NOAEL Studies Colorant

Carbon Black NOAEL Studies

INCI: CI 77266

CAS: 1333-86-4

Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.

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California Proposition 65 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
California Proposition 65 California Proposition 65 listing ABcancer listing type - - 2003-02-21 California Proposition 65 listing {"cancer_reproductive":"cancer","listed_date":"2003-02-21","listing_mechanism":"AB","madl":null,"nsrl":null,"source_table":"prop65_listings"}
California Proposition 65 California Proposition 65 listing ABcancer listing type - - 2003-02-21 California Proposition 65 listing {"cancer_reproductive":"cancer","listed_date":"2003-02-21","listing_mechanism":"AB","madl":null,"nsrl":null,"source_table":"prop65_listings"}
California Proposition 65 California Proposition 65 listing ABcancer listing type - - 2003-02-21 California Proposition 65 listing {"cancer_reproductive":"cancer","listed_date":"2003-02-21","listing_mechanism":"AB","madl":null,"nsrl":null,"source_table":"prop65_listings"}
IARC Monographs 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
IARC Monographs IARC carcinogenicity classification 2B IARC group - - 2006 IARC Monographs {"additional_info":"volume_publication_year=2010","evaluation_year":2006,"source_table":"iarc_classifications","volume":"Sup 7, 65, 93"}
IARC Monographs IARC carcinogenicity classification 2B IARC group - - 2006 IARC Monographs {"additional_info":"volume_publication_year=2010","evaluation_year":2006,"source_table":"iarc_classifications","volume":"Sup 7, 65, 93"}
IARC Monographs IARC carcinogenicity classification 2B IARC group - - 2006 IARC Monographs {"additional_info":"volume_publication_year=2010","evaluation_year":2006,"source_table":"iarc_classifications","volume":"Sup 7, 65, 93"}
NTP_ICE_cancer 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_cancer IARC group 2 unitless - - - WOE; IARC Carcinogenicity sheet=Data; excel_row=8445; Record_ID=cancer_6638; Data_Type=WOE; Formulation_Name=Carbon black; Mixture=Chemical; DTXSID=DTXSID7051216; Assay=IARC Carcinogenicity; Endpoint=IARC group; Response=2B; Response_Unit=Unitless; URL=http://publications.iarc.fr/139; http://publications.iarc.fr/83; http://publications.iarc.fr/111; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7051216
SCCS_vision_codex 28 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =1000 mg/kg/day rat oral 13 weeks NOAEL study {"citation":"Ref.: Sathish, 2012","dose":"Conclusion The study authors concluded that the repeated daily oral administration to rats of carbon black for 13 weeks at 100, 300 or 1000 mg/kg/day was well tolerated, with some non- adverse findings related to the staining properties of carbon black.","effect":"m black discolouration. These findings were also considered to be related to the coloured nature of the test item and hence non adverse. There were no other histopathological findings attributed to carbon black. Conclusion The study authors concluded that the repeated daily oral administration to rats of carbon black for 13 weeks at 100, 300 or 1000 mg/kg/day was well tolerated, with some non- adverse findings related to the staining properties of carbon black. Accordingly, under the conditions of this study, the No Observed Adverse Effect Level (NOAEL) was 1000 mg/kg/day. Ref.: Sathish, 2012","page":33,"pdf":"sccs_o_144.pdf","row_type":"noael_study","study_id":"sccs_o_144_noael_001"}
SCCS_vision_codex NOAEL =1 - rat - subchronic repeated dose toxicity {"dose":"The magnitude of the response to LSCB in rats was between those for high- and mid-dose HSCB.","effect":"were similar in magnitude. Lung inflammation and histopathology were more severe and prolonged in rats than in mice and hamsters. The magnitude of the response to LSCB in rats was between those for high- and mid-dose HSCB. The results show that hamsters have the most efficient clearance mechanisms and the least severe responses of the three species. The results from rats also show that particle surface area is an important determinant of target tissue dose and, therefore, effects. From these results, a subchronic NOAEL of 1 mg/m3 respirable HSCB (Printex 90) can be assigned to female rats, mice, and hamsters. Conclusion Particle retention kinetics, inflammation, and histopathology were examined in female rats, mice, and hamsters exposed for 13 weeks to high surface area carbon black (HSCB) at doses of 0, 1, 7, and 50 mg/m3. Rats were also exposed to 50 mg/m3 low surface area carbon black (LSCB). Groups of animals were sacrificed immediately after 13 weeks of exposure, and after 3 and 11 months of recovery for bronchoalveolar la","page":38,"pdf":"sccs_o_144.pdf","row_type":"noael_study","study_id":"sccs_o_144_noael_003"}
SCCS_vision_codex NOAEL =7 - rat - 13 weeks NOAEL study {"citation":"Ref.: Elder et al","dose":"he end of exposure was similar to HSCB mid-dose group (7 mg/m3) in terms of retained particle surface area.","effect":"he end of exposure was similar to HSCB mid-dose group (7 mg/m3) in terms of retained particle surface area. Prolonged retention of carbon black particles in the lung was found in rats and mice exposed for 13 weeks to 7 and 50 mg/m3, and in hamsters exposed for 13 weeks to 50 mg/m3. These data show that hamsters have the most efficient clearance mechanism. Low-surface carbon black (50 mg/m3) was more efficiently cleared from the lungs than was 50 mg/m3 high-surface carbon black. The study authors concluded that the NOAEL for rats, mice and hamster was 1 mg/m3. Ref.: Elder et al., 2005, Carter et al., 2006","page":38,"pdf":"sccs_o_144.pdf","row_type":"noael_study","study_id":"sccs_o_144_noael_004"}
SCCS_vision_codex NOAEL =1515 - rat inhalation 11 months carcinogenicity {"effect":"SCCS/1515/13 Second revision of the opinion on carbon black, nano-form ___________________________________________________________________________________________ 39 SCCS comment The responses after inhalation of carbon black at 1 and 7 mg/m3 among rats, mice and hamsters were similar in magnitude. The NOAEL for inhalation of carbon black nanomaterials for rats, mice and hamster was 1 mg/m3. The mid (7 mg/m3) and high (50 mg/m3) doses of carbon black induced pathological lung alterations in mice and rats that were persistent as they were not resolved after the recovery period up to 11 months after exposure. 3.3.5.3. Chronic (> 12 months) toxicity Not submitted. See also Section 3.3.7. Carcinogenicity. 3.3.6. Mutagenicity / Genotoxicity Only more recent studies have been included. 3.3.6.1 Mutagenicity / Genoto","page":39,"pdf":"sccs_o_144.pdf","row_type":"noael_study","study_id":"sccs_o_144_noael_005"}
SCCS_vision_codex NOAEL =0 mg/kg bw/d rat oral developmental developmental toxicity {"citation":"Ref.: Ramesh (2012)","dose":"Conclusion The study authors concluded that oral administration of carbon black to pregnant rats at 100, 300 or 1 000 mg/kg bw/d during the sensitive period of organogenesis was well tolerated.","effect":"major malformations. Minor foetal anomalies and normal variants observed were of the type and incidences commonly observed in rats of this strain and age and hence were to be incidental. Conclusion The study authors concluded that oral administration of carbon black to pregnant rats at 100, 300 or 1 000 mg/kg bw/d during the sensitive period of organogenesis was well tolerated. There were no adverse maternal changes or any effects on embryo-foetal development. Accordingly, under the conditions of this study, The No Observed Adverse Effect Level (NOAEL) for maternal toxicity and the No Observed Effect Level (NOEL) for developmental toxicity were both set at 1 000 mg/kg bw/d. Ref.: Ramesh (2012)","page":85,"pdf":"sccs_o_144.pdf","row_type":"noael_study","study_id":"sccs_o_144_noael_006"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/d rat oral 11 months genotoxicity {"dose":"The NOAEL for inhalation of carbon black nanomaterials for rats, mice and hamster was 1 mg/m3, while the NOAEL for oral administration of carbon black to rats was 1000 mg/kg bw/d.","effect":"SCCS/1515/13 Second revision of the opinion on carbon black, nano-form ___________________________________________________________________________________________ 95 persistent as they were not resolved after the recovery period up to 11 months after exposure. SCCS notes that the responses after inhalation of carbon black at 1 and 7 mg/m3 among rats, mice and hamsters were similar in magnitude. The NOAEL for inhalation of carbon black nanomaterials for rats, mice and hamster was 1 mg/m3, while the NOAEL for oral administration of carbon black to rats was 1000 mg/kg bw/d. Mutagenicity / genotoxicity In vitro studies Cell-free systems Measurement of single strand DNA breaks production, using supercoiled plasmid DNA as indicator, showed that nano carbon black particles (diameter 14 nm) exhibited significantly more free radical activity than fine carbon black particles (diameter 260 nm). The results with fine carbo","page":95,"pdf":"sccs_o_144.pdf","row_type":"noael_study","study_id":"sccs_o_144_noael_013"}
SCCS_vision_codex NOAEL =38 - rat - - NOAEL study {"effect":"Unlabeled table on page 38: The study authors concluded that the NOAEL for rats, mice and hamster was 1 mg/m3.","page":38,"pdf":"sccs_o_144.pdf","row_type":"noael_study","study_id":"sccs_o_144_noael_015"}
SCCS_vision_codex NOAEL =1000 mg/kg/day rat oral 13 weeks NOAEL study {"citation":"Ref.: Sathish, 2012","dose":"Conclusion The study authors concluded that the repeated daily oral administration to rats of carbon black for 13 weeks at 100, 300 or 1000 mg/kg/day was well tolerated, with some non- adverse findings related to the staining properties of carbon black.","effect":"m black discolouration. These findings were also considered to be related to the coloured nature of the test item and hence non adverse. There were no other histopathological findings attributed to carbon black. Conclusion The study authors concluded that the repeated daily oral administration to rats of carbon black for 13 weeks at 100, 300 or 1000 mg/kg/day was well tolerated, with some non- adverse findings related to the staining properties of carbon black. Accordingly, under the conditions of this study, the No Observed Adverse Effect Level (NOAEL) was 1000 mg/kg/day. Ref.: Sathish, 2012","page":33,"pdf":"sccs_o_144.pdf","row_type":"noael_study","study_id":"sccs_o_144_noael_001"}
