s are marketed with the symbol (+) and therefore may also be added to, s, toys, textiles,, CI 61570

{"dose":"For the latter, a NOAEL value of 2 mg/kg bw/day was proposed.","effect":"SCCP/0873/05 Opinion on the safety evaluation of parabens 9 Therefore, it is the opinion of the SCCP that methyl and ethyl paraben can be safely used up to the maximum authorized concentration as actually established (0.4%). Propyl, butyl and isobutyl paraben Propyl paraben - The developmental rat study provided for propyl paraben failed to indicate a clear NOAEL value, but it suggested that the potency of propyl paraben is clearly lower than the potency of butyl paraben [Oishi 2002b]. For the latter, a NOAEL value of 2 mg/kg bw/day was proposed. This value was obtained in a study where the compound was orally administered to male Wistar rats for 17 days and the investigated reproductive parameters included testicular weight, aquaporin-1 immunoexpression, rete testis distention and efferent duct epithelial cell height [Fisher 1999]. - The LOAEL-value for propyl paraben in","page":9,"pdf":"sccp_o_019.pdf","row_type":"noael_study","study_id":"sccp_o_019_noael_010"}

sccp_o_019.pdf

{"dose":"For the latter, a NOAEL value of 2 mg/kg bw/day was proposed.","effect":"SCCP/0873/05 Opinion on the safety evaluation of parabens 9 Therefore, it is the opinion of the SCCP that methyl and ethyl paraben can be safely used up to the maximum authorized concentration as actually established (0.4%). Propyl, butyl and isobutyl paraben Propyl paraben - The developmental rat study provided for propyl paraben failed to indicate a clear NOAEL value, but it suggested that the potency of propyl paraben is clearly lower than the potency of butyl paraben [Oishi 2002b]. For the latter, a NOAEL value of 2 mg/kg bw/day was proposed. This value was obtained in a study where the compound was orally administered to male Wistar rats for 17 days and the investigated reproductive parameters included testicular weight, aquaporin-1 immunoexpression, rete testis distention and efferent duct epithelial cell height [Fisher 1999]. - The LOAEL-value for propyl paraben in","page":9,"pdf":"sccp_o_019.pdf","row_type":"noael_study","study_id":"sccp_o_019_noael_010"}

sccp_o_019.pdf

{"dose":"For the latter, a NOAEL value of 2 mg/kg bw/day was proposed.","effect":"SCCP/0873/05 Opinion on the safety evaluation of parabens 9 Therefore, it is the opinion of the SCCP that methyl and ethyl paraben can be safely used up to the maximum authorized concentration as actually established (0.4%). Propyl, butyl and isobutyl paraben Propyl paraben - The developmental rat study provided for propyl paraben failed to indicate a clear NOAEL value, but it suggested that the potency of propyl paraben is clearly lower than the potency of butyl paraben [Oishi 2002b]. For the latter, a NOAEL value of 2 mg/kg bw/day was proposed. This value was obtained in a study where the compound was orally administered to male Wistar rats for 17 days and the investigated reproductive parameters included testicular weight, aquaporin-1 immunoexpression, rete testis distention and efferent duct epithelial cell height [Fisher 1999]. - The LOAEL-value for propyl paraben in","page":9,"pdf":"sccp_o_019.pdf","row_type":"noael_study","study_id":"sccp_o_019_noael_010"}

sccp_o_019.pdf

{"dose":"For the latter, a NOAEL value of 2 mg/kg bw/day was proposed.","effect":"SCCP/0873/05 Opinion on the safety evaluation of parabens 9 Therefore, it is the opinion of the SCCP that methyl and ethyl paraben can be safely used up to the maximum authorized concentration as actually established (0.4%). Propyl, butyl and isobutyl paraben Propyl paraben - The developmental rat study provided for propyl paraben failed to indicate a clear NOAEL value, but it suggested that the potency of propyl paraben is clearly lower than the potency of butyl paraben [Oishi 2002b]. For the latter, a NOAEL value of 2 mg/kg bw/day was proposed. This value was obtained in a study where the compound was orally administered to male Wistar rats for 17 days and the investigated reproductive parameters included testicular weight, aquaporin-1 immunoexpression, rete testis distention and efferent duct epithelial cell height [Fisher 1999]. - The LOAEL-value for propyl paraben in Wistar rats was shown to be 10 mg/kg bw/day [Oishi 2002a]. - The major adverse effects of concern caused by propyl paraben involve the male reproduct","page":9,"pdf":"sccp_o_019.pdf","row_type":"noael_study","study_id":"sccp_o_019_noael_011"}

