| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
=1.4 |
mg/kg bw |
rat |
oral |
90-day |
- |
SOURCE_SUBDIR=sccs_o_187; REPORT_TITLE=OPINION ON Butylphenyl methylpropional (BMHCA); OPINION_NUMBER=SCCS/1540/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 August 2015; VALUE_TEXT== 1.4; DOSE=SCCS/1540/14 12 August 2015 Opinion on Butylphenyl methylpropional ___________________________________________________________________________________________ 40 CALCULATION OF THE MARGIN OF SAFETY (aggregate exposure) Total systemic exposure dose (SED) = 1.4 mg/kg bw No observed adverse effect level NOAEL = 5 mg/kg bw/d (90-day, oral, rat) Marg...; EFFECT=SCCS-rejected applicant NOAEL: SCCS/1540/14 12 August 2015 Opinion on Butylphenyl methylpropional ___________________________________________________________________________________________ 40 CALCULATION OF THE MARGIN OF SAFETY (aggregate exposure) Total systemic exposure dose (SED) = 1.4 mg/kg bw No observed adverse effect level NOAEL = 5 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL/SED = 3.6 Individual MoS values for the respective product groups: 1. Lip products: 220000 (possible oral exposure not considered) 2. Deodorants/antiperspirants: 2300 3. Hydroalcoholic products for shaved skin: 89 4. Hydroalcoholic products for unshaved skin: 160 5. Facial cream, facial make-up, hand cream: 31 6. Mouthwash, toothpaste: 4.8 8. Make-up remover, nail care: <120 (no data on nail plate penetration available) 9. Shampoo, rinse-off con; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"SCCS/1540/14 12 August 2015 Opinion on Butylphenyl methylpropional ___________________________________________________________________________________________ 40 CALCULATION OF THE MARGIN OF SAFETY (aggregate exposure) Total systemic exposure dose (SED) = 1.4 mg/kg bw No observed adverse effect level NOAEL = 5 mg/kg bw/d (90-day, oral, rat) Marg...","duration":"90-day","effect":"SCCS-rejected applicant NOAEL: SCCS/1540/14 12 August 2015 Opinion on Butylphenyl methylpropional ___________________________________________________________________________________________ 40 CALCULATION OF THE MARGIN OF SAFETY (aggregate exposure) Total systemic exposure dose (SED) = 1.4 mg/kg bw No observed adverse effect level NOAEL = 5 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL/SED = 3.6 Individual MoS values for the respective product groups: 1. Lip products: 220000 (possible oral exposure not considered) 2. Deodorants/antiperspirants: 2300 3. Hydroalcoholic products for shaved skin: 89 4. Hydroalcoholic products for unshaved skin: 160 5. Facial cream, facial make-up, hand cream: 31 6. Mouthwash, toothpaste: 4.8 8. Make-up remover, nail care: <120 (no data on nail plate penetration available) 9. Shampoo, rinse-off con","endpoint":"","ingredient":"was introduced in Annex III of the Cosmetics Directive 76/768/EEC by the","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 1.4","page":40,"route":"oral","species":"rat","study_id":"sccs_o_187_noael_014"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
=5 |
mg/kg bw/d |
rat |
oral |
90-day |
- |
SOURCE_SUBDIR=sccs_o_187; REPORT_TITLE=OPINION ON Butylphenyl methylpropional (BMHCA); OPINION_NUMBER=SCCS/1540/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 August 2015; VALUE_TEXT== 5; DOSE=SCCS/1540/14 12 August 2015 Opinion on Butylphenyl methylpropional ___________________________________________________________________________________________ 40 CALCULATION OF THE MARGIN OF SAFETY (aggregate exposure) Total systemic exposure dose (SED) = 1.4 mg/kg bw No observed adverse effect level NOAEL = 5 mg/kg bw/d (90-day, oral, rat) Marg...; EFFECT=SCCS-rejected applicant NOAEL: SCCS/1540/14 12 August 2015 Opinion on Butylphenyl methylpropional ___________________________________________________________________________________________ 40 CALCULATION OF THE MARGIN OF SAFETY (aggregate exposure) Total systemic exposure dose (SED) = 1.4 mg/kg bw No observed adverse effect level NOAEL = 5 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL/SED = 3.6 Individual MoS values for the respective product groups: 1. Lip products: 220000 (possible oral exposure not considered) 2. Deodorants/antiperspirants: 2300 3. Hydroalcoholic products for shaved skin: 89 4. Hydroalcoholic products for unshaved skin: 160 5. Facial cream, facial make-up, hand cream: 31 6. Mouthwash, toothpaste: 4.8 8. Make-up remover, nail care: <120 (no data on nail plate penetration available) 9. Shampoo, rinse-off condition; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"SCCS/1540/14 12 August 2015 Opinion on Butylphenyl methylpropional ___________________________________________________________________________________________ 40 CALCULATION OF THE MARGIN OF SAFETY (aggregate exposure) Total systemic exposure dose (SED) = 1.4 mg/kg bw No observed adverse effect level NOAEL = 5 mg/kg bw/d (90-day, oral, rat) Marg...","duration":"90-day","effect":"SCCS-rejected applicant NOAEL: SCCS/1540/14 12 August 2015 Opinion on Butylphenyl methylpropional ___________________________________________________________________________________________ 40 CALCULATION OF THE MARGIN OF SAFETY (aggregate exposure) Total systemic exposure dose (SED) = 1.4 mg/kg bw No observed adverse effect level NOAEL = 5 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL/SED = 3.6 Individual MoS values for the respective product groups: 1. Lip products: 220000 (possible oral exposure not considered) 2. Deodorants/antiperspirants: 2300 3. Hydroalcoholic products for shaved skin: 89 4. Hydroalcoholic products for unshaved skin: 160 5. Facial cream, facial make-up, hand cream: 31 6. Mouthwash, toothpaste: 4.8 8. Make-up remover, nail care: <120 (no data on nail plate penetration available) 9. Shampoo, rinse-off condition","endpoint":"","ingredient":"was introduced in Annex III of the Cosmetics Directive 76/768/EEC by the","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 5","page":40,"route":"oral","species":"rat","study_id":"sccs_o_187_noael_015"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
5 |
mg/kg bw/d |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_187; REPORT_TITLE=OPINION ON Butylphenyl methylpropional (BMHCA); OPINION_NUMBER=SCCS/1540/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 August 2015; VALUE_TEXT=5; DOSE=Based on the NOAEL of 5 mg/kg bw/d, the MoS derived for aggregate exposure would be no higher than 53, thus still much lower than 100.; EFFECT=25 (22080 x 0.0012 x 0.05) 3. Make up: 0.988 (7900 x 0.0005 x 0.25) 4. Liquid foundation: 0.833 (8330 x 0.0004 x 0.25) 5. Face cream: 3.018 (24140 x 0.0005 x 0.25) 6. Body lotion: 30.8 (123200 x 0.001 x 0.25) 7. Shampoo/Conditioner: 0.189 (1510 x 0.0005 x 0.25) / 0.075 (600 x 0.0005 x 0.25) 8. Hair styling: 0.574 (5740 x 0.0004 x 0.25) 9. Shower gel/bath products: 0.698 (2790 x 0.001 x 0.25) / 0.833 (3330 x 0.001 x 0.25) Adding of all of these numbers leads to a total SED level of: 95.2 µg/kg bw/day. Based on the NOAEL of 5 mg/kg bw/d, the MoS derived for aggregate exposure would be no higher than 53, thus still much lower than 100. Individual MoS values for the respective product groups: 1. Hydroalcoholic products (for shaved skin): 89 2. Deodorants: 3800 3. Make up: 5100; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"Based on the NOAEL of 5 mg/kg bw/d, the MoS derived for aggregate exposure would be no higher than 53, thus still much lower than 100.","duration":"","effect":"25 (22080 x 0.0012 x 0.05) 3. Make up: 0.988 (7900 x 0.0005 x 0.25) 4. Liquid foundation: 0.833 (8330 x 0.0004 x 0.25) 5. Face cream: 3.018 (24140 x 0.0005 x 0.25) 6. Body lotion: 30.8 (123200 x 0.001 x 0.25) 7. Shampoo/Conditioner: 0.189 (1510 x 0.0005 x 0.25) / 0.075 (600 x 0.0005 x 0.25) 8. Hair styling: 0.574 (5740 x 0.0004 x 0.25) 9. Shower gel/bath products: 0.698 (2790 x 0.001 x 0.25) / 0.833 (3330 x 0.001 x 0.25) Adding of all of these numbers leads to a total SED level of: 95.2 µg/kg bw/day. Based on the NOAEL of 5 mg/kg bw/d, the MoS derived for aggregate exposure would be no higher than 53, thus still much lower than 100. Individual MoS values for the respective product groups: 1. Hydroalcoholic products (for shaved skin): 89 2. Deodorants: 3800 3. Make up: 5100","endpoint":"","ingredient":"was introduced in Annex III of the Cosmetics Directive 76/768/EEC by the","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"5","page":41,"route":"","species":"","study_id":"sccs_o_187_noael_017"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
=1.4 |
mg/kg bw |
rat |
oral |
90-day |
- |
SOURCE_SUBDIR=sccs_o_189; REPORT_TITLE=OPINION ON Butylphenyl methylpropional (BMHCA); OPINION_NUMBER=SCCS/1540/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 March 2016; VALUE_TEXT== 1.4; DOSE=SCCS/1540/14 Revision of opinion on Butylphenyl methylpropional ___________________________________________________________________________________________ 40 CALCULATION OF THE MARGIN OF SAFETY (aggregate exposure) Total systemic exposure dose (SED) = 1.4 mg/kg bw No observed adverse effect level NOAEL = 5 mg/kg bw/d (90-day, oral, rat) Margin...; EFFECT=SCCS-rejected applicant NOAEL: SCCS/1540/14 Revision of opinion on Butylphenyl methylpropional ___________________________________________________________________________________________ 40 CALCULATION OF THE MARGIN OF SAFETY (aggregate exposure) Total systemic exposure dose (SED) = 1.4 mg/kg bw No observed adverse effect level NOAEL = 5 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL/SED = 3.6 Individual MoS values for the respective product groups: 1. Lip products: 220000 (possible oral exposure not considered) 2. Deodorants/antiperspirants: 2300 3. Hydroalcoholic products for shaved skin: 89 4. Hydroalcoholic products for unshaved skin: 160 5. Facial cream, facial make-up, hand cream: 31 6. Mouthwash, toothpaste: 4.8 8. Make-up remover, nail care: <120 (no data on nail plate penetration available) 9. Shampoo, rinse-off con; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"SCCS/1540/14 Revision of opinion on Butylphenyl methylpropional ___________________________________________________________________________________________ 40 CALCULATION OF THE MARGIN OF SAFETY (aggregate exposure) Total systemic exposure dose (SED) = 1.4 mg/kg bw No observed adverse effect level NOAEL = 5 mg/kg bw/d (90-day, oral, rat) Margin...","duration":"90-day","effect":"SCCS-rejected applicant NOAEL: SCCS/1540/14 Revision of opinion on Butylphenyl methylpropional ___________________________________________________________________________________________ 40 CALCULATION OF THE MARGIN OF SAFETY (aggregate exposure) Total systemic exposure dose (SED) = 1.4 mg/kg bw No observed adverse effect level NOAEL = 5 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL/SED = 3.6 Individual MoS values for the respective product groups: 1. Lip products: 220000 (possible oral exposure not considered) 2. Deodorants/antiperspirants: 2300 3. Hydroalcoholic products for shaved skin: 89 4. Hydroalcoholic products for unshaved skin: 160 5. Facial cream, facial make-up, hand cream: 31 6. Mouthwash, toothpaste: 4.8 8. Make-up remover, nail care: <120 (no data on nail plate penetration available) 9. Shampoo, rinse-off con","endpoint":"","ingredient":"was introduced in Annex III of the Cosmetics Directive 76/768/EEC by the","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 1.4","page":40,"route":"oral","species":"rat","study_id":"sccs_o_189_noael_013"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
=5 |
mg/kg bw/d |
rat |
oral |
90-day |
- |
SOURCE_SUBDIR=sccs_o_189; REPORT_TITLE=OPINION ON Butylphenyl methylpropional (BMHCA); OPINION_NUMBER=SCCS/1540/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 March 2016; VALUE_TEXT== 5; DOSE=SCCS/1540/14 Revision of opinion on Butylphenyl methylpropional ___________________________________________________________________________________________ 40 CALCULATION OF THE MARGIN OF SAFETY (aggregate exposure) Total systemic exposure dose (SED) = 1.4 mg/kg bw No observed adverse effect level NOAEL = 5 mg/kg bw/d (90-day, oral, rat) Margin...; EFFECT=SCCS-rejected applicant NOAEL: SCCS/1540/14 Revision of opinion on Butylphenyl methylpropional ___________________________________________________________________________________________ 40 CALCULATION OF THE MARGIN OF SAFETY (aggregate exposure) Total systemic exposure dose (SED) = 1.4 mg/kg bw No observed adverse effect level NOAEL = 5 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL/SED = 3.6 Individual MoS values for the respective product groups: 1. Lip products: 220000 (possible oral exposure not considered) 2. Deodorants/antiperspirants: 2300 3. Hydroalcoholic products for shaved skin: 89 4. Hydroalcoholic products for unshaved skin: 160 5. Facial cream, facial make-up, hand cream: 31 6. Mouthwash, toothpaste: 4.8 8. Make-up remover, nail care: <120 (no data on nail plate penetration available) 9. Shampoo, rinse-off condition; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"SCCS/1540/14 Revision of opinion on Butylphenyl methylpropional ___________________________________________________________________________________________ 40 CALCULATION OF THE MARGIN OF SAFETY (aggregate exposure) Total systemic exposure dose (SED) = 1.4 mg/kg bw No observed adverse effect level NOAEL = 5 mg/kg bw/d (90-day, oral, rat) Margin...","duration":"90-day","effect":"SCCS-rejected applicant NOAEL: SCCS/1540/14 Revision of opinion on Butylphenyl methylpropional ___________________________________________________________________________________________ 40 CALCULATION OF THE MARGIN OF SAFETY (aggregate exposure) Total systemic exposure dose (SED) = 1.4 mg/kg bw No observed adverse effect level NOAEL = 5 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL/SED = 3.6 Individual MoS values for the respective product groups: 1. Lip products: 220000 (possible oral exposure not considered) 2. Deodorants/antiperspirants: 2300 3. Hydroalcoholic products for shaved skin: 89 4. Hydroalcoholic products for unshaved skin: 160 5. Facial cream, facial make-up, hand cream: 31 6. Mouthwash, toothpaste: 4.8 8. Make-up remover, nail care: <120 (no data on nail plate penetration available) 9. Shampoo, rinse-off condition","endpoint":"","ingredient":"was introduced in Annex III of the Cosmetics Directive 76/768/EEC by the","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 5","page":40,"route":"oral","species":"rat","study_id":"sccs_o_189_noael_014"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
5 |
mg/kg bw/d |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_189; REPORT_TITLE=OPINION ON Butylphenyl methylpropional (BMHCA); OPINION_NUMBER=SCCS/1540/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 March 2016; VALUE_TEXT=5; DOSE=Based on the NOAEL of 5 mg/kg bw/d, the MoS derived for aggregate exposure would be no higher than 53, thus still much lower than 100.; EFFECT=25 (22080 x 0.0012 x 0.05) 3. Make up: 0.988 (7900 x 0.0005 x 0.25) 4. Liquid foundation: 0.833 (8330 x 0.0004 x 0.25) 5. Face cream: 3.018 (24140 x 0.0005 x 0.25) 6. Body lotion: 30.8 (123200 x 0.001 x 0.25) 7. Shampoo/Conditioner: 0.189 (1510 x 0.0005 x 0.25) / 0.075 (600 x 0.0005 x 0.25) 8. Hair styling: 0.574 (5740 x 0.0004 x 0.25) 9. Shower gel/bath products: 0.698 (2790 x 0.001 x 0.25) / 0.833 (3330 x 0.001 x 0.25) Adding of all of these numbers leads to a total SED level of: 95.2 µg/kg bw/day. Based on the NOAEL of 5 mg/kg bw/d, the MoS derived for aggregate exposure would be no higher than 53, thus still much lower than 100. Individual MoS values for the respective product groups: 1. Hydroalcoholic products (for shaved skin): 89 2. Deodorants: 3800 3. Make up: 5100; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"Based on the NOAEL of 5 mg/kg bw/d, the MoS derived for aggregate exposure would be no higher than 53, thus still much lower than 100.","duration":"","effect":"25 (22080 x 0.0012 x 0.05) 3. Make up: 0.988 (7900 x 0.0005 x 0.25) 4. Liquid foundation: 0.833 (8330 x 0.0004 x 0.25) 5. Face cream: 3.018 (24140 x 0.0005 x 0.25) 6. Body lotion: 30.8 (123200 x 0.001 x 0.25) 7. Shampoo/Conditioner: 0.189 (1510 x 0.0005 x 0.25) / 0.075 (600 x 0.0005 x 0.25) 8. Hair styling: 0.574 (5740 x 0.0004 x 0.25) 9. Shower gel/bath products: 0.698 (2790 x 0.001 x 0.25) / 0.833 (3330 x 0.001 x 0.25) Adding of all of these numbers leads to a total SED level of: 95.2 µg/kg bw/day. Based on the NOAEL of 5 mg/kg bw/d, the MoS derived for aggregate exposure would be no higher than 53, thus still much lower than 100. Individual MoS values for the respective product groups: 1. Hydroalcoholic products (for shaved skin): 89 2. Deodorants: 3800 3. Make up: 5100","endpoint":"","ingredient":"was introduced in Annex III of the Cosmetics Directive 76/768/EEC by the","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"5","page":41,"route":"","species":"","study_id":"sccs_o_189_noael_016"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
=0.0281 |
mg/kg bw |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_213; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT== 0.0281; DOSE=SCCS/1591/17 Final version The use of a first-tier deterministic approach (adding all of the numbers derived above) leads to the total SED level of 0.0281 mg/kg bw/day.; EFFECT=SCCS/1591/17 Final version The use of a first-tier deterministic approach (adding all of the numbers derived above) leads to the total SED level of 0.0281 mg/kg bw/day. CALCULATION OF THE MARGIN OF SAFETY (aggregate exposure) Total systemic exposure dose (SED) = 0.0281 mg/kg bw No observed adverse effect level NOAELsys = 4.5 mg/kg bw/d (EOGRTS, oral, rat)Bioavailability 50% * NOAELsys = 2.25 mg/kg bw/d Margin of Safety (MOS) NOAELsys/SED = 80 * Standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation, 2018. Individual MoS calculations for the respective product groups: Product types Systemic Exposure Dose [µg/kg bw/day] Individual MoS calculations for the respective product groups Hydroalcoholic-based fragrances (e.g. Eau de Toilette, perfume,; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"SCCS/1591/17 Final version The use of a first-tier deterministic approach (adding all of the numbers derived above) leads to the total SED level of 0.0281 mg/kg bw/day.","duration":"","effect":"SCCS/1591/17 Final version The use of a first-tier deterministic approach (adding all of the numbers derived above) leads to the total SED level of 0.0281 mg/kg bw/day. CALCULATION OF THE MARGIN OF SAFETY (aggregate exposure) Total systemic exposure dose (SED) = 0.0281 mg/kg bw No observed adverse effect level NOAELsys = 4.5 mg/kg bw/d (EOGRTS, oral, rat)Bioavailability 50% * NOAELsys = 2.25 mg/kg bw/d Margin of Safety (MOS) NOAELsys/SED = 80 * Standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation, 2018. Individual MoS calculations for the respective product groups: Product types Systemic Exposure Dose [µg/kg bw/day] Individual MoS calculations for the respective product groups Hydroalcoholic-based fragrances (e.g. Eau de Toilette, perfume,","endpoint":"","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 0.0281","page":48,"route":"oral","species":"rat","study_id":"sccs_o_213_noael_016"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
50 |
% |
human |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_213; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=50; DOSE=After 48 h, TBBA, lysmerol, lysmerylic acid and hydroxyl-lysmerylic acid represent on average 14.3, 1.82, 0.20 and 0.16%, respectively, of the dose administered.; EFFECT=Peak excretion for all metabolites occurred between 2 and 5 h after oral application, with the primary metabolites (lysmerol and lysmerylic acid) being excreted about 1 h earlier than the secondary metabolites (hydroxylated lysmerylic acid and TBBA). After 48 h, TBBA, lysmerol, lysmerylic acid and hydroxyl-lysmerylic acid represent on average 14.3, 1.82, 0.20 and 0.16%, respectively, of the dose administered. As there are no oral bioavailability data available, a default value of 50% is used to calculate systemic NOAEL. Human data /; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"After 48 h, TBBA, lysmerol, lysmerylic acid and hydroxyl-lysmerylic acid represent on average 14.3, 1.82, 0.20 and 0.16%, respectively, of the dose administered.","duration":"","effect":"Peak excretion for all metabolites occurred between 2 and 5 h after oral application, with the primary metabolites (lysmerol and lysmerylic acid) being excreted about 1 h earlier than the secondary metabolites (hydroxylated lysmerylic acid and TBBA). After 48 h, TBBA, lysmerol, lysmerylic acid and hydroxyl-lysmerylic acid represent on average 14.3, 1.82, 0.20 and 0.16%, respectively, of the dose administered. As there are no oral bioavailability data available, a default value of 50% is used to calculate systemic NOAEL. Human data /","endpoint":"","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"%","noael_value":"50","page":52,"route":"oral","species":"human","study_id":"sccs_o_213_noael_025"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
=0.0281 |
mg/kg bw |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_213_0; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT== 0.0281; DOSE=SCCS/1591/17 Final version The use of a first-tier deterministic approach (adding all of the numbers derived above) leads to the total SED level of 0.0281 mg/kg bw/day.; EFFECT=SCCS/1591/17 Final version The use of a first-tier deterministic approach (adding all of the numbers derived above) leads to the total SED level of 0.0281 mg/kg bw/day. CALCULATION OF THE MARGIN OF SAFETY (aggregate exposure) Total systemic exposure dose (SED) = 0.0281 mg/kg bw No observed adverse effect level NOAELsys = 4.5 mg/kg bw/d (EOGRTS, oral, rat)Bioavailability 50% * NOAELsys = 2.25 mg/kg bw/d Margin of Safety (MOS) NOAELsys/SED = 80 * Standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation, 2018. Individual MoS calculations for the respective product groups: Product types Systemic Exposure Dose [µg/kg bw/day] Individual MoS calculations for the respective product groups Hydroalcoholic-based fragrances (e.g. Eau de Toilette, perfume,; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"SCCS/1591/17 Final version The use of a first-tier deterministic approach (adding all of the numbers derived above) leads to the total SED level of 0.0281 mg/kg bw/day.","duration":"","effect":"SCCS/1591/17 Final version The use of a first-tier deterministic approach (adding all of the numbers derived above) leads to the total SED level of 0.0281 mg/kg bw/day. CALCULATION OF THE MARGIN OF SAFETY (aggregate exposure) Total systemic exposure dose (SED) = 0.0281 mg/kg bw No observed adverse effect level NOAELsys = 4.5 mg/kg bw/d (EOGRTS, oral, rat)Bioavailability 50% * NOAELsys = 2.25 mg/kg bw/d Margin of Safety (MOS) NOAELsys/SED = 80 * Standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation, 2018. Individual MoS calculations for the respective product groups: Product types Systemic Exposure Dose [µg/kg bw/day] Individual MoS calculations for the respective product groups Hydroalcoholic-based fragrances (e.g. Eau de Toilette, perfume,","endpoint":"","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 0.0281","page":48,"route":"oral","species":"rat","study_id":"sccs_o_213_0_noael_016"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
50 |
% |
human |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_213_0; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=50; DOSE=After 48 h, TBBA, lysmerol, lysmerylic acid and hydroxyl-lysmerylic acid represent on average 14.3, 1.82, 0.20 and 0.16%, respectively, of the dose administered.; EFFECT=Peak excretion for all metabolites occurred between 2 and 5 h after oral application, with the primary metabolites (lysmerol and lysmerylic acid) being excreted about 1 h earlier than the secondary metabolites (hydroxylated lysmerylic acid and TBBA). After 48 h, TBBA, lysmerol, lysmerylic acid and hydroxyl-lysmerylic acid represent on average 14.3, 1.82, 0.20 and 0.16%, respectively, of the dose administered. As there are no oral bioavailability data available, a default value of 50% is used to calculate systemic NOAEL. Human data /; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"After 48 h, TBBA, lysmerol, lysmerylic acid and hydroxyl-lysmerylic acid represent on average 14.3, 1.82, 0.20 and 0.16%, respectively, of the dose administered.","duration":"","effect":"Peak excretion for all metabolites occurred between 2 and 5 h after oral application, with the primary metabolites (lysmerol and lysmerylic acid) being excreted about 1 h earlier than the secondary metabolites (hydroxylated lysmerylic acid and TBBA). After 48 h, TBBA, lysmerol, lysmerylic acid and hydroxyl-lysmerylic acid represent on average 14.3, 1.82, 0.20 and 0.16%, respectively, of the dose administered. As there are no oral bioavailability data available, a default value of 50% is used to calculate systemic NOAEL. Human data /","endpoint":"","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"%","noael_value":"50","page":52,"route":"oral","species":"human","study_id":"sccs_o_213_0_noael_025"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
dermal absorption |
5 |
mg/kg bw/day |
human |
dermal |
- |
dermal absorption |
SOURCE_SUBDIR=sccs_o_187; REPORT_TITLE=OPINION ON Butylphenyl methylpropional (BMHCA); OPINION_NUMBER=SCCS/1540/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 August 2015; VALUE_TEXT=5; DOSE=A NOAEL of 5 mg/kg bw/day.; EFFECT=absorption rate is set at 6%, based on the only human study available (see 3.3.4.2.1.) and the following reasoning: Considering that an amount of 1.4% was excreted in the urine within 24 hours and no radioactivity has been detected thereafter, a mean value of 2% was taken for the fraction systemically bioavailable after dermal exposure. Further, with regards to possible intra-species variation, an additional assessment factor of 3 has been used leading to an overall default value of 6% for dermal absorption. 4. A NOAEL of 5 mg/kg bw/day. Based on assumptions 1 and 2, the percentage of BMHCA reported to be present in the different types of cosmetic products was as low as 0.0158 – 0.1184%. This means that the applicant claimed that no more than 0.1184% of BMHCA will be found in any of the finished products available at the market. Based on these numbers and the additional suggestion that the dermal absorption may not exceed a fraction of only 6%, the applicant derived the above mentioned MoS value of 359 (total SED of 6.963 µg/kg; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"A NOAEL of 5 mg/kg bw/day.","duration":"","effect":"absorption rate is set at 6%, based on the only human study available (see 3.3.4.2.1.) and the following reasoning: Considering that an amount of 1.4% was excreted in the urine within 24 hours and no radioactivity has been detected thereafter, a mean value of 2% was taken for the fraction systemically bioavailable after dermal exposure. Further, with regards to possible intra-species variation, an additional assessment factor of 3 has been used leading to an overall default value of 6% for dermal absorption. 4. A NOAEL of 5 mg/kg bw/day. Based on assumptions 1 and 2, the percentage of BMHCA reported to be present in the different types of cosmetic products was as low as 0.0158 – 0.1184%. This means that the applicant claimed that no more than 0.1184% of BMHCA will be found in any of the finished products available at the market. Based on these numbers and the additional suggestion that the dermal absorption may not exceed a fraction of only 6%, the applicant derived the above mentioned MoS value of 359 (total SED of 6.963 µg/kg","endpoint":"dermal absorption","ingredient":"was introduced in Annex III of the Cosmetics Directive 76/768/EEC by the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"5","page":40,"route":"dermal","species":"human","study_id":"sccs_o_187_noael_016"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
dermal absorption |
5 |
mg/kg bw/day |
human |
dermal |
- |
dermal absorption |
SOURCE_SUBDIR=sccs_o_189; REPORT_TITLE=OPINION ON Butylphenyl methylpropional (BMHCA); OPINION_NUMBER=SCCS/1540/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 March 2016; VALUE_TEXT=5; DOSE=A NOAEL of 5 mg/kg bw/day.; EFFECT=absorption rate is set at 6%, based on the only human study available (see 3.3.4.2.1.) and the following reasoning: Considering that an amount of 1.4% was excreted in the urine within 24 hours and no radioactivity has been detected thereafter, a mean value of 2% was taken for the fraction systemically bioavailable after dermal exposure. Further, with regards to possible intra-species variation, an additional assessment factor of 3 has been used leading to an overall default value of 6% for dermal absorption. 4. A NOAEL of 5 mg/kg bw/day. Based on assumptions 1 and 2, the percentage of BMHCA reported to be present in the different types of cosmetic products was as low as 0.0158 – 0.1184%. This means that the applicant claimed that no more than 0.1184% of BMHCA will be found in any of the finished products available at the market. Based on these numbers and the additional suggestion that the dermal absorption may not exceed a fraction of only 6%, the applicant derived the above mentioned MoS value of 359 (total SED of 6.963 µg/kg; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"A NOAEL of 5 mg/kg bw/day.","duration":"","effect":"absorption rate is set at 6%, based on the only human study available (see 3.3.4.2.1.) and the following reasoning: Considering that an amount of 1.4% was excreted in the urine within 24 hours and no radioactivity has been detected thereafter, a mean value of 2% was taken for the fraction systemically bioavailable after dermal exposure. Further, with regards to possible intra-species variation, an additional assessment factor of 3 has been used leading to an overall default value of 6% for dermal absorption. 4. A NOAEL of 5 mg/kg bw/day. Based on assumptions 1 and 2, the percentage of BMHCA reported to be present in the different types of cosmetic products was as low as 0.0158 – 0.1184%. This means that the applicant claimed that no more than 0.1184% of BMHCA will be found in any of the finished products available at the market. Based on these numbers and the additional suggestion that the dermal absorption may not exceed a fraction of only 6%, the applicant derived the above mentioned MoS value of 359 (total SED of 6.963 µg/kg","endpoint":"dermal absorption","ingredient":"was introduced in Annex III of the Cosmetics Directive 76/768/EEC by the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"5","page":40,"route":"dermal","species":"human","study_id":"sccs_o_189_noael_015"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