SCCS_vision_codex NOAEL =1 - rat - subchronic repeated dose toxicity {"dose":"The magnitude of the response to LSCB in rats was between those for high- and mid-dose HSCB.","effect":"were similar in magnitude. Lung inflammation and histopathology were more severe and prolonged in rats than in mice and hamsters. The magnitude of the response to LSCB in rats was between those for high- and mid-dose HSCB. The results show that hamsters have the most efficient clearance mechanisms and the least severe responses of the three species. The results from rats also show that particle surface area is an important determinant of target tissue dose and, therefore, effects. From these results, a subchronic NOAEL of 1 mg/m3 respirable HSCB (Printex 90) can be assigned to female rats, mice, and hamsters. Conclusion Particle retention kinetics, inflammation, and histopathology were examined in female rats, mice, and hamsters exposed for 13 weeks to high surface area carbon black (HSCB) at doses of 0, 1, 7, and 50 mg/m3. Rats were also exposed to 50 mg/m3 low surface area carbon black (LSCB). Groups of animals were sacrificed immediately after 13 weeks of exposure, and after 3 and 11 months of recovery for bronchoalveolar la","page":38,"pdf":"sccs_o_144.pdf","row_type":"noael_study","study_id":"sccs_o_144_noael_003"}
SCCS_vision_codex NOAEL =7 - rat - 13 weeks NOAEL study {"citation":"Ref.: Elder et al","dose":"he end of exposure was similar to HSCB mid-dose group (7 mg/m3) in terms of retained particle surface area.","effect":"he end of exposure was similar to HSCB mid-dose group (7 mg/m3) in terms of retained particle surface area. Prolonged retention of carbon black particles in the lung was found in rats and mice exposed for 13 weeks to 7 and 50 mg/m3, and in hamsters exposed for 13 weeks to 50 mg/m3. These data show that hamsters have the most efficient clearance mechanism. Low-surface carbon black (50 mg/m3) was more efficiently cleared from the lungs than was 50 mg/m3 high-surface carbon black. The study authors concluded that the NOAEL for rats, mice and hamster was 1 mg/m3. Ref.: Elder et al., 2005, Carter et al., 2006","page":38,"pdf":"sccs_o_144.pdf","row_type":"noael_study","study_id":"sccs_o_144_noael_004"}
SCCS_vision_codex NOAEL =1515 - rat inhalation 11 months carcinogenicity {"effect":"SCCS/1515/13 Second revision of the opinion on carbon black, nano-form ___________________________________________________________________________________________ 39 SCCS comment The responses after inhalation of carbon black at 1 and 7 mg/m3 among rats, mice and hamsters were similar in magnitude. The NOAEL for inhalation of carbon black nanomaterials for rats, mice and hamster was 1 mg/m3. The mid (7 mg/m3) and high (50 mg/m3) doses of carbon black induced pathological lung alterations in mice and rats that were persistent as they were not resolved after the recovery period up to 11 months after exposure. 3.3.5.3. Chronic (> 12 months) toxicity Not submitted. See also Section 3.3.7. Carcinogenicity. 3.3.6. Mutagenicity / Genotoxicity Only more recent studies have been included. 3.3.6.1 Mutagenicity / Genoto","page":39,"pdf":"sccs_o_144.pdf","row_type":"noael_study","study_id":"sccs_o_144_noael_005"}
SCCS_vision_codex NOAEL =0 mg/kg bw/d rat oral developmental developmental toxicity {"citation":"Ref.: Ramesh (2012)","dose":"Conclusion The study authors concluded that oral administration of carbon black to pregnant rats at 100, 300 or 1 000 mg/kg bw/d during the sensitive period of organogenesis was well tolerated.","effect":"major malformations. Minor foetal anomalies and normal variants observed were of the type and incidences commonly observed in rats of this strain and age and hence were to be incidental. Conclusion The study authors concluded that oral administration of carbon black to pregnant rats at 100, 300 or 1 000 mg/kg bw/d during the sensitive period of organogenesis was well tolerated. There were no adverse maternal changes or any effects on embryo-foetal development. Accordingly, under the conditions of this study, The No Observed Adverse Effect Level (NOAEL) for maternal toxicity and the No Observed Effect Level (NOEL) for developmental toxicity were both set at 1 000 mg/kg bw/d. Ref.: Ramesh (2012)","page":85,"pdf":"sccs_o_144.pdf","row_type":"noael_study","study_id":"sccs_o_144_noael_006"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/d rat oral 11 months genotoxicity {"dose":"The NOAEL for inhalation of carbon black nanomaterials for rats, mice and hamster was 1 mg/m3, while the NOAEL for oral administration of carbon black to rats was 1000 mg/kg bw/d.","effect":"SCCS/1515/13 Second revision of the opinion on carbon black, nano-form ___________________________________________________________________________________________ 95 persistent as they were not resolved after the recovery period up to 11 months after exposure. SCCS notes that the responses after inhalation of carbon black at 1 and 7 mg/m3 among rats, mice and hamsters were similar in magnitude. The NOAEL for inhalation of carbon black nanomaterials for rats, mice and hamster was 1 mg/m3, while the NOAEL for oral administration of carbon black to rats was 1000 mg/kg bw/d. Mutagenicity / genotoxicity In vitro studies Cell-free systems Measurement of single strand DNA breaks production, using supercoiled plasmid DNA as indicator, showed that nano carbon black particles (diameter 14 nm) exhibited significantly more free radical activity than fine carbon black particles (diameter 260 nm). The results with fine carbo","page":95,"pdf":"sccs_o_144.pdf","row_type":"noael_study","study_id":"sccs_o_144_noael_013"}
SCCS_vision_codex NOAEL =38 - rat - - NOAEL study {"effect":"Unlabeled table on page 38: The study authors concluded that the NOAEL for rats, mice and hamster was 1 mg/m3.","page":38,"pdf":"sccs_o_144.pdf","row_type":"noael_study","study_id":"sccs_o_144_noael_015"}
SCCS_vision_codex NOAEL =1000 mg/kg/day rat oral 13 weeks NOAEL study {"citation":"Ref.: Sathish, 2012","dose":"Conclusion The study authors concluded that the repeated daily oral administration to rats of carbon black for 13 weeks at 100, 300 or 1000 mg/kg/day was well tolerated, with some non- adverse findings related to the staining properties of carbon black.","effect":"m black discolouration. These findings were also considered to be related to the coloured nature of the test item and hence non adverse. There were no other histopathological findings attributed to carbon black. Conclusion The study authors concluded that the repeated daily oral administration to rats of carbon black for 13 weeks at 100, 300 or 1000 mg/kg/day was well tolerated, with some non- adverse findings related to the staining properties of carbon black. Accordingly, under the conditions of this study, the No Observed Adverse Effect Level (NOAEL) was 1000 mg/kg/day. Ref.: Sathish, 2012","page":33,"pdf":"sccs_o_144.pdf","row_type":"noael_study","study_id":"sccs_o_144_noael_001"}
SCCS_vision_codex NOAEL =1 - rat - subchronic repeated dose toxicity {"dose":"The magnitude of the response to LSCB in rats was between those for high- and mid-dose HSCB.","effect":"were similar in magnitude. Lung inflammation and histopathology were more severe and prolonged in rats than in mice and hamsters. The magnitude of the response to LSCB in rats was between those for high- and mid-dose HSCB. The results show that hamsters have the most efficient clearance mechanisms and the least severe responses of the three species. The results from rats also show that particle surface area is an important determinant of target tissue dose and, therefore, effects. From these results, a subchronic NOAEL of 1 mg/m3 respirable HSCB (Printex 90) can be assigned to female rats, mice, and hamsters. Conclusion Particle retention kinetics, inflammation, and histopathology were examined in female rats, mice, and hamsters exposed for 13 weeks to high surface area carbon black (HSCB) at doses of 0, 1, 7, and 50 mg/m3. Rats were also exposed to 50 mg/m3 low surface area carbon black (LSCB). Groups of animals were sacrificed immediately after 13 weeks of exposure, and after 3 and 11 months of recovery for bronchoalveolar la","page":38,"pdf":"sccs_o_144.pdf","row_type":"noael_study","study_id":"sccs_o_144_noael_003"}
SCCS_vision_codex NOAEL =7 - rat - 13 weeks NOAEL study {"citation":"Ref.: Elder et al","dose":"he end of exposure was similar to HSCB mid-dose group (7 mg/m3) in terms of retained particle surface area.","effect":"he end of exposure was similar to HSCB mid-dose group (7 mg/m3) in terms of retained particle surface area. Prolonged retention of carbon black particles in the lung was found in rats and mice exposed for 13 weeks to 7 and 50 mg/m3, and in hamsters exposed for 13 weeks to 50 mg/m3. These data show that hamsters have the most efficient clearance mechanism. Low-surface carbon black (50 mg/m3) was more efficiently cleared from the lungs than was 50 mg/m3 high-surface carbon black. The study authors concluded that the NOAEL for rats, mice and hamster was 1 mg/m3. Ref.: Elder et al., 2005, Carter et al., 2006","page":38,"pdf":"sccs_o_144.pdf","row_type":"noael_study","study_id":"sccs_o_144_noael_004"}
SCCS_vision_codex NOAEL =1515 - rat inhalation 11 months carcinogenicity {"effect":"SCCS/1515/13 Second revision of the opinion on carbon black, nano-form ___________________________________________________________________________________________ 39 SCCS comment The responses after inhalation of carbon black at 1 and 7 mg/m3 among rats, mice and hamsters were similar in magnitude. The NOAEL for inhalation of carbon black nanomaterials for rats, mice and hamster was 1 mg/m3. The mid (7 mg/m3) and high (50 mg/m3) doses of carbon black induced pathological lung alterations in mice and rats that were persistent as they were not resolved after the recovery period up to 11 months after exposure. 3.3.5.3. Chronic (> 12 months) toxicity Not submitted. See also Section 3.3.7. Carcinogenicity. 3.3.6. Mutagenicity / Genotoxicity Only more recent studies have been included. 3.3.6.1 Mutagenicity / Genoto","page":39,"pdf":"sccs_o_144.pdf","row_type":"noael_study","study_id":"sccs_o_144_noael_005"}