sccp_o_019.pdf

{"dose":"For the latter, a NOAEL value of 2 mg/kg bw/day was proposed.","effect":"SCCP/0873/05 Opinion on the safety evaluation of parabens 9 Therefore, it is the opinion of the SCCP that methyl and ethyl paraben can be safely used up to the maximum authorized concentration as actually established (0.4%). Propyl, butyl and isobutyl paraben Propyl paraben - The developmental rat study provided for propyl paraben failed to indicate a clear NOAEL value, but it suggested that the potency of propyl paraben is clearly lower than the potency of butyl paraben [Oishi 2002b]. For the latter, a NOAEL value of 2 mg/kg bw/day was proposed. This value was obtained in a study where the compound was orally administered to male Wistar rats for 17 days and the investigated reproductive parameters included testicular weight, aquaporin-1 immunoexpression, rete testis distention and efferent duct epithelial cell height [Fisher 1999]. - The LOAEL-value for propyl paraben in Wistar rats was shown to be 10 mg/kg bw/day [Oishi 2002a]. - The major adverse effects of concern caused by propyl paraben involve the male reproduct","page":9,"pdf":"sccp_o_019.pdf","row_type":"noael_study","study_id":"sccp_o_019_noael_011"}

sccp_o_019.pdf

{"dose":"For the latter, a NOAEL value of 2 mg/kg bw/day was proposed.","effect":"SCCP/0873/05 Opinion on the safety evaluation of parabens 9 Therefore, it is the opinion of the SCCP that methyl and ethyl paraben can be safely used up to the maximum authorized concentration as actually established (0.4%). Propyl, butyl and isobutyl paraben Propyl paraben - The developmental rat study provided for propyl paraben failed to indicate a clear NOAEL value, but it suggested that the potency of propyl paraben is clearly lower than the potency of butyl paraben [Oishi 2002b]. For the latter, a NOAEL value of 2 mg/kg bw/day was proposed. This value was obtained in a study where the compound was orally administered to male Wistar rats for 17 days and the investigated reproductive parameters included testicular weight, aquaporin-1 immunoexpression, rete testis distention and efferent duct epithelial cell height [Fisher 1999]. - The LOAEL-value for propyl paraben in Wistar rats was shown to be 10 mg/kg bw/day [Oishi 2002a]. - The major adverse effects of concern caused by propyl paraben involve the male reproduct","page":9,"pdf":"sccp_o_019.pdf","row_type":"noael_study","study_id":"sccp_o_019_noael_011"}

sccp_o_019.pdf

SOURCE_SUBDIR=sccp_o_019; REPORT_TITLE=Extended Opinion on the Safety Evaluation of Parabens; OPINION_NUMBER=SCCP/0873/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=28 January 2005; VALUE_TEXT=10; DOSE=In these calculations, the following parameters were considered: - NOAEL (developmental toxicity of propyl and butyl paraben) 10 mg/kg bw/day - total global exposure to all cosmetic products:; EFFECT=ete risk evaluation, data on reproduction in long-term animal experiments, data from multiple generation experiments and more detailed knowledge on the pharmacokinetics of parabens under use conditions, are required. c) A preliminary risk assessment followed by the calculation of the Margin of Safety (MoS) for the use of parabens as a preservative in cosmetic products, leads to worst case MoS's of 122 and 73 for adults and children, respectively. In these calculations, the following parameters were considered: - NOAEL (developmental toxicity of propyl and butyl paraben) 10 mg/kg bw/day - total global exposure to all cosmetic products: 17.7 g - percutaneous absorption (based on human in vitro studies): 3.5% - contribution of dietary parabens: not considered (very small) - mean human body weight: 60 kg - maximum permitted concentration of paraben mixture: 0.8% - larger body surface per body mass of children versus that of adults: factor 1.7 - extensive biotransformation of parabens into p-hydroxybenzoic acid (li; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"","citation":"","dose":"In these calculations, the following parameters were considered: - NOAEL (developmental toxicity of propyl and butyl paraben) 10 mg/kg bw/day - total global exposure to all cosmetic products:","duration":"developmental","effect":"ete risk evaluation, data on reproduction in long-term animal experiments, data from multiple generation experiments and more detailed knowledge on the pharmacokinetics of parabens under use conditions, are required. c) A preliminary risk assessment followed by the calculation of the Margin of Safety (MoS) for the use of parabens as a preservative in cosmetic products, leads to worst case MoS's of 122 and 73 for adults and children, respectively. In these calculations, the following parameters were considered: - NOAEL (developmental toxicity of propyl and butyl paraben) 10 mg/kg bw/day - total global exposure to all cosmetic products: 17.7 g - percutaneous absorption (based on human in vitro studies): 3.5% - contribution of dietary parabens: not considered (very small) - mean human body weight: 60 kg - maximum permitted concentration of paraben mixture: 0.8% - larger body surface per body mass of children versus that of adults: factor 1.7 - extensive biotransformation of parabens into p-hydroxybenzoic acid (li","endpoint":"developmental toxicity","ingredient":"s are marketed with the symbol (+) and therefore may also be added to","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"10","page":6,"route":"oral","species":"human","study_id":"sccp_o_019_noael_005"}

