lowest tested dosage of 107 mg/kg bw/day (99% glyoxal) corresponded to the lowest-observed-adverse-effect level (LOAEL) for a 90-day exposure of rats via drinking-water. No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of approx. 250 mg/kg bw (related to pure active ingredient). A prenatal developmental toxicity study performed according to current testing guidelines and under GLP conditions showed a NOAEL of 125 mg/kg bw for prenatal developmental toxicity. This was the highest investigated dose level. The NOAEL for maternal toxicity was achieved at 25 mg/kg bw in this study related to pure active ingredient. Glyoxal is irritating to mucous membranes and acts as a skin sensitising agent in humans and experimental animals. 3.3.13.2 EU Classification Glyoxal is listed on Annex I of Directive 67/458/EEC in the EU chemical legislation (since 26th – 28th ATP; Annex I Index# 605-016-007) with a classification as: Xn;","endpoint":"repeated dose toxicity","ingredient":"Glyoxal (INCI name)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"125","page":52,"route":"","species":"rat","study_id":"sccp_o_023_noael_022"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 25 mg/kg bw rat - 90-day repeated dose toxicity SOURCE_SUBDIR=sccp_o_023; REPORT_TITLE=Opinion on Glyoxal; OPINION_NUMBER=SCCP/0881/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=25; DOSE=No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of approx.; EFFECT=effect level (LOAEL) for a 90-day exposure of rats via drinking-water. No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of approx. 250 mg/kg bw (related to pure active ingredient). A prenatal developmental toxicity study performed according to current testing guidelines and under GLP conditions showed a NOAEL of 125 mg/kg bw for prenatal developmental toxicity. This was the highest investigated dose level. The NOAEL for maternal toxicity was achieved at 25 mg/kg bw in this study related to pure active ingredient. Glyoxal is irritating to mucous membranes and acts as a skin sensitising agent in humans and experimental animals. 3.3.13.2 EU Classification Glyoxal is listed on Annex I of Directive 67/458/EEC in the EU chemical legislation (since 26th – 28th ATP; Annex I Index# 605-016-007) with a classification as: Xn; Muta. Cat. 3; R68 Possible risk of irreversible effects. Concentration limit for labelling 1% Xi; R43 May ca; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"107-22-2","citation":"","dose":"No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of approx.","duration":"90-day","effect":"effect level (LOAEL) for a 90-day exposure of rats via drinking-water. No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of approx. 250 mg/kg bw (related to pure active ingredient). A prenatal developmental toxicity study performed according to current testing guidelines and under GLP conditions showed a NOAEL of 125 mg/kg bw for prenatal developmental toxicity. This was the highest investigated dose level. The NOAEL for maternal toxicity was achieved at 25 mg/kg bw in this study related to pure active ingredient. Glyoxal is irritating to mucous membranes and acts as a skin sensitising agent in humans and experimental animals. 3.3.13.2 EU Classification Glyoxal is listed on Annex I of Directive 67/458/EEC in the EU chemical legislation (since 26th – 28th ATP; Annex I Index# 605-016-007) with a classification as: Xn; Muta. Cat. 3; R68 Possible risk of irreversible effects. Concentration limit for labelling 1% Xi; R43 May ca","endpoint":"repeated dose toxicity","ingredient":"Glyoxal (INCI name)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"25","page":52,"route":"","species":"rat","study_id":"sccp_o_023_noael_023"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 127 mg/kg bw/day rat - 28-day repeated dose toxicity SOURCE_SUBDIR=sccp_o_023; REPORT_TITLE=Opinion on Glyoxal; OPINION_NUMBER=SCCP/0881/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=127; DOSE=A 28-day study in which glyoxal was administered to rats in drinking-water resulted in a no- observed-adverse-effect level (NOAEL) of 100 mg glyoxal/kg body weight per day (It is not clear from the report if the actual glyoxal dose was calculated as 40% glyoxal, Thus, the NOAEL could be 40 mg/kg bw/day).; EFFECT=ritations, depending on the application time. Glyoxal is irritating to mucous membranes and acts