SCCS_vision_codex NOAEL =0 mg/kg bw/d rat oral developmental developmental toxicity {"citation":"Ref.: Ramesh (2012)","dose":"Conclusion The study authors concluded that oral administration of carbon black to pregnant rats at 100, 300 or 1 000 mg/kg bw/d during the sensitive period of organogenesis was well tolerated.","effect":"major malformations. Minor foetal anomalies and normal variants observed were of the type and incidences commonly observed in rats of this strain and age and hence were to be incidental. Conclusion The study authors concluded that oral administration of carbon black to pregnant rats at 100, 300 or 1 000 mg/kg bw/d during the sensitive period of organogenesis was well tolerated. There were no adverse maternal changes or any effects on embryo-foetal development. Accordingly, under the conditions of this study, The No Observed Adverse Effect Level (NOAEL) for maternal toxicity and the No Observed Effect Level (NOEL) for developmental toxicity were both set at 1 000 mg/kg bw/d. Ref.: Ramesh (2012)","page":85,"pdf":"sccs_o_144.pdf","row_type":"noael_study","study_id":"sccs_o_144_noael_006"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/d rat oral 11 months genotoxicity {"dose":"The NOAEL for inhalation of carbon black nanomaterials for rats, mice and hamster was 1 mg/m3, while the NOAEL for oral administration of carbon black to rats was 1000 mg/kg bw/d.","effect":"SCCS/1515/13 Second revision of the opinion on carbon black, nano-form ___________________________________________________________________________________________ 95 persistent as they were not resolved after the recovery period up to 11 months after exposure. SCCS notes that the responses after inhalation of carbon black at 1 and 7 mg/m3 among rats, mice and hamsters were similar in magnitude. The NOAEL for inhalation of carbon black nanomaterials for rats, mice and hamster was 1 mg/m3, while the NOAEL for oral administration of carbon black to rats was 1000 mg/kg bw/d. Mutagenicity / genotoxicity In vitro studies Cell-free systems Measurement of single strand DNA breaks production, using supercoiled plasmid DNA as indicator, showed that nano carbon black particles (diameter 14 nm) exhibited significantly more free radical activity than fine carbon black particles (diameter 260 nm). The results with fine carbo","page":95,"pdf":"sccs_o_144.pdf","row_type":"noael_study","study_id":"sccs_o_144_noael_013"}
SCCS_vision_codex NOAEL =38 - rat - - NOAEL study {"effect":"Unlabeled table on page 38: The study authors concluded that the NOAEL for rats, mice and hamster was 1 mg/m3.","page":38,"pdf":"sccs_o_144.pdf","row_type":"noael_study","study_id":"sccs_o_144_noael_015"}
SCCS_vision_codex NOAEL =1000 mg/kg/day rat oral 13 weeks NOAEL study {"citation":"Ref.: Sathish, 2012","dose":"Conclusion The study authors concluded that the repeated daily oral administration to rats of carbon black for 13 weeks at 100, 300 or 1000 mg/kg/day was well tolerated, with some non- adverse findings related to the staining properties of carbon black.","effect":"m black discolouration. These findings were also considered to be related to the coloured nature of the test item and hence non adverse. There were no other histopathological findings attributed to carbon black. Conclusion The study authors concluded that the repeated daily oral administration to rats of carbon black for 13 weeks at 100, 300 or 1000 mg/kg/day was well tolerated, with some non- adverse findings related to the staining properties of carbon black. Accordingly, under the conditions of this study, the No Observed Adverse Effect Level (NOAEL) was 1000 mg/kg/day. Ref.: Sathish, 2012","page":33,"pdf":"sccs_o_144.pdf","row_type":"noael_study","study_id":"sccs_o_144_noael_001"}
SCCS_vision_codex NOAEL =1 - rat - subchronic repeated dose toxicity {"dose":"The magnitude of the response to LSCB in rats was between those for high- and mid-dose HSCB.","effect":"were similar in magnitude. Lung inflammation and histopathology were more severe and prolonged in rats than in mice and hamsters. The magnitude of the response to LSCB in rats was between those for high- and mid-dose HSCB. The results show that hamsters have the most efficient clearance mechanisms and the least severe responses of the three species. The results from rats also show that particle surface area is an important determinant of target tissue dose and, therefore, effects. From these results, a subchronic NOAEL of 1 mg/m3 respirable HSCB (Printex 90) can be assigned to female rats, mice, and hamsters. Conclusion Particle retention kinetics, inflammation, and histopathology were examined in female rats, mice, and hamsters exposed for 13 weeks to high surface area carbon black (HSCB) at doses of 0, 1, 7, and 50 mg/m3. Rats were also exposed to 50 mg/m3 low surface area carbon black (LSCB). Groups of animals were sacrificed immediately after 13 weeks of exposure, and after 3 and 11 months of recovery for bronchoalveolar la","page":38,"pdf":"sccs_o_144.pdf","row_type":"noael_study","study_id":"sccs_o_144_noael_003"}
SCCS_vision_codex NOAEL =7 - rat - 13 weeks NOAEL study {"citation":"Ref.: Elder et al","dose":"he end of exposure was similar to HSCB mid-dose group (7 mg/m3) in terms of retained particle surface area.","effect":"he end of exposure was similar to HSCB mid-dose group (7 mg/m3) in terms of retained particle surface area. Prolonged retention of carbon black particles in the lung was found in rats and mice exposed for 13 weeks to 7 and 50 mg/m3, and in hamsters exposed for 13 weeks to 50 mg/m3. These data show that hamsters have the most efficient clearance mechanism. Low-surface carbon black (50 mg/m3) was more efficiently cleared from the lungs than was 50 mg/m3 high-surface carbon black. The study authors concluded that the NOAEL for rats, mice and hamster was 1 mg/m3. Ref.: Elder et al., 2005, Carter et al., 2006","page":38,"pdf":"sccs_o_144.pdf","row_type":"noael_study","study_id":"sccs_o_144_noael_004"}
SCCS_vision_codex NOAEL =1515 - rat inhalation 11 months carcinogenicity {"effect":"SCCS/1515/13 Second revision of the opinion on carbon black, nano-form ___________________________________________________________________________________________ 39 SCCS comment The responses after inhalation of carbon black at 1 and 7 mg/m3 among rats, mice and hamsters were similar in magnitude. The NOAEL for inhalation of carbon black nanomaterials for rats, mice and hamster was 1 mg/m3. The mid (7 mg/m3) and high (50 mg/m3) doses of carbon black induced pathological lung alterations in mice and rats that were persistent as they were not resolved after the recovery period up to 11 months after exposure. 3.3.5.3. Chronic (> 12 months) toxicity Not submitted. See also Section 3.3.7. Carcinogenicity. 3.3.6. Mutagenicity / Genotoxicity Only more recent studies have been included. 3.3.6.1 Mutagenicity / Genoto","page":39,"pdf":"sccs_o_144.pdf","row_type":"noael_study","study_id":"sccs_o_144_noael_005"}
SCCS_vision_codex NOAEL =0 mg/kg bw/d rat oral developmental developmental toxicity {"citation":"Ref.: Ramesh (2012)","dose":"Conclusion The study authors concluded that oral administration of carbon black to pregnant rats at 100, 300 or 1 000 mg/kg bw/d during the sensitive period of organogenesis was well tolerated.","effect":"major malformations. Minor foetal anomalies and normal variants observed were of the type and incidences commonly observed in rats of this strain and age and hence were to be incidental. Conclusion The study authors concluded that oral administration of carbon black to pregnant rats at 100, 300 or 1 000 mg/kg bw/d during the sensitive period of organogenesis was well tolerated. There were no adverse maternal changes or any effects on embryo-foetal development. Accordingly, under the conditions of this study, The No Observed Adverse Effect Level (NOAEL) for maternal toxicity and the No Observed Effect Level (NOEL) for developmental toxicity were both set at 1 000 mg/kg bw/d. Ref.: Ramesh (2012)","page":85,"pdf":"sccs_o_144.pdf","row_type":"noael_study","study_id":"sccs_o_144_noael_006"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/d rat oral 11 months genotoxicity {"dose":"The NOAEL for inhalation of carbon black nanomaterials for rats, mice and hamster was 1 mg/m3, while the NOAEL for oral administration of carbon black to rats was 1000 mg/kg bw/d.","effect":"SCCS/1515/13 Second revision of the opinion on carbon black, nano-form ___________________________________________________________________________________________ 95 persistent as they were not resolved after the recovery period up to 11 months after exposure. SCCS notes that the responses after inhalation of carbon black at 1 and 7 mg/m3 among rats, mice and hamsters were similar in magnitude. The NOAEL for inhalation of carbon black nanomaterials for rats, mice and hamster was 1 mg/m3, while the NOAEL for oral administration of carbon black to rats was 1000 mg/kg bw/d. Mutagenicity / genotoxicity In vitro studies Cell-free systems Measurement of single strand DNA breaks production, using supercoiled plasmid DNA as indicator, showed that nano carbon black particles (diameter 14 nm) exhibited significantly more free radical activity than fine carbon black particles (diameter 260 nm). The results with fine carbo","page":95,"pdf":"sccs_o_144.pdf","row_type":"noael_study","study_id":"sccs_o_144_noael_013"}
SCCS_vision_codex NOAEL =38 - rat - - NOAEL study {"effect":"Unlabeled table on page 38: The study authors concluded that the NOAEL for rats, mice and hamster was 1 mg/m3.","page":38,"pdf":"sccs_o_144.pdf","row_type":"noael_study","study_id":"sccs_o_144_noael_015"}