5 |
mg/kg bw/day |
rat |
- |
2 weeks |
developmental toxicity |
SOURCE_SUBDIR=sccs_o_187; REPORT_TITLE=OPINION ON Butylphenyl methylpropional (BMHCA); OPINION_NUMBER=SCCS/1540/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 August 2015; VALUE_TEXT=5; DOSE=In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months.; EFFECT=gns of systemic toxicity. By contrast, other species such as mice and dogs were less sensitive. In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months. So, from the animal data available male rats revealed as most sensitive species with regard to BMHCA-mediated testicular toxicity. On the other hand, in female rats developmental toxicity was accompanied by systemic toxicity and found already at lower concentrations. Here, a NOAEL is to be set at 5 mg/kg bw/day. This value is identical to the one defined for general; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months.","duration":"2 weeks","effect":"gns of systemic toxicity. By contrast, other species such as mice and dogs were less sensitive. In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months. So, from the animal data available male rats revealed as most sensitive species with regard to BMHCA-mediated testicular toxicity. On the other hand, in female rats developmental toxicity was accompanied by systemic toxicity and found already at lower concentrations. Here, a NOAEL is to be set at 5 mg/kg bw/day. This value is identical to the one defined for general","endpoint":"developmental toxicity","ingredient":"was introduced in Annex III of the Cosmetics Directive 76/768/EEC by the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"5","page":44,"route":"","species":"rat","study_id":"sccs_o_187_noael_021"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
40 |
mg/kg bw/day |
rat |
- |
2 weeks |
developmental toxicity |
SOURCE_SUBDIR=sccs_o_189; REPORT_TITLE=OPINION ON Butylphenyl methylpropional (BMHCA); OPINION_NUMBER=SCCS/1540/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 March 2016; VALUE_TEXT=40; DOSE=SCCS/1540/14 Revision of opinion on Butylphenyl methylpropional ___________________________________________________________________________________________ 32 after a single application of 50 mg/kg bw/day.; EFFECT=SCCS/1540/14 Revision of opinion on Butylphenyl methylpropional ___________________________________________________________________________________________ 32 after a single application of 50 mg/kg bw/day. In all investigations available, testicular toxicity in rats was accompanied by signs of systemic toxicity. By contrast, other species such as mice and dogs were less sensitive (cf. 3.3.5.1. and 3.3.5.2.). In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months. So, from the animal data available male rats revealed as most sensitive species with regard to BMHCA-mediated testicular toxicity. On the other hand, in female rats developmental toxicity was accompanied by systemic toxicity and was already found at lower concentrations. Here, a NOAEL based on developmental toxicity is to be set at 5 mg/kg bw/day. This value is identical to the one def; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"SCCS/1540/14 Revision of opinion on Butylphenyl methylpropional ___________________________________________________________________________________________ 32 after a single application of 50 mg/kg bw/day.","duration":"2 weeks","effect":"SCCS/1540/14 Revision of opinion on Butylphenyl methylpropional ___________________________________________________________________________________________ 32 after a single application of 50 mg/kg bw/day. In all investigations available, testicular toxicity in rats was accompanied by signs of systemic toxicity. By contrast, other species such as mice and dogs were less sensitive (cf. 3.3.5.1. and 3.3.5.2.). In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months. So, from the animal data available male rats revealed as most sensitive species with regard to BMHCA-mediated testicular toxicity. On the other hand, in female rats developmental toxicity was accompanied by systemic toxicity and was already found at lower concentrations. Here, a NOAEL based on developmental toxicity is to be set at 5 mg/kg bw/day. This value is identical to the one def","endpoint":"developmental toxicity","ingredient":"was introduced in Annex III of the Cosmetics Directive 76/768/EEC by the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"40","page":32,"route":"","species":"rat","study_id":"sccs_o_189_noael_011"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
40 |
mg/kg bw/day |
rat |
- |
2 weeks |
developmental toxicity |
SOURCE_SUBDIR=sccs_o_213; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=40; DOSE=In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months.; EFFECT=SCCS/1591/17 Final version Opinion on the safety Butylphenyl methylpropional (p- BMHCA) in cosmetic products - Submission II ___________________________________________________________________________________________ 35 such as mice and dogs were less sensitive. In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months. So, from the animal data available, male rats revealed as most sensitive species with regard to p-BMHCA-mediated testicular toxicity. On the other hand, in female rats developmental toxicity was accompanied by systemic toxicity and was already found at lower concentrations. Here, a NOAEL based on developmental toxicity is to be set at 5 mg/kg bw/day. This value is identical to the one; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months.","duration":"2 weeks","effect":"SCCS/1591/17 Final version Opinion on the safety Butylphenyl methylpropional (p- BMHCA) in cosmetic products - Submission II ___________________________________________________________________________________________ 35 such as mice and dogs were less sensitive. In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months. So, from the animal data available, male rats revealed as most sensitive species with regard to p-BMHCA-mediated testicular toxicity. On the other hand, in female rats developmental toxicity was accompanied by systemic toxicity and was already found at lower concentrations. Here, a NOAEL based on developmental toxicity is to be set at 5 mg/kg bw/day. This value is identical to the one","endpoint":"developmental toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"40","page":35,"route":"","species":"rat","study_id":"sccs_o_213_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
10 |
mg/kg bw/d |
rat |
oral |
developmental |
developmental toxicity |
SOURCE_SUBDIR=sccs_o_213; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=10; DOSE=0 and F1 parental rats was 10 mg/kg bw/d, the highest dose tested.; EFFECT=0 and F1 parental rats was 10 mg/kg bw/d, the highest dose tested. The NOAEL for developmental toxicity in the F1 and F2 progeny was 3 mg/kg bw/d (equivalent to a mean overall oral dose of 4.5 mg/kg bw/d), based on reduced pup body weights in the F1 and F2 offspring, which were observed at 10 mg/kg bw/d. As these weight reductions were only observed in the presence of maternal toxicity, including lower weight gain during pregnancy, they are not considered as an indication for specific developmental toxicity. The NOAEL for developmental neurotoxicity (DNT) for the F1 progeny is 10 mg/kg bw/d, the highest dose tested. Although an inhibitory effect at this dose on the peripheral AChE activity in pups and adolescent rats cannot be excluded, there were no corresponding effects evident in the neurobehavioral or neuropathological examinations. The NOAEL for developmental immunotoxicity (DIT) for the F1 progeny is 10 mg/kg bw/d, the highest dose tested. The NOAEL for general, systemic toxicity is 3 mg/kg bw/d (equivalent to a mean ov; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"0 and F1 parental rats was 10 mg/kg bw/d, the highest dose tested.","duration":"developmental","effect":"0 and F1 parental rats was 10 mg/kg bw/d, the highest dose tested. The NOAEL for developmental toxicity in the F1 and F2 progeny was 3 mg/kg bw/d (equivalent to a mean overall oral dose of 4.5 mg/kg bw/d), based on reduced pup body weights in the F1 and F2 offspring, which were observed at 10 mg/kg bw/d. As these weight reductions were only observed in the presence of maternal toxicity, including lower weight gain during pregnancy, they are not considered as an indication for specific developmental toxicity. The NOAEL for developmental neurotoxicity (DNT) for the F1 progeny is 10 mg/kg bw/d, the highest dose tested. Although an inhibitory effect at this dose on the peripheral AChE activity in pups and adolescent rats cannot be excluded, there were no corresponding effects evident in the neurobehavioral or neuropathological examinations. The NOAEL for developmental immunotoxicity (DIT) for the F1 progeny is 10 mg/kg bw/d, the highest dose tested. The NOAEL for general, systemic toxicity is 3 mg/kg bw/d (equivalent to a mean ov","endpoint":"developmental toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"10","page":40,"route":"oral","species":"rat","study_id":"sccs_o_213_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
10 |
mg/kg bw/d |
rat |
oral |
developmental |
developmental toxicity |
SOURCE_SUBDIR=sccs_o_213; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=10; DOSE=The NOAEL for developmental neurotoxicity (DNT) for the F1 progeny is 10 mg/kg bw/d, the highest dose tested.; EFFECT=re only observed in the presence of maternal toxicity, including lower weight gain during pregnancy, they are not considered as an indication for specific developmental toxicity. The NOAEL for developmental neurotoxicity (DNT) for the F1 progeny is 10 mg/kg bw/d, the highest dose tested. Although an inhibitory effect at this dose on the peripheral AChE activity in pups and adolescent rats cannot be excluded, there were no corresponding effects evident in the neurobehavioral or neuropathological examinations. The NOAEL for developmental immunotoxicity (DIT) for the F1 progeny is 10 mg/kg bw/d, the highest dose tested. The NOAEL for general, systemic toxicity is 3 mg/kg bw/d (equivalent to a mean overall oral dose of 4.5 mg/kg bw/d) for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity, as well as corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females. Ref.: BASF SE, 2015, 2017b,; CITATION=Ref.: BASF SE, 2015, 2017b,; CITATION_NUMBERS=[2015,2017]; REFERENCE=Ref.: BASF SE, 2015, 2017b,; DETAILS_JSON={"cas_number":"80-54-6","citation":"Ref.: BASF SE, 2015, 2017b,","dose":"The NOAEL for developmental neurotoxicity (DNT) for the F1 progeny is 10 mg/kg bw/d, the highest dose tested.","duration":"developmental","effect":"re only observed in the presence of maternal toxicity, including lower weight gain during pregnancy, they are not considered as an indication for specific developmental toxicity. The NOAEL for developmental neurotoxicity (DNT) for the F1 progeny is 10 mg/kg bw/d, the highest dose tested. Although an inhibitory effect at this dose on the peripheral AChE activity in pups and adolescent rats cannot be excluded, there were no corresponding effects evident in the neurobehavioral or neuropathological examinations. The NOAEL for developmental immunotoxicity (DIT) for the F1 progeny is 10 mg/kg bw/d, the highest dose tested. The NOAEL for general, systemic toxicity is 3 mg/kg bw/d (equivalent to a mean overall oral dose of 4.5 mg/kg bw/d) for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity, as well as corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females. Ref.: BASF SE, 2015, 2017b,","endpoint":"developmental toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"10","page":40,"route":"oral","species":"rat","study_id":"sccs_o_213_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
40 |
mg/kg bw/day |
rat |
- |
2 weeks |
developmental toxicity |
SOURCE_SUBDIR=sccs_o_213_0; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=40; DOSE=In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months.; EFFECT=SCCS/1591/17 Final version Opinion on the safety Butylphenyl methylpropional (p- BMHCA) in cosmetic products - Submission II ___________________________________________________________________________________________ 35 such as mice and dogs were less sensitive. In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months. So, from the animal data available, male rats revealed as most sensitive species with regard to p-BMHCA-mediated testicular toxicity. On the other hand, in female rats developmental toxicity was accompanied by systemic toxicity and was already found at lower concentrations. Here, a NOAEL based on developmental toxicity is to be set at 5 mg/kg bw/day. This value is identical to the one; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months.","duration":"2 weeks","effect":"SCCS/1591/17 Final version Opinion on the safety Butylphenyl methylpropional (p- BMHCA) in cosmetic products - Submission II ___________________________________________________________________________________________ 35 such as mice and dogs were less sensitive. In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months. So, from the animal data available, male rats revealed as most sensitive species with regard to p-BMHCA-mediated testicular toxicity. On the other hand, in female rats developmental toxicity was accompanied by systemic toxicity and was already found at lower concentrations. Here, a NOAEL based on developmental toxicity is to be set at 5 mg/kg bw/day. This value is identical to the one","endpoint":"developmental toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"40","page":35,"route":"","species":"rat","study_id":"sccs_o_213_0_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
10 |
mg/kg bw/d |
rat |
oral |
developmental |
developmental toxicity |
SOURCE_SUBDIR=sccs_o_213_0; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=10; DOSE=0 and F1 parental rats was 10 mg/kg bw/d, the highest dose tested.; EFFECT=0 and F1 parental rats was 10 mg/kg bw/d, the highest dose tested. The NOAEL for developmental toxicity in the F1 and F2 progeny was 3 mg/kg bw/d (equivalent to a mean overall oral dose of 4.5 mg/kg bw/d), based on reduced pup body weights in the F1 and F2 offspring, which were observed at 10 mg/kg bw/d. As these weight reductions were only observed in the presence of maternal toxicity, including lower weight gain during pregnancy, they are not considered as an indication for specific developmental toxicity. The NOAEL for developmental neurotoxicity (DNT) for the F1 progeny is 10 mg/kg bw/d, the highest dose tested. Although an inhibitory effect at this dose on the peripheral AChE activity in pups and adolescent rats cannot be excluded, there were no corresponding effects evident in the neurobehavioral or neuropathological examinations. The NOAEL for developmental immunotoxicity (DIT) for the F1 progeny is 10 mg/kg bw/d, the highest dose tested. The NOAEL for general, systemic toxicity is 3 mg/kg bw/d (equivalent to a mean ov; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"0 and F1 parental rats was 10 mg/kg bw/d, the highest dose tested.","duration":"developmental","effect":"0 and F1 parental rats was 10 mg/kg bw/d, the highest dose tested. The NOAEL for developmental toxicity in the F1 and F2 progeny was 3 mg/kg bw/d (equivalent to a mean overall oral dose of 4.5 mg/kg bw/d), based on reduced pup body weights in the F1 and F2 offspring, which were observed at 10 mg/kg bw/d. As these weight reductions were only observed in the presence of maternal toxicity, including lower weight gain during pregnancy, they are not considered as an indication for specific developmental toxicity. The NOAEL for developmental neurotoxicity (DNT) for the F1 progeny is 10 mg/kg bw/d, the highest dose tested. Although an inhibitory effect at this dose on the peripheral AChE activity in pups and adolescent rats cannot be excluded, there were no corresponding effects evident in the neurobehavioral or neuropathological examinations. The NOAEL for developmental immunotoxicity (DIT) for the F1 progeny is 10 mg/kg bw/d, the highest dose tested. The NOAEL for general, systemic toxicity is 3 mg/kg bw/d (equivalent to a mean ov","endpoint":"developmental toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"10","page":40,"route":"oral","species":"rat","study_id":"sccs_o_213_0_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
10 |
mg/kg bw/d |
rat |
oral |
developmental |
developmental toxicity |
SOURCE_SUBDIR=sccs_o_213_0; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=10; DOSE=The NOAEL for developmental neurotoxicity (DNT) for the F1 progeny is 10 mg/kg bw/d, the highest dose tested.; EFFECT=re only observed in the presence of maternal toxicity, including lower weight gain during pregnancy, they are not considered as an indication for specific developmental toxicity. The NOAEL for developmental neurotoxicity (DNT) for the F1 progeny is 10 mg/kg bw/d, the highest dose tested. Although an inhibitory effect at this dose on the peripheral AChE activity in pups and adolescent rats cannot be excluded, there were no corresponding effects evident in the neurobehavioral or neuropathological examinations. The NOAEL for developmental immunotoxicity (DIT) for the F1 progeny is 10 mg/kg bw/d, the highest dose tested. The NOAEL for general, systemic toxicity is 3 mg/kg bw/d (equivalent to a mean overall oral dose of 4.5 mg/kg bw/d) for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity, as well as corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females. Ref.: BASF SE, 2015, 2017b,; CITATION=Ref.: BASF SE, 2015, 2017b,; CITATION_NUMBERS=[2015,2017]; REFERENCE=Ref.: BASF SE, 2015, 2017b,; DETAILS_JSON={"cas_number":"80-54-6","citation":"Ref.: BASF SE, 2015, 2017b,","dose":"The NOAEL for developmental neurotoxicity (DNT) for the F1 progeny is 10 mg/kg bw/d, the highest dose tested.","duration":"developmental","effect":"re only observed in the presence of maternal toxicity, including lower weight gain during pregnancy, they are not considered as an indication for specific developmental toxicity. The NOAEL for developmental neurotoxicity (DNT) for the F1 progeny is 10 mg/kg bw/d, the highest dose tested. Although an inhibitory effect at this dose on the peripheral AChE activity in pups and adolescent rats cannot be excluded, there were no corresponding effects evident in the neurobehavioral or neuropathological examinations. The NOAEL for developmental immunotoxicity (DIT) for the F1 progeny is 10 mg/kg bw/d, the highest dose tested. The NOAEL for general, systemic toxicity is 3 mg/kg bw/d (equivalent to a mean overall oral dose of 4.5 mg/kg bw/d) for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity, as well as corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females. Ref.: BASF SE, 2015, 2017b,","endpoint":"developmental toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"10","page":40,"route":"oral","species":"rat","study_id":"sccs_o_213_0_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
25 |
mg/kg bw/day |
rat |
oral |
Subacute |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_187; REPORT_TITLE=OPINION ON Butylphenyl methylpropional (BMHCA); OPINION_NUMBER=SCCS/1540/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 August 2015; VALUE_TEXT=25; DOSE=dened testes in 1/8 rats at 200 mg/kg bw/day and in 6/8 rats at the highest dose group.; EFFECT=dened testes in 1/8 rats at 200 mg/kg bw/day and in 6/8 rats at the highest dose group. Kidney weights were decreased in the high dose group, and a dose-related decrease in the testes weights was observed at doses of ≥100 mg/kg bw/day. Histology of the testes revealed degeneration and loss of germ cells in the seminiferous epithelium at ≥50 mg/kg bw/day. Subacute administration of BMHCA to male rats led to treatment-related effects at ≥50 mg/kg bw/day including dose-related testicular findings. From this study the NOAEL derived was suggested at 25 mg/kg bw/day. The NOAEL of 25 mg/kg bw/day has been confirmed in a subsequent study (refs.: Givaudan, 1991, RIFM #16176). 3rd Study: Givaudan, 1990b, RIFM#12139 Guideline/Method: Explorative oral and toxicokinetics study Species/strain: Mice Group size: 5 males/group Test substance: BMHCA Batch: no data Purity: no data Vehicle: Rape oil Doses: 0, 100 mg/kg bw/day (5 mL/kg bw/day), once daily Route: Oral (gavage) Exposure: 5 days GLP: no Method: The animals were observed for mortality,; CITATION=(refs.: Givaudan, 1991, RIFM #16176); CITATION_NUMBERS=[1991,1617,6]; REFERENCE=(refs.: Givaudan, 1991, RIFM #16176); DETAILS_JSON={"cas_number":"80-54-6","citation":"(refs.: Givaudan, 1991, RIFM #16176)","dose":"dened testes in 1/8 rats at 200 mg/kg bw/day and in 6/8 rats at the highest dose group.","duration":"Subacute","effect":"dened testes in 1/8 rats at 200 mg/kg bw/day and in 6/8 rats at the highest dose group. Kidney weights were decreased in the high dose group, and a dose-related decrease in the testes weights was observed at doses of ≥100 mg/kg bw/day. Histology of the testes revealed degeneration and loss of germ cells in the seminiferous epithelium at ≥50 mg/kg bw/day. Subacute administration of BMHCA to male rats led to treatment-related effects at ≥50 mg/kg bw/day including dose-related testicular findings. From this study the NOAEL derived was suggested at 25 mg/kg bw/day. The NOAEL of 25 mg/kg bw/day has been confirmed in a subsequent study (refs.: Givaudan, 1991, RIFM #16176). 3rd Study: Givaudan, 1990b, RIFM#12139 Guideline/Method: Explorative oral and toxicokinetics study Species/strain: Mice Group size: 5 males/group Test substance: BMHCA Batch: no data Purity: no data Vehicle: Rape oil Doses: 0, 100 mg/kg bw/day (5 mL/kg bw/day), once daily Route: Oral (gavage) Exposure: 5 days GLP: no Method: The animals were observed for mortality,","endpoint":"repeated dose toxicity","ingredient":"was introduced in Annex III of the Cosmetics Directive 76/768/EEC by the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"25","page":21,"route":"oral","species":"rat","study_id":"sccs_o_187_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
25 |
mg/kg bw/day |
rat |
oral |
Subacute |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_187; REPORT_TITLE=OPINION ON Butylphenyl methylpropional (BMHCA); OPINION_NUMBER=SCCS/1540/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 August 2015; VALUE_TEXT=25; DOSE=6/8 rats at the highest dose group.; EFFECT=6/8 rats at the highest dose group. Kidney weights were decreased in the high dose group, and a dose-related decrease in the testes weights was observed at doses of ≥100 mg/kg bw/day. Histology of the testes revealed degeneration and loss of germ cells in the seminiferous epithelium at ≥50 mg/kg bw/day. Subacute administration of BMHCA to male rats led to treatment-related effects at ≥50 mg/kg bw/day including dose-related testicular findings. From this study the NOAEL derived was suggested at 25 mg/kg bw/day. The NOAEL of 25 mg/kg bw/day has been confirmed in a subsequent study (refs.: Givaudan, 1991, RIFM #16176). 3rd Study: Givaudan, 1990b, RIFM#12139 Guideline/Method: Explorative oral and toxicokinetics study Species/strain: Mice Group size: 5 males/group Test substance: BMHCA Batch: no data Purity: no data Vehicle: Rape oil Doses: 0, 100 mg/kg bw/day (5 mL/kg bw/day), once daily Route: Oral (gavage) Exposure: 5 days GLP: no Method: The animals were observed for mortality, clinical signs, and body weight changes. At terminat; CITATION=(refs.: Givaudan, 1991, RIFM #16176); CITATION_NUMBERS=[1991,1617,6]; REFERENCE=(refs.: Givaudan, 1991, RIFM #16176); DETAILS_JSON={"cas_number":"80-54-6","citation":"(refs.: Givaudan, 1991, RIFM #16176)","dose":"6/8 rats at the highest dose group.","duration":"Subacute","effect":"6/8 rats at the highest dose group. Kidney weights were decreased in the high dose group, and a dose-related decrease in the testes weights was observed at doses of ≥100 mg/kg bw/day. Histology of the testes revealed degeneration and loss of germ cells in the seminiferous epithelium at ≥50 mg/kg bw/day. Subacute administration of BMHCA to male rats led to treatment-related effects at ≥50 mg/kg bw/day including dose-related testicular findings. From this study the NOAEL derived was suggested at 25 mg/kg bw/day. The NOAEL of 25 mg/kg bw/day has been confirmed in a subsequent study (refs.: Givaudan, 1991, RIFM #16176). 3rd Study: Givaudan, 1990b, RIFM#12139 Guideline/Method: Explorative oral and toxicokinetics study Species/strain: Mice Group size: 5 males/group Test substance: BMHCA Batch: no data Purity: no data Vehicle: Rape oil Doses: 0, 100 mg/kg bw/day (5 mL/kg bw/day), once daily Route: Oral (gavage) Exposure: 5 days GLP: no Method: The animals were observed for mortality, clinical signs, and body weight changes. At terminat","endpoint":"repeated dose toxicity","ingredient":"was introduced in Annex III of the Cosmetics Directive 76/768/EEC by the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"25","page":21,"route":"oral","species":"rat","study_id":"sccs_o_187_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
25 |
mg/kg bw/day |
rat |
- |
4 week |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_187; REPORT_TITLE=OPINION ON Butylphenyl methylpropional (BMHCA); OPINION_NUMBER=SCCS/1540/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 August 2015; VALUE_TEXT=25; DOSE=y was observed at 50 mg/kg bw/day.; EFFECT=y was observed at 50 mg/kg bw/day. Disturbances of spermatogenesis and spermatogenesis, testicular increases in Sertoli cell tubules and increased surface density in Leydig cells were described along with a decreased density of spermatozoa, nucleated cells and spermatoceles in the epididymides of the high dose animals. In the 4 week recovery group, the same testicular pathology was observed to a lesser extent. Based on these data it was concluded that BMHCA led to treatment-related effects at ≥25 mg/kg bw/day. The NOAEL for testicular toxicity and systemic toxicity was suggested to be at 25 mg/kg bw/day and 5 mg/kg bw/day, respectively. Follow up study (Givaudan, 1990f, RIFM#12145): 20 male and 20 female albino rats (Fü SPF) were administered BMHCA (purity: 97.4%) at 0 or 50 mg/kg bw/day in rape oil, 7 days a week for 24 or 52 days. Treatment-related effects again included the decrease of plasma cholesterol, cholinesterase and acetylcholinesterase levels. 2nd Study: Givaudan, 1990g, RIFM #12140 Guideline/Method: Subchronic stu; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"y was observed at 50 mg/kg bw/day.","duration":"4 week","effect":"y was observed at 50 mg/kg bw/day. Disturbances of spermatogenesis and spermatogenesis, testicular increases in Sertoli cell tubules and increased surface density in Leydig cells were described along with a decreased density of spermatozoa, nucleated cells and spermatoceles in the epididymides of the high dose animals. In the 4 week recovery group, the same testicular pathology was observed to a lesser extent. Based on these data it was concluded that BMHCA led to treatment-related effects at ≥25 mg/kg bw/day. The NOAEL for testicular toxicity and systemic toxicity was suggested to be at 25 mg/kg bw/day and 5 mg/kg bw/day, respectively. Follow up study (Givaudan, 1990f, RIFM#12145): 20 male and 20 female albino rats (Fü SPF) were administered BMHCA (purity: 97.4%) at 0 or 50 mg/kg bw/day in rape oil, 7 days a week for 24 or 52 days. Treatment-related effects again included the decrease of plasma cholesterol, cholinesterase and acetylcholinesterase levels. 2nd Study: Givaudan, 1990g, RIFM #12140 Guideline/Method: Subchronic stu","endpoint":"repeated dose toxicity","ingredient":"was introduced in Annex III of the Cosmetics Directive 76/768/EEC by the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"25","page":24,"route":"","species":"rat","study_id":"sccs_o_187_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
5 |
mg/kg bw/day |
rat |
- |