sccp_o_019.pdf

SOURCE_SUBDIR=sccp_o_019; REPORT_TITLE=Extended Opinion on the Safety Evaluation of Parabens; OPINION_NUMBER=SCCP/0873/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=28 January 2005; VALUE_TEXT=100; DOSE=The maternal NOAEL for butyl paraben was established on 100 mg/kg bw/day.; EFFECT=gestation days 6-19 (sperm positive day being gestation day 0). Foetuses were evaluated on gestation day 20. The highest dosage level caused decreases in maternal weight gain (significant during gestation day 18-20 interval). Maternal food consumption was, however, also decreased in that group for the gestation days 6-20 interval. No differences from the control group could be observed in any of the developmental parameters including embryo/foetal viability, foetal weight, malformations or variations. The maternal NOAEL for butyl paraben was established on 100 mg/kg bw/day. It was further concluded that butyl paraben does not have the potential to cause developmental toxicity in the Sprague-Dawley rat at oral dosages up to 1000 mg/kg bw/day [Daston 2004]. 3.2.4. Breast cancer and the use of paraben-containing cosmetics The suggested link between the use of (paraben-containing) underarm cosmetics and breast cancer has been discussed and refuted in a separate SCCP opinion on Parabens, underarm cosmetics and breast cancer [SCCP/0; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"","citation":"","dose":"The maternal NOAEL for butyl paraben was established on 100 mg/kg bw/day.","duration":"developmental","effect":"gestation days 6-19 (sperm positive day being gestation day 0). Foetuses were evaluated on gestation day 20. The highest dosage level caused decreases in maternal weight gain (significant during gestation day 18-20 interval). Maternal food consumption was, however, also decreased in that group for the gestation days 6-20 interval. No differences from the control group could be observed in any of the developmental parameters including embryo/foetal viability, foetal weight, malformations or variations. The maternal NOAEL for butyl paraben was established on 100 mg/kg bw/day. It was further concluded that butyl paraben does not have the potential to cause developmental toxicity in the Sprague-Dawley rat at oral dosages up to 1000 mg/kg bw/day [Daston 2004]. 3.2.4. Breast cancer and the use of paraben-containing cosmetics The suggested link between the use of (paraben-containing) underarm cosmetics and breast cancer has been discussed and refuted in a separate SCCP opinion on Parabens, underarm cosmetics and breast cancer [SCCP/0","endpoint":"developmental toxicity","ingredient":"s are marketed with the symbol (+) and therefore may also be added to","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":8,"route":"oral","species":"rat","study_id":"sccp_o_019_noael_008"}

sccp_o_019.pdf

SOURCE_SUBDIR=sccp_o_019; REPORT_TITLE=Extended Opinion on the Safety Evaluation of Parabens; OPINION_NUMBER=SCCP/0873/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=28 January 2005; VALUE_TEXT=1000; DOSE=A supplementary study in the rat on propyl paraben, given as a solution instead of a ground powder, was requested. f) Finally, the report stated several subchronic and chronic toxicity tests conducted in rats, dogs and mice, resulting in a NOAEL-value of 1000 mg/kg bw/day.; EFFECT=hown no evidence of accumulation of either parent compound or metabolites in the tissues. e) A number of special studies revealed that the parabens (in particular propyl and butyl paraben) were able to induce cell proliferation in the forestomach and glandular stomach of rats. A supplementary study in the rat on propyl paraben, given as a solution instead of a ground powder, was requested. f) Finally, the report stated several subchronic and chronic toxicity tests conducted in rats, dogs and mice, resulting in a NOAEL-value of 1000 mg/kg bw/day. Based on this value, the EC Scientific Committee on Food established a temporary Acceptable Daily Intake (ADI) of up to 10 mg/kg as the sum of methyl, ethyl and propyl paraben and their sodium salts. That ADI was temporary since the Committee asked for some additional information with regard to the reproductive effects and more data on the cell proliferation effect of the compounds in the rat forestomach.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"","citation":"","dose":"A supplementary study in the rat on propyl paraben, given as a solution instead of a ground powder, was requested. f) Finally, the report stated several subchronic and chronic toxicity tests conducted in rats, dogs and mice, resulting in a NOAEL-value of 1000 mg/kg bw/day.","duration":"subchronic","effect":"hown no evidence of accumulation of either parent compound or metabolites in the tissues. e) A number of special studies revealed that the parabens (in particular propyl and butyl paraben) were able to induce cell proliferation in the forestomach and glandular stomach of rats. A supplementary study in the rat on propyl paraben, given as a solution instead of a ground powder, was requested. f) Finally, the report stated several subchronic and chronic toxicity tests conducted in rats