ToxValDB_ECHA_IUCLID 15 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_ECHA_IUCLID LEL =1000 mg/kg bw/day Rat oral - acute QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6605975fe4b063812d6fa6ed; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24448/7/3/2?documentUUID=78da8852-ad83-4e3e-a7e7-e05caf013b6c; YEAR=1995; ORIGINAL_YEAR=1995; STUDY_GROUP=ECHA IUCLID:15811963:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_66d6739aaef6405270883372de0c94d8
ToxValDB_ECHA_IUCLID LOAEC =6 mg/m3 Rat inhalation subchronic; 2 months subchronic QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24448/7/6/3?documentUUID=78da8852-ad83-4e3e-a7e7-e05caf013b6c; YEAR=1995; ORIGINAL_YEAR=1995; STUDY_GROUP=ECHA IUCLID:15828248:F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_d637ae2ed9518c6a53164ddfca09f9c6
ToxValDB_ECHA_IUCLID LOAEC =2.5 mg/m3 Rat inhalation chronic; 24 months chronic QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24448/7/6/3?documentUUID=78da8852-ad83-4e3e-a7e7-e05caf013b6c; YEAR=1995; ORIGINAL_YEAR=1995; STUDY_GROUP=ECHA IUCLID:15829026:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_65db862b7f92c3ef16db3e9a8ba238e6
ToxValDB_ECHA_IUCLID LOAEL =11 mg/m3 Rat inhalation subchronic; 12 weeks subchronic QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24448/7/6/3?documentUUID=78da8852-ad83-4e3e-a7e7-e05caf013b6c; YEAR=1995; ORIGINAL_YEAR=1995; STUDY_GROUP=ECHA IUCLID:15828929:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_21cb7a28e94eafb73d86afb4acbf3334
ToxValDB_ECHA_IUCLID LOEC =9.08 mg/m3 Rat inhalation short-term; 3 days short-term QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24448/7/6/3?documentUUID=78da8852-ad83-4e3e-a7e7-e05caf013b6c; YEAR=1995; ORIGINAL_YEAR=1995; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15827404_15827405:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_c0f103cb3917bc08d861ef03b523bf10
ToxValDB_ECHA_IUCLID LOEC >=1.55 mg/m3 Hamster inhalation subchronic; 53 days subchronic QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24448/7/6/3?documentUUID=78da8852-ad83-4e3e-a7e7-e05caf013b6c; YEAR=1995; ORIGINAL_YEAR=1995; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15829665_15829666:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_6365bb3e0ec031daba9ef836e66969aa
ToxValDB_ECHA_IUCLID LOEC <=1.56 mg/m3 Hamster inhalation subchronic; 53 days subchronic QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24448/7/6/3?documentUUID=78da8852-ad83-4e3e-a7e7-e05caf013b6c; YEAR=1995; ORIGINAL_YEAR=1995; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15829665_15829666:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_cb5451c72f4f6aafc339370ee11960a3
ToxValDB_ECHA_IUCLID NOAEC >=7.4 mg/m3 Mouse inhalation chronic; 10 months chronic QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24448/7/6/3?documentUUID=78da8852-ad83-4e3e-a7e7-e05caf013b6c; YEAR=1995; ORIGINAL_YEAR=1995; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15829625_15829626:F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_519b9a5adc2b903494ca5cc1a206342d
ToxValDB_ECHA_IUCLID NOAEC >=2.5 mg/m3 Rat inhalation acute; 16 hours acute QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24448/7/6/3?documentUUID=78da8852-ad83-4e3e-a7e7-e05caf013b6c; YEAR=1995; ORIGINAL_YEAR=1995; TOXICOLOGICAL_EFFECT=lungs; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15829633_15829634:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_e4334a693d25319cf9dc85d386c286f1
ToxValDB_ECHA_IUCLID NOAEC >=1.1 mg/m3 Rat inhalation acute; 6 hours acute QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24448/7/6/3?documentUUID=78da8852-ad83-4e3e-a7e7-e05caf013b6c; YEAR=1995; ORIGINAL_YEAR=1995; TOXICOLOGICAL_EFFECT=lungs; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15829641_15829642_15829643_15829644_15829645_15829646:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_3e2d0bc0165d739e092cc83ef72b54ea
ToxValDB_ECHA_IUCLID NOAEC >=7.1 mg/m3 Rat inhalation acute; 6 hours acute QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24448/7/6/3?documentUUID=78da8852-ad83-4e3e-a7e7-e05caf013b6c; YEAR=1995; ORIGINAL_YEAR=1995; TOXICOLOGICAL_EFFECT=lungs; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15829641_15829642_15829643_15829644_15829645_15829646:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_d1a35b96e81bdc128b136c80534ae188
ToxValDB_ECHA_IUCLID NOAEC >=52.8 mg/m3 Rat inhalation acute; 6 hours acute QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24448/7/6/3?documentUUID=78da8852-ad83-4e3e-a7e7-e05caf013b6c; YEAR=1995; ORIGINAL_YEAR=1995; TOXICOLOGICAL_EFFECT=lungs; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15829641_15829642_15829643_15829644_15829645_15829646:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_22f5210b9ccce0c6b4d156ef13290e62
ToxValDB_ECHA_IUCLID NOAEC >34000 mg/m3 Mouse inhalation - reproduction developmental QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7c8bce4b0a7c65d219dc3; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24448/7/9/2?documentUUID=78da8852-ad83-4e3e-a7e7-e05caf013b6c; YEAR=1995; ORIGINAL_YEAR=1995; TOXICOLOGICAL_EFFECT=F2:; STUDY_GROUP=ECHA IUCLID:15860273:M:F2-; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_52f9064a866afe365f65ae88a503330e
ToxValDB_ECHA_IUCLID NOEC =9.83 mg/m3 Rat inhalation short-term; 3 days short-term QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24448/7/6/3?documentUUID=78da8852-ad83-4e3e-a7e7-e05caf013b6c; YEAR=1995; ORIGINAL_YEAR=1995; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15827404_15827405:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_76da124d5fcbb5648431c09a03b51b5a
ToxValDB_ECHA_IUCLID NOEC =34 mg/m3 Mouse inhalation - reproduction developmental QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7c8bce4b0a7c65d219dc3; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24448/7/9/2?documentUUID=78da8852-ad83-4e3e-a7e7-e05caf013b6c; YEAR=1995; ORIGINAL_YEAR=1995; TOXICOLOGICAL_EFFECT=P0: clinical signs|P0: mortality; TOXICOLOGICAL_EFFECT_CATEGORY=clinical signs|mortality/survival; STUDY_GROUP=ECHA IUCLID_dup_Toxicity Reproduction_15855702_15856470:F:P0-; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_726ec19806f2424f0649197ecc55ff67
ToxValDB_GESTIS_DNEL 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_GESTIS_DNEL DNEL systemic =1 mg/m3 Human inhalation - Toxicity Value STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6543dd69e4b045b9ff7cd87e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.dguv.de/ifa/gestis/gestis-dnel-liste/index-2.jsp; STUDY_GROUP=GESTIS DNEL:15630579:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_a94e8e43b0adc0e9bdb4bd10efd9b0c0
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 15 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 1000 mg/kg/day rat oral 13 weeks - SOURCE_SUBDIR=sccs_o_144; REPORT_TITLE=OPINION on Carbon Black (nano-form); OPINION_NUMBER=SCCS/1515/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=1000; DOSE=Conclusion The study authors concluded that the repeated daily oral administration to rats of carbon black for 13 weeks at 100, 300 or 1000 mg/kg/day was well tolerated, with some non- adverse findings related to the staining properties of carbon black.; EFFECT=m black discolouration. These findings were also considered to be related to the coloured nature of the test item and hence non adverse. There were no other histopathological findings attributed to carbon black. Conclusion The study authors concluded that the repeated daily oral administration to rats of carbon black for 13 weeks at 100, 300 or 1000 mg/kg/day was well tolerated, with some non- adverse findings related to the staining properties of carbon black. Accordingly, under the conditions of this study, the No Observed Adverse Effect Level (NOAEL) was 1000 mg/kg/day. Ref.: Sathish, 2012; CITATION=Ref.: Sathish, 2012; CITATION_NUMBERS=[2012]; REFERENCE=Ref.: Sathish, 2012; DETAILS_JSON={"cas_number":"1333-86-4","citation":"Ref.: Sathish, 2012","dose":"Conclusion The study authors concluded that the repeated daily oral administration to rats of carbon black for 13 weeks at 100, 300 or 1000 mg/kg/day was well tolerated, with some non- adverse findings related to the staining properties of carbon black.","duration":"13 weeks","effect":"m black discolouration. These findings were also considered to be related to the coloured nature of the test item and hence non adverse. There were no other histopathological findings attributed to carbon black. Conclusion The study authors concluded that the repeated daily oral administration to rats of carbon black for 13 weeks at 100, 300 or 1000 mg/kg/day was well tolerated, with some non- adverse findings related to the staining properties of carbon black. Accordingly, under the conditions of this study, the No Observed Adverse Effect Level (NOAEL) was 1000 mg/kg/day. Ref.: Sathish, 2012","endpoint":"","ingredient":"codes........................................7","loael_value":"","noael_unit":"mg/kg/day","noael_value":"1000","page":33,"route":"oral","species":"rat","study_id":"sccs_o_144_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 1000 mg/kg/day rat oral 13 weeks - SOURCE_SUBDIR=sccs_o_144; REPORT_TITLE=OPINION on Carbon Black (nano-form); OPINION_NUMBER=SCCS/1515/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=1000; DOSE=Conclusion The study authors concluded that the repeated daily oral administration to rats of carbon black for 13 weeks at 100, 300 or 1000 mg/kg/day was well tolerated, with some non- adverse findings related to the staining properties of carbon black.; EFFECT=ings were also considered to be related to the coloured nature of the test item and hence non adverse. There were no other histopathological findings attributed to carbon black. Conclusion The study authors concluded that the repeated daily oral administration to rats of carbon black for 13 weeks at 100, 300 or 1000 mg/kg/day was well tolerated, with some non- adverse findings related to the staining properties of carbon