Prenatal |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_187; REPORT_TITLE=OPINION ON Butylphenyl methylpropional (BMHCA); OPINION_NUMBER=SCCS/1540/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 August 2015; VALUE_TEXT=5; DOSE=l toxicity at 15 and 45 mg/kg bw/day, but not at 5 mg/kg bw/day (body weight gain and impaired liver function).; EFFECT=l toxicity at 15 and 45 mg/kg bw/day, but not at 5 mg/kg bw/day (body weight gain and impaired liver function). Gestation became affected at 45 mg/kg bw/day (increased number of postimplantation losses). Prenatal developmental toxicity with regard to reduced fetal body weights was observed in the mid and high dose groups, thereby corresponding to significant maternal toxicity at the same dose levels. Further, the overall incidence of skeletal variations was significantly increased in mid and high dose animals. The NOAEL for both maternal and prenatal developmental toxicity was 5 mg/kg bw/day (or 4.1 mg/kg bw/day, effective dose). SCCS conclusion on reproductive toxicity: Adverse effects of BMHCA on the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies. A NOAEL of 25 mg/kg bw/day in male rats with regard to this endpoint is substantiated by studies applying the compound for 5 days, 90 days or in the frame of an 1-generation study over 6 weeks prior until mating. I; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"l toxicity at 15 and 45 mg/kg bw/day, but not at 5 mg/kg bw/day (body weight gain and impaired liver function).","duration":"Prenatal","effect":"l toxicity at 15 and 45 mg/kg bw/day, but not at 5 mg/kg bw/day (body weight gain and impaired liver function). Gestation became affected at 45 mg/kg bw/day (increased number of postimplantation losses). Prenatal developmental toxicity with regard to reduced fetal body weights was observed in the mid and high dose groups, thereby corresponding to significant maternal toxicity at the same dose levels. Further, the overall incidence of skeletal variations was significantly increased in mid and high dose animals. The NOAEL for both maternal and prenatal developmental toxicity was 5 mg/kg bw/day (or 4.1 mg/kg bw/day, effective dose). SCCS conclusion on reproductive toxicity: Adverse effects of BMHCA on the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies. A NOAEL of 25 mg/kg bw/day in male rats with regard to this endpoint is substantiated by studies applying the compound for 5 days, 90 days or in the frame of an 1-generation study over 6 weeks prior until mating. I","endpoint":"repeated dose toxicity","ingredient":"was introduced in Annex III of the Cosmetics Directive 76/768/EEC by the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"5","page":31,"route":"","species":"rat","study_id":"sccs_o_187_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
25 |
mg/kg bw/day |
rat |
- |
prenatal |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_187; REPORT_TITLE=OPINION ON Butylphenyl methylpropional (BMHCA); OPINION_NUMBER=SCCS/1540/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 August 2015; VALUE_TEXT=25; DOSE=se groups, thereby corresponding to significant maternal toxicity at the same dose levels.; EFFECT=se groups, thereby corresponding to significant maternal toxicity at the same dose levels. Further, the overall incidence of skeletal variations was significantly increased in mid and high dose animals. The NOAEL for both maternal and prenatal developmental toxicity was 5 mg/kg bw/day (or 4.1 mg/kg bw/day, effective dose). SCCS conclusion on reproductive toxicity: Adverse effects of BMHCA on the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies. A NOAEL of 25 mg/kg bw/day in male rats with regard to this endpoint is substantiated by studies applying the compound for 5 days, 90 days or in the frame of an 1-generation study over 6 weeks prior until mating. It is to be emphasised that reproductive toxicity already occasionally became visible after a single application of 50 mg/kg bw/day. In all investigations available, testicular toxicity in rats was accompanied by signs of systemic toxicity. By contrast, other species such as mice and dogs were less sensitive (cf.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"se groups, thereby corresponding to significant maternal toxicity at the same dose levels.","duration":"prenatal","effect":"se groups, thereby corresponding to significant maternal toxicity at the same dose levels. Further, the overall incidence of skeletal variations was significantly increased in mid and high dose animals. The NOAEL for both maternal and prenatal developmental toxicity was 5 mg/kg bw/day (or 4.1 mg/kg bw/day, effective dose). SCCS conclusion on reproductive toxicity: Adverse effects of BMHCA on the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies. A NOAEL of 25 mg/kg bw/day in male rats with regard to this endpoint is substantiated by studies applying the compound for 5 days, 90 days or in the frame of an 1-generation study over 6 weeks prior until mating. It is to be emphasised that reproductive toxicity already occasionally became visible after a single application of 50 mg/kg bw/day. In all investigations available, testicular toxicity in rats was accompanied by signs of systemic toxicity. By contrast, other species such as mice and dogs were less sensitive (cf.","endpoint":"repeated dose toxicity","ingredient":"was introduced in Annex III of the Cosmetics Directive 76/768/EEC by the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"25","page":31,"route":"","species":"rat","study_id":"sccs_o_187_noael_011"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
5 |
mg/kg bw/day |
rat |
- |
2 weeks |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_187; REPORT_TITLE=OPINION ON Butylphenyl methylpropional (BMHCA); OPINION_NUMBER=SCCS/1540/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 August 2015; VALUE_TEXT=5; DOSE=Here, a NOAEL based on developmental toxicity is to be set at 5 mg/kg bw/day.; EFFECT=SCCS/1540/14 12 August 2015 Opinion on Butylphenyl methylpropional ___________________________________________________________________________________________ 32 after treatment periods of 2 weeks and 3 months. So, from the animal data available male rats revealed as most sensitive species with regard to BMHCA-mediated testicular toxicity. On the other hand, in female rats developmental toxicity was accompanied by systemic toxicity and found already at lower concentrations. Here, a NOAEL based on developmental toxicity is to be set at 5 mg/kg bw/day. This value is identical to the one defined for general systemic toxicity in rats based on repeated dose (90-days) toxicity studies (cf. 3.3.5.2.). Since the onset of developmental toxicity was tightly accompanied by maternal toxicity, the malformations and tissue variations observed likely resulted from general fetotoxicity rather than from specific teratogenicity 3.3.9. Toxicokinetics 3.3.9.1. Metabolism in vitro Study (BASF SE 2010; GLP): Invest; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"Here, a NOAEL based on developmental toxicity is to be set at 5 mg/kg bw/day.","duration":"2 weeks","effect":"SCCS/1540/14 12 August 2015 Opinion on Butylphenyl methylpropional ___________________________________________________________________________________________ 32 after treatment periods of 2 weeks and 3 months. So, from the animal data available male rats revealed as most sensitive species with regard to BMHCA-mediated testicular toxicity. On the other hand, in female rats developmental toxicity was accompanied by systemic toxicity and found already at lower concentrations. Here, a NOAEL based on developmental toxicity is to be set at 5 mg/kg bw/day. This value is identical to the one defined for general systemic toxicity in rats based on repeated dose (90-days) toxicity studies (cf. 3.3.5.2.). Since the onset of developmental toxicity was tightly accompanied by maternal toxicity, the malformations and tissue variations observed likely resulted from general fetotoxicity rather than from specific teratogenicity 3.3.9. Toxicokinetics 3.3.9.1. Metabolism in vitro Study (BASF SE 2010; GLP): Invest","endpoint":"repeated dose toxicity","ingredient":"was introduced in Annex III of the Cosmetics Directive 76/768/EEC by the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"5","page":32,"route":"","species":"rat","study_id":"sccs_o_187_noael_013"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
50 |
mg/kg bw/day |
rat |
oral |
subacute |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_187; REPORT_TITLE=OPINION ON Butylphenyl methylpropional (BMHCA); OPINION_NUMBER=SCCS/1540/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 August 2015; VALUE_TEXT=50; DOSE=nd food consumption and/or clinical signs of toxicity were observed after subacute oral administration of BMHCA at doses of ≥50 mg/kg bw/day (rats) and ≥200 mg/kg bw/day (dogs).; EFFECT=nd food consumption and/or clinical signs of toxicity were observed after subacute oral administration of BMHCA at doses of ≥50 mg/kg bw/day (rats) and ≥200 mg/kg bw/day (dogs). Clinical chemistry and histopathological examinations repeatedly revealed adverse effects on the liver and male reproductive system (testicular toxicity). In a 90-day GLP study in rats BMHCA dose-dependently induced systemic toxicity in both sexes at levels of ≥25 mg/kg bw/day and testicular toxicity in males at ≥50 mg/kg bw/day. Thus oral NOAEL values of 5 mg/kg bw/day and 25 mg/kg bw/day can be derived for systemic effects and reproductive effects, respectively. This result has been further supported by reproductive toxicity studies (cf. below). Reproductive toxicity Adverse effects of BMHCA on the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies. A NOAEL of 25 mg/kg bw/day in male rats with regard to this endpoint is substantiated by studies applying the compound for 5 days, 90 days or; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"nd food consumption and/or clinical signs of toxicity were observed after subacute oral administration of BMHCA at doses of ≥50 mg/kg bw/day (rats) and ≥200 mg/kg bw/day (dogs).","duration":"subacute","effect":"nd food consumption and/or clinical signs of toxicity were observed after subacute oral administration of BMHCA at doses of ≥50 mg/kg bw/day (rats) and ≥200 mg/kg bw/day (dogs). Clinical chemistry and histopathological examinations repeatedly revealed adverse effects on the liver and male reproductive system (testicular toxicity). In a 90-day GLP study in rats BMHCA dose-dependently induced systemic toxicity in both sexes at levels of ≥25 mg/kg bw/day and testicular toxicity in males at ≥50 mg/kg bw/day. Thus oral NOAEL values of 5 mg/kg bw/day and 25 mg/kg bw/day can be derived for systemic effects and reproductive effects, respectively. This result has been further supported by reproductive toxicity studies (cf. below). Reproductive toxicity Adverse effects of BMHCA on the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies. A NOAEL of 25 mg/kg bw/day in male rats with regard to this endpoint is substantiated by studies applying the compound for 5 days, 90 days or","endpoint":"repeated dose toxicity","ingredient":"was introduced in Annex III of the Cosmetics Directive 76/768/EEC by the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":44,"route":"oral","species":"rat","study_id":"sccs_o_187_noael_018"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
25 |
mg/kg bw/day |
rat |
oral |
5 days |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_187; REPORT_TITLE=OPINION ON Butylphenyl methylpropional (BMHCA); OPINION_NUMBER=SCCS/1540/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 August 2015; VALUE_TEXT=25; DOSE=induced systemic toxicity in both sexes at levels of ≥25 mg/kg bw/day and testicular toxicity in males at ≥50 mg/kg bw/day.; EFFECT=induced systemic toxicity in both sexes at levels of ≥25 mg/kg bw/day and testicular toxicity in males at ≥50 mg/kg bw/day. Thus oral NOAEL values of 5 mg/kg bw/day and 25 mg/kg bw/day can be derived for systemic effects and reproductive effects, respectively. This result has been further supported by reproductive toxicity studies (cf. below). Reproductive toxicity Adverse effects of BMHCA on the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies. A NOAEL of 25 mg/kg bw/day in male rats with regard to this endpoint is substantiated by studies applying the compound for 5 days, 90 days or in the frame of an 1-generation study over 6 weeks prior to mating. In all investigations available, testicular toxicity in rats was accompanied by signs of systemic toxicity. By contrast, other species such as mice and dogs were less sensitive. In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"induced systemic toxicity in both sexes at levels of ≥25 mg/kg bw/day and testicular toxicity in males at ≥50 mg/kg bw/day.","duration":"5 days","effect":"induced systemic toxicity in both sexes at levels of ≥25 mg/kg bw/day and testicular toxicity in males at ≥50 mg/kg bw/day. Thus oral NOAEL values of 5 mg/kg bw/day and 25 mg/kg bw/day can be derived for systemic effects and reproductive effects, respectively. This result has been further supported by reproductive toxicity studies (cf. below). Reproductive toxicity Adverse effects of BMHCA on the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies. A NOAEL of 25 mg/kg bw/day in male rats with regard to this endpoint is substantiated by studies applying the compound for 5 days, 90 days or in the frame of an 1-generation study over 6 weeks prior to mating. In all investigations available, testicular toxicity in rats was accompanied by signs of systemic toxicity. By contrast, other species such as mice and dogs were less sensitive. In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3","endpoint":"repeated dose toxicity","ingredient":"was introduced in Annex III of the Cosmetics Directive 76/768/EEC by the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"25","page":44,"route":"oral","species":"rat","study_id":"sccs_o_187_noael_019"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
40 |
mg/kg bw/day |
rat |
- |
5 days |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_187; REPORT_TITLE=OPINION ON Butylphenyl methylpropional (BMHCA); OPINION_NUMBER=SCCS/1540/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 August 2015; VALUE_TEXT=40; DOSE=the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies.; EFFECT=the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies. A NOAEL of 25 mg/kg bw/day in male rats with regard to this endpoint is substantiated by studies applying the compound for 5 days, 90 days or in the frame of an 1-generation study over 6 weeks prior to mating. In all investigations available, testicular toxicity in rats was accompanied by signs of systemic toxicity. By contrast, other species such as mice and dogs were less sensitive. In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months. So, from the animal data available male rats revealed as most sensitive species with regard to BMHCA-mediated testicular toxicity. On the other hand, in female rats developmental toxicity was accompanied by systemic toxicity and found already at lower concentrations. Here, a NOAEL is to be set at 5 mg/kg bw/day. This value is identical to the one defined for general; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies.","duration":"5 days","effect":"the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies. A NOAEL of 25 mg/kg bw/day in male rats with regard to this endpoint is substantiated by studies applying the compound for 5 days, 90 days or in the frame of an 1-generation study over 6 weeks prior to mating. In all investigations available, testicular toxicity in rats was accompanied by signs of systemic toxicity. By contrast, other species such as mice and dogs were less sensitive. In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months. So, from the animal data available male rats revealed as most sensitive species with regard to BMHCA-mediated testicular toxicity. On the other hand, in female rats developmental toxicity was accompanied by systemic toxicity and found already at lower concentrations. Here, a NOAEL is to be set at 5 mg/kg bw/day. This value is identical to the one defined for general","endpoint":"repeated dose toxicity","ingredient":"was introduced in Annex III of the Cosmetics Directive 76/768/EEC by the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"40","page":44,"route":"","species":"rat","study_id":"sccs_o_187_noael_020"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
25 |
mg/kg bw/day |
rat |
oral |
Subacute |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_189; REPORT_TITLE=OPINION ON Butylphenyl methylpropional (BMHCA); OPINION_NUMBER=SCCS/1540/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 March 2016; VALUE_TEXT=25; DOSE=dened testes in 1/8 rats at 200 mg/kg bw/day and in 6/8 rats at the highest dose group.; EFFECT=dened testes in 1/8 rats at 200 mg/kg bw/day and in 6/8 rats at the highest dose group. Kidney weights were decreased in the high dose group, and a dose-related decrease in the testes weights was observed at doses of ≥100 mg/kg bw/day. Histology of the testes revealed degeneration and loss of germ cells in the seminiferous epithelium at ≥50 mg/kg bw/day. Subacute administration of BMHCA to male rats led to treatment-related effects at ≥50 mg/kg bw/day including dose-related testicular findings. From this study the NOAEL derived was suggested at 25 mg/kg bw/day. The NOAEL of 25 mg/kg bw/day has been confirmed in a subsequent study (refs.: Givaudan, 1991, RIFM #16176). 3rd Study: Givaudan, 1990b, RIFM#12139 Guideline/Method: Explorative oral and toxicokinetics study Species/strain: Mice Group size: 5 males/group Test substance: BMHCA Batch: no data Purity: no data Vehicle: Rape oil Doses: 0, 100 mg/kg bw/day (5 mL/kg bw/day), once daily Route: Oral (gavage) Exposure: 5 days GLP: no Method: The animals were observed for mortality,; CITATION=(refs.: Givaudan, 1991, RIFM #16176); CITATION_NUMBERS=[1991,1617,6]; REFERENCE=(refs.: Givaudan, 1991, RIFM #16176); DETAILS_JSON={"cas_number":"80-54-6","citation":"(refs.: Givaudan, 1991, RIFM #16176)","dose":"dened testes in 1/8 rats at 200 mg/kg bw/day and in 6/8 rats at the highest dose group.","duration":"Subacute","effect":"dened testes in 1/8 rats at 200 mg/kg bw/day and in 6/8 rats at the highest dose group. Kidney weights were decreased in the high dose group, and a dose-related decrease in the testes weights was observed at doses of ≥100 mg/kg bw/day. Histology of the testes revealed degeneration and loss of germ cells in the seminiferous epithelium at ≥50 mg/kg bw/day. Subacute administration of BMHCA to male rats led to treatment-related effects at ≥50 mg/kg bw/day including dose-related testicular findings. From this study the NOAEL derived was suggested at 25 mg/kg bw/day. The NOAEL of 25 mg/kg bw/day has been confirmed in a subsequent study (refs.: Givaudan, 1991, RIFM #16176). 3rd Study: Givaudan, 1990b, RIFM#12139 Guideline/Method: Explorative oral and toxicokinetics study Species/strain: Mice Group size: 5 males/group Test substance: BMHCA Batch: no data Purity: no data Vehicle: Rape oil Doses: 0, 100 mg/kg bw/day (5 mL/kg bw/day), once daily Route: Oral (gavage) Exposure: 5 days GLP: no Method: The animals were observed for mortality,","endpoint":"repeated dose toxicity","ingredient":"was introduced in Annex III of the Cosmetics Directive 76/768/EEC by the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"25","page":21,"route":"oral","species":"rat","study_id":"sccs_o_189_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
25 |
mg/kg bw/day |
rat |
oral |
Subacute |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_189; REPORT_TITLE=OPINION ON Butylphenyl methylpropional (BMHCA); OPINION_NUMBER=SCCS/1540/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 March 2016; VALUE_TEXT=25; DOSE=6/8 rats at the highest dose group.; EFFECT=6/8 rats at the highest dose group. Kidney weights were decreased in the high dose group, and a dose-related decrease in the testes weights was observed at doses of ≥100 mg/kg bw/day. Histology of the testes revealed degeneration and loss of germ cells in the seminiferous epithelium at ≥50 mg/kg bw/day. Subacute administration of BMHCA to male rats led to treatment-related effects at ≥50 mg/kg bw/day including dose-related testicular findings. From this study the NOAEL derived was suggested at 25 mg/kg bw/day. The NOAEL of 25 mg/kg bw/day has been confirmed in a subsequent study (refs.: Givaudan, 1991, RIFM #16176). 3rd Study: Givaudan, 1990b, RIFM#12139 Guideline/Method: Explorative oral and toxicokinetics study Species/strain: Mice Group size: 5 males/group Test substance: BMHCA Batch: no data Purity: no data Vehicle: Rape oil Doses: 0, 100 mg/kg bw/day (5 mL/kg bw/day), once daily Route: Oral (gavage) Exposure: 5 days GLP: no Method: The animals were observed for mortality, clinical signs, and body weight changes. At terminat; CITATION=(refs.: Givaudan, 1991, RIFM #16176); CITATION_NUMBERS=[1991,1617,6]; REFERENCE=(refs.: Givaudan, 1991, RIFM #16176); DETAILS_JSON={"cas_number":"80-54-6","citation":"(refs.: Givaudan, 1991, RIFM #16176)","dose":"6/8 rats at the highest dose group.","duration":"Subacute","effect":"6/8 rats at the highest dose group. Kidney weights were decreased in the high dose group, and a dose-related decrease in the testes weights was observed at doses of ≥100 mg/kg bw/day. Histology of the testes revealed degeneration and loss of germ cells in the seminiferous epithelium at ≥50 mg/kg bw/day. Subacute administration of BMHCA to male rats led to treatment-related effects at ≥50 mg/kg bw/day including dose-related testicular findings. From this study the NOAEL derived was suggested at 25 mg/kg bw/day. The NOAEL of 25 mg/kg bw/day has been confirmed in a subsequent study (refs.: Givaudan, 1991, RIFM #16176). 3rd Study: Givaudan, 1990b, RIFM#12139 Guideline/Method: Explorative oral and toxicokinetics study Species/strain: Mice Group size: 5 males/group Test substance: BMHCA Batch: no data Purity: no data Vehicle: Rape oil Doses: 0, 100 mg/kg bw/day (5 mL/kg bw/day), once daily Route: Oral (gavage) Exposure: 5 days GLP: no Method: The animals were observed for mortality, clinical signs, and body weight changes. At terminat","endpoint":"repeated dose toxicity","ingredient":"was introduced in Annex III of the Cosmetics Directive 76/768/EEC by the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"25","page":21,"route":"oral","species":"rat","study_id":"sccs_o_189_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
5 |
mg/kg bw/day |
rat |
- |
Prenatal |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_189; REPORT_TITLE=OPINION ON Butylphenyl methylpropional (BMHCA); OPINION_NUMBER=SCCS/1540/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 March 2016; VALUE_TEXT=5; DOSE=xicity at 15 and 45 mg/kg bw/day, but not at 5 mg/kg bw/day (body weight gain and impaired liver function).; EFFECT=xicity at 15 and 45 mg/kg bw/day, but not at 5 mg/kg bw/day (body weight gain and impaired liver function). Gestation became affected at 45 mg/kg bw/day (increased number of post-implantation losses). Prenatal developmental toxicity with regard to reduced foetal body weights was observed in the mid- and high-dose groups, thereby corresponding to significant maternal toxicity at the same dose levels. Further, the overall incidence of skeletal variations was significantly increased in mid- and high-dose animals. The NOAEL for both maternal and prenatal developmental toxicity was 5 mg/kg bw/day (or 4.1 mg/kg bw/day, effective dose). SCCS conclusion on reproductive toxicity: Adverse effects of BMHCA on the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies. A NOAEL of 25 mg/kg bw/day in male rats with regard to this endpoint is substantiated by studies applying the compound for 5 days, 90 days or in the frame of a 1-generation study over 6 weeks prior to mating. It is; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"xicity at 15 and 45 mg/kg bw/day, but not at 5 mg/kg bw/day (body weight gain and impaired liver function).","duration":"Prenatal","effect":"xicity at 15 and 45 mg/kg bw/day, but not at 5 mg/kg bw/day (body weight gain and impaired liver function). Gestation became affected at 45 mg/kg bw/day (increased number of post-implantation losses). Prenatal developmental toxicity with regard to reduced foetal body weights was observed in the mid- and high-dose groups, thereby corresponding to significant maternal toxicity at the same dose levels. Further, the overall incidence of skeletal variations was significantly increased in mid- and high-dose animals. The NOAEL for both maternal and prenatal developmental toxicity was 5 mg/kg bw/day (or 4.1 mg/kg bw/day, effective dose). SCCS conclusion on reproductive toxicity: Adverse effects of BMHCA on the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies. A NOAEL of 25 mg/kg bw/day in male rats with regard to this endpoint is substantiated by studies applying the compound for 5 days, 90 days or in the frame of a 1-generation study over 6 weeks prior to mating. It is","endpoint":"repeated dose toxicity","ingredient":"was introduced in Annex III of the Cosmetics Directive 76/768/EEC by the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"5","page":31,"route":"","species":"rat","study_id":"sccs_o_189_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
25 |
mg/kg bw/day |
rat |
- |
prenatal |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_189; REPORT_TITLE=OPINION ON Butylphenyl methylpropional (BMHCA); OPINION_NUMBER=SCCS/1540/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 March 2016; VALUE_TEXT=25; DOSE=e groups, thereby corresponding to significant maternal toxicity at the same dose levels.; EFFECT=e groups, thereby corresponding to significant maternal toxicity at the same dose levels. Further, the overall incidence of skeletal variations was significantly increased in mid- and high-dose animals. The NOAEL for both maternal and prenatal developmental toxicity was 5 mg/kg bw/day (or 4.1 mg/kg bw/day, effective dose). SCCS conclusion on reproductive toxicity: Adverse effects of BMHCA on the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies. A NOAEL of 25 mg/kg bw/day in male rats with regard to this endpoint is substantiated by studies applying the compound for 5 days, 90 days or in the frame of a 1-generation study over 6 weeks prior to mating. It is to be emphasised that reproductive toxicity already became occasionally visible; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"e groups, thereby corresponding to significant maternal toxicity at the same dose levels.","duration":"prenatal","effect":"e groups, thereby corresponding to significant maternal toxicity at the same dose levels. Further, the overall incidence of skeletal variations was significantly increased in mid- and high-dose animals. The NOAEL for both maternal and prenatal developmental toxicity was 5 mg/kg bw/day (or 4.1 mg/kg bw/day, effective dose). SCCS conclusion on reproductive toxicity: Adverse effects of BMHCA on the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies. A NOAEL of 25 mg/kg bw/day in male rats with regard to this endpoint is substantiated by studies applying the compound for 5 days, 90 days or in the frame of a 1-generation study over 6 weeks prior to mating. It is to be emphasised that reproductive toxicity already became occasionally visible","endpoint":"repeated dose toxicity","ingredient":"was introduced in Annex III of the Cosmetics Directive 76/768/EEC by the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"25","page":31,"route":"","species":"rat","study_id":"sccs_o_189_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
5 |
mg/kg bw/day |
rat |
- |
2 weeks |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_189; REPORT_TITLE=OPINION ON Butylphenyl methylpropional (BMHCA); OPINION_NUMBER=SCCS/1540/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 March 2016; VALUE_TEXT=5; DOSE=In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months.; EFFECT=trast, other species such as mice and dogs were less sensitive (cf. 3.3.5.1. and 3.3.5.2.). In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months. So, from the animal data available male rats revealed as most sensitive species with regard to BMHCA-mediated testicular toxicity. On the other hand, in female rats developmental toxicity was accompanied by systemic toxicity and was already found at lower concentrations. Here, a NOAEL based on developmental toxicity is to be set at 5 mg/kg bw/day. This value is identical to the one defined for general systemic toxicity in rats based on repeated dose (90-days) toxicity studies (cf. 3.3.5.2.). Since the onset of developmental toxicity was tightly accompanied by maternal toxicity, the malformations and tissue variations observed likely resulted from general fetotoxicity rather than from specific teratogenicity. 3.3.9. Toxicokinetics 3.3.9.1. Metabolism in vitro Study (BASF SE 2010; GLP): Inves; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months.","duration":"2 weeks","effect":"trast, other species such as mice and dogs were less sensitive (cf. 3.3.5.1. and 3.3.5.2.). In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months. So, from the animal data available male rats revealed as most sensitive species with regard to BMHCA-mediated testicular toxicity. On the other hand, in female rats developmental toxicity was accompanied by systemic toxicity and was already found at lower concentrations. Here, a NOAEL based on developmental toxicity is to be set at 5 mg/kg bw/day. This value is identical to the one defined for general systemic toxicity in rats based on repeated dose (90-days) toxicity studies (cf. 3.3.5.2.). Since the onset of developmental toxicity was tightly accompanied by maternal toxicity, the malformations and tissue variations observed likely resulted from general fetotoxicity rather than from specific teratogenicity. 3.3.9. Toxicokinetics 3.3.9.1. Metabolism in vitro Study (BASF SE 2010; GLP): Inves","endpoint":"repeated dose toxicity","ingredient":"was introduced in Annex III of the Cosmetics Directive 76/768/EEC by the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"5","page":32,"route":"","species":"rat","study_id":"sccs_o_189_noael_012"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
50 |
mg/kg bw/day |
rat |
oral |
