Glyoxal (INCI name), HYDROXYETHYL-2-NITRO-P-TOLUIDINE

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"}

sccp_o_023.pdf

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"}

sccp_o_023.pdf

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"}

sccp_o_023.pdf

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"}

sccp_o_023.pdf

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"}

sccp_o_023.pdf

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"}

sccp_o_023.pdf

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"}

sccp_o_023.pdf

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"}

sccp_o_023.pdf

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"}

sccp_o_023.pdf

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"}

sccp_o_023.pdf

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"}

sccp_o_023.pdf

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"}

sccp_o_023.pdf

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"}

sccp_o_023.pdf

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"}

sccp_o_023.pdf

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"}

sccp_o_023.pdf

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"}

sccp_o_023.pdf

{"absorption_percent":"100%","basis":"SCCP/0881/05 Opinion on glyoxal 53 Since data for in vivo or in vitro dermal absorption are missing, 100% absorption has to be used for the calculations according to the requirements of the SCCP as laid down in the document SCCNFP/0321/00.","page":53,"pdf":"sccp_o_023.pdf","row_type":"dermal_absorption_study"}

sccp_o_023.pdf

{"absorption_percent":"100%","basis":"SCCP/0881/05 Opinion on glyoxal 53 Since data for in vivo or in vitro dermal absorption are missing, 100% absorption has to be used for the calculations according to the requirements of the SCCP as laid down in the document SCCNFP/0321/00.","page":53,"pdf":"sccp_o_023.pdf","row_type":"dermal_absorption_study"}

sccp_o_023.pdf

{"absorption_percent":"100%","basis":"SCCP/0881/05 Opinion on glyoxal 53 Since data for in vivo or in vitro dermal absorption are missing, 100% absorption has to be used for the calculations according to the requirements of the SCCP as laid down in the document SCCNFP/0321/00.","page":53,"pdf":"sccp_o_023.pdf","row_type":"dermal_absorption_study"}

sccp_o_023.pdf

{"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"}

sccp_o_023.pdf

{"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"}

sccp_o_023.pdf

{"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"}

sccp_o_023.pdf

{"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"}

sccp_o_023.pdf

{"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"}

sccp_o_023.pdf

{"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"}

sccp_o_023.pdf

{"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"}

sccp_o_023.pdf

{"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"}

sccp_o_023.pdf

{"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"}

sccp_o_023.pdf

{"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"}

sccp_o_023.pdf

{"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"}

sccp_o_023.pdf

{"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"}

sccp_o_023.pdf

{"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"}

sccp_o_023.pdf

{"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"}

sccp_o_023.pdf

{"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"}

sccp_o_023.pdf

{"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"}

sccp_o_023.pdf

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"}

sccp_o_023.pdf

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"}

sccp_o_023.pdf

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"}

sccp_o_023.pdf

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"}

sccp_o_023.pdf

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"}

sccp_o_023.pdf

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"}

sccp_o_023.pdf

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"}

sccp_o_023.pdf

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"}

sccp_o_023.pdf

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"}

sccp_o_023.pdf

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"}

sccp_o_023.pdf

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"}

sccp_o_023.pdf

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"}

sccp_o_023.pdf

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"}

sccp_o_023.pdf

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"}

sccp_o_023.pdf

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"}

sccp_o_023.pdf

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"}

sccp_o_023.pdf

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"}

sccp_o_023.pdf

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"}

sccp_o_023.pdf

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"}

sccp_o_023.pdf