black. Accordingly, under the conditions of this study, the No Observed Adverse Effect Level (NOAEL) was 1000 mg/kg/day. Ref.: Sathish, 2012; CITATION=Ref.: Sathish, 2012; CITATION_NUMBERS=[2012]; REFERENCE=Ref.: Sathish, 2012; DETAILS_JSON={"cas_number":"1333-86-4","citation":"Ref.: Sathish, 2012","dose":"Conclusion The study authors concluded that the repeated daily oral administration to rats of carbon black for 13 weeks at 100, 300 or 1000 mg/kg/day was well tolerated, with some non- adverse findings related to the staining properties of carbon black.","duration":"13 weeks","effect":"ings were also considered to be related to the coloured nature of the test item and hence non adverse. There were no other histopathological findings attributed to carbon black. Conclusion The study authors concluded that the repeated daily oral administration to rats of carbon black for 13 weeks at 100, 300 or 1000 mg/kg/day was well tolerated, with some non- adverse findings related to the staining properties of carbon black. Accordingly, under the conditions of this study, the No Observed Adverse Effect Level (NOAEL) was 1000 mg/kg/day. Ref.: Sathish, 2012","endpoint":"","ingredient":"codes........................................7","loael_value":"","noael_unit":"mg/kg/day","noael_value":"1000","page":33,"route":"oral","species":"rat","study_id":"sccs_o_144_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 7 - rat - 13 weeks - SOURCE_SUBDIR=sccs_o_144; REPORT_TITLE=OPINION on Carbon Black (nano-form); OPINION_NUMBER=SCCS/1515/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=unclear:he end of exposure was similar to HSCB mid-dose group (7 mg/m3) in terms of retained particle surface area. Prolonged retention of carbon black particles in the lung was found in rats and mice exposed for 13 weeks to 7 and 50 mg/m3, and in hamsters exposed for 13 weeks to 50 mg/m3. These data show that hamsters have the most efficient clearance mechanism. Low-surface carbon black (50 mg/m3) was more efficiently cleared from the lungs than was 50 mg/m3 high-surface carbon black. The study authors concluded that the NOAEL for rats, mice and hamster was 1 mg/m3. Ref.: Elder et al., 2005, Carter et al., 2006; DOSE=he end of exposure was similar to HSCB mid-dose group (7 mg/m3) in terms of retained particle surface area.; EFFECT=he end of exposure was similar to HSCB mid-dose group (7 mg/m3) in terms of retained particle surface area. Prolonged retention of carbon black particles in the lung was found in rats and mice exposed for 13 weeks to 7 and 50 mg/m3, and in hamsters exposed for 13 weeks to 50 mg/m3. These data show that hamsters have the most efficient clearance mechanism. Low-surface carbon black (50 mg/m3) was more efficiently cleared from the lungs than was 50 mg/m3 high-surface carbon black. The study authors concluded that the NOAEL for rats, mice and hamster was 1 mg/m3. Ref.: Elder et al., 2005, Carter et al., 2006; CITATION=Ref.: Elder et al; CITATION_NUMBERS=[]; REFERENCE=Ref.: Elder et al; DETAILS_JSON={"cas_number":"1333-86-4","citation":"Ref.: Elder et al","dose":"he end of exposure was similar to HSCB mid-dose group (7 mg/m3) in terms of retained particle surface area.","duration":"13 weeks","effect":"he end of exposure was similar to HSCB mid-dose group (7 mg/m3) in terms of retained particle surface area. Prolonged retention of carbon black particles in the lung was found in rats and mice exposed for 13 weeks to 7 and 50 mg/m3, and in hamsters exposed for 13 weeks to 50 mg/m3. These data show that hamsters have the most efficient clearance mechanism. Low-surface carbon black (50 mg/m3) was more efficiently cleared from the lungs than was 50 mg/m3 high-surface carbon black. The study authors concluded that the NOAEL for rats, mice and hamster was 1 mg/m3. Ref.: Elder et al., 2005, Carter et al., 2006","endpoint":"","ingredient":"codes........................................7","loael_value":"","noael_unit":"","noael_value":"unclear:he end of exposure was similar to HSCB mid-dose group (7 mg/m3) in terms of retained particle surface area. Prolonged retention of carbon black particles in the lung was found in rats and mice exposed for 13 weeks to 7 and 50 mg/m3, and in hamsters exposed for 13 weeks to 50 mg/m3. These data show that hamsters have the most efficient clearance mechanism. Low-surface carbon black (50 mg/m3) was more efficiently cleared from the lungs than was 50 mg/m3 high-surface carbon black. The study authors concluded that the NOAEL for rats, mice and hamster was 1 mg/m3. Ref.: Elder et al., 2005, Carter et al., 2006","page":38,"route":"","species":"rat","study_id":"sccs_o_144_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 1000 mg/kg bw/d rat oral chronic - SOURCE_SUBDIR=sccs_o_144; REPORT_TITLE=OPINION on Carbon Black (nano-form); OPINION_NUMBER=SCCS/1515/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=1000; DOSE=Safety evaluation (including calculation of the MoS) The calculation of margin of safety (MoS) is not relevant for this assessment given the very low, if any, dermal penetration of nano-carbon black when applied on skin, and in consideration of the low toxicity (NOAEL for oral administration of carbon black to rats as 1000 mg/kg bw/d) observed.; EFFECT=ociated with a significant increase in the prevalence of respiratory symptoms along with both acute, partially reversible and chronic irreversible significant decreases in some parameters of pulmonary function. 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) The calculation of margin of safety (MoS) is not relevant for this assessment given the very low, if any, dermal penetration of nano-carbon black when applied on skin, and in consideration of the low toxicity (NOAEL for oral administration of carbon black to rats as 1000 mg/kg bw/d) observed. The NOAEL for inhalation of carbon black nanomaterials for rats, mice and hamsters is reported to be 1 mg/m3. In view of the potential for persistent lung inflammation, similar to other nanomaterials evaluated so far, applications that might lead to inhalation exposure of the consumer to carbon black nanoparticles (such as powders or sprayable products) are not recommended. 3.3.14. Discussion General considerations Carbon black nanop; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1333-86-4","citation":"","dose":"Safety evaluation (including calculation of the MoS) The calculation of margin of safety (MoS) is not relevant for this assessment given the very low, if any, dermal penetration of nano-carbon black when applied on skin, and in consideration of the low toxicity (NOAEL for oral administration of carbon black to rats as 1000 mg/kg bw/d) observed.","duration":"chronic","effect":"ociated with a significant increase in the prevalence of respiratory symptoms along with both acute, partially reversible and chronic irreversible significant decreases in some parameters of pulmonary function. 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) The calculation of margin of safety (MoS) is not relevant for this assessment given the very low, if any, dermal penetration of nano-carbon black when applied on skin, and in consideration of the low toxicity (NOAEL for oral administration of carbon black to rats as 1000 mg/kg bw/d) observed. The NOAEL for inhalation of carbon black nanomaterials for rats, mice and hamsters is reported to be 1 mg/m3. In view of the potential for persistent lung inflammation, similar to other nanomaterials evaluated so far, applications that might lead to inhalation exposure of the consumer to carbon black nanoparticles (such as powders or sprayable products) are not recommended. 3.3.14. Discussion General considerations Carbon black nanop","endpoint":"","ingredient":"codes........................................7","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":92,"route":"oral","species":"rat","study_id":"sccs_o_144_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 1000 mg/kg bw/d rat oral chronic - SOURCE_SUBDIR=sccs_o_144; REPORT_TITLE=OPINION on Carbon Black (nano-form); OPINION_NUMBER=SCCS/1515/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=1000; DOSE=Safety evaluation (including calculation of the MoS) The calculation of margin of safety (MoS) is not relevant for this assessment given the very low, if any, dermal penetration of nano-carbon black when applied on skin, and in consideration of the low toxicity (NOAEL for oral administration of carbon black to rats as 1000 mg/kg bw/d) observed.; EFFECT=both acute, partially reversible and chronic irreversible significant decreases in some parameters of pulmonary function. 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) The calculation of margin of safety (MoS) is not relevant for this assessment given the very low, if any, dermal penetration of nano-carbon black when applied on skin, and in consideration of the low toxicity (NOAEL for oral administration of carbon black to rats as 1000 mg/kg bw/d) observed. The NOAEL for inhalation of carbon black nanomaterials for rats, mice and hamsters is reported to be 1 mg/m3. In view of the potential for persistent lung inflammation, similar to other nanomaterials evaluated so far, applications that might lead to inhalation exposure of the consumer to carbon black nanoparticles (such as powders or sprayable products) are not recommended. 3.3.14. Discussion General considerations Carbon black nanoparticles are non-porous materials engineered to be sorbents, but by virtue of their very; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1333-86-4","citation":"","dose":"Safety evaluation (including calculation of the MoS) The calculation of margin of safety (MoS) is not relevant for this assessment given the very low, if any, dermal penetration of nano-carbon black when applied on skin, and in consideration of the low toxicity (NOAEL for oral administration of carbon black to rats as 1000 mg/kg bw/d) observed.","duration":"chronic","effect":"both acute, partially reversible and chronic irreversible significant decreases in some parameters of pulmonary function. 