as a skin sensitising agent in humans and experimental animals. A 28-day study in which glyoxal was administered to rats in drinking-water resulted in a no- observed-adverse-effect level (NOAEL) of 100 mg glyoxal/kg body weight per day (It is not clear from the report if the actual glyoxal dose was calculated as 40% glyoxal, Thus, the NOAEL could be 40 mg/kg bw/day). The 90-day feeding of glyoxal to rats resulted in a NOAEL of 127 mg/kg bw/day (dosage corresponding to 100% glyoxal). Effects stated at higher dosages in the two studies above were retardation of body weight gain. In a study examining more sensitive end-points (serum clinical biochemistry), the lowest tested dosage of 107 mg/kg bw/day (99% glyoxal) corresponded to the lowest-observed-adverse-effect level (LOAEL) for a 90-day exposure of rats via drinking-water. No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"107-22-2","citation":"","dose":"A 28-day study in which glyoxal was administered to rats in drinking-water resulted in a no- observed-adverse-effect level (NOAEL) of 100 mg glyoxal/kg body weight per day (It is not clear from the report if the actual glyoxal dose was calculated as 40% glyoxal, Thus, the NOAEL could be 40 mg/kg bw/day).","duration":"28-day","effect":"ritations, depending on the application time. Glyoxal is irritating to mucous membranes and acts as a skin sensitising agent in humans and experimental animals. A 28-day study in which glyoxal was administered to rats in drinking-water resulted in a no- observed-adverse-effect level (NOAEL) of 100 mg glyoxal/kg body weight per day (It is not clear from the report if the actual glyoxal dose was calculated as 40% glyoxal, Thus, the NOAEL could be 40 mg/kg bw/day). The 90-day feeding of glyoxal to rats resulted in a NOAEL of 127 mg/kg bw/day (dosage corresponding to 100% glyoxal). Effects stated at higher dosages in the two studies above were retardation of body weight gain. In a study examining more sensitive end-points (serum clinical biochemistry), the lowest tested dosage of 107 mg/kg bw/day (99% glyoxal) corresponded to the lowest-observed-adverse-effect level (LOAEL) for a 90-day exposure of rats via drinking-water. No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a","endpoint":"repeated dose toxicity","ingredient":"Glyoxal (INCI name)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"127","page":55,"route":"","species":"rat","study_id":"sccp_o_023_noael_026"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 125 mg/kg bw rat - 90-day repeated dose toxicity SOURCE_SUBDIR=sccp_o_023; REPORT_TITLE=Opinion on Glyoxal; OPINION_NUMBER=SCCP/0881/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=125; DOSE=try), the lowest tested dosage of 107 mg/kg bw/day (99% glyoxal) corresponded to the lowest-observed-adverse-effect level (LOAEL) for a 90-day exposure of rats via drinking-water.; EFFECT=try), the lowest tested dosage of 107 mg/kg bw/day (99% glyoxal) corresponded to the lowest-observed-adverse-effect level (LOAEL) for a 90-day exposure of rats via drinking-water. No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of approx. 250 mg/kg bw (related to pure active ingredient). A prenatal developmental toxicity study performed according to current testing guidelines and under GLP conditions showed a NOAEL of 125 mg/kg bw for prenatal developmental toxicity. This was the highest investigated dose level. The NOAEL for maternal toxicity was achieved at 25 mg/kg bw in this study related to pure active ingredient. Glyoxal is directly genotoxic in vitro in bacterial and mammalian cells, inducing, for example, DNA adducts, mutations, chromosomal aberrations, DNA repair, sister chromatid exchanges, and DNA single strand breaks. In vivo, a genotoxic activity of glyoxal was established at the site of application in the pylo; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"107-22-2","citation":"","dose":"try), the lowest tested dosage of 107 mg/kg bw/day (99% glyoxal) corresponded to the lowest-observed-adverse-effect level (LOAEL) for a 90-day exposure of rats via drinking-water.","duration":"90-day","effect":"try), the lowest tested dosage of 107 mg/kg bw/day (99% glyoxal) corresponded to the lowest-observed-adverse-effect level (LOAEL) for a 90-day exposure of rats via drinking-water. No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of approx. 