subacute |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_189; REPORT_TITLE=OPINION ON Butylphenyl methylpropional (BMHCA); OPINION_NUMBER=SCCS/1540/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 March 2016; VALUE_TEXT=50; DOSE=nd food consumption and/or clinical signs of toxicity were observed after subacute oral administration of BMHCA at doses of ≥50 mg/kg bw/day (rats) and ≥200 mg/kg bw/day (dogs).; EFFECT=nd food consumption and/or clinical signs of toxicity were observed after subacute oral administration of BMHCA at doses of ≥50 mg/kg bw/day (rats) and ≥200 mg/kg bw/day (dogs). Clinical chemistry and histopathological examinations repeatedly revealed adverse effects on the liver and male reproductive system (testicular toxicity). In a 90-day GLP study in rats BMHCA dose-dependently induced systemic toxicity in both sexes at levels of ≥25 mg/kg bw/day and testicular toxicity in males at ≥50 mg/kg bw/day. Thus oral NOAEL values of 5 mg/kg bw/day and 25 mg/kg bw/day can be derived; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"nd food consumption and/or clinical signs of toxicity were observed after subacute oral administration of BMHCA at doses of ≥50 mg/kg bw/day (rats) and ≥200 mg/kg bw/day (dogs).","duration":"subacute","effect":"nd food consumption and/or clinical signs of toxicity were observed after subacute oral administration of BMHCA at doses of ≥50 mg/kg bw/day (rats) and ≥200 mg/kg bw/day (dogs). Clinical chemistry and histopathological examinations repeatedly revealed adverse effects on the liver and male reproductive system (testicular toxicity). In a 90-day GLP study in rats BMHCA dose-dependently induced systemic toxicity in both sexes at levels of ≥25 mg/kg bw/day and testicular toxicity in males at ≥50 mg/kg bw/day. Thus oral NOAEL values of 5 mg/kg bw/day and 25 mg/kg bw/day can be derived","endpoint":"repeated dose toxicity","ingredient":"was introduced in Annex III of the Cosmetics Directive 76/768/EEC by the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":43,"route":"oral","species":"rat","study_id":"sccs_o_189_noael_017"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
25 |
mg/kg bw/day |
rat |
- |
5 days |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_189; REPORT_TITLE=OPINION ON Butylphenyl methylpropional (BMHCA); OPINION_NUMBER=SCCS/1540/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 March 2016; VALUE_TEXT=25; DOSE=Reproductive toxicity Adverse effects of BMHCA on the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies.; EFFECT=SCCS/1540/14 Revision of opinion on Butylphenyl methylpropional ___________________________________________________________________________________________ 44 for systemic effects and reproductive effects, respectively. This result has been further supported by reproductive toxicity studies (cf. below). Reproductive toxicity Adverse effects of BMHCA on the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies. A NOAEL of 25 mg/kg bw/day in male rats with regard to this endpoint is substantiated by studies applying the compound for 5 days, 90 days or in the frame of an 1-generation study over 6 weeks prior to mating. In all investigations available, testicular toxicity in rats was accompanied by signs of systemic toxicity. By contrast, other species such as mice and dogs were less sensitive. In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"Reproductive toxicity Adverse effects of BMHCA on the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies.","duration":"5 days","effect":"SCCS/1540/14 Revision of opinion on Butylphenyl methylpropional ___________________________________________________________________________________________ 44 for systemic effects and reproductive effects, respectively. This result has been further supported by reproductive toxicity studies (cf. below). Reproductive toxicity Adverse effects of BMHCA on the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies. A NOAEL of 25 mg/kg bw/day in male rats with regard to this endpoint is substantiated by studies applying the compound for 5 days, 90 days or in the frame of an 1-generation study over 6 weeks prior to mating. In all investigations available, testicular toxicity in rats was accompanied by signs of systemic toxicity. By contrast, other species such as mice and dogs were less sensitive. In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3","endpoint":"repeated dose toxicity","ingredient":"was introduced in Annex III of the Cosmetics Directive 76/768/EEC by the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"25","page":44,"route":"","species":"rat","study_id":"sccs_o_189_noael_018"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
40 |
mg/kg bw/day |
rat |
- |
5 days |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_189; REPORT_TITLE=OPINION ON Butylphenyl methylpropional (BMHCA); OPINION_NUMBER=SCCS/1540/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 March 2016; VALUE_TEXT=40; DOSE=the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies.; EFFECT=the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies. A NOAEL of 25 mg/kg bw/day in male rats with regard to this endpoint is substantiated by studies applying the compound for 5 days, 90 days or in the frame of an 1-generation study over 6 weeks prior to mating. In all investigations available, testicular toxicity in rats was accompanied by signs of systemic toxicity. By contrast, other species such as mice and dogs were less sensitive. In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months. So, from the animal data available male rats revealed as most sensitive species with regard to BMHCA-mediated testicular toxicity. On the other hand, in female rats developmental toxicity was accompanied by systemic toxicity and found already at lower concentrations. Here, a NOAEL is to be set at 5 mg/kg bw/day. This value is identical to the one defined for general systemic toxicity i; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies.","duration":"5 days","effect":"the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies. A NOAEL of 25 mg/kg bw/day in male rats with regard to this endpoint is substantiated by studies applying the compound for 5 days, 90 days or in the frame of an 1-generation study over 6 weeks prior to mating. In all investigations available, testicular toxicity in rats was accompanied by signs of systemic toxicity. By contrast, other species such as mice and dogs were less sensitive. In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months. So, from the animal data available male rats revealed as most sensitive species with regard to BMHCA-mediated testicular toxicity. On the other hand, in female rats developmental toxicity was accompanied by systemic toxicity and found already at lower concentrations. Here, a NOAEL is to be set at 5 mg/kg bw/day. This value is identical to the one defined for general systemic toxicity i","endpoint":"repeated dose toxicity","ingredient":"was introduced in Annex III of the Cosmetics Directive 76/768/EEC by the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"40","page":44,"route":"","species":"rat","study_id":"sccs_o_189_noael_019"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
5 |
mg/kg bw/day |
rat |
oral |
2 weeks |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_189; REPORT_TITLE=OPINION ON Butylphenyl methylpropional (BMHCA); OPINION_NUMBER=SCCS/1540/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 March 2016; VALUE_TEXT=5; DOSE=In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months.; EFFECT=gns of systemic toxicity. By contrast, other species such as mice and dogs were less sensitive. In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months. So, from the animal data available male rats revealed as most sensitive species with regard to BMHCA-mediated testicular toxicity. On the other hand, in female rats developmental toxicity was accompanied by systemic toxicity and found already at lower concentrations. Here, a NOAEL is to be set at 5 mg/kg bw/day. This value is identical to the one defined for general systemic toxicity in rats based on repeated dose toxicity studies (cf. above). The data available point to rats as most sensitive animal species tested. Toxicokinetic studies revealed that hepatic metabolism of BMHCA in rats results in significantly higher levels of TBBA when compared to other species. The SCCS is aware of older short-term studies applying TBBA to rats via the oral route and suggesting that this metabolite may a; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months.","duration":"2 weeks","effect":"gns of systemic toxicity. By contrast, other species such as mice and dogs were less sensitive. In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months. So, from the animal data available male rats revealed as most sensitive species with regard to BMHCA-mediated testicular toxicity. On the other hand, in female rats developmental toxicity was accompanied by systemic toxicity and found already at lower concentrations. Here, a NOAEL is to be set at 5 mg/kg bw/day. This value is identical to the one defined for general systemic toxicity in rats based on repeated dose toxicity studies (cf. above). The data available point to rats as most sensitive animal species tested. Toxicokinetic studies revealed that hepatic metabolism of BMHCA in rats results in significantly higher levels of TBBA when compared to other species. The SCCS is aware of older short-term studies applying TBBA to rats via the oral route and suggesting that this metabolite may a","endpoint":"repeated dose toxicity","ingredient":"was introduced in Annex III of the Cosmetics Directive 76/768/EEC by the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"5","page":44,"route":"oral","species":"rat","study_id":"sccs_o_189_noael_020"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
5 |
mg/kg bw/day |
rat |
oral |
90 days |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_213; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=5; DOSE=Decreases in plasma cholinesterase activity levels in both sexes of rats were observed after oral exposure to ≥25 mg/kg bw/day for 90 days.; EFFECT=tive than dogs to this compound irrespective of the length of treatment. Clinical chemistry and histopathological examinations repeatedly revealed adverse effects on the liver and male reproductive system. Decreases in plasma cholinesterase activity levels in both sexes of rats were observed after oral exposure to ≥25 mg/kg bw/day for 90 days. In addition, effects on adrenal glands in females were also observed at the same dose levels. From this most meaningful oral study, with respect to the doses administered, a NOAEL of 5 mg/kg bw/day can be derived for systemic effects. On the other hand, dermal administration in rats for 5 days led to adverse effects (including testicular toxicity) only at excessive dose levels (2000 mg/kg bw/day). No 90-day studies on dermal or inhalative administration were available. 3.3.5.1 Repeated dose short-term oral / dermal / inhalation toxicity Additional data from Applicant’s submission II dossier The results of screening studies provided (BASF SE, 2011b, SMI: 15, #59014 and Givaudan, 2009, SMI; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"Decreases in plasma cholinesterase activity levels in both sexes of rats were observed after oral exposure to ≥25 mg/kg bw/day for 90 days.","duration":"90 days","effect":"tive than dogs to this compound irrespective of the length of treatment. Clinical chemistry and histopathological examinations repeatedly revealed adverse effects on the liver and male reproductive system. Decreases in plasma cholinesterase activity levels in both sexes of rats were observed after oral exposure to ≥25 mg/kg bw/day for 90 days. In addition, effects on adrenal glands in females were also observed at the same dose levels. From this most meaningful oral study, with respect to the doses administered, a NOAEL of 5 mg/kg bw/day can be derived for systemic effects. On the other hand, dermal administration in rats for 5 days led to adverse effects (including testicular toxicity) only at excessive dose levels (2000 mg/kg bw/day). No 90-day studies on dermal or inhalative administration were available. 3.3.5.1 Repeated dose short-term oral / dermal / inhalation toxicity Additional data from Applicant’s submission II dossier The results of screening studies provided (BASF SE, 2011b, SMI: 15, #59014 and Givaudan, 2009, SMI","endpoint":"repeated dose toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"5","page":20,"route":"oral","species":"rat","study_id":"sccs_o_213_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
25 |
mg/kg bw/day |
rat |
- |
5 days |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_213; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=25; DOSE=Currently there is no evidence from repeated dose studies that p-BMHCA is able to induce hyperplasia or neoplasia.; EFFECT=S conclusion on carcinogenicity No carcinogenicity data are available for p-BMHCA. Currently there is no evidence from repeated dose studies that p-BMHCA is able to induce hyperplasia or neoplasia. Additional data from Applicant’s submission II dossier No additional data. 3.3.8 Reproductive toxicity From submission I SCCS conclusion on reproductive toxicity Adverse effects of p-BMHCA on the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies. A NOAEL of 25 mg/kg bw/day in male rats with regard to this endpoint is substantiated by studies applying the compound for 5 days, 90 days or in the frame of a 1-generation study over 6 weeks prior to mating. It is to be emphasised that reproductive toxicity already became occasionally visible after a single application of 50 mg/kg bw/day. In all investigations available, testicular toxicity in rats was accompanied by signs of systemic toxicity. By contrast, other species; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"Currently there is no evidence from repeated dose studies that p-BMHCA is able to induce hyperplasia or neoplasia.","duration":"5 days","effect":"S conclusion on carcinogenicity No carcinogenicity data are available for p-BMHCA. Currently there is no evidence from repeated dose studies that p-BMHCA is able to induce hyperplasia or neoplasia. Additional data from Applicant’s submission II dossier No additional data. 3.3.8 Reproductive toxicity From submission I SCCS conclusion on reproductive toxicity Adverse effects of p-BMHCA on the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies. A NOAEL of 25 mg/kg bw/day in male rats with regard to this endpoint is substantiated by studies applying the compound for 5 days, 90 days or in the frame of a 1-generation study over 6 weeks prior to mating. It is to be emphasised that reproductive toxicity already became occasionally visible after a single application of 50 mg/kg bw/day. In all investigations available, testicular toxicity in rats was accompanied by signs of systemic toxicity. By contrast, other species","endpoint":"repeated dose toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"25","page":34,"route":"","species":"rat","study_id":"sccs_o_213_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
5 |
mg/kg bw/day |
rat |
- |
2 weeks |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_213; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=5; DOSE=In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months.; EFFECT=_________________________________________ 35 such as mice and dogs were less sensitive. In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months. So, from the animal data available, male rats revealed as most sensitive species with regard to p-BMHCA-mediated testicular toxicity. On the other hand, in female rats developmental toxicity was accompanied by systemic toxicity and was already found at lower concentrations. Here, a NOAEL based on developmental toxicity is to be set at 5 mg/kg bw/day. This value is identical to the one defined for general systemic toxicity in rats based on repeated dose (90-days) toxicity studies. Since the onset of developmental toxicity was tightly accompanied by maternal toxicity, the malformations and tissue variations observed likely resulted from general fetotoxicity rather than from specific teratogenicity. 3.3.8.1 Two generation reproduction toxicity Additional data from Applicant’s submission II dossier; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months.","duration":"2 weeks","effect":"_________________________________________ 35 such as mice and dogs were less sensitive. In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months. So, from the animal data available, male rats revealed as most sensitive species with regard to p-BMHCA-mediated testicular toxicity. On the other hand, in female rats developmental toxicity was accompanied by systemic toxicity and was already found at lower concentrations. Here, a NOAEL based on developmental toxicity is to be set at 5 mg/kg bw/day. This value is identical to the one defined for general systemic toxicity in rats based on repeated dose (90-days) toxicity studies. Since the onset of developmental toxicity was tightly accompanied by maternal toxicity, the malformations and tissue variations observed likely resulted from general fetotoxicity rather than from specific teratogenicity. 3.3.8.1 Two generation reproduction toxicity Additional data from Applicant’s submission II dossier","endpoint":"repeated dose toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"5","page":35,"route":"","species":"rat","study_id":"sccs_o_213_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
45 |
mg/kg bw/d |
rat |
- |
Developmental |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_213; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=45; DOSE=SCCS overall comment on reproductive toxicity based on studies from submission I and II In the previous Opinion (SCCS/1540/14) the SCCS concluded that based on the study in which pregnant female rats were exposed to p-BMHCA at 5, 15 or 45 mg/kg bw/d (BASF SE, 2004, RIFM# 52014), a NOAEL based on developmental toxicity could be set at 5 mg/kg bw/...; EFFECT=osmetic products - Submission II ___________________________________________________________________________________________ 41 3.3.8.3 Developmental Toxicity Additional data from Applicant’s submission II dossier No additional data. SCCS overall comment on reproductive toxicity based on studies from submission I and II In the previous Opinion (SCCS/1540/14) the SCCS concluded that based on the study in which pregnant female rats were exposed to p-BMHCA at 5, 15 or 45 mg/kg bw/d (BASF SE, 2004, RIFM# 52014), a NOAEL based on developmental toxicity could be set at 5 mg/kg bw/day. This value was identical to the one defined for general systemic toxicity in rats based on repeated dose (90-days) toxicity studies (Givaudan, 1990a, RIFM #12144, Givaudan, 1990i, RIFM #12143). However, based on the study provided with submission II, the SCCS considers that the NOAEL for developmental toxicity should be set 4.5 mg/kg bw/d. 3.3.9 Toxicokinetics From submission I SCCS conclusion on toxicokinetics Quantitative data on the toxicokinet; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"SCCS overall comment on reproductive toxicity based on studies from submission I and II In the previous Opinion (SCCS/1540/14) the SCCS concluded that based on the study in which pregnant female rats were exposed to p-BMHCA at 5, 15 or 45 mg/kg bw/d (BASF SE, 2004, RIFM# 52014), a NOAEL based on developmental toxicity could be set at 5 mg/kg bw/...","duration":"Developmental","effect":"osmetic products - Submission II ___________________________________________________________________________________________ 41 3.3.8.3 Developmental Toxicity Additional data from Applicant’s submission II dossier No additional data. SCCS overall comment on reproductive toxicity based on studies from submission I and II In the previous Opinion (SCCS/1540/14) the SCCS concluded that based on the study in which pregnant female rats were exposed to p-BMHCA at 5, 15 or 45 mg/kg bw/d (BASF SE, 2004, RIFM# 52014), a NOAEL based on developmental toxicity could be set at 5 mg/kg bw/day. This value was identical to the one defined for general systemic toxicity in rats based on repeated dose (90-days) toxicity studies (Givaudan, 1990a, RIFM #12144, Givaudan, 1990i, RIFM #12143). However, based on the study provided with submission II, the SCCS considers that the NOAEL for developmental toxicity should be set 4.5 mg/kg bw/d. 3.3.9 Toxicokinetics From submission I SCCS conclusion on toxicokinetics Quantitative data on the toxicokinet","endpoint":"repeated dose toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"45","page":41,"route":"","species":"rat","study_id":"sccs_o_213_noael_014"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
4.5 |
mg/kg bw/d |
rat |
oral |
developmental |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_213; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=4.5; DOSE=(SCCS/1540/14) the SCCS concluded that based on the study in which pregnant female rats were exposed to p-BMHCA at 5, 15 or 45 mg/kg bw/d (BASF SE, 2004, RIFM# 52014), a NOAEL based on developmental toxicity could be set at 5 mg/kg bw/day.; EFFECT=(SCCS/1540/14) the SCCS concluded that based on the study in which pregnant female rats were exposed to p-BMHCA at 5, 15 or 45 mg/kg bw/d (BASF SE, 2004, RIFM# 52014), a NOAEL based on developmental toxicity could be set at 5 mg/kg bw/day. This value was identical to the one defined for general systemic toxicity in rats based on repeated dose (90-days) toxicity studies (Givaudan, 1990a, RIFM #12144, Givaudan, 1990i, RIFM #12143). However, based on the study provided with submission II, the SCCS considers that the NOAEL for developmental toxicity should be set 4.5 mg/kg bw/d. 3.3.9 Toxicokinetics From submission I SCCS conclusion on toxicokinetics Quantitative data on the toxicokinetics of p-BMHCA are available from rat, mouse, rabbit, guinea pig, dog and rhesus monkey and human studies. Given its physicochemical properties, p-BMHCA is likely to have high bioavailability via the oral route. After oral and dermal administration to experimental animals and humans, there is clear evidence of systemic absorption of p-BMHCA. Howev; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"(SCCS/1540/14) the SCCS concluded that based on the study in which pregnant female rats were exposed to p-BMHCA at 5, 15 or 45 mg/kg bw/d (BASF SE, 2004, RIFM# 52014), a NOAEL based on developmental toxicity could be set at 5 mg/kg bw/day.","duration":"developmental","effect":"(SCCS/1540/14) the SCCS concluded that based on the study in which pregnant female rats were exposed to p-BMHCA at 5, 15 or 45 mg/kg bw/d (BASF SE, 2004, RIFM# 52014), a NOAEL based on developmental toxicity could be set at 5 mg/kg bw/day. This value was identical to the one defined for general systemic toxicity in rats based on repeated dose (90-days) toxicity studies (Givaudan, 1990a, RIFM #12144, Givaudan, 1990i, RIFM #12143). However, based on the study provided with submission II, the SCCS considers that the NOAEL for developmental toxicity should be set 4.5 mg/kg bw/d. 3.3.9 Toxicokinetics From submission I SCCS conclusion on toxicokinetics Quantitative data on the toxicokinetics of p-BMHCA are available from rat, mouse, rabbit, guinea pig, dog and rhesus monkey and human studies. Given its physicochemical properties, p-BMHCA is likely to have high bioavailability via the oral route. After oral and dermal administration to experimental animals and humans, there is clear evidence of systemic absorption of p-BMHCA. Howev","endpoint":"repeated dose toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"4.5","page":41,"route":"oral","species":"rat","study_id":"sccs_o_213_noael_015"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
50 |
mg/kg bw/day |
rat |
oral |
subacute |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_213; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=50; DOSE=food consumption and/or clinical signs of toxicity were observed after subacute oral administration of p-BMHCA at doses of ≥50 mg/kg bw/day (rats) and ≥200 mg/kg bw/day (dogs).; EFFECT=food consumption and/or clinical signs of toxicity were observed after subacute oral administration of p-BMHCA at doses of ≥50 mg/kg bw/day (rats) and ≥200 mg/kg bw/day (dogs). Clinical chemistry and histopathological examinations repeatedly revealed adverse effects on the liver and male reproductive system (testicular toxicity). In a 90-day GLP study in rats BMHCA dose-dependently induced systemic toxicity in both sexes at levels of ≥25 mg/kg bw/day and testicular toxicity in males at ≥50 mg/kg bw/day. Thus oral NOAEL values of 5 mg/kg bw/day and 25 mg/kg bw/day were derived for systemic effects and reproductive effects, respectively. Reproductive toxicity Based on the previous SCCS Opinion (SCCS/1540/14) and submission II: Adverse effects of p-BMHCA on the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies. A NOAEL of 25 mg/kg bw/day in male rats with regard to this endpoint is substantiated by studies applying the compound for 5 days, 90 days or in the frame o; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"food consumption and/or clinical signs of toxicity were observed after subacute oral administration of p-BMHCA at doses of ≥50 mg/kg bw/day (rats) and ≥200 mg/kg bw/day (dogs).","duration":"subacute","effect":"food consumption and/or clinical signs of toxicity were observed after subacute oral administration of p-BMHCA at doses of ≥50 mg/kg bw/day (rats) and ≥200 mg/kg bw/day (dogs). Clinical chemistry and histopathological examinations repeatedly revealed adverse effects on the liver and male reproductive system (testicular toxicity). In a 90-day GLP study in rats BMHCA dose-dependently induced systemic toxicity in both sexes at levels of ≥25 mg/kg bw/day and testicular toxicity in males at ≥50 mg/kg bw/day. Thus oral NOAEL values of 5 mg/kg bw/day and 25 mg/kg bw/day were derived for systemic effects and reproductive effects, respectively. Reproductive toxicity Based on the previous SCCS Opinion (SCCS/1540/14) and submission II: Adverse effects of p-BMHCA on the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies. A NOAEL of 25 mg/kg bw/day in male rats with regard to this endpoint is substantiated by studies applying the compound for 5 days, 90 days or in the frame o","endpoint":"repeated dose toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":49,"route":"oral","species":"rat","study_id":"sccs_o_213_noael_017"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
25 |
mg/kg bw/day |
rat |
oral |
5 days |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_213; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=25; DOSE=se-dependently induced systemic toxicity in both sexes at levels of ≥25 mg/kg bw/day and testicular toxicity in males at ≥50 mg/kg bw/day.; EFFECT=se-dependently induced systemic toxicity in both sexes at levels of ≥25 mg/kg bw/day and testicular toxicity in males at ≥50 mg/kg bw/day. Thus oral NOAEL values of 5 mg/kg bw/day and 25 mg/kg bw/day were derived for systemic effects and reproductive effects, respectively. Reproductive toxicity Based on the previous SCCS Opinion (SCCS/1540/14) and submission II: Adverse effects of p-BMHCA on the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies. A NOAEL of 25 mg/kg bw/day in male rats with regard to this endpoint is substantiated by studies applying the compound for 5 days, 90 days or in the frame of a 1-generation study over 6 weeks prior to mating. In all investigations available, testicular toxicity in rats was accompanied by signs of systemic toxicity. By contrast, other species such as mice and dogs were less sensitive. In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"se-dependently induced systemic toxicity in both sexes at levels of ≥25 mg/kg bw/day and testicular toxicity in males at ≥50 mg/kg bw/day.","duration":"5 days","effect":"se-dependently induced systemic toxicity in both sexes at levels of ≥25 mg/kg bw/day and testicular toxicity in males at ≥50 mg/kg bw/day. Thus oral NOAEL values of 5 mg/kg bw/day and 25 mg/kg bw/day were derived for systemic effects and reproductive effects, respectively. Reproductive toxicity Based on the previous SCCS Opinion (SCCS/1540/14) and submission II: Adverse effects of p-BMHCA on the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies. A NOAEL of 25 mg/kg bw/day in male rats with regard to this endpoint is substantiated by studies applying the compound for 5 days, 90 days or in the frame of a 1-generation study over 6 weeks prior to mating. In all investigations available, testicular toxicity in rats was accompanied by signs of systemic toxicity. By contrast, other species such as mice and dogs were less sensitive. In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3","endpoint":"repeated dose toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"25","page":49,"route":"oral","species":"rat","study_id":"sccs_o_213_noael_018"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
40 |
mg/kg bw/day |
rat |
- |
5 days |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_213; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=40; DOSE=the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies.; EFFECT=the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies. A NOAEL of 25 mg/kg bw/day in male rats with regard to this endpoint is substantiated by studies applying the compound for 5 days, 90 days or in the frame of a 1-generation study over 6 weeks prior to mating. In all investigations available, testicular toxicity in rats was accompanied by signs of systemic toxicity. By contrast, other species such as mice and dogs were less sensitive. In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months. So, from the animal data available, male rats revealed as the most sensitive species with regard to p-BMHCA- mediated testicular toxicity. On the other hand, in female rats developmental toxicity was accompanied by systemic toxicity and found already at lower concentrations. Here, a NOAEL is to be set at 5 mg/kg bw/day. This value is identical to the one defined for general systemic to; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies.","duration":"5 days","effect":"the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies. A NOAEL of 25 mg/kg bw/day in male rats with regard to this endpoint is substantiated by studies applying the compound for 5 days, 90 days or in the frame of a 1-generation study over 6 weeks prior to mating. In all investigations available, testicular toxicity in rats was accompanied by signs of systemic toxicity. By contrast, other species such as mice and dogs were less sensitive. In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months. So, from the animal data available, male rats revealed as the most sensitive species with regard to p-BMHCA- mediated testicular toxicity. On the other hand, in female rats developmental toxicity was accompanied by systemic toxicity and found already at lower concentrations. Here, a NOAEL is to be set at 5 mg/kg bw/day. This value is identical to the one defined for general systemic to","endpoint":"repeated dose toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"40","page":49,"route":"","species":"rat","study_id":"sccs_o_213_noael_019"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