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) The calculation of margin of safety (MoS) is not relevant for this assessment given the very low, if any, dermal penetration of nano-carbon black when applied on skin, and in consideration of the low toxicity (NOAEL for oral administration of carbon black to rats as 1000 mg/kg bw/d) observed. The NOAEL for inhalation of carbon black nanomaterials for rats, mice and hamsters is reported to be 1 mg/m3. In view of the potential for persistent lung inflammation, similar to other nanomaterials evaluated so far, applications that might lead to inhalation exposure of the consumer to carbon black nanoparticles (such as powders or sprayable products) are not recommended. 3.3.14. Discussion General considerations Carbon black nanoparticles are non-porous materials engineered to be sorbents, but by virtue of their very","endpoint":"","ingredient":"codes........................................7","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":92,"route":"oral","species":"rat","study_id":"sccs_o_144_noael_011"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 38 - rat - - - SOURCE_SUBDIR=sccs_o_144; REPORT_TITLE=OPINION on Carbon Black (nano-form); OPINION_NUMBER=SCCS/1515/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=unclear:Unlabeled table on page 38: The study authors concluded that the NOAEL for rats, mice and hamster was 1 mg/m3.; EFFECT=Unlabeled table on page 38: The study authors concluded that the NOAEL for rats, mice and hamster was 1 mg/m3.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1333-86-4","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 38: The study authors concluded that the NOAEL for rats, mice and hamster was 1 mg/m3.","endpoint":"","ingredient":"codes........................................7","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 38: The study authors concluded that the NOAEL for rats, mice and hamster was 1 mg/m3.","page":38,"route":"","species":"rat","study_id":"sccs_o_144_noael_015"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies carcinogenicity 1515 - rat inhalation 11 months carcinogenicity SOURCE_SUBDIR=sccs_o_144; REPORT_TITLE=OPINION on Carbon Black (nano-form); OPINION_NUMBER=SCCS/1515/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=unclear:SCCS/1515/13 Second revision of the opinion on carbon black, nano-form ___________________________________________________________________________________________ 39 SCCS comment The responses after inhalation of carbon black at 1 and 7 mg/m3 among rats, mice and hamsters were similar in magnitude. The NOAEL for inhalation of carbon black nanomaterials for rats, mice and hamster was 1 mg/m3. The mid (7 mg/m3) and high (50 mg/m3) doses of carbon black induced pathological lung alterations in mice and rats that were persistent as they were not resolved after the recovery period up to 11 months after exposure. 3.3.5.3. Chronic (> 12 months) toxicity Not submitted. See also Section 3.3.7. Carcinogenicity. 3.3.6. Mutagenicity / Genotoxicity Only more recent studies have been included. 3.3.6.1 Mutagenicity / Genoto; EFFECT=SCCS/1515/13 Second revision of the opinion on carbon black, nano-form ___________________________________________________________________________________________ 39 SCCS comment The responses after inhalation of carbon black at 1 and 7 mg/m3 among rats, mice and hamsters were similar in magnitude. The NOAEL for inhalation of carbon black nanomaterials for rats, mice and hamster was 1 mg/m3. The mid (7 mg/m3) and high (50 mg/m3) doses of carbon black induced pathological lung alterations in mice and rats that were persistent as they were not resolved after the recovery period up to 11 months after exposure. 3.3.5.3. Chronic (> 12 months) toxicity Not submitted. See also Section 3.3.7. Carcinogenicity. 3.3.6. Mutagenicity / Genotoxicity Only more recent studies have been included. 3.3.6.1 Mutagenicity / Genoto; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1333-86-4","citation":"","dose":"","duration":"11 months","effect":"SCCS/1515/13 Second revision of the opinion on carbon black, nano-form ___________________________________________________________________________________________ 39 SCCS comment The responses after inhalation of carbon black at 1 and 7 mg/m3 among rats, mice and hamsters were similar in magnitude. The NOAEL for inhalation of carbon black nanomaterials for rats, mice and hamster was 1 mg/m3. The mid (7 mg/m3) and high (50 mg/m3) doses of carbon black induced pathological lung alterations in mice and rats that were persistent as they were not resolved after the recovery period up to 11 months after exposure. 3.3.5.3. Chronic (> 12 months) toxicity Not submitted. See also Section 3.3.7. Carcinogenicity. 3.3.6. Mutagenicity / Genotoxicity Only more recent studies have been included. 3.3.6.1 Mutagenicity / Genoto","endpoint":"carcinogenicity","ingredient":"codes........................................7","loael_value":"","noael_unit":"","noael_value":"unclear:SCCS/1515/13 Second revision of the opinion on carbon black, nano-form ___________________________________________________________________________________________ 39 SCCS comment The responses after inhalation of carbon black at 1 and 7 mg/m3 among rats, mice and hamsters were similar in magnitude. The NOAEL for inhalation of carbon black nanomaterials for rats, mice and hamster was 1 mg/m3. The mid (7 mg/m3) and high (50 mg/m3) doses of carbon black induced pathological lung alterations in mice and rats that were persistent as they were not resolved after the recovery period up to 11 months after exposure. 3.3.5.3. Chronic (> 12 months) toxicity Not submitted. See also Section 3.3.7. Carcinogenicity. 3.3.6. Mutagenicity / Genotoxicity Only more recent studies have been included. 3.3.6.1 Mutagenicity / Genoto","page":39,"route":"inhalation","species":"rat","study_id":"sccs_o_144_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 0 mg/kg bw/d rat oral developmental developmental toxicity SOURCE_SUBDIR=sccs_o_144; REPORT_TITLE=OPINION on Carbon Black (nano-form); OPINION_NUMBER=SCCS/1515/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=000; DOSE=Conclusion The study authors concluded that oral administration of carbon black to pregnant rats at 100, 300 or 1 000 mg/kg bw/d during the sensitive period of organogenesis was well tolerated.; EFFECT=major malformations. Minor foetal anomalies and normal variants observed were of the type and incidences commonly observed in rats of this strain and age and hence were to be incidental. Conclusion The study authors concluded that oral administration of carbon black to pregnant rats at 100, 300 or 1 000 mg/kg bw/d during the sensitive period of organogenesis was well tolerated. There were no adverse maternal changes or any effects on embryo-foetal development. Accordingly, under the conditions of this study, The No Observed Adverse Effect Level (NOAEL) for maternal toxicity and the No Observed Effect Level (NOEL) for developmental toxicity were both set at 1 000 mg/kg bw/d. Ref.: Ramesh (2012); CITATION=Ref.: Ramesh (2012); CITATION_NUMBERS=[2012]; REFERENCE=Ref.: Ramesh (2012); DETAILS_JSON={"cas_number":"1333-86-4","citation":"Ref.: Ramesh (2012)","dose":"Conclusion The study authors concluded that oral administration of carbon black to pregnant rats at 100, 300 or 1 000 mg/kg bw/d during the sensitive period of organogenesis was well tolerated.","duration":"developmental","effect":"major malformations. Minor foetal anomalies and normal variants observed were of the type and incidences commonly observed in rats of this strain and age and hence were to be incidental. Conclusion The study authors concluded that oral administration of carbon black to pregnant rats at 100, 300 or 1 000 mg/kg bw/d during the sensitive period of organogenesis was well tolerated. There were no adverse maternal changes or any effects on embryo-foetal development. Accordingly, under the conditions of this study, The No Observed Adverse Effect Level (NOAEL) for maternal toxicity and the No Observed Effect Level (NOEL) for developmental toxicity were both set at 1 000 mg/kg bw/d. Ref.: Ramesh (2012)","endpoint":"developmental toxicity","ingredient":"codes........................................7","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"000","page":85,"route":"oral","species":"rat","study_id":"sccs_o_144_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 0 mg/kg bw/d rat oral developmental developmental toxicity SOURCE_SUBDIR=sccs_o_144; REPORT_TITLE=OPINION on Carbon Black (nano-form); OPINION_NUMBER=SCCS/1515/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=000; DOSE=Conclusion The study authors concluded that oral administration of carbon black to pregnant rats at 100, 300 or 1 000 mg/kg bw/d during the sensitive period of organogenesis was well tolerated.; EFFECT=anomalies and normal variants observed were of the type and incidences commonly observed in rats of this strain and age and hence were to be incidental. Conclusion The study authors concluded that oral administration of carbon black to pregnant rats at 100, 300 or 1 000 mg/kg bw/d during the sensitive period of organogenesis was well tolerated. There were no adverse maternal changes or any effects on embryo-foetal development. Accordingly, under the conditions of this study, The No Observed Adverse Effect Level (NOAEL) for maternal toxicity and the No Observed Effect Level (NOEL) for developmental toxicity were both set at 1 000 mg/kg bw/d. Ref.: Ramesh (2012); CITATION=Ref.: Ramesh (2012); CITATION_NUMBERS=[2012]; REFERENCE=Ref.: Ramesh (2012); DETAILS_JSON={"cas_number":"1333-86-4","citation":"Ref.: Ramesh (2012)","dose":"Conclusion The study authors concluded that oral administration of carbon black to pregnant rats at 100, 300 or 1 000 mg/kg bw/d during the sensitive period of organogenesis was well tolerated.","duration":"developmental","effect":"anomalies and normal variants observed were of the type and incidences commonly observed in rats of this strain and age and hence were to be incidental. Conclusion