250 mg/kg bw (related to pure active ingredient). A prenatal developmental toxicity study performed according to current testing guidelines and under GLP conditions showed a NOAEL of 125 mg/kg bw for prenatal developmental toxicity. This was the highest investigated dose level. The NOAEL for maternal toxicity was achieved at 25 mg/kg bw in this study related to pure active ingredient. Glyoxal is directly genotoxic in vitro in bacterial and mammalian cells, inducing, for example, DNA adducts, mutations, chromosomal aberrations, DNA repair, sister chromatid exchanges, and DNA single strand breaks. In vivo, a genotoxic activity of glyoxal was established at the site of application in the pylo","endpoint":"repeated dose toxicity","ingredient":"Glyoxal (INCI name)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"125","page":55,"route":"","species":"rat","study_id":"sccp_o_023_noael_027"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 25 mg/kg bw rat oral 90-day repeated dose toxicity SOURCE_SUBDIR=sccp_o_023; REPORT_TITLE=Opinion on Glyoxal; OPINION_NUMBER=SCCP/0881/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=25; DOSE=No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of approx.; EFFECT=effect level (LOAEL) for a 90-day exposure of rats via drinking-water. No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of approx. 250 mg/kg bw (related to pure active ingredient). A prenatal developmental toxicity study performed according to current testing guidelines and under GLP conditions showed a NOAEL of 125 mg/kg bw for prenatal developmental toxicity. This was the highest investigated dose level. The NOAEL for maternal toxicity was achieved at 25 mg/kg bw in this study related to pure active ingredient. Glyoxal is directly genotoxic in vitro in bacterial and mammalian cells, inducing, for example, DNA adducts, mutations, chromosomal aberrations, DNA repair, sister chromatid exchanges, and DNA single strand breaks. In vivo, a genotoxic activity of glyoxal was established at the site of application in the pyloric mucosa of rats by demonstration of unscheduled DNA synthesis and DNA single strand breaks. After oral app; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"107-22-2","citation":"","dose":"No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of approx.","duration":"90-day","effect":"effect level (LOAEL) for a 90-day exposure of rats via drinking-water. No dose-dependent effects on reproductive organs were observed in repeated dose toxicity studies lasting for a sufficient period of 90 days up to a dose of approx. 250 mg/kg bw (related to pure active ingredient). A prenatal developmental toxicity study performed according to current testing guidelines and under GLP conditions showed a NOAEL of 125 mg/kg bw for prenatal developmental toxicity. This was the highest investigated dose level. The NOAEL for maternal toxicity was achieved at 25 mg/kg bw in this study related to pure active ingredient. Glyoxal is directly genotoxic in vitro in bacterial and mammalian cells, inducing, for example, DNA adducts, mutations, chromosomal aberrations, DNA repair, sister chromatid exchanges, and DNA single strand breaks. In vivo, a genotoxic activity of glyoxal was established at the site of application in the pyloric mucosa of rats by demonstration of unscheduled DNA synthesis and DNA single strand breaks. After oral app","endpoint":"repeated dose toxicity","ingredient":"Glyoxal (INCI name)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"25","page":55,"route":"oral","species":"rat","study_id":"sccp_o_023_noael_028"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 50NP6JJ975 UNII - - - chemical {"approval_status":null,"molecular_formula":"C2H2O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"50NP6JJ975"}
openFDA substances FDA UNII substance identifier 50NP6JJ975 UNII - - - chemical {"approval_status":null,"molecular_formula":"C2H2O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"50NP6JJ975"}
openFDA substances FDA UNII substance identifier 50NP6JJ975 UNII - - - chemical {"approval_status":null,"molecular_formula":"C2H2O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"50NP6JJ975"}
openFDA substances FDA UNII substance identifier 50NP6JJ975 UNII - - - chemical {"approval_status":null,"molecular_formula":"C2H2O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"50NP6JJ975"}