5 |
mg/kg bw/day |
rat |
- |
2 weeks |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_213; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=5; DOSE=In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months.; EFFECT=ystemic toxicity. By contrast, other species such as mice and dogs were less sensitive. In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months. So, from the animal data available, male rats revealed as the most sensitive species with regard to p-BMHCA- mediated testicular toxicity. On the other hand, in female rats developmental toxicity was accompanied by systemic toxicity and found already at lower concentrations. Here, a NOAEL is to be set at 5 mg/kg bw/day. This value is identical to the one defined for general systemic toxicity in rats based on repeated dose toxicity studies. The data available point to; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months.","duration":"2 weeks","effect":"ystemic toxicity. By contrast, other species such as mice and dogs were less sensitive. In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months. So, from the animal data available, male rats revealed as the most sensitive species with regard to p-BMHCA- mediated testicular toxicity. On the other hand, in female rats developmental toxicity was accompanied by systemic toxicity and found already at lower concentrations. Here, a NOAEL is to be set at 5 mg/kg bw/day. This value is identical to the one defined for general systemic toxicity in rats based on repeated dose toxicity studies. The data available point to","endpoint":"repeated dose toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"5","page":49,"route":"","species":"rat","study_id":"sccs_o_213_noael_020"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
5 |
mg/kg bw/day |
rat |
oral |
90 days |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_213_0; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=5; DOSE=Decreases in plasma cholinesterase activity levels in both sexes of rats were observed after oral exposure to ≥25 mg/kg bw/day for 90 days.; EFFECT=tive than dogs to this compound irrespective of the length of treatment. Clinical chemistry and histopathological examinations repeatedly revealed adverse effects on the liver and male reproductive system. Decreases in plasma cholinesterase activity levels in both sexes of rats were observed after oral exposure to ≥25 mg/kg bw/day for 90 days. In addition, effects on adrenal glands in females were also observed at the same dose levels. From this most meaningful oral study, with respect to the doses administered, a NOAEL of 5 mg/kg bw/day can be derived for systemic effects. On the other hand, dermal administration in rats for 5 days led to adverse effects (including testicular toxicity) only at excessive dose levels (2000 mg/kg bw/day). No 90-day studies on dermal or inhalative administration were available. 3.3.5.1 Repeated dose short-term oral / dermal / inhalation toxicity Additional data from Applicant’s submission II dossier The results of screening studies provided (BASF SE, 2011b, SMI: 15, #59014 and Givaudan, 2009, SMI; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"Decreases in plasma cholinesterase activity levels in both sexes of rats were observed after oral exposure to ≥25 mg/kg bw/day for 90 days.","duration":"90 days","effect":"tive than dogs to this compound irrespective of the length of treatment. Clinical chemistry and histopathological examinations repeatedly revealed adverse effects on the liver and male reproductive system. Decreases in plasma cholinesterase activity levels in both sexes of rats were observed after oral exposure to ≥25 mg/kg bw/day for 90 days. In addition, effects on adrenal glands in females were also observed at the same dose levels. From this most meaningful oral study, with respect to the doses administered, a NOAEL of 5 mg/kg bw/day can be derived for systemic effects. On the other hand, dermal administration in rats for 5 days led to adverse effects (including testicular toxicity) only at excessive dose levels (2000 mg/kg bw/day). No 90-day studies on dermal or inhalative administration were available. 3.3.5.1 Repeated dose short-term oral / dermal / inhalation toxicity Additional data from Applicant’s submission II dossier The results of screening studies provided (BASF SE, 2011b, SMI: 15, #59014 and Givaudan, 2009, SMI","endpoint":"repeated dose toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"5","page":20,"route":"oral","species":"rat","study_id":"sccs_o_213_0_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
25 |
mg/kg bw/day |
rat |
- |
5 days |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_213_0; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=25; DOSE=Currently there is no evidence from repeated dose studies that p-BMHCA is able to induce hyperplasia or neoplasia.; EFFECT=S conclusion on carcinogenicity No carcinogenicity data are available for p-BMHCA. Currently there is no evidence from repeated dose studies that p-BMHCA is able to induce hyperplasia or neoplasia. Additional data from Applicant’s submission II dossier No additional data. 3.3.8 Reproductive toxicity From submission I SCCS conclusion on reproductive toxicity Adverse effects of p-BMHCA on the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies. A NOAEL of 25 mg/kg bw/day in male rats with regard to this endpoint is substantiated by studies applying the compound for 5 days, 90 days or in the frame of a 1-generation study over 6 weeks prior to mating. It is to be emphasised that reproductive toxicity already became occasionally visible after a single application of 50 mg/kg bw/day. In all investigations available, testicular toxicity in rats was accompanied by signs of systemic toxicity. By contrast, other species; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"Currently there is no evidence from repeated dose studies that p-BMHCA is able to induce hyperplasia or neoplasia.","duration":"5 days","effect":"S conclusion on carcinogenicity No carcinogenicity data are available for p-BMHCA. Currently there is no evidence from repeated dose studies that p-BMHCA is able to induce hyperplasia or neoplasia. Additional data from Applicant’s submission II dossier No additional data. 3.3.8 Reproductive toxicity From submission I SCCS conclusion on reproductive toxicity Adverse effects of p-BMHCA on the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies. A NOAEL of 25 mg/kg bw/day in male rats with regard to this endpoint is substantiated by studies applying the compound for 5 days, 90 days or in the frame of a 1-generation study over 6 weeks prior to mating. It is to be emphasised that reproductive toxicity already became occasionally visible after a single application of 50 mg/kg bw/day. In all investigations available, testicular toxicity in rats was accompanied by signs of systemic toxicity. By contrast, other species","endpoint":"repeated dose toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"25","page":34,"route":"","species":"rat","study_id":"sccs_o_213_0_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
5 |
mg/kg bw/day |
rat |
- |
2 weeks |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_213_0; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=5; DOSE=In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months.; EFFECT=_________________________________________ 35 such as mice and dogs were less sensitive. In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months. So, from the animal data available, male rats revealed as most sensitive species with regard to p-BMHCA-mediated testicular toxicity. On the other hand, in female rats developmental toxicity was accompanied by systemic toxicity and was already found at lower concentrations. Here, a NOAEL based on developmental toxicity is to be set at 5 mg/kg bw/day. This value is identical to the one defined for general systemic toxicity in rats based on repeated dose (90-days) toxicity studies. Since the onset of developmental toxicity was tightly accompanied by maternal toxicity, the malformations and tissue variations observed likely resulted from general fetotoxicity rather than from specific teratogenicity. 3.3.8.1 Two generation reproduction toxicity Additional data from Applicant’s submission II dossier; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months.","duration":"2 weeks","effect":"_________________________________________ 35 such as mice and dogs were less sensitive. In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months. So, from the animal data available, male rats revealed as most sensitive species with regard to p-BMHCA-mediated testicular toxicity. On the other hand, in female rats developmental toxicity was accompanied by systemic toxicity and was already found at lower concentrations. Here, a NOAEL based on developmental toxicity is to be set at 5 mg/kg bw/day. This value is identical to the one defined for general systemic toxicity in rats based on repeated dose (90-days) toxicity studies. Since the onset of developmental toxicity was tightly accompanied by maternal toxicity, the malformations and tissue variations observed likely resulted from general fetotoxicity rather than from specific teratogenicity. 3.3.8.1 Two generation reproduction toxicity Additional data from Applicant’s submission II dossier","endpoint":"repeated dose toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"5","page":35,"route":"","species":"rat","study_id":"sccs_o_213_0_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
45 |
mg/kg bw/d |
rat |
- |
Developmental |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_213_0; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=45; DOSE=SCCS overall comment on reproductive toxicity based on studies from submission I and II In the previous Opinion (SCCS/1540/14) the SCCS concluded that based on the study in which pregnant female rats were exposed to p-BMHCA at 5, 15 or 45 mg/kg bw/d (BASF SE, 2004, RIFM# 52014), a NOAEL based on developmental toxicity could be set at 5 mg/kg bw/...; EFFECT=osmetic products - Submission II ___________________________________________________________________________________________ 41 3.3.8.3 Developmental Toxicity Additional data from Applicant’s submission II dossier No additional data. SCCS overall comment on reproductive toxicity based on studies from submission I and II In the previous Opinion (SCCS/1540/14) the SCCS concluded that based on the study in which pregnant female rats were exposed to p-BMHCA at 5, 15 or 45 mg/kg bw/d (BASF SE, 2004, RIFM# 52014), a NOAEL based on developmental toxicity could be set at 5 mg/kg bw/day. This value was identical to the one defined for general systemic toxicity in rats based on repeated dose (90-days) toxicity studies (Givaudan, 1990a, RIFM #12144, Givaudan, 1990i, RIFM #12143). However, based on the study provided with submission II, the SCCS considers that the NOAEL for developmental toxicity should be set 4.5 mg/kg bw/d. 3.3.9 Toxicokinetics From submission I SCCS conclusion on toxicokinetics Quantitative data on the toxicokinet; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"SCCS overall comment on reproductive toxicity based on studies from submission I and II In the previous Opinion (SCCS/1540/14) the SCCS concluded that based on the study in which pregnant female rats were exposed to p-BMHCA at 5, 15 or 45 mg/kg bw/d (BASF SE, 2004, RIFM# 52014), a NOAEL based on developmental toxicity could be set at 5 mg/kg bw/...","duration":"Developmental","effect":"osmetic products - Submission II ___________________________________________________________________________________________ 41 3.3.8.3 Developmental Toxicity Additional data from Applicant’s submission II dossier No additional data. SCCS overall comment on reproductive toxicity based on studies from submission I and II In the previous Opinion (SCCS/1540/14) the SCCS concluded that based on the study in which pregnant female rats were exposed to p-BMHCA at 5, 15 or 45 mg/kg bw/d (BASF SE, 2004, RIFM# 52014), a NOAEL based on developmental toxicity could be set at 5 mg/kg bw/day. This value was identical to the one defined for general systemic toxicity in rats based on repeated dose (90-days) toxicity studies (Givaudan, 1990a, RIFM #12144, Givaudan, 1990i, RIFM #12143). However, based on the study provided with submission II, the SCCS considers that the NOAEL for developmental toxicity should be set 4.5 mg/kg bw/d. 3.3.9 Toxicokinetics From submission I SCCS conclusion on toxicokinetics Quantitative data on the toxicokinet","endpoint":"repeated dose toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"45","page":41,"route":"","species":"rat","study_id":"sccs_o_213_0_noael_014"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
4.5 |
mg/kg bw/d |
rat |
oral |
developmental |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_213_0; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=4.5; DOSE=(SCCS/1540/14) the SCCS concluded that based on the study in which pregnant female rats were exposed to p-BMHCA at 5, 15 or 45 mg/kg bw/d (BASF SE, 2004, RIFM# 52014), a NOAEL based on developmental toxicity could be set at 5 mg/kg bw/day.; EFFECT=(SCCS/1540/14) the SCCS concluded that based on the study in which pregnant female rats were exposed to p-BMHCA at 5, 15 or 45 mg/kg bw/d (BASF SE, 2004, RIFM# 52014), a NOAEL based on developmental toxicity could be set at 5 mg/kg bw/day. This value was identical to the one defined for general systemic toxicity in rats based on repeated dose (90-days) toxicity studies (Givaudan, 1990a, RIFM #12144, Givaudan, 1990i, RIFM #12143). However, based on the study provided with submission II, the SCCS considers that the NOAEL for developmental toxicity should be set 4.5 mg/kg bw/d. 3.3.9 Toxicokinetics From submission I SCCS conclusion on toxicokinetics Quantitative data on the toxicokinetics of p-BMHCA are available from rat, mouse, rabbit, guinea pig, dog and rhesus monkey and human studies. Given its physicochemical properties, p-BMHCA is likely to have high bioavailability via the oral route. After oral and dermal administration to experimental animals and humans, there is clear evidence of systemic absorption of p-BMHCA. Howev; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"(SCCS/1540/14) the SCCS concluded that based on the study in which pregnant female rats were exposed to p-BMHCA at 5, 15 or 45 mg/kg bw/d (BASF SE, 2004, RIFM# 52014), a NOAEL based on developmental toxicity could be set at 5 mg/kg bw/day.","duration":"developmental","effect":"(SCCS/1540/14) the SCCS concluded that based on the study in which pregnant female rats were exposed to p-BMHCA at 5, 15 or 45 mg/kg bw/d (BASF SE, 2004, RIFM# 52014), a NOAEL based on developmental toxicity could be set at 5 mg/kg bw/day. This value was identical to the one defined for general systemic toxicity in rats based on repeated dose (90-days) toxicity studies (Givaudan, 1990a, RIFM #12144, Givaudan, 1990i, RIFM #12143). However, based on the study provided with submission II, the SCCS considers that the NOAEL for developmental toxicity should be set 4.5 mg/kg bw/d. 3.3.9 Toxicokinetics From submission I SCCS conclusion on toxicokinetics Quantitative data on the toxicokinetics of p-BMHCA are available from rat, mouse, rabbit, guinea pig, dog and rhesus monkey and human studies. Given its physicochemical properties, p-BMHCA is likely to have high bioavailability via the oral route. After oral and dermal administration to experimental animals and humans, there is clear evidence of systemic absorption of p-BMHCA. Howev","endpoint":"repeated dose toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"4.5","page":41,"route":"oral","species":"rat","study_id":"sccs_o_213_0_noael_015"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
50 |
mg/kg bw/day |
rat |
oral |
subacute |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_213_0; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=50; DOSE=food consumption and/or clinical signs of toxicity were observed after subacute oral administration of p-BMHCA at doses of ≥50 mg/kg bw/day (rats) and ≥200 mg/kg bw/day (dogs).; EFFECT=food consumption and/or clinical signs of toxicity were observed after subacute oral administration of p-BMHCA at doses of ≥50 mg/kg bw/day (rats) and ≥200 mg/kg bw/day (dogs). Clinical chemistry and histopathological examinations repeatedly revealed adverse effects on the liver and male reproductive system (testicular toxicity). In a 90-day GLP study in rats BMHCA dose-dependently induced systemic toxicity in both sexes at levels of ≥25 mg/kg bw/day and testicular toxicity in males at ≥50 mg/kg bw/day. Thus oral NOAEL values of 5 mg/kg bw/day and 25 mg/kg bw/day were derived for systemic effects and reproductive effects, respectively. Reproductive toxicity Based on the previous SCCS Opinion (SCCS/1540/14) and submission II: Adverse effects of p-BMHCA on the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies. A NOAEL of 25 mg/kg bw/day in male rats with regard to this endpoint is substantiated by studies applying the compound for 5 days, 90 days or in the frame o; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"food consumption and/or clinical signs of toxicity were observed after subacute oral administration of p-BMHCA at doses of ≥50 mg/kg bw/day (rats) and ≥200 mg/kg bw/day (dogs).","duration":"subacute","effect":"food consumption and/or clinical signs of toxicity were observed after subacute oral administration of p-BMHCA at doses of ≥50 mg/kg bw/day (rats) and ≥200 mg/kg bw/day (dogs). Clinical chemistry and histopathological examinations repeatedly revealed adverse effects on the liver and male reproductive system (testicular toxicity). In a 90-day GLP study in rats BMHCA dose-dependently induced systemic toxicity in both sexes at levels of ≥25 mg/kg bw/day and testicular toxicity in males at ≥50 mg/kg bw/day. Thus oral NOAEL values of 5 mg/kg bw/day and 25 mg/kg bw/day were derived for systemic effects and reproductive effects, respectively. Reproductive toxicity Based on the previous SCCS Opinion (SCCS/1540/14) and submission II: Adverse effects of p-BMHCA on the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies. A NOAEL of 25 mg/kg bw/day in male rats with regard to this endpoint is substantiated by studies applying the compound for 5 days, 90 days or in the frame o","endpoint":"repeated dose toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":49,"route":"oral","species":"rat","study_id":"sccs_o_213_0_noael_017"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
25 |
mg/kg bw/day |
rat |
oral |
5 days |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_213_0; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=25; DOSE=se-dependently induced systemic toxicity in both sexes at levels of ≥25 mg/kg bw/day and testicular toxicity in males at ≥50 mg/kg bw/day.; EFFECT=se-dependently induced systemic toxicity in both sexes at levels of ≥25 mg/kg bw/day and testicular toxicity in males at ≥50 mg/kg bw/day. Thus oral NOAEL values of 5 mg/kg bw/day and 25 mg/kg bw/day were derived for systemic effects and reproductive effects, respectively. Reproductive toxicity Based on the previous SCCS Opinion (SCCS/1540/14) and submission II: Adverse effects of p-BMHCA on the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies. A NOAEL of 25 mg/kg bw/day in male rats with regard to this endpoint is substantiated by studies applying the compound for 5 days, 90 days or in the frame of a 1-generation study over 6 weeks prior to mating. In all investigations available, testicular toxicity in rats was accompanied by signs of systemic toxicity. By contrast, other species such as mice and dogs were less sensitive. In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"se-dependently induced systemic toxicity in both sexes at levels of ≥25 mg/kg bw/day and testicular toxicity in males at ≥50 mg/kg bw/day.","duration":"5 days","effect":"se-dependently induced systemic toxicity in both sexes at levels of ≥25 mg/kg bw/day and testicular toxicity in males at ≥50 mg/kg bw/day. Thus oral NOAEL values of 5 mg/kg bw/day and 25 mg/kg bw/day were derived for systemic effects and reproductive effects, respectively. Reproductive toxicity Based on the previous SCCS Opinion (SCCS/1540/14) and submission II: Adverse effects of p-BMHCA on the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies. A NOAEL of 25 mg/kg bw/day in male rats with regard to this endpoint is substantiated by studies applying the compound for 5 days, 90 days or in the frame of a 1-generation study over 6 weeks prior to mating. In all investigations available, testicular toxicity in rats was accompanied by signs of systemic toxicity. By contrast, other species such as mice and dogs were less sensitive. In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3","endpoint":"repeated dose toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"25","page":49,"route":"oral","species":"rat","study_id":"sccs_o_213_0_noael_018"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
40 |
mg/kg bw/day |
rat |
- |
5 days |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_213_0; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=40; DOSE=the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies.; EFFECT=the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies. A NOAEL of 25 mg/kg bw/day in male rats with regard to this endpoint is substantiated by studies applying the compound for 5 days, 90 days or in the frame of a 1-generation study over 6 weeks prior to mating. In all investigations available, testicular toxicity in rats was accompanied by signs of systemic toxicity. By contrast, other species such as mice and dogs were less sensitive. In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months. So, from the animal data available, male rats revealed as the most sensitive species with regard to p-BMHCA- mediated testicular toxicity. On the other hand, in female rats developmental toxicity was accompanied by systemic toxicity and found already at lower concentrations. Here, a NOAEL is to be set at 5 mg/kg bw/day. This value is identical to the one defined for general systemic to; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies.","duration":"5 days","effect":"the male reproductive system have been consistently observed in several repeated dose and reproduction toxicity studies. A NOAEL of 25 mg/kg bw/day in male rats with regard to this endpoint is substantiated by studies applying the compound for 5 days, 90 days or in the frame of a 1-generation study over 6 weeks prior to mating. In all investigations available, testicular toxicity in rats was accompanied by signs of systemic toxicity. By contrast, other species such as mice and dogs were less sensitive. In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months. So, from the animal data available, male rats revealed as the most sensitive species with regard to p-BMHCA- mediated testicular toxicity. On the other hand, in female rats developmental toxicity was accompanied by systemic toxicity and found already at lower concentrations. Here, a NOAEL is to be set at 5 mg/kg bw/day. This value is identical to the one defined for general systemic to","endpoint":"repeated dose toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"40","page":49,"route":"","species":"rat","study_id":"sccs_o_213_0_noael_019"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
5 |
mg/kg bw/day |
rat |
- |
2 weeks |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_213_0; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=5; DOSE=In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months.; EFFECT=ystemic toxicity. By contrast, other species such as mice and dogs were less sensitive. In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months. So, from the animal data available, male rats revealed as the most sensitive species with regard to p-BMHCA- mediated testicular toxicity. On the other hand, in female rats developmental toxicity was accompanied by systemic toxicity and found already at lower concentrations. Here, a NOAEL is to be set at 5 mg/kg bw/day. This value is identical to the one defined for general systemic toxicity in rats based on repeated dose toxicity studies. The data available point to; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months.","duration":"2 weeks","effect":"ystemic toxicity. By contrast, other species such as mice and dogs were less sensitive. In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity after treatment periods of 2 weeks and 3 months. So, from the animal data available, male rats revealed as the most sensitive species with regard to p-BMHCA- mediated testicular toxicity. On the other hand, in female rats developmental toxicity was accompanied by systemic toxicity and found already at lower concentrations. Here, a NOAEL is to be set at 5 mg/kg bw/day. This value is identical to the one defined for general systemic toxicity in rats based on repeated dose toxicity studies. The data available point to","endpoint":"repeated dose toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"5","page":49,"route":"","species":"rat","study_id":"sccs_o_213_0_noael_020"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
5 |
mg/kg bw/day |
rat |
oral |
90 days |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_187; REPORT_TITLE=OPINION ON Butylphenyl methylpropional (BMHCA); OPINION_NUMBER=SCCS/1540/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 August 2015; VALUE_TEXT=5; DOSE=Decreases in plasma cholinesterase activity levels in both sexes of rats were observed after oral exposure to ≥25 mg/kg bw/day for 90 days.; EFFECT=gainst this compound compared to dogs. Clinical chemistry and histopathological examinations repeatedly revealed adverse effects on the liver and male reproductive system (testicular toxicity; cf. 3.3.8.). Decreases in plasma cholinesterase activity levels in both sexes of rats were observed after oral exposure to ≥25 mg/kg bw/day for 90 days. In addition, effects on adrenal glands in females were also observed at the same dose levels. From this most meaningful oral study, with respect to the doses administered, a NOAEL of 5 mg/kg bw/day can be derived for systemic effects. On the other hand, dermal administration in rats for 5 days led to adverse effects (including testicular toxicity) only at excessive dose levels (2000 mg/kg bw/day). No 90-days studies on dermal or inhalative administration were available. 3.3.5.3. Chronic (> 12 months) toxicity No data available. 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"Decreases in plasma cholinesterase activity levels in both sexes of rats were observed after oral exposure to ≥25 mg/kg bw/day for 90 days.","duration":"90 days","effect":"gainst this compound compared to dogs. Clinical chemistry and histopathological examinations repeatedly revealed adverse effects on the liver and male reproductive system (testicular toxicity; cf. 3.3.8.). Decreases in plasma cholinesterase activity levels in both sexes of rats were observed after oral exposure to ≥25 mg/kg bw/day for 90 days. In addition, effects on adrenal glands in females were also observed at the same dose levels. From this most meaningful oral study, with respect to the doses administered, a NOAEL of 5 mg/kg bw/day can be derived for systemic effects. On the other hand, dermal administration in rats for 5 days led to adverse effects (including testicular toxicity) only at excessive dose levels (2000 mg/kg bw/day). No 90-days studies on dermal or inhalative administration were available. 3.3.5.3. Chronic (> 12 months) toxicity No data available. 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro","endpoint":"reproductive toxicity","ingredient":"was introduced in Annex III of the Cosmetics Directive 76/768/EEC by the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"5","page":25,"route":"oral","species":"rat","study_id":"sccs_o_187_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
~14.5 |
mg/kg bw/day |
rat |