The study authors concluded that oral administration of carbon black to pregnant rats at 100, 300 or 1 000 mg/kg bw/d during the sensitive period of organogenesis was well tolerated. There were no adverse maternal changes or any effects on embryo-foetal development. Accordingly, under the conditions of this study, The No Observed Adverse Effect Level (NOAEL) for maternal toxicity and the No Observed Effect Level (NOEL) for developmental toxicity were both set at 1 000 mg/kg bw/d. Ref.: Ramesh (2012)","endpoint":"developmental toxicity","ingredient":"codes........................................7","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"000","page":85,"route":"oral","species":"rat","study_id":"sccs_o_144_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 0 mg/kg bw/d rat oral developmental developmental toxicity SOURCE_SUBDIR=sccs_o_144; REPORT_TITLE=OPINION on Carbon Black (nano-form); OPINION_NUMBER=SCCS/1515/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=000; DOSE=Conclusion The study authors concluded that oral administration of carbon black to pregnant rats at 100, 300 or 1 000 mg/kg bw/d during the sensitive period of organogenesis was well tolerated.; EFFECT=cidences commonly observed in rats of this strain and age and hence were to be incidental. Conclusion The study authors concluded that oral administration of carbon black to pregnant rats at 100, 300 or 1 000 mg/kg bw/d during the sensitive period of organogenesis was well tolerated. There were no adverse maternal changes or any effects on embryo-foetal development. Accordingly, under the conditions of this study, The No Observed Adverse Effect Level (NOAEL) for maternal toxicity and the No Observed Effect Level (NOEL) for developmental toxicity were both set at 1 000 mg/kg bw/d. Ref.: Ramesh (2012); CITATION=Ref.: Ramesh (2012); CITATION_NUMBERS=[2012]; REFERENCE=Ref.: Ramesh (2012); DETAILS_JSON={"cas_number":"1333-86-4","citation":"Ref.: Ramesh (2012)","dose":"Conclusion The study authors concluded that oral administration of carbon black to pregnant rats at 100, 300 or 1 000 mg/kg bw/d during the sensitive period of organogenesis was well tolerated.","duration":"developmental","effect":"cidences commonly observed in rats of this strain and age and hence were to be incidental. Conclusion The study authors concluded that oral administration of carbon black to pregnant rats at 100, 300 or 1 000 mg/kg bw/d during the sensitive period of organogenesis was well tolerated. There were no adverse maternal changes or any effects on embryo-foetal development. Accordingly, under the conditions of this study, The No Observed Adverse Effect Level (NOAEL) for maternal toxicity and the No Observed Effect Level (NOEL) for developmental toxicity were both set at 1 000 mg/kg bw/d. Ref.: Ramesh (2012)","endpoint":"developmental toxicity","ingredient":"codes........................................7","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"000","page":85,"route":"oral","species":"rat","study_id":"sccs_o_144_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 1000 mg/kg bw/d rat oral 11 months genotoxicity SOURCE_SUBDIR=sccs_o_144; REPORT_TITLE=OPINION on Carbon Black (nano-form); OPINION_NUMBER=SCCS/1515/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=1000; DOSE=The NOAEL for inhalation of carbon black nanomaterials for rats, mice and hamster was 1 mg/m3, while the NOAEL for oral administration of carbon black to rats was 1000 mg/kg bw/d.; EFFECT=SCCS/1515/13 Second revision of the opinion on carbon black, nano-form ___________________________________________________________________________________________ 95 persistent as they were not resolved after the recovery period up to 11 months after exposure. SCCS notes that the responses after inhalation of carbon black at 1 and 7 mg/m3 among rats, mice and hamsters were similar in magnitude. The NOAEL for inhalation of carbon black nanomaterials for rats, mice and hamster was 1 mg/m3, while the NOAEL for oral administration of carbon black to rats was 1000 mg/kg bw/d. Mutagenicity / genotoxicity In vitro studies Cell-free systems Measurement of single strand DNA breaks production, using supercoiled plasmid DNA as indicator, showed that nano carbon black particles (diameter 14 nm) exhibited significantly more free radical activity than fine carbon black particles (diameter 260 nm). The results with fine carbo; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1333-86-4","citation":"","dose":"The NOAEL for inhalation of carbon black nanomaterials for rats, mice and hamster was 1 mg/m3, while the NOAEL for oral administration of carbon black to rats was 1000 mg/kg bw/d.","duration":"11 months","effect":"SCCS/1515/13 Second revision of the opinion on carbon black, nano-form ___________________________________________________________________________________________ 95 persistent as they were not resolved after the recovery period up to 11 months after exposure. SCCS notes that the responses after inhalation of carbon black at 1 and 7 mg/m3 among rats, mice and hamsters were similar in magnitude. The NOAEL for inhalation of carbon black nanomaterials for rats, mice and hamster was 1 mg/m3, while the NOAEL for oral administration of carbon black to rats was 1000 mg/kg bw/d. Mutagenicity / genotoxicity In vitro studies Cell-free systems Measurement of single strand DNA breaks production, using supercoiled plasmid DNA as indicator, showed that nano carbon black particles (diameter 14 nm) exhibited significantly more free radical activity than fine carbon black particles (diameter 260 nm). The results with fine carbo","endpoint":"genotoxicity","ingredient":"codes........................................7","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":95,"route":"oral","species":"rat","study_id":"sccs_o_144_noael_013"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 1 - rat - subchronic repeated dose toxicity SOURCE_SUBDIR=sccs_o_144; REPORT_TITLE=OPINION on Carbon Black (nano-form); OPINION_NUMBER=SCCS/1515/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=unclear:were similar in magnitude. Lung inflammation and histopathology were more severe and prolonged in rats than in mice and hamsters. The magnitude of the response to LSCB in rats was between those for high- and mid-dose HSCB. The results show that hamsters have the most efficient clearance mechanisms and the least severe responses of the three species. The results from rats also show that particle surface area is an important determinant of target tissue dose and, therefore, effects. From these results, a subchronic NOAEL of 1 mg/m3 respirable HSCB (Printex 90) can be assigned to female rats, mice, and hamsters. Conclusion Particle retention kinetics, inflammation, and histopathology were examined in female rats, mice, and hamsters exposed for 13 weeks to high surface area carbon black (HSCB) at doses of 0, 1, 7, and 50 mg/m3. Rats were also exposed to 50 mg/m3 low surface area carbon black (LSCB). Groups of animals were sacrificed immediately after 13 weeks of exposure, and after 3 and 11 months of recovery for bronchoalveolar la; DOSE=The magnitude of the response to LSCB in rats was between those for high- and mid-dose HSCB.; EFFECT=were similar in magnitude. Lung inflammation and histopathology were more severe and prolonged in rats than in mice and hamsters. The magnitude of the response to LSCB in rats was between those for high- and mid-dose HSCB. The results show that hamsters have the most efficient clearance mechanisms and the least severe responses of the three species. The results from rats also show that particle surface area is an important determinant of target tissue dose and, therefore, effects. From these results, a subchronic NOAEL of 1 mg/m3 respirable HSCB (Printex 90) can be assigned to female rats, mice, and hamsters. Conclusion Particle retention kinetics, inflammation, and histopathology were examined in female rats, mice, and hamsters exposed for 13 weeks to high surface area carbon black (HSCB) at doses of 0, 1, 7, and 50 mg/m3. Rats were also exposed to 50 mg/m3 low surface area carbon black (LSCB). Groups of animals were sacrificed immediately after 13 weeks of exposure, and after 3 and 11 months of recovery for bronchoalveolar la; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1333-86-4","citation":"","dose":"The magnitude of the response to LSCB in rats was between those for high- and mid-dose HSCB.","duration":"subchronic","effect":"were similar in magnitude. Lung inflammation and histopathology were more severe and prolonged in rats than in mice and hamsters. The magnitude of the response to LSCB in rats was between those for high- and mid-dose HSCB. The results show that hamsters have the most efficient clearance mechanisms and the least severe responses of the three species. The results from rats also show that particle surface area is an important determinant of target tissue dose and, therefore, effects. From these results, a subchronic NOAEL of 1 mg/m3 respirable HSCB (Printex 90) can be assigned to female rats, mice, and hamsters. Conclusion Particle retention kinetics, inflammation, and histopathology were examined in female rats, mice, and hamsters exposed for 13 weeks to high surface area carbon black (HSCB) at doses of 0, 1, 7, and 50 mg/m3. Rats were also exposed to 50 mg/m3 low surface area carbon black (LSCB). Groups of animals were sacrificed immediately after 13 weeks of exposure, and after 3 and 11 months of recovery for bronchoalveolar la","endpoint":"repeated dose toxicity","ingredient":"codes........................................7","loael_value":"","noael_unit":"","noael_value":"unclear:were similar in magnitude. Lung inflammation and histopathology were more severe and prolonged in rats than in mice and hamsters. The magnitude of the response to LSCB in rats was between those for high- and mid-dose HSCB. The results show that hamsters have the most efficient clearance mechanisms and the least severe responses of the three species. The results from rats also show that particle surface