oral |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_187; REPORT_TITLE=OPINION ON Butylphenyl methylpropional (BMHCA); OPINION_NUMBER=SCCS/1540/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 August 2015; VALUE_TEXT=~14.5; DOSE=19% (400/200 ppm) and 22% (800/400 ppm).; LOAEL_VALUE=28.7 mg/kg bw/day; EFFECT=een day 0 and 4. No pup mortality was observed between postnatal day 4 and 21. Birth weight reduction: 19% (400/200 ppm) and 22% (800/400 ppm). Reduction of pup weight at weaning and pup weight gain: 17%/16% (400/200 ppm) and 21%/21% (800/200 ppm). Based on these data it can be concluded that dietary administration of BMHCA led to dose- dependent signs of systemic and reproductive toxicity (impaired fertility and pre-postnatal developmental toxicity). The dose of 400 ppm (~14.5 mg/kg bw/day) was suggested to be a NOAEL in males and a LOAEL in females (dams) with regard to systemic toxicity. By contrast, 800 ppm (~28.7 mg/kg bw/day) was suggested as NOAEL with regard to testicular (reproductive) toxicity. SCCS comment: The suggested NOAEL of ~29 mg/kg bw/day in rats with regard to testicular toxicity is in line with the observation from a 90-day study in rats (see section 3.3.5.2.1.). In this latter study a NOAEL of 25 mg/kg bw/day was derived for testicular toxicity. Similar as with this 1-generation study, in the 90-days study; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"19% (400/200 ppm) and 22% (800/400 ppm).","duration":"developmental","effect":"een day 0 and 4. No pup mortality was observed between postnatal day 4 and 21. Birth weight reduction: 19% (400/200 ppm) and 22% (800/400 ppm). Reduction of pup weight at weaning and pup weight gain: 17%/16% (400/200 ppm) and 21%/21% (800/200 ppm). Based on these data it can be concluded that dietary administration of BMHCA led to dose- dependent signs of systemic and reproductive toxicity (impaired fertility and pre-postnatal developmental toxicity). The dose of 400 ppm (~14.5 mg/kg bw/day) was suggested to be a NOAEL in males and a LOAEL in females (dams) with regard to systemic toxicity. By contrast, 800 ppm (~28.7 mg/kg bw/day) was suggested as NOAEL with regard to testicular (reproductive) toxicity. SCCS comment: The suggested NOAEL of ~29 mg/kg bw/day in rats with regard to testicular toxicity is in line with the observation from a 90-day study in rats (see section 3.3.5.2.1.). In this latter study a NOAEL of 25 mg/kg bw/day was derived for testicular toxicity. Similar as with this 1-generation study, in the 90-days study","endpoint":"reproductive toxicity","ingredient":"was introduced in Annex III of the Cosmetics Directive 76/768/EEC by the","loael_value":"28.7 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"~14.5","page":30,"route":"oral","species":"rat","study_id":"sccs_o_187_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
~28.7 |
mg/kg bw/day |
rat |
oral |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_187; REPORT_TITLE=OPINION ON Butylphenyl methylpropional (BMHCA); OPINION_NUMBER=SCCS/1540/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 August 2015; VALUE_TEXT=~28.7; DOSE=17%/16% (400/200 ppm) and 21%/21% (800/200 ppm).; LOAEL_VALUE=28.7 mg/kg bw/day; EFFECT=ppm). Reduction of pup weight at weaning and pup weight gain: 17%/16% (400/200 ppm) and 21%/21% (800/200 ppm). Based on these data it can be concluded that dietary administration of BMHCA led to dose- dependent signs of systemic and reproductive toxicity (impaired fertility and pre-postnatal developmental toxicity). The dose of 400 ppm (~14.5 mg/kg bw/day) was suggested to be a NOAEL in males and a LOAEL in females (dams) with regard to systemic toxicity. By contrast, 800 ppm (~28.7 mg/kg bw/day) was suggested as NOAEL with regard to testicular (reproductive) toxicity. SCCS comment: The suggested NOAEL of ~29 mg/kg bw/day in rats with regard to testicular toxicity is in line with the observation from a 90-day study in rats (see section 3.3.5.2.1.). In this latter study a NOAEL of 25 mg/kg bw/day was derived for testicular toxicity. Similar as with this 1-generation study, in the 90-days study the NOAEL derived for systemic toxicity was lower, too (i.e., 5 mg/kg bw/day). 3.3.8.2. Teratogenicity Study: BASF SE, 2004, RIFM# 520; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"17%/16% (400/200 ppm) and 21%/21% (800/200 ppm).","duration":"developmental","effect":"ppm). Reduction of pup weight at weaning and pup weight gain: 17%/16% (400/200 ppm) and 21%/21% (800/200 ppm). Based on these data it can be concluded that dietary administration of BMHCA led to dose- dependent signs of systemic and reproductive toxicity (impaired fertility and pre-postnatal developmental toxicity). The dose of 400 ppm (~14.5 mg/kg bw/day) was suggested to be a NOAEL in males and a LOAEL in females (dams) with regard to systemic toxicity. By contrast, 800 ppm (~28.7 mg/kg bw/day) was suggested as NOAEL with regard to testicular (reproductive) toxicity. SCCS comment: The suggested NOAEL of ~29 mg/kg bw/day in rats with regard to testicular toxicity is in line with the observation from a 90-day study in rats (see section 3.3.5.2.1.). In this latter study a NOAEL of 25 mg/kg bw/day was derived for testicular toxicity. Similar as with this 1-generation study, in the 90-days study the NOAEL derived for systemic toxicity was lower, too (i.e., 5 mg/kg bw/day). 3.3.8.2. Teratogenicity Study: BASF SE, 2004, RIFM# 520","endpoint":"reproductive toxicity","ingredient":"was introduced in Annex III of the Cosmetics Directive 76/768/EEC by the","loael_value":"28.7 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"~28.7","page":30,"route":"oral","species":"rat","study_id":"sccs_o_187_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
~29 |
mg/kg bw/day |
rat |
oral |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_187; REPORT_TITLE=OPINION ON Butylphenyl methylpropional (BMHCA); OPINION_NUMBER=SCCS/1540/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 August 2015; VALUE_TEXT=~29; DOSE=d 21%/21% (800/200 ppm).; LOAEL_VALUE=28.7 mg/kg bw/day; EFFECT=d 21%/21% (800/200 ppm). Based on these data it can be concluded that dietary administration of BMHCA led to dose- dependent signs of systemic and reproductive toxicity (impaired fertility and pre-postnatal developmental toxicity). The dose of 400 ppm (~14.5 mg/kg bw/day) was suggested to be a NOAEL in males and a LOAEL in females (dams) with regard to systemic toxicity. By contrast, 800 ppm (~28.7 mg/kg bw/day) was suggested as NOAEL with regard to testicular (reproductive) toxicity. SCCS comment: The suggested NOAEL of ~29 mg/kg bw/day in rats with regard to testicular toxicity is in line with the observation from a 90-day study in rats (see section 3.3.5.2.1.). In this latter study a NOAEL of 25 mg/kg bw/day was derived for testicular toxicity. Similar as with this 1-generation study, in the 90-days study the NOAEL derived for systemic toxicity was lower, too (i.e., 5 mg/kg bw/day). 3.3.8.2. Teratogenicity Study: BASF SE, 2004, RIFM# 52014 Guideline/Method: OECD 414, 87/302/EEC, US EPA OPPTS 870.3700 Species/strain: Rat (; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"d 21%/21% (800/200 ppm).","duration":"developmental","effect":"d 21%/21% (800/200 ppm). Based on these data it can be concluded that dietary administration of BMHCA led to dose- dependent signs of systemic and reproductive toxicity (impaired fertility and pre-postnatal developmental toxicity). The dose of 400 ppm (~14.5 mg/kg bw/day) was suggested to be a NOAEL in males and a LOAEL in females (dams) with regard to systemic toxicity. By contrast, 800 ppm (~28.7 mg/kg bw/day) was suggested as NOAEL with regard to testicular (reproductive) toxicity. SCCS comment: The suggested NOAEL of ~29 mg/kg bw/day in rats with regard to testicular toxicity is in line with the observation from a 90-day study in rats (see section 3.3.5.2.1.). In this latter study a NOAEL of 25 mg/kg bw/day was derived for testicular toxicity. Similar as with this 1-generation study, in the 90-days study the NOAEL derived for systemic toxicity was lower, too (i.e., 5 mg/kg bw/day). 3.3.8.2. Teratogenicity Study: BASF SE, 2004, RIFM# 52014 Guideline/Method: OECD 414, 87/302/EEC, US EPA OPPTS 870.3700 Species/strain: Rat (","endpoint":"reproductive toxicity","ingredient":"was introduced in Annex III of the Cosmetics Directive 76/768/EEC by the","loael_value":"28.7 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"~29","page":30,"route":"oral","species":"rat","study_id":"sccs_o_187_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
25 |
mg/kg bw/day |
rat |
- |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_187; REPORT_TITLE=OPINION ON Butylphenyl methylpropional (BMHCA); OPINION_NUMBER=SCCS/1540/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 August 2015; VALUE_TEXT=25; DOSE=The dose of 400 ppm (~14.5 mg/kg bw/day) was suggested to be a NOAEL in males and a LOAEL in females (dams) with regard to systemic toxicity.; LOAEL_VALUE=28.7 mg/kg bw/day; EFFECT=d fertility and pre-postnatal developmental toxicity). The dose of 400 ppm (~14.5 mg/kg bw/day) was suggested to be a NOAEL in males and a LOAEL in females (dams) with regard to systemic toxicity. By contrast, 800 ppm (~28.7 mg/kg bw/day) was suggested as NOAEL with regard to testicular (reproductive) toxicity. SCCS comment: The suggested NOAEL of ~29 mg/kg bw/day in rats with regard to testicular toxicity is in line with the observation from a 90-day study in rats (see section 3.3.5.2.1.). In this latter study a NOAEL of 25 mg/kg bw/day was derived for testicular toxicity. Similar as with this 1-generation study, in the 90-days study the NOAEL derived for systemic toxicity was lower, too (i.e., 5 mg/kg bw/day). 3.3.8.2. Teratogenicity Study: BASF SE, 2004, RIFM# 52014 Guideline/Method: OECD 414, 87/302/EEC, US EPA OPPTS 870.3700 Species/strain: Rat (Wistar) Group size: 25 pregnant rats/group Test substance: BMHCA Batch: 000STD77L0 Purity: 98.1% Doses: 0, 5, 15, 45 mg/kg bw/day (effective doses: 0, 4.1, 12.7, 40.7 mg/kg bw/da; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"The dose of 400 ppm (~14.5 mg/kg bw/day) was suggested to be a NOAEL in males and a LOAEL in females (dams) with regard to systemic toxicity.","duration":"developmental","effect":"d fertility and pre-postnatal developmental toxicity). The dose of 400 ppm (~14.5 mg/kg bw/day) was suggested to be a NOAEL in males and a LOAEL in females (dams) with regard to systemic toxicity. By contrast, 800 ppm (~28.7 mg/kg bw/day) was suggested as NOAEL with regard to testicular (reproductive) toxicity. SCCS comment: The suggested NOAEL of ~29 mg/kg bw/day in rats with regard to testicular toxicity is in line with the observation from a 90-day study in rats (see section 3.3.5.2.1.). In this latter study a NOAEL of 25 mg/kg bw/day was derived for testicular toxicity. Similar as with this 1-generation study, in the 90-days study the NOAEL derived for systemic toxicity was lower, too (i.e., 5 mg/kg bw/day). 3.3.8.2. Teratogenicity Study: BASF SE, 2004, RIFM# 52014 Guideline/Method: OECD 414, 87/302/EEC, US EPA OPPTS 870.3700 Species/strain: Rat (Wistar) Group size: 25 pregnant rats/group Test substance: BMHCA Batch: 000STD77L0 Purity: 98.1% Doses: 0, 5, 15, 45 mg/kg bw/day (effective doses: 0, 4.1, 12.7, 40.7 mg/kg bw/da","endpoint":"reproductive toxicity","ingredient":"was introduced in Annex III of the Cosmetics Directive 76/768/EEC by the","loael_value":"28.7 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"25","page":30,"route":"","species":"rat","study_id":"sccs_o_187_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
5 |
mg/kg bw/day |
rat |
oral |
90-day |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_187; REPORT_TITLE=OPINION ON Butylphenyl methylpropional (BMHCA); OPINION_NUMBER=SCCS/1540/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 August 2015; VALUE_TEXT=5; DOSE=By contrast, 800 ppm (~28.7 mg/kg bw/day) was suggested as NOAEL with regard to testicular (reproductive) toxicity.; LOAEL_VALUE=28.7 mg/kg bw/day; EFFECT=ales and a LOAEL in females (dams) with regard to systemic toxicity. By contrast, 800 ppm (~28.7 mg/kg bw/day) was suggested as NOAEL with regard to testicular (reproductive) toxicity. SCCS comment: The suggested NOAEL of ~29 mg/kg bw/day in rats with regard to testicular toxicity is in line with the observation from a 90-day study in rats (see section 3.3.5.2.1.). In this latter study a NOAEL of 25 mg/kg bw/day was derived for testicular toxicity. Similar as with this 1-generation study, in the 90-days study the NOAEL derived for systemic toxicity was lower, too (i.e., 5 mg/kg bw/day). 3.3.8.2. Teratogenicity Study: BASF SE, 2004, RIFM# 52014 Guideline/Method: OECD 414, 87/302/EEC, US EPA OPPTS 870.3700 Species/strain: Rat (Wistar) Group size: 25 pregnant rats/group Test substance: BMHCA Batch: 000STD77L0 Purity: 98.1% Doses: 0, 5, 15, 45 mg/kg bw/day (effective doses: 0, 4.1, 12.7, 40.7 mg/kg bw/day) Vehicle: Olive oil Route: Oral (gavage) Application volume: 5 mL/kg bw Exposure period: gestation days 6 – 20 GLP: yes Study; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"By contrast, 800 ppm (~28.7 mg/kg bw/day) was suggested as NOAEL with regard to testicular (reproductive) toxicity.","duration":"90-day","effect":"ales and a LOAEL in females (dams) with regard to systemic toxicity. By contrast, 800 ppm (~28.7 mg/kg bw/day) was suggested as NOAEL with regard to testicular (reproductive) toxicity. SCCS comment: The suggested NOAEL of ~29 mg/kg bw/day in rats with regard to testicular toxicity is in line with the observation from a 90-day study in rats (see section 3.3.5.2.1.). In this latter study a NOAEL of 25 mg/kg bw/day was derived for testicular toxicity. Similar as with this 1-generation study, in the 90-days study the NOAEL derived for systemic toxicity was lower, too (i.e., 5 mg/kg bw/day). 3.3.8.2. Teratogenicity Study: BASF SE, 2004, RIFM# 52014 Guideline/Method: OECD 414, 87/302/EEC, US EPA OPPTS 870.3700 Species/strain: Rat (Wistar) Group size: 25 pregnant rats/group Test substance: BMHCA Batch: 000STD77L0 Purity: 98.1% Doses: 0, 5, 15, 45 mg/kg bw/day (effective doses: 0, 4.1, 12.7, 40.7 mg/kg bw/day) Vehicle: Olive oil Route: Oral (gavage) Application volume: 5 mL/kg bw Exposure period: gestation days 6 – 20 GLP: yes Study","endpoint":"reproductive toxicity","ingredient":"was introduced in Annex III of the Cosmetics Directive 76/768/EEC by the","loael_value":"28.7 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"5","page":30,"route":"oral","species":"rat","study_id":"sccs_o_187_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
40 |
mg/kg bw/day |
rat |
- |
5 days |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_187; REPORT_TITLE=OPINION ON Butylphenyl methylpropional (BMHCA); OPINION_NUMBER=SCCS/1540/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 August 2015; VALUE_TEXT=40; DOSE=It is to be emphasised that reproductive toxicity already occasionally became visible after a single application of 50 mg/kg bw/day.; EFFECT=h regard to this endpoint is substantiated by studies applying the compound for 5 days, 90 days or in the frame of an 1-generation study over 6 weeks prior until mating. It is to be emphasised that reproductive toxicity already occasionally became visible after a single application of 50 mg/kg bw/day. In all investigations available, testicular toxicity in rats was accompanied by signs of systemic toxicity. By contrast, other species such as mice and dogs were less sensitive (cf. 3.3.5.1. and 3.3.5.2.). In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"It is to be emphasised that reproductive toxicity already occasionally became visible after a single application of 50 mg/kg bw/day.","duration":"5 days","effect":"h regard to this endpoint is substantiated by studies applying the compound for 5 days, 90 days or in the frame of an 1-generation study over 6 weeks prior until mating. It is to be emphasised that reproductive toxicity already occasionally became visible after a single application of 50 mg/kg bw/day. In all investigations available, testicular toxicity in rats was accompanied by signs of systemic toxicity. By contrast, other species such as mice and dogs were less sensitive (cf. 3.3.5.1. and 3.3.5.2.). In dogs, a NOAEL of 40 mg/kg bw/day has been established based on the onset of testicular toxicity","endpoint":"reproductive toxicity","ingredient":"was introduced in Annex III of the Cosmetics Directive 76/768/EEC by the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"40","page":31,"route":"","species":"rat","study_id":"sccs_o_187_noael_012"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
5 |
mg/kg bw/day |
rat |
oral |
90 days |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_189; REPORT_TITLE=OPINION ON Butylphenyl methylpropional (BMHCA); OPINION_NUMBER=SCCS/1540/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 March 2016; VALUE_TEXT=5; DOSE=Decreases in plasma cholinesterase activity levels in both sexes of rats were observed after oral exposure to ≥25 mg/kg bw/day for 90 days.; EFFECT=sensitive than dogs to this compound. Clinical chemistry and histopathological examinations repeatedly revealed adverse effects on the liver and male reproductive system (testicular toxicity; cf. 3.3.8.). Decreases in plasma cholinesterase activity levels in both sexes of rats were observed after oral exposure to ≥25 mg/kg bw/day for 90 days. In addition, effects on adrenal glands in females were also observed at the same dose levels. From this most meaningful oral study, with respect to the doses administered, a NOAEL of 5 mg/kg bw/day can be derived for systemic effects. On the other hand, dermal administration in rats for 5 days led to adverse effects (including testicular toxicity) only at excessive dose levels (2000 mg/kg bw/day). No 90-day studies on dermal or inhalative administration were available. 3.3.5.3. Chronic (> 12 months) toxicity No data available.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"Decreases in plasma cholinesterase activity levels in both sexes of rats were observed after oral exposure to ≥25 mg/kg bw/day for 90 days.","duration":"90 days","effect":"sensitive than dogs to this compound. Clinical chemistry and histopathological examinations repeatedly revealed adverse effects on the liver and male reproductive system (testicular toxicity; cf. 3.3.8.). Decreases in plasma cholinesterase activity levels in both sexes of rats were observed after oral exposure to ≥25 mg/kg bw/day for 90 days. In addition, effects on adrenal glands in females were also observed at the same dose levels. From this most meaningful oral study, with respect to the doses administered, a NOAEL of 5 mg/kg bw/day can be derived for systemic effects. On the other hand, dermal administration in rats for 5 days led to adverse effects (including testicular toxicity) only at excessive dose levels (2000 mg/kg bw/day). No 90-day studies on dermal or inhalative administration were available. 3.3.5.3. Chronic (> 12 months) toxicity No data available.","endpoint":"reproductive toxicity","ingredient":"was introduced in Annex III of the Cosmetics Directive 76/768/EEC by the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"5","page":25,"route":"oral","species":"rat","study_id":"sccs_o_189_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
~14.5 |
mg/kg bw/day |
rat |
oral |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_189; REPORT_TITLE=OPINION ON Butylphenyl methylpropional (BMHCA); OPINION_NUMBER=SCCS/1540/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 March 2016; VALUE_TEXT=~14.5; DOSE=19% (400/200 ppm) and 22% (800/400 ppm).; LOAEL_VALUE=28.7 mg/kg bw/day; EFFECT=een day 0 and 4. No pup mortality was observed between postnatal day 4 and 21. Birth weight reduction: 19% (400/200 ppm) and 22% (800/400 ppm). Reduction of pup weight at weaning and pup weight gain: 17%/16% (400/200 ppm) and 21%/21% (800/200 ppm). Based on these data it can be concluded that dietary administration of BMHCA led to dose- dependent signs of systemic and reproductive toxicity (impaired fertility and pre-postnatal developmental toxicity). The dose of 400 ppm (~14.5 mg/kg bw/day) was suggested to be a NOAEL in males and a LOAEL in females (dams) with regard to systemic toxicity. By contrast, 800 ppm (~28.7 mg/kg bw/day) was suggested as NOAEL with regard to testicular (reproductive) toxicity. SCCS comment: The suggested NOAEL of ~29 mg/kg bw/day in rats with regard to testicular toxicity is in line with the observation from a 90-day study in rats (see section 3.3.5.2.1.). In this latter study a NOAEL of 25 mg/kg bw/day was derived for testicular toxicity. Similar as with this 1-generation study, in the 90-day study; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"19% (400/200 ppm) and 22% (800/400 ppm).","duration":"developmental","effect":"een day 0 and 4. No pup mortality was observed between postnatal day 4 and 21. Birth weight reduction: 19% (400/200 ppm) and 22% (800/400 ppm). Reduction of pup weight at weaning and pup weight gain: 17%/16% (400/200 ppm) and 21%/21% (800/200 ppm). Based on these data it can be concluded that dietary administration of BMHCA led to dose- dependent signs of systemic and reproductive toxicity (impaired fertility and pre-postnatal developmental toxicity). The dose of 400 ppm (~14.5 mg/kg bw/day) was suggested to be a NOAEL in males and a LOAEL in females (dams) with regard to systemic toxicity. By contrast, 800 ppm (~28.7 mg/kg bw/day) was suggested as NOAEL with regard to testicular (reproductive) toxicity. SCCS comment: The suggested NOAEL of ~29 mg/kg bw/day in rats with regard to testicular toxicity is in line with the observation from a 90-day study in rats (see section 3.3.5.2.1.). In this latter study a NOAEL of 25 mg/kg bw/day was derived for testicular toxicity. Similar as with this 1-generation study, in the 90-day study","endpoint":"reproductive toxicity","ingredient":"was introduced in Annex III of the Cosmetics Directive 76/768/EEC by the","loael_value":"28.7 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"~14.5","page":30,"route":"oral","species":"rat","study_id":"sccs_o_189_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
~28.7 |
mg/kg bw/day |
rat |
oral |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_189; REPORT_TITLE=OPINION ON Butylphenyl methylpropional (BMHCA); OPINION_NUMBER=SCCS/1540/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 March 2016; VALUE_TEXT=~28.7; DOSE=17%/16% (400/200 ppm) and 21%/21% (800/200 ppm).; LOAEL_VALUE=28.7 mg/kg bw/day; EFFECT=ppm). Reduction of pup weight at weaning and pup weight gain: 17%/16% (400/200 ppm) and 21%/21% (800/200 ppm). Based on these data it can be concluded that dietary administration of BMHCA led to dose- dependent signs of systemic and reproductive toxicity (impaired fertility and pre-postnatal developmental toxicity). The dose of 400 ppm (~14.5 mg/kg bw/day) was suggested to be a NOAEL in males and a LOAEL in females (dams) with regard to systemic toxicity. By contrast, 800 ppm (~28.7 mg/kg bw/day) was suggested as NOAEL with regard to testicular (reproductive) toxicity. SCCS comment: The suggested NOAEL of ~29 mg/kg bw/day in rats with regard to testicular toxicity is in line with the observation from a 90-day study in rats (see section 3.3.5.2.1.). In this latter study a NOAEL of 25 mg/kg bw/day was derived for testicular toxicity. Similar as with this 1-generation study, in the 90-day study the NOAEL derived for systemic toxicity was also lower (i.e., 5 mg/kg bw/day). 3.3.8.2. Teratogenicity Study: BASF SE, 2004, RIFM# 5201; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"17%/16% (400/200 ppm) and 21%/21% (800/200 ppm).","duration":"developmental","effect":"ppm). Reduction of pup weight at weaning and pup weight gain: 17%/16% (400/200 ppm) and 21%/21% (800/200 ppm). Based on these data it can be concluded that dietary administration of BMHCA led to dose- dependent signs of systemic and reproductive toxicity (impaired fertility and pre-postnatal developmental toxicity). The dose of 400 ppm (~14.5 mg/kg bw/day) was suggested to be a NOAEL in males and a LOAEL in females (dams) with regard to systemic toxicity. By contrast, 800 ppm (~28.7 mg/kg bw/day) was suggested as NOAEL with regard to testicular (reproductive) toxicity. SCCS comment: The suggested NOAEL of ~29 mg/kg bw/day in rats with regard to testicular toxicity is in line with the observation from a 90-day study in rats (see section 3.3.5.2.1.). In this latter study a NOAEL of 25 mg/kg bw/day was derived for testicular toxicity. Similar as with this 1-generation study, in the 90-day study the NOAEL derived for systemic toxicity was also lower (i.e., 5 mg/kg bw/day). 3.3.8.2. Teratogenicity Study: BASF SE, 2004, RIFM# 5201","endpoint":"reproductive toxicity","ingredient":"was introduced in Annex III of the Cosmetics Directive 76/768/EEC by the","loael_value":"28.7 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"~28.7","page":30,"route":"oral","species":"rat","study_id":"sccs_o_189_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
~29 |
mg/kg bw/day |
rat |
oral |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_189; REPORT_TITLE=OPINION ON Butylphenyl methylpropional (BMHCA); OPINION_NUMBER=SCCS/1540/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 March 2016; VALUE_TEXT=~29; DOSE=d 21%/21% (800/200 ppm).; LOAEL_VALUE=28.7 mg/kg bw/day; EFFECT=d 21%/21% (800/200 ppm). Based on these data it can be concluded that dietary administration of BMHCA led to dose- dependent signs of systemic and reproductive toxicity (impaired fertility and pre-postnatal developmental toxicity). The dose of 400 ppm (~14.5 mg/kg bw/day) was suggested to be a NOAEL in males and a LOAEL in females (dams) with regard to systemic toxicity. By contrast, 800 ppm (~28.7 mg/kg bw/day) was suggested as NOAEL with regard to testicular (reproductive) toxicity. SCCS comment: The suggested NOAEL of ~29 mg/kg bw/day in rats with regard to testicular toxicity is in line with the observation from a 90-day study in rats (see section 3.3.5.2.1.). In this latter study a NOAEL of 25 mg/kg bw/day was derived for testicular toxicity. Similar as with this 1-generation study, in the 90-day study the NOAEL derived for systemic toxicity was also lower (i.e., 5 mg/kg bw/day). 3.3.8.2. Teratogenicity Study: BASF SE, 2004, RIFM# 52014 Guideline/Method: OECD 414, 87/302/EEC, US EPA OPPTS 870.3700 Species/strain: Rat (W; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"d 21%/21% (800/200 ppm).","duration":"developmental","effect":"d 21%/21% (800/200 ppm). Based on these data it can be concluded that dietary administration of BMHCA led to dose- dependent signs of systemic and reproductive toxicity (impaired fertility and pre-postnatal developmental toxicity). The dose of 400 ppm (~14.5 mg/kg bw/day) was suggested to be a NOAEL in males and a LOAEL in females (dams) with regard to systemic toxicity. By contrast, 800 ppm (~28.7 mg/kg bw/day) was suggested as NOAEL with regard to testicular (reproductive) toxicity. SCCS comment: The suggested NOAEL of ~29 mg/kg bw/day in rats with regard to testicular toxicity is in line with the observation from a 90-day study in rats (see section 3.3.5.2.1.). In this latter study a NOAEL of 25 mg/kg bw/day was derived for testicular toxicity. Similar as with this 1-generation study, in the 90-day study the NOAEL derived for systemic toxicity was also lower (i.e., 5 mg/kg bw/day). 3.3.8.2. Teratogenicity Study: BASF SE, 2004, RIFM# 52014 Guideline/Method: OECD 414, 87/302/EEC, US EPA OPPTS 870.3700 Species/strain: Rat (W","endpoint":"reproductive toxicity","ingredient":"was introduced in Annex III of the Cosmetics Directive 76/768/EEC by the","loael_value":"28.7 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"~29","page":30,"route":"oral","species":"rat","study_id":"sccs_o_189_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
25 |
mg/kg bw/day |
rat |
- |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_189; REPORT_TITLE=OPINION ON Butylphenyl methylpropional (BMHCA); OPINION_NUMBER=SCCS/1540/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 March 2016; VALUE_TEXT=25; DOSE=The dose of 400 ppm (~14.5 mg/kg bw/day) was suggested to be a NOAEL in males and a LOAEL in females (dams) with regard to systemic toxicity.; LOAEL_VALUE=28.7 mg/kg bw/day; EFFECT=d fertility and pre-postnatal developmental toxicity). The dose of 400 ppm (~14.5 mg/kg bw/day) was suggested to be a NOAEL in males and a LOAEL in females (dams) with regard to systemic toxicity. By contrast, 800 ppm (~28.7 mg/kg bw/day) was suggested as NOAEL with regard to testicular (reproductive) toxicity. SCCS comment: The suggested NOAEL of ~29 mg/kg bw/day in rats with regard to testicular toxicity is in line with the observation from a 90-day study in rats (see section 3.3.5.2.1.). In this latter study a NOAEL of 25 mg/kg bw/day was derived for testicular toxicity. Similar as with this 1-generation study, in the 90-day study the NOAEL derived for systemic toxicity was also lower (i.e., 5 mg/kg bw/day). 3.3.8.2. Teratogenicity Study: BASF SE, 2004, RIFM# 52014 Guideline/Method: OECD 414, 87/302/EEC, US EPA OPPTS 870.3700 Species/strain: Rat (Wistar) Group size: 25 pregnant rats/group Test substance: BMHCA Batch: 000STD77L0 Purity: 98.1% Doses: 0, 5, 15, 45 mg/kg bw/day (effective doses: 0, 4.1, 12.7, 40.7 mg/kg bw/day; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"The dose of 400 ppm (~14.5 mg/kg bw/day) was suggested to be a NOAEL in males and a LOAEL in females (dams) with regard to systemic toxicity.","duration":"developmental","effect":"d fertility and pre-postnatal developmental toxicity). The dose of 400 ppm (~14.5 mg/kg bw/day) was suggested to be a NOAEL in males and a LOAEL in females (dams) with regard to systemic toxicity. By contrast, 800 ppm (~28.7 mg/kg bw/day) was suggested as NOAEL with regard to testicular (reproductive) toxicity. SCCS comment: The suggested NOAEL of ~29 mg/kg bw/day in rats with regard to testicular toxicity is in line with the observation from a 90-day study in rats (see section 3.3.5.2.1.). In this latter study a NOAEL of 25 mg/kg bw/day was derived for testicular toxicity. Similar as with this 1-generation study, in the 90-day study the NOAEL derived for systemic toxicity was also lower (i.e., 5 mg/kg bw/day). 3.3.8.2. Teratogenicity Study: BASF SE, 2004, RIFM# 52014 Guideline/Method: OECD 414, 87/302/EEC, US EPA OPPTS 870.3700 Species/strain: Rat (Wistar) Group size: 25 pregnant rats/group Test substance: BMHCA Batch: 000STD77L0 Purity: 98.1% Doses: 0, 5, 15, 45 mg/kg bw/day (effective doses: 0, 4.1, 12.7, 40.7 mg/kg bw/day","endpoint":"reproductive toxicity","ingredient":"was introduced in Annex III of the Cosmetics Directive 76/768/EEC by the","loael_value":"28.7 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"25","page":30,"route":"","species":"rat","study_id":"sccs_o_189_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
5 |
mg/kg bw/day |
rat |
oral |
90-day |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_189; REPORT_TITLE=OPINION ON Butylphenyl methylpropional (BMHCA); OPINION_NUMBER=SCCS/1540/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 March 2016; VALUE_TEXT=5; DOSE=By contrast, 800 ppm (~28.7 mg/kg bw/day) was suggested as NOAEL with regard to testicular (reproductive) toxicity.; LOAEL_VALUE=28.7 mg/kg bw/day; EFFECT=males and a LOAEL in females (dams) with regard to systemic toxicity. By contrast, 800 ppm (~28.7 mg/kg bw/day) was suggested as NOAEL with regard to testicular (reproductive) toxicity. SCCS comment: The suggested NOAEL of ~29 mg/kg bw/day in rats with regard to testicular toxicity is in line with the observation from a 90-day study in rats (see section 3.3.5.2.1.). In this latter study a NOAEL of 25 mg/kg bw/day was derived for testicular toxicity. Similar as with this 1-generation study, in the 90-day study the NOAEL derived for systemic toxicity was also lower (i.e., 5 mg/kg bw/day). 3.3.8.2. Teratogenicity Study: BASF SE, 2004, RIFM# 52014 Guideline/Method: OECD 414, 87/302/EEC, US EPA OPPTS 870.3700 Species/strain: Rat (Wistar) Group size: 25 pregnant rats/group Test substance: BMHCA Batch: 000STD77L0 Purity: 98.1% Doses: 0, 5, 15, 45 mg/kg bw/day (effective doses: 0, 4.1, 12.7, 40.7 mg/kg bw/day) Vehicle: Olive oil Route: Oral (gavage) Application volume: 5 mL/kg bw Exposure period: gestation days 6 – 20 GLP: yes Study; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"By contrast, 800 ppm (~28.7 mg/kg bw/day) was suggested as NOAEL with regard to testicular (reproductive) toxicity.","duration":"90-day","effect":"males and a LOAEL in females (dams) with regard to systemic toxicity. By contrast, 800 ppm (~28.7 mg/kg bw/day) was suggested as NOAEL with regard to testicular (reproductive) toxicity. SCCS comment: The suggested NOAEL of ~29 mg/kg bw/day in rats with regard to testicular toxicity is in line with the observation from a 90-day study in rats (see section 3.3.5.2.1.). In this latter study a NOAEL of 25 mg/kg bw/day was derived for testicular toxicity. Similar as with this 1-generation study, in the 90-day study the NOAEL derived for systemic toxicity was also lower (i.e., 5 mg/kg bw/day). 3.3.8.2. Teratogenicity Study: BASF SE, 2004, RIFM# 52014 Guideline/Method: OECD 414, 87/302/EEC, US EPA OPPTS 870.3700 Species/strain: Rat (Wistar) Group size: 25 pregnant rats/group Test substance: BMHCA Batch: 000STD77L0 Purity: 98.1% Doses: 0, 5, 15, 45 mg/kg bw/day (effective doses: 0, 4.1, 12.7, 40.7 mg/kg bw/day) Vehicle: Olive oil Route: Oral (gavage) Application volume: 5 mL/kg bw Exposure period: gestation days 6 – 20 GLP: yes Study","endpoint":"reproductive toxicity","ingredient":"was introduced in Annex III of the Cosmetics Directive 76/768/EEC by the","loael_value":"28.7 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"5","page":30,"route":"oral","species":"rat","study_id":"sccs_o_189_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
10 |
mg/kg bw/d |
rat |
oral |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_213; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=10; DOSE=Under the conditions of this study, the NOAEL for fertility and reproductive performance in the F0 and F1 parental rats was 10 mg/kg bw/d, the highest dose tested.; EFFECT=cell counts in the spleen tissue (B-, T-lymphocytes, CD4-, CD8- T lymphocytes and natural killer (NK) cells) displayed any treatment-related changes. Conclusion The extended one-generation reproduction toxicity study is predominantly designed to focus on reproductive and developmental effects that may occur as a result of pre- and postnatal exposure to a substance as well as an evaluation of systemic toxicity in pregnant and lactating females and young and adult offspring. Under the conditions of this study, the NOAEL for fertility and reproductive performance in the F0 and F1 parental rats was 10 mg/kg bw/d, the highest dose tested. The NOAEL for developmental toxicity in the F1 and F2 progeny was 3 mg/kg bw/d (equivalent to a mean overall oral dose of 4.5 mg/kg bw/d), based on reduced pup body weights in the F1 and F2 offspring, which were observed at 10 mg/kg bw/d. As these weight reductions were only observed in the presence of maternal toxicity, including lower weight gain during pregnancy, they are not considered as an i; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"Under the conditions of this study, the NOAEL for fertility and reproductive performance in the F0 and F1 parental rats was 10 mg/kg bw/d, the highest dose tested.","duration":"developmental","effect":"cell counts in the spleen tissue (B-, T-lymphocytes, CD4-, CD8- T lymphocytes and natural killer (NK) cells) displayed any treatment-related changes. Conclusion The extended one-generation reproduction toxicity study is predominantly designed to focus on reproductive and developmental effects that may occur as a result of pre- and postnatal exposure to a substance as well as an evaluation of systemic toxicity in pregnant and lactating females and young and adult offspring. Under the conditions of this study, the NOAEL for fertility and reproductive performance in the F0 and F1 parental rats was 10 mg/kg bw/d, the highest dose tested. The NOAEL for developmental toxicity in the F1 and F2 progeny was 3 mg/kg bw/d (equivalent to a mean overall oral dose of 4.5 mg/kg bw/d), based on reduced pup body weights in the F1 and F2 offspring, which were observed at 10 mg/kg bw/d. As these weight reductions were only observed in the presence of maternal toxicity, including lower weight gain during pregnancy, they are not considered as an i","endpoint":"reproductive toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"10","page":40,"route":"oral","species":"rat","study_id":"sccs_o_213_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
10 |
mg/kg bw/d |
rat |
oral |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_213; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=10; DOSE=Under the conditions of this study, the NOAEL for fertility and reproductive performance in the F0 and F1 parental rats was 10 mg/kg bw/d, the highest dose tested.; EFFECT=ent-related changes. Conclusion The extended one-generation reproduction toxicity study is predominantly designed to focus on reproductive and developmental effects that may occur as a result of pre- and postnatal exposure to a substance as well as an evaluation of systemic toxicity in pregnant and lactating females and young and adult offspring. Under the conditions of this study, the NOAEL for fertility and reproductive performance in the F0 and F1 parental rats was 10 mg/kg bw/d, the highest dose tested. The NOAEL for developmental toxicity in the F1 and F2 progeny was 3 mg/kg bw/d (equivalent to a mean overall oral dose of 4.5 mg/kg bw/d), based on reduced pup body weights in the F1 and F2 offspring, which were observed at 10 mg/kg bw/d. As these weight reductions were only observed in the presence of maternal toxicity, including lower weight gain during pregnancy, they are not considered as an indication for specific developmental toxicity. The NOAEL for developmental neurotoxicity (DNT) for the F1 progeny is 10 mg/kg bw; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"Under the conditions of this study, the NOAEL for fertility and reproductive performance in the F0 and F1 parental rats was 10 mg/kg bw/d, the highest dose tested.","duration":"developmental","effect":"ent-related changes. Conclusion The extended one-generation reproduction toxicity study is predominantly designed to focus on reproductive and developmental effects that may occur as a result of pre- and postnatal exposure to a substance as well as an evaluation of systemic toxicity in pregnant and lactating females and young and adult offspring. Under the conditions of this study, the NOAEL for fertility and reproductive performance in the F0 and F1 parental rats was 10 mg/kg bw/d, the highest dose tested. The NOAEL for developmental toxicity in the F1 and F2 progeny was 3 mg/kg bw/d (equivalent to a mean overall oral dose of 4.5 mg/kg bw/d), based on reduced pup body weights in the F1 and F2 offspring, which were observed at 10 mg/kg bw/d. As these weight reductions were only observed in the presence of maternal toxicity, including lower weight gain during pregnancy, they are not considered as an indication for specific developmental toxicity. The NOAEL for developmental neurotoxicity (DNT) for the F1 progeny is 10 mg/kg bw","endpoint":"reproductive toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"10","page":40,"route":"oral","species":"rat","study_id":"sccs_o_213_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
10 |
mg/kg bw/d |
rat |
oral |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_213; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=10; DOSE=The NOAEL for developmental neurotoxicity (DNT) for the F1 progeny is 10 mg/kg bw/d, the highest dose tested.; EFFECT=t considered as an indication for specific developmental toxicity. The NOAEL for developmental neurotoxicity (DNT) for the F1 progeny is 10 mg/kg bw/d, the highest dose tested. Although an inhibitory effect at this dose on the peripheral AChE activity in pups and adolescent rats cannot be excluded, there were no corresponding effects evident in the neurobehavioral or neuropathological examinations. The NOAEL for developmental immunotoxicity (DIT) for the F1 progeny is 10 mg/kg bw/d, the highest dose tested. The NOAEL for general, systemic toxicity is 3 mg/kg bw/d (equivalent to a mean overall oral dose of 4.5 mg/kg bw/d) for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity, as well as corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females. Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicit; CITATION=Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicit; CITATION_NUMBERS=[2015,2017,4,8]; REFERENCE=Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicit; DETAILS_JSON={"cas_number":"80-54-6","citation":"Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicit","dose":"The NOAEL for developmental neurotoxicity (DNT) for the F1 progeny is 10 mg/kg bw/d, the highest dose tested.","duration":"developmental","effect":"t considered as an indication for specific developmental toxicity. The NOAEL for developmental neurotoxicity (DNT) for the F1 progeny is 10 mg/kg bw/d, the highest dose tested. Although an inhibitory effect at this dose on the peripheral AChE activity in pups and adolescent rats cannot be excluded, there were no corresponding effects evident in the neurobehavioral or neuropathological examinations. The NOAEL for developmental immunotoxicity (DIT) for the F1 progeny is 10 mg/kg bw/d, the highest dose tested. The NOAEL for general, systemic toxicity is 3 mg/kg bw/d (equivalent to a mean overall oral dose of 4.5 mg/kg bw/d) for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity, as well as corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females. Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicit","endpoint":"reproductive toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"10","page":40,"route":"oral","species":"rat","study_id":"sccs_o_213_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
10 |
mg/kg bw/d |
- |
oral |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_213; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=10; DOSE=F1 progeny is 10 mg/kg bw/d, the highest dose tested.; EFFECT=SCCS-rejected applicant NOAEL: F1 progeny is 10 mg/kg bw/d, the highest dose tested. The NOAEL for general, systemic toxicity is 3 mg/kg bw/d (equivalent to a mean overall oral dose of 4.5 mg/kg bw/d) for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity, as well as corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females. Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicity of p- BMHCA in this study is 10 mg/kg bw/d and the NOAEL for developmental toxicity is 3 mg/kg bw/d. However, the SCCS does not agree with the developmental neurotoxicity NOAEL since inhibition of AChE in different tissues at 10 mg/kg bw/d should be considered adverse. Based on the overall assessment, the NOAEL value of 4.5 mg/kg bw/d could be applied for MoS calculation.; CITATION=Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicity of p- BMHCA in this study is 10 mg/kg bw/d and; CITATION_NUMBERS=[2015,2017,4,8,10]; REFERENCE=Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicity of p- BMHCA in this study is 10 mg/kg bw/d and; DETAILS_JSON={"cas_number":"80-54-6","citation":"Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicity of p- BMHCA in this study is 10 mg/kg bw/d and","dose":"F1 progeny is 10 mg/kg bw/d, the highest dose tested.","duration":"developmental","effect":"SCCS-rejected applicant NOAEL: F1 progeny is 10 mg/kg bw/d, the highest dose tested. The NOAEL for general, systemic toxicity is 3 mg/kg bw/d (equivalent to a mean overall oral dose of 4.5 mg/kg bw/d) for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity, as well as corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females. Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicity of p- BMHCA in this study is 10 mg/kg bw/d and the NOAEL for developmental toxicity is 3 mg/kg bw/d. However, the SCCS does not agree with the developmental neurotoxicity NOAEL since inhibition of AChE in different tissues at 10 mg/kg bw/d should be considered adverse. Based on the overall assessment, the NOAEL value of 4.5 mg/kg bw/d could be applied for MoS calculation.","endpoint":"reproductive toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"10","page":40,"route":"oral","species":"","study_id":"sccs_o_213_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
10 |
mg/kg bw/d |
- |
oral |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_213; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=10; DOSE=valent to a mean overall oral dose of 4.5 mg/kg bw/d) for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity, as well as corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females.; EFFECT=SCCS-rejected applicant NOAEL: valent to a mean overall oral dose of 4.5 mg/kg bw/d) for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity, as well as corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females. Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicity of p- BMHCA in this study is 10 mg/kg bw/d and the NOAEL for developmental toxicity is 3 mg/kg bw/d. However, the SCCS does not agree with the developmental neurotoxicity NOAEL since inhibition of AChE in different tissues at 10 mg/kg bw/d should be considered adverse. Based on the overall assessment, the NOAEL value of 4.5 mg/kg bw/d could be applied for MoS calculation.; CITATION=Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicity of p- BMHCA in this study is 10 mg/kg bw/d and; CITATION_NUMBERS=[2015,2017,4,8,10]; REFERENCE=Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicity of p- BMHCA in this study is 10 mg/kg bw/d and; DETAILS_JSON={"cas_number":"80-54-6","citation":"Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicity of p- BMHCA in this study is 10 mg/kg bw/d and","dose":"valent to a mean overall oral dose of 4.5 mg/kg bw/d) for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity, as well as corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females.","duration":"developmental","effect":"SCCS-rejected applicant NOAEL: valent to a mean overall oral dose of 4.5 mg/kg bw/d) for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity, as well as corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females. Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicity of p- BMHCA in this study is 10 mg/kg bw/d and the NOAEL for developmental toxicity is 3 mg/kg bw/d. However, the SCCS does not agree with the developmental neurotoxicity NOAEL since inhibition of AChE in different tissues at 10 mg/kg bw/d should be considered adverse. Based on the overall assessment, the NOAEL value of 4.5 mg/kg bw/d could be applied for MoS calculation.","endpoint":"reproductive toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"10","page":40,"route":"oral","species":"","study_id":"sccs_o_213_noael_011"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
10 |
mg/kg bw/d |
- |
- |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_213; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=10; DOSE=evidence for distinct liver toxicity, as well as corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females.; EFFECT=SCCS-rejected applicant NOAEL: evidence for distinct liver toxicity, as well as corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females. Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicity of p- BMHCA in this study is 10 mg/kg bw/d and the NOAEL for developmental toxicity is 3 mg/kg bw/d. However, the SCCS does not agree with the developmental neurotoxicity NOAEL since inhibition of AChE in different tissues at 10 mg/kg bw/d should be considered adverse. Based on the overall assessment, the NOAEL value of 4.5 mg/kg bw/d could be applied for MoS calculation.; CITATION=Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicity of p- BMHCA in this study is 10 mg/kg bw/d and; CITATION_NUMBERS=[2015,2017,4,8,10]; REFERENCE=Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicity of p- BMHCA in this study is 10 mg/kg bw/d and; DETAILS_JSON={"cas_number":"80-54-6","citation":"Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicity of p- BMHCA in this study is 10 mg/kg bw/d and","dose":"evidence for distinct liver toxicity, as well as corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females.","duration":"developmental","effect":"SCCS-rejected applicant NOAEL: evidence for distinct liver toxicity, as well as corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females. Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicity of p- BMHCA in this study is 10 mg/kg bw/d and the NOAEL for developmental toxicity is 3 mg/kg bw/d. However, the SCCS does not agree with the developmental neurotoxicity NOAEL since inhibition of AChE in different tissues at 10 mg/kg bw/d should be considered adverse. Based on the overall assessment, the NOAEL value of 4.5 mg/kg bw/d could be applied for MoS calculation.","endpoint":"reproductive toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"10","page":40,"route":"","species":"","study_id":"sccs_o_213_noael_012"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
4.5 |
mg/kg bw/d |
- |
- |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_213; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=4.5; DOSE=meters, which were observed at 10 mg/kg bw/d predominantly in females.; EFFECT=SCCS-rejected applicant NOAEL: meters, which were observed at 10 mg/kg bw/d predominantly in females. Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicity of p- BMHCA in this study is 10 mg/kg bw/d and the NOAEL for developmental toxicity is 3 mg/kg bw/d. However, the SCCS does not agree with the developmental neurotoxicity NOAEL since inhibition of AChE in different tissues at 10 mg/kg bw/d should be considered adverse. Based on the overall assessment, the NOAEL value of 4.5 mg/kg bw/d could be applied for MoS calculation.; CITATION=Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicity of p- BMHCA in this study is 10 mg/kg bw/d and; CITATION_NUMBERS=[2015,2017,4,8,10]; REFERENCE=Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicity of p- BMHCA in this study is 10 mg/kg bw/d and; DETAILS_JSON={"cas_number":"80-54-6","citation":"Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicity of p- BMHCA in this study is 10 mg/kg bw/d and","dose":"meters, which were observed at 10 mg/kg bw/d predominantly in females.","duration":"developmental","effect":"SCCS-rejected applicant NOAEL: meters, which were observed at 10 mg/kg bw/d predominantly in females. Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicity of p- BMHCA in this study is 10 mg/kg bw/d and the NOAEL for developmental toxicity is 3 mg/kg bw/d. However, the SCCS does not agree with the developmental neurotoxicity NOAEL since inhibition of AChE in different tissues at 10 mg/kg bw/d should be considered adverse. Based on the overall assessment, the NOAEL value of 4.5 mg/kg bw/d could be applied for MoS calculation.","endpoint":"reproductive toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"4.5","page":40,"route":"","species":"","study_id":"sccs_o_213_noael_013"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
10 |
mg/kg bw/d |
rat |
oral |
- |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_213; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=10; DOSE=In the extended one-generation reproduction toxicity study which results were provided in submission II, the NOAEL for general, systemic toxicity of p-BMHCA applied in encapsulated form at 1, 3, or 10 mg/kg bw/d, was established at 3 mg/kg bw/d for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity.; EFFECT=ia the oral route and suggesting that this metabolite may also exert testicular toxicity (along with systemic toxicity). However, the doses applied in these studies from the 1960s – 1980s were high and the quality of the studies generally low. The data available therefore do not support the conclusion that this metabolite would be mainly responsible for the testicular effects observed with p-BMHCA in rats. In the extended one-generation reproduction toxicity study which results were provided in submission II, the NOAEL for general, systemic toxicity of p-BMHCA applied in encapsulated form at 1, 3, or 10 mg/kg bw/d, was established at 3 mg/kg bw/d for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity. This value was further supported by corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females. The NOAEL for fertility and reproductive toxicity of p-BMHCA in this study could be establi; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"In the extended one-generation reproduction toxicity study which results were provided in submission II, the NOAEL for general, systemic toxicity of p-BMHCA applied in encapsulated form at 1, 3, or 10 mg/kg bw/d, was established at 3 mg/kg bw/d for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity.","duration":"","effect":"ia the oral route and suggesting that this metabolite may also exert testicular toxicity (along with systemic toxicity). However, the doses applied in these studies from the 1960s – 1980s were high and the quality of the studies generally low. The data available therefore do not support the conclusion that this metabolite would be mainly responsible for the testicular effects observed with p-BMHCA in rats. In the extended one-generation reproduction toxicity study which results were provided in submission II, the NOAEL for general, systemic toxicity of p-BMHCA applied in encapsulated form at 1, 3, or 10 mg/kg bw/d, was established at 3 mg/kg bw/d for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity. This value was further supported by corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females. The NOAEL for fertility and reproductive toxicity of p-BMHCA in this study could be establi","endpoint":"reproductive toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"10","page":50,"route":"oral","species":"rat","study_id":"sccs_o_213_noael_021"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
10 |
mg/kg bw/d |
- |
oral |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_213; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=10; DOSE=ion reproduction toxicity study which results were provided in submission II, the NOAEL for general, systemic toxicity of p-BMHCA applied in encapsulated form at 1, 3, or 10 mg/kg bw/d, was established at 3 mg/kg bw/d for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity.; EFFECT=ion reproduction toxicity study which results were provided in submission II, the NOAEL for general, systemic toxicity of p-BMHCA applied in encapsulated form at 1, 3, or 10 mg/kg bw/d, was established at 3 mg/kg bw/d for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity. This value was further supported by corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females. The NOAEL for fertility and reproductive toxicity of p-BMHCA in this study could be established at 10 mg/kg bw/d. The NOAEL for developmental toxicity in the F1 and F2 progeny was 3 mg/kg bw/d (equivalent to a mean overall oral dose of 4.5 mg/kg bw/d), based on reduced pup body weights in the F1 and F2 offspring, which were observed at 10 mg/kg bw/d. This NOAEL for developmental toxicity is used for the calculation of the MoS. As these weight reductions were only observed in the presence of maternal toxicity, including lowe; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"ion reproduction toxicity study which results were provided in submission II, the NOAEL for general, systemic toxicity of p-BMHCA applied in encapsulated form at 1, 3, or 10 mg/kg bw/d, was established at 3 mg/kg bw/d for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity.","duration":"developmental","effect":"ion reproduction toxicity study which results were provided in submission II, the NOAEL for general, systemic toxicity of p-BMHCA applied in encapsulated form at 1, 3, or 10 mg/kg bw/d, was established at 3 mg/kg bw/d for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity. This value was further supported by corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females. The NOAEL for fertility and reproductive toxicity of p-BMHCA in this study could be established at 10 mg/kg bw/d. The NOAEL for developmental toxicity in the F1 and F2 progeny was 3 mg/kg bw/d (equivalent to a mean overall oral dose of 4.5 mg/kg bw/d), based on reduced pup body weights in the F1 and F2 offspring, which were observed at 10 mg/kg bw/d. This NOAEL for developmental toxicity is used for the calculation of the MoS. As these weight reductions were only observed in the presence of maternal toxicity, including lowe","endpoint":"reproductive toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"10","page":50,"route":"oral","species":"","study_id":"sccs_o_213_noael_022"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
10 |
mg/kg bw/d |
- |
oral |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_213; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=10; DOSE=city of p-BMHCA applied in encapsulated form at 1, 3, or 10 mg/kg bw/d, was established at 3 mg/kg bw/d for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity.; EFFECT=city of p-BMHCA applied in encapsulated form at 1, 3, or 10 mg/kg bw/d, was established at 3 mg/kg bw/d for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity. This value was further supported by corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females. The NOAEL for fertility and reproductive toxicity of p-BMHCA in this study could be established at 10 mg/kg bw/d. The NOAEL for developmental toxicity in the F1 and F2 progeny was 3 mg/kg bw/d (equivalent to a mean overall oral dose of 4.5 mg/kg bw/d), based on reduced pup body weights in the F1 and F2 offspring, which were observed at 10 mg/kg bw/d. This NOAEL for developmental toxicity is used for the calculation of the MoS. As these weight reductions were only observed in the presence of maternal toxicity, including lower weight gain during pregnancy, they are not considered as an indication for specific developmental toxicity. Irr; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"city of p-BMHCA applied in encapsulated form at 1, 3, or 10 mg/kg bw/d, was established at 3 mg/kg bw/d for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity.","duration":"developmental","effect":"city of p-BMHCA applied in encapsulated form at 1, 3, or 10 mg/kg bw/d, was established at 3 mg/kg bw/d for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity. This value was further supported by corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females. The NOAEL for fertility and reproductive toxicity of p-BMHCA in this study could be established at 10 mg/kg bw/d. The NOAEL for developmental toxicity in the F1 and F2 progeny was 3 mg/kg bw/d (equivalent to a mean overall oral dose of 4.5 mg/kg bw/d), based on reduced pup body weights in the F1 and F2 offspring, which were observed at 10 mg/kg bw/d. This NOAEL for developmental toxicity is used for the calculation of the MoS. As these weight reductions were only observed in the presence of maternal toxicity, including lower weight gain during pregnancy, they are not considered as an indication for specific developmental toxicity. Irr","endpoint":"reproductive toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"10","page":50,"route":"oral","species":"","study_id":"sccs_o_213_noael_023"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
10 |
mg/kg bw/d |
rabbit |
oral |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_213; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=10; DOSE=d by corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females.; EFFECT=SCCS-rejected applicant NOAEL: d by corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females. The NOAEL for fertility and reproductive toxicity of p-BMHCA in this study could be established at 10 mg/kg bw/d. The NOAEL for developmental toxicity in the F1 and F2 progeny was 3 mg/kg bw/d (equivalent to a mean overall oral dose of 4.5 mg/kg bw/d), based on reduced pup body weights in the F1 and F2 offspring, which were observed at 10 mg/kg bw/d. This NOAEL for developmental toxicity is used for the calculation of the MoS. As these weight reductions were only observed in the presence of maternal toxicity, including lower weight gain during pregnancy, they are not considered as an indication for specific developmental toxicity. Irritation/sensitisation Based on the previous SCCS Opinion (SCCS/1540/14): Para-BMHCA as neat compound is irritating to the skin and eyes of rabbits. A solution of 2% p-BMHCA in propylene glycol led to mild skin erythema. In general the obse; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"d by corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females.","duration":"developmental","effect":"SCCS-rejected applicant NOAEL: d by corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females. The NOAEL for fertility and reproductive toxicity of p-BMHCA in this study could be established at 10 mg/kg bw/d. The NOAEL for developmental toxicity in the F1 and F2 progeny was 3 mg/kg bw/d (equivalent to a mean overall oral dose of 4.5 mg/kg bw/d), based on reduced pup body weights in the F1 and F2 offspring, which were observed at 10 mg/kg bw/d. This NOAEL for developmental toxicity is used for the calculation of the MoS. As these weight reductions were only observed in the presence of maternal toxicity, including lower weight gain during pregnancy, they are not considered as an indication for specific developmental toxicity. Irritation/sensitisation Based on the previous SCCS Opinion (SCCS/1540/14): Para-BMHCA as neat compound is irritating to the skin and eyes of rabbits. A solution of 2% p-BMHCA in propylene glycol led to mild skin erythema. In general the obse","endpoint":"reproductive toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"10","page":50,"route":"oral","species":"rabbit","study_id":"sccs_o_213_noael_024"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