area is an important determinant of target tissue dose and, therefore, effects. From these results, a subchronic NOAEL of 1 mg/m3 respirable HSCB (Printex 90) can be assigned to female rats, mice, and hamsters. Conclusion Particle retention kinetics, inflammation, and histopathology were examined in female rats, mice, and hamsters exposed for 13 weeks to high surface area carbon black (HSCB) at doses of 0, 1, 7, and 50 mg/m3. Rats were also exposed to 50 mg/m3 low surface area carbon black (LSCB). Groups of animals were sacrificed immediately after 13 weeks of exposure, and after 3 and 11 months of recovery for bronchoalveolar la","page":38,"route":"","species":"rat","study_id":"sccs_o_144_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 1000 mg/kg/day rat oral 13-week repeated dose toxicity SOURCE_SUBDIR=sccs_o_144; REPORT_TITLE=OPINION on Carbon Black (nano-form); OPINION_NUMBER=SCCS/1515/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=1000; DOSE=Repeated dose toxicity Oral administration.; EFFECT=o notes that no information is available in relation to particles smaller than 20 nm. Repeated dose toxicity Oral administration. In a 13-week study with rats performed according to OECD guidelines, the animals received carbon black nanomaterials (diameter 20 – 30 nm) by gavage (0, 100, 300, and 1000 mg/kg/d) for 90 consecutive days. It was concluded that carbon black was well tolerated, with only some non-adverse findings related to the staining properties of carbon black. Under the conditions of the study, the NOAEL was 1000 mg/kg/day. Inhalation exposure. In a 4-week nose-only inhalation study (4 h/day) the levels of IL-10 were significantly elevated in BALF from the exposed rats (Kim et al. 2011). The SCCS considers this as a poorly carried-out study because no BALF cell count was performed and no information concerning group sizes was available. Another study (Lim et al. 2012) showed mild respiratory toxicity in male rats exposed to nano-sized carbon black for 13 weeks at a concentration of approximately 9 mg/m3 through n; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1333-86-4","citation":"","dose":"Repeated dose toxicity Oral administration.","duration":"13-week","effect":"o notes that no information is available in relation to particles smaller than 20 nm. Repeated dose toxicity Oral administration. In a 13-week study with rats performed according to OECD guidelines, the animals received carbon black nanomaterials (diameter 20 – 30 nm) by gavage (0, 100, 300, and 1000 mg/kg/d) for 90 consecutive days. It was concluded that carbon black was well tolerated, with only some non-adverse findings related to the staining properties of carbon black. Under the conditions of the study, the NOAEL was 1000 mg/kg/day. Inhalation exposure. In a 4-week nose-only inhalation study (4 h/day) the levels of IL-10 were significantly elevated in BALF from the exposed rats (Kim et al. 2011). The SCCS considers this as a poorly carried-out study because no BALF cell count was performed and no information concerning group sizes was available. Another study (Lim et al. 2012) showed mild respiratory toxicity in male rats exposed to nano-sized carbon black for 13 weeks at a concentration of approximately 9 mg/m3 through n","endpoint":"repeated dose toxicity","ingredient":"codes........................................7","loael_value":"","noael_unit":"mg/kg/day","noael_value":"1000","page":94,"route":"oral","species":"rat","study_id":"sccs_o_144_noael_012"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 0 mg/kg bw/d rat oral developmental reproductive toxicity SOURCE_SUBDIR=sccs_o_144; REPORT_TITLE=OPINION on Carbon Black (nano-form); OPINION_NUMBER=SCCS/1515/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=000; DOSE=The NOAEL for maternal toxicity and for developmental toxicity were both set at 1 000 mg/kg bw/d.; EFFECT=and the pregnant mice after exposure of the pregnant mice to carbon black by inhalation. Time mated mice received four intratracheal instillations (altogether up to 0.268 mg) of carbon black. The F2 offspring, whose fathers were prenatally exposed to nanosized carbon black, showed lowered sperm production. Pregnant rats received carbon black by oral administration of carbon black during the sensitive period of organogenesis. There were no adverse maternal changes or any effects on embryo-foetal development. The NOAEL for maternal toxicity and for developmental toxicity were both set at 1 000 mg/kg bw/d. SCCS is of the opinion that oral and dermal exposure to carbon black is of little concern in relation to reproductive toxicity; however, inhalation exposure should be avoided. 3.3.9. Toxicokinetics The text is in part condensed from IARC (2010) Retention of carbon black nano particles The lung retention of inhaled carbon black particles (Printex 90 and Sterling V) were investigated in Fischer 344 rats, B6C3F1 mice and F1B; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1333-86-4","citation":"","dose":"The NOAEL for maternal toxicity and for developmental toxicity were both set at 1 000 mg/kg bw/d.","duration":"developmental","effect":"and the pregnant mice after exposure of the pregnant mice to carbon black by inhalation. Time mated mice received four intratracheal instillations (altogether up to 0.268 mg) of carbon black. The F2 offspring, whose fathers were prenatally exposed to nanosized carbon black, showed lowered sperm production. Pregnant rats received carbon black by oral administration of carbon black during the sensitive period of organogenesis. There were no adverse maternal changes or any effects on embryo-foetal development. The NOAEL for maternal toxicity and for developmental toxicity were both set at 1 000 mg/kg bw/d. SCCS is of the opinion that oral and dermal exposure to carbon black is of little concern in relation to reproductive toxicity; however, inhalation exposure should be avoided. 3.3.9. Toxicokinetics The text is in part condensed from IARC (2010) Retention of carbon black nano particles The lung retention of inhaled carbon black particles (Printex 90 and Sterling V) were investigated in Fischer 344 rats, B6C3F1 mice and F1B","endpoint":"reproductive toxicity","ingredient":"codes........................................7","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"000","page":86,"route":"oral","species":"rat","study_id":"sccs_o_144_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 0 mg/kg bw/d rat oral developmental reproductive toxicity SOURCE_SUBDIR=sccs_o_144; REPORT_TITLE=OPINION on Carbon Black (nano-form); OPINION_NUMBER=SCCS/1515/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=000; DOSE=The NOAEL for maternal toxicity and for developmental toxicity were both set at 1 000 mg/kg bw/d.; EFFECT=ffspring. Inhalation exposure did not affect gestation and lactation. Time mated mice received four intratracheal instillations (altogether up to 0.268 mg) of carbon black. The F2 offspring, whose fathers were prenatally exposed to nanosized carbon black, showed lowered sperm production. Pregnant rats received carbon black by oral administration of carbon black (diameter 20-30 nm) during the sensitive period of organogenesis. There were no adverse maternal changes or any effects on embryo-foetal development. The NOAEL for maternal toxicity and for developmental toxicity were both set at 1 000 mg/kg bw/d. SCCS is of the opinion that oral exposure to carbon black is of little concern in relation to reproductive toxicity. This is also true for dermal exposure due to lack of any significant dermal penetration of carbon black nanoparticles of 20nm, or larger, in healthy intact skin. However, applications that may lead to inhalation exposure should be avoided. Toxicokinetics The lung retention of inhaled carbon black particles has; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1333-86-4","citation":"","dose":"The NOAEL for maternal toxicity and for developmental toxicity were both set at 1 000 mg/kg bw/d.","duration":"developmental","effect":"ffspring. Inhalation exposure did not affect gestation and lactation. Time mated mice received four intratracheal instillations (altogether up to 0.268 mg) of carbon black. The F2 offspring, whose fathers were prenatally exposed to nanosized carbon black, showed lowered sperm production. Pregnant rats received carbon black by oral administration of carbon black (diameter 20-30 nm) during the sensitive period of organogenesis. There were no adverse maternal changes or any effects on embryo-foetal development. The NOAEL for maternal toxicity and for developmental toxicity were both set at 1 000 mg/kg bw/d. SCCS is of the opinion that oral exposure to carbon black is of little concern in relation to reproductive toxicity. This is also true for dermal exposure due to lack of any significant dermal penetration of carbon black nanoparticles of 20nm, or larger, in healthy intact skin. However, applications that may lead to inhalation exposure should be avoided. Toxicokinetics The lung retention of inhaled carbon black particles has","endpoint":"reproductive toxicity","ingredient":"codes........................................7","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"000","page":98,"route":"oral","species":"rat","study_id":"sccs_o_144_noael_014"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 4XYU5U00C4 UNII - - - chemical {"approval_status":null,"molecular_formula":"C72H26O7S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"4XYU5U00C4"}
openFDA substances FDA UNII substance identifier 4XYU5U00C4 UNII - - - chemical {"approval_status":null,"molecular_formula":"C72H26O7S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"4XYU5U00C4"}
openFDA substances FDA UNII substance identifier 4XYU5U00C4 UNII - - - chemical {"approval_status":null,"molecular_formula":"C72H26O7S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"4XYU5U00C4"}
openFDA substances FDA UNII substance identifier 4XYU5U00C4 UNII - - - chemical {"approval_status":null,"molecular_formula":"C72H26O7S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"4XYU5U00C4"}