10 |
mg/kg bw/d |
rat |
oral |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_213_0; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=10; DOSE=Under the conditions of this study, the NOAEL for fertility and reproductive performance in the F0 and F1 parental rats was 10 mg/kg bw/d, the highest dose tested.; EFFECT=cell counts in the spleen tissue (B-, T-lymphocytes, CD4-, CD8- T lymphocytes and natural killer (NK) cells) displayed any treatment-related changes. Conclusion The extended one-generation reproduction toxicity study is predominantly designed to focus on reproductive and developmental effects that may occur as a result of pre- and postnatal exposure to a substance as well as an evaluation of systemic toxicity in pregnant and lactating females and young and adult offspring. Under the conditions of this study, the NOAEL for fertility and reproductive performance in the F0 and F1 parental rats was 10 mg/kg bw/d, the highest dose tested. The NOAEL for developmental toxicity in the F1 and F2 progeny was 3 mg/kg bw/d (equivalent to a mean overall oral dose of 4.5 mg/kg bw/d), based on reduced pup body weights in the F1 and F2 offspring, which were observed at 10 mg/kg bw/d. As these weight reductions were only observed in the presence of maternal toxicity, including lower weight gain during pregnancy, they are not considered as an i; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"Under the conditions of this study, the NOAEL for fertility and reproductive performance in the F0 and F1 parental rats was 10 mg/kg bw/d, the highest dose tested.","duration":"developmental","effect":"cell counts in the spleen tissue (B-, T-lymphocytes, CD4-, CD8- T lymphocytes and natural killer (NK) cells) displayed any treatment-related changes. Conclusion The extended one-generation reproduction toxicity study is predominantly designed to focus on reproductive and developmental effects that may occur as a result of pre- and postnatal exposure to a substance as well as an evaluation of systemic toxicity in pregnant and lactating females and young and adult offspring. Under the conditions of this study, the NOAEL for fertility and reproductive performance in the F0 and F1 parental rats was 10 mg/kg bw/d, the highest dose tested. The NOAEL for developmental toxicity in the F1 and F2 progeny was 3 mg/kg bw/d (equivalent to a mean overall oral dose of 4.5 mg/kg bw/d), based on reduced pup body weights in the F1 and F2 offspring, which were observed at 10 mg/kg bw/d. As these weight reductions were only observed in the presence of maternal toxicity, including lower weight gain during pregnancy, they are not considered as an i","endpoint":"reproductive toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"10","page":40,"route":"oral","species":"rat","study_id":"sccs_o_213_0_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
10 |
mg/kg bw/d |
rat |
oral |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_213_0; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=10; DOSE=Under the conditions of this study, the NOAEL for fertility and reproductive performance in the F0 and F1 parental rats was 10 mg/kg bw/d, the highest dose tested.; EFFECT=ent-related changes. Conclusion The extended one-generation reproduction toxicity study is predominantly designed to focus on reproductive and developmental effects that may occur as a result of pre- and postnatal exposure to a substance as well as an evaluation of systemic toxicity in pregnant and lactating females and young and adult offspring. Under the conditions of this study, the NOAEL for fertility and reproductive performance in the F0 and F1 parental rats was 10 mg/kg bw/d, the highest dose tested. The NOAEL for developmental toxicity in the F1 and F2 progeny was 3 mg/kg bw/d (equivalent to a mean overall oral dose of 4.5 mg/kg bw/d), based on reduced pup body weights in the F1 and F2 offspring, which were observed at 10 mg/kg bw/d. As these weight reductions were only observed in the presence of maternal toxicity, including lower weight gain during pregnancy, they are not considered as an indication for specific developmental toxicity. The NOAEL for developmental neurotoxicity (DNT) for the F1 progeny is 10 mg/kg bw; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"Under the conditions of this study, the NOAEL for fertility and reproductive performance in the F0 and F1 parental rats was 10 mg/kg bw/d, the highest dose tested.","duration":"developmental","effect":"ent-related changes. Conclusion The extended one-generation reproduction toxicity study is predominantly designed to focus on reproductive and developmental effects that may occur as a result of pre- and postnatal exposure to a substance as well as an evaluation of systemic toxicity in pregnant and lactating females and young and adult offspring. Under the conditions of this study, the NOAEL for fertility and reproductive performance in the F0 and F1 parental rats was 10 mg/kg bw/d, the highest dose tested. The NOAEL for developmental toxicity in the F1 and F2 progeny was 3 mg/kg bw/d (equivalent to a mean overall oral dose of 4.5 mg/kg bw/d), based on reduced pup body weights in the F1 and F2 offspring, which were observed at 10 mg/kg bw/d. As these weight reductions were only observed in the presence of maternal toxicity, including lower weight gain during pregnancy, they are not considered as an indication for specific developmental toxicity. The NOAEL for developmental neurotoxicity (DNT) for the F1 progeny is 10 mg/kg bw","endpoint":"reproductive toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"10","page":40,"route":"oral","species":"rat","study_id":"sccs_o_213_0_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
10 |
mg/kg bw/d |
rat |
oral |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_213_0; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=10; DOSE=The NOAEL for developmental neurotoxicity (DNT) for the F1 progeny is 10 mg/kg bw/d, the highest dose tested.; EFFECT=t considered as an indication for specific developmental toxicity. The NOAEL for developmental neurotoxicity (DNT) for the F1 progeny is 10 mg/kg bw/d, the highest dose tested. Although an inhibitory effect at this dose on the peripheral AChE activity in pups and adolescent rats cannot be excluded, there were no corresponding effects evident in the neurobehavioral or neuropathological examinations. The NOAEL for developmental immunotoxicity (DIT) for the F1 progeny is 10 mg/kg bw/d, the highest dose tested. The NOAEL for general, systemic toxicity is 3 mg/kg bw/d (equivalent to a mean overall oral dose of 4.5 mg/kg bw/d) for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity, as well as corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females. Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicit; CITATION=Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicit; CITATION_NUMBERS=[2015,2017,4,8]; REFERENCE=Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicit; DETAILS_JSON={"cas_number":"80-54-6","citation":"Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicit","dose":"The NOAEL for developmental neurotoxicity (DNT) for the F1 progeny is 10 mg/kg bw/d, the highest dose tested.","duration":"developmental","effect":"t considered as an indication for specific developmental toxicity. The NOAEL for developmental neurotoxicity (DNT) for the F1 progeny is 10 mg/kg bw/d, the highest dose tested. Although an inhibitory effect at this dose on the peripheral AChE activity in pups and adolescent rats cannot be excluded, there were no corresponding effects evident in the neurobehavioral or neuropathological examinations. The NOAEL for developmental immunotoxicity (DIT) for the F1 progeny is 10 mg/kg bw/d, the highest dose tested. The NOAEL for general, systemic toxicity is 3 mg/kg bw/d (equivalent to a mean overall oral dose of 4.5 mg/kg bw/d) for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity, as well as corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females. Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicit","endpoint":"reproductive toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"10","page":40,"route":"oral","species":"rat","study_id":"sccs_o_213_0_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
10 |
mg/kg bw/d |
- |
oral |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_213_0; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=10; DOSE=F1 progeny is 10 mg/kg bw/d, the highest dose tested.; EFFECT=SCCS-rejected applicant NOAEL: F1 progeny is 10 mg/kg bw/d, the highest dose tested. The NOAEL for general, systemic toxicity is 3 mg/kg bw/d (equivalent to a mean overall oral dose of 4.5 mg/kg bw/d) for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity, as well as corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females. Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicity of p- BMHCA in this study is 10 mg/kg bw/d and the NOAEL for developmental toxicity is 3 mg/kg bw/d. However, the SCCS does not agree with the developmental neurotoxicity NOAEL since inhibition of AChE in different tissues at 10 mg/kg bw/d should be considered adverse. Based on the overall assessment, the NOAEL value of 4.5 mg/kg bw/d could be applied for MoS calculation.; CITATION=Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicity of p- BMHCA in this study is 10 mg/kg bw/d and; CITATION_NUMBERS=[2015,2017,4,8,10]; REFERENCE=Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicity of p- BMHCA in this study is 10 mg/kg bw/d and; DETAILS_JSON={"cas_number":"80-54-6","citation":"Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicity of p- BMHCA in this study is 10 mg/kg bw/d and","dose":"F1 progeny is 10 mg/kg bw/d, the highest dose tested.","duration":"developmental","effect":"SCCS-rejected applicant NOAEL: F1 progeny is 10 mg/kg bw/d, the highest dose tested. The NOAEL for general, systemic toxicity is 3 mg/kg bw/d (equivalent to a mean overall oral dose of 4.5 mg/kg bw/d) for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity, as well as corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females. Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicity of p- BMHCA in this study is 10 mg/kg bw/d and the NOAEL for developmental toxicity is 3 mg/kg bw/d. However, the SCCS does not agree with the developmental neurotoxicity NOAEL since inhibition of AChE in different tissues at 10 mg/kg bw/d should be considered adverse. Based on the overall assessment, the NOAEL value of 4.5 mg/kg bw/d could be applied for MoS calculation.","endpoint":"reproductive toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"10","page":40,"route":"oral","species":"","study_id":"sccs_o_213_0_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
10 |
mg/kg bw/d |
- |
oral |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_213_0; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=10; DOSE=valent to a mean overall oral dose of 4.5 mg/kg bw/d) for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity, as well as corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females.; EFFECT=SCCS-rejected applicant NOAEL: valent to a mean overall oral dose of 4.5 mg/kg bw/d) for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity, as well as corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females. Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicity of p- BMHCA in this study is 10 mg/kg bw/d and the NOAEL for developmental toxicity is 3 mg/kg bw/d. However, the SCCS does not agree with the developmental neurotoxicity NOAEL since inhibition of AChE in different tissues at 10 mg/kg bw/d should be considered adverse. Based on the overall assessment, the NOAEL value of 4.5 mg/kg bw/d could be applied for MoS calculation.; CITATION=Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicity of p- BMHCA in this study is 10 mg/kg bw/d and; CITATION_NUMBERS=[2015,2017,4,8,10]; REFERENCE=Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicity of p- BMHCA in this study is 10 mg/kg bw/d and; DETAILS_JSON={"cas_number":"80-54-6","citation":"Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicity of p- BMHCA in this study is 10 mg/kg bw/d and","dose":"valent to a mean overall oral dose of 4.5 mg/kg bw/d) for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity, as well as corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females.","duration":"developmental","effect":"SCCS-rejected applicant NOAEL: valent to a mean overall oral dose of 4.5 mg/kg bw/d) for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity, as well as corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females. Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicity of p- BMHCA in this study is 10 mg/kg bw/d and the NOAEL for developmental toxicity is 3 mg/kg bw/d. However, the SCCS does not agree with the developmental neurotoxicity NOAEL since inhibition of AChE in different tissues at 10 mg/kg bw/d should be considered adverse. Based on the overall assessment, the NOAEL value of 4.5 mg/kg bw/d could be applied for MoS calculation.","endpoint":"reproductive toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"10","page":40,"route":"oral","species":"","study_id":"sccs_o_213_0_noael_011"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
10 |
mg/kg bw/d |
- |
- |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_213_0; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=10; DOSE=evidence for distinct liver toxicity, as well as corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females.; EFFECT=SCCS-rejected applicant NOAEL: evidence for distinct liver toxicity, as well as corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females. Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicity of p- BMHCA in this study is 10 mg/kg bw/d and the NOAEL for developmental toxicity is 3 mg/kg bw/d. However, the SCCS does not agree with the developmental neurotoxicity NOAEL since inhibition of AChE in different tissues at 10 mg/kg bw/d should be considered adverse. Based on the overall assessment, the NOAEL value of 4.5 mg/kg bw/d could be applied for MoS calculation.; CITATION=Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicity of p- BMHCA in this study is 10 mg/kg bw/d and; CITATION_NUMBERS=[2015,2017,4,8,10]; REFERENCE=Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicity of p- BMHCA in this study is 10 mg/kg bw/d and; DETAILS_JSON={"cas_number":"80-54-6","citation":"Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicity of p- BMHCA in this study is 10 mg/kg bw/d and","dose":"evidence for distinct liver toxicity, as well as corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females.","duration":"developmental","effect":"SCCS-rejected applicant NOAEL: evidence for distinct liver toxicity, as well as corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females. Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicity of p- BMHCA in this study is 10 mg/kg bw/d and the NOAEL for developmental toxicity is 3 mg/kg bw/d. However, the SCCS does not agree with the developmental neurotoxicity NOAEL since inhibition of AChE in different tissues at 10 mg/kg bw/d should be considered adverse. Based on the overall assessment, the NOAEL value of 4.5 mg/kg bw/d could be applied for MoS calculation.","endpoint":"reproductive toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"10","page":40,"route":"","species":"","study_id":"sccs_o_213_0_noael_012"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
4.5 |
mg/kg bw/d |
- |
- |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_213_0; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=4.5; DOSE=meters, which were observed at 10 mg/kg bw/d predominantly in females.; EFFECT=SCCS-rejected applicant NOAEL: meters, which were observed at 10 mg/kg bw/d predominantly in females. Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicity of p- BMHCA in this study is 10 mg/kg bw/d and the NOAEL for developmental toxicity is 3 mg/kg bw/d. However, the SCCS does not agree with the developmental neurotoxicity NOAEL since inhibition of AChE in different tissues at 10 mg/kg bw/d should be considered adverse. Based on the overall assessment, the NOAEL value of 4.5 mg/kg bw/d could be applied for MoS calculation.; CITATION=Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicity of p- BMHCA in this study is 10 mg/kg bw/d and; CITATION_NUMBERS=[2015,2017,4,8,10]; REFERENCE=Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicity of p- BMHCA in this study is 10 mg/kg bw/d and; DETAILS_JSON={"cas_number":"80-54-6","citation":"Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicity of p- BMHCA in this study is 10 mg/kg bw/d and","dose":"meters, which were observed at 10 mg/kg bw/d predominantly in females.","duration":"developmental","effect":"SCCS-rejected applicant NOAEL: meters, which were observed at 10 mg/kg bw/d predominantly in females. Ref.: BASF SE, 2015, 2017b, SMII, 4, 8 SCCS comment The SCCS agrees that NOAEL for fertility and reproductive as well as systemic toxicity of p- BMHCA in this study is 10 mg/kg bw/d and the NOAEL for developmental toxicity is 3 mg/kg bw/d. However, the SCCS does not agree with the developmental neurotoxicity NOAEL since inhibition of AChE in different tissues at 10 mg/kg bw/d should be considered adverse. Based on the overall assessment, the NOAEL value of 4.5 mg/kg bw/d could be applied for MoS calculation.","endpoint":"reproductive toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"4.5","page":40,"route":"","species":"","study_id":"sccs_o_213_0_noael_013"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
10 |
mg/kg bw/d |
rat |
oral |
- |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_213_0; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=10; DOSE=In the extended one-generation reproduction toxicity study which results were provided in submission II, the NOAEL for general, systemic toxicity of p-BMHCA applied in encapsulated form at 1, 3, or 10 mg/kg bw/d, was established at 3 mg/kg bw/d for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity.; EFFECT=ia the oral route and suggesting that this metabolite may also exert testicular toxicity (along with systemic toxicity). However, the doses applied in these studies from the 1960s – 1980s were high and the quality of the studies generally low. The data available therefore do not support the conclusion that this metabolite would be mainly responsible for the testicular effects observed with p-BMHCA in rats. In the extended one-generation reproduction toxicity study which results were provided in submission II, the NOAEL for general, systemic toxicity of p-BMHCA applied in encapsulated form at 1, 3, or 10 mg/kg bw/d, was established at 3 mg/kg bw/d for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity. This value was further supported by corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females. The NOAEL for fertility and reproductive toxicity of p-BMHCA in this study could be establi; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"In the extended one-generation reproduction toxicity study which results were provided in submission II, the NOAEL for general, systemic toxicity of p-BMHCA applied in encapsulated form at 1, 3, or 10 mg/kg bw/d, was established at 3 mg/kg bw/d for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity.","duration":"","effect":"ia the oral route and suggesting that this metabolite may also exert testicular toxicity (along with systemic toxicity). However, the doses applied in these studies from the 1960s – 1980s were high and the quality of the studies generally low. The data available therefore do not support the conclusion that this metabolite would be mainly responsible for the testicular effects observed with p-BMHCA in rats. In the extended one-generation reproduction toxicity study which results were provided in submission II, the NOAEL for general, systemic toxicity of p-BMHCA applied in encapsulated form at 1, 3, or 10 mg/kg bw/d, was established at 3 mg/kg bw/d for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity. This value was further supported by corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females. The NOAEL for fertility and reproductive toxicity of p-BMHCA in this study could be establi","endpoint":"reproductive toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"10","page":50,"route":"oral","species":"rat","study_id":"sccs_o_213_0_noael_021"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
10 |
mg/kg bw/d |
- |
oral |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_213_0; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=10; DOSE=ion reproduction toxicity study which results were provided in submission II, the NOAEL for general, systemic toxicity of p-BMHCA applied in encapsulated form at 1, 3, or 10 mg/kg bw/d, was established at 3 mg/kg bw/d for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity.; EFFECT=ion reproduction toxicity study which results were provided in submission II, the NOAEL for general, systemic toxicity of p-BMHCA applied in encapsulated form at 1, 3, or 10 mg/kg bw/d, was established at 3 mg/kg bw/d for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity. This value was further supported by corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females. The NOAEL for fertility and reproductive toxicity of p-BMHCA in this study could be established at 10 mg/kg bw/d. The NOAEL for developmental toxicity in the F1 and F2 progeny was 3 mg/kg bw/d (equivalent to a mean overall oral dose of 4.5 mg/kg bw/d), based on reduced pup body weights in the F1 and F2 offspring, which were observed at 10 mg/kg bw/d. This NOAEL for developmental toxicity is used for the calculation of the MoS. As these weight reductions were only observed in the presence of maternal toxicity, including lowe; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"ion reproduction toxicity study which results were provided in submission II, the NOAEL for general, systemic toxicity of p-BMHCA applied in encapsulated form at 1, 3, or 10 mg/kg bw/d, was established at 3 mg/kg bw/d for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity.","duration":"developmental","effect":"ion reproduction toxicity study which results were provided in submission II, the NOAEL for general, systemic toxicity of p-BMHCA applied in encapsulated form at 1, 3, or 10 mg/kg bw/d, was established at 3 mg/kg bw/d for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity. This value was further supported by corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females. The NOAEL for fertility and reproductive toxicity of p-BMHCA in this study could be established at 10 mg/kg bw/d. The NOAEL for developmental toxicity in the F1 and F2 progeny was 3 mg/kg bw/d (equivalent to a mean overall oral dose of 4.5 mg/kg bw/d), based on reduced pup body weights in the F1 and F2 offspring, which were observed at 10 mg/kg bw/d. This NOAEL for developmental toxicity is used for the calculation of the MoS. As these weight reductions were only observed in the presence of maternal toxicity, including lowe","endpoint":"reproductive toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"10","page":50,"route":"oral","species":"","study_id":"sccs_o_213_0_noael_022"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
10 |
mg/kg bw/d |
- |
oral |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_213_0; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=10; DOSE=city of p-BMHCA applied in encapsulated form at 1, 3, or 10 mg/kg bw/d, was established at 3 mg/kg bw/d for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity.; EFFECT=city of p-BMHCA applied in encapsulated form at 1, 3, or 10 mg/kg bw/d, was established at 3 mg/kg bw/d for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity. This value was further supported by corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females. The NOAEL for fertility and reproductive toxicity of p-BMHCA in this study could be established at 10 mg/kg bw/d. The NOAEL for developmental toxicity in the F1 and F2 progeny was 3 mg/kg bw/d (equivalent to a mean overall oral dose of 4.5 mg/kg bw/d), based on reduced pup body weights in the F1 and F2 offspring, which were observed at 10 mg/kg bw/d. This NOAEL for developmental toxicity is used for the calculation of the MoS. As these weight reductions were only observed in the presence of maternal toxicity, including lower weight gain during pregnancy, they are not considered as an indication for specific developmental toxicity. Irr; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"city of p-BMHCA applied in encapsulated form at 1, 3, or 10 mg/kg bw/d, was established at 3 mg/kg bw/d for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity.","duration":"developmental","effect":"city of p-BMHCA applied in encapsulated form at 1, 3, or 10 mg/kg bw/d, was established at 3 mg/kg bw/d for the F0 and F1 parental as well as adolescent animals, based on evidence for distinct liver toxicity. This value was further supported by corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females. The NOAEL for fertility and reproductive toxicity of p-BMHCA in this study could be established at 10 mg/kg bw/d. The NOAEL for developmental toxicity in the F1 and F2 progeny was 3 mg/kg bw/d (equivalent to a mean overall oral dose of 4.5 mg/kg bw/d), based on reduced pup body weights in the F1 and F2 offspring, which were observed at 10 mg/kg bw/d. This NOAEL for developmental toxicity is used for the calculation of the MoS. As these weight reductions were only observed in the presence of maternal toxicity, including lower weight gain during pregnancy, they are not considered as an indication for specific developmental toxicity. Irr","endpoint":"reproductive toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"10","page":50,"route":"oral","species":"","study_id":"sccs_o_213_0_noael_023"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
10 |
mg/kg bw/d |
rabbit |
oral |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_213_0; REPORT_TITLE=OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products; OPINION_NUMBER=SCCS/1591/17; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 10 May 2019; VALUE_TEXT=10; DOSE=d by corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females.; EFFECT=SCCS-rejected applicant NOAEL: d by corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females. The NOAEL for fertility and reproductive toxicity of p-BMHCA in this study could be established at 10 mg/kg bw/d. The NOAEL for developmental toxicity in the F1 and F2 progeny was 3 mg/kg bw/d (equivalent to a mean overall oral dose of 4.5 mg/kg bw/d), based on reduced pup body weights in the F1 and F2 offspring, which were observed at 10 mg/kg bw/d. This NOAEL for developmental toxicity is used for the calculation of the MoS. As these weight reductions were only observed in the presence of maternal toxicity, including lower weight gain during pregnancy, they are not considered as an indication for specific developmental toxicity. Irritation/sensitisation Based on the previous SCCS Opinion (SCCS/1540/14): Para-BMHCA as neat compound is irritating to the skin and eyes of rabbits. A solution of 2% p-BMHCA in propylene glycol led to mild skin erythema. In general the obse; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80-54-6","citation":"","dose":"d by corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females.","duration":"developmental","effect":"SCCS-rejected applicant NOAEL: d by corresponding effects on food consumption, body weights and clinical pathological parameters, which were observed at 10 mg/kg bw/d predominantly in females. The NOAEL for fertility and reproductive toxicity of p-BMHCA in this study could be established at 10 mg/kg bw/d. The NOAEL for developmental toxicity in the F1 and F2 progeny was 3 mg/kg bw/d (equivalent to a mean overall oral dose of 4.5 mg/kg bw/d), based on reduced pup body weights in the F1 and F2 offspring, which were observed at 10 mg/kg bw/d. This NOAEL for developmental toxicity is used for the calculation of the MoS. As these weight reductions were only observed in the presence of maternal toxicity, including lower weight gain during pregnancy, they are not considered as an indication for specific developmental toxicity. Irritation/sensitisation Based on the previous SCCS Opinion (SCCS/1540/14): Para-BMHCA as neat compound is irritating to the skin and eyes of rabbits. A solution of 2% p-BMHCA in propylene glycol led to mild skin erythema. In general the obse","endpoint":"reproductive toxicity","ingredient":"by other scientific bodies (e.g. under REACH) should also be","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"10","page":50,"route":"oral","species":"rabbit","study_id":"sccs_o_213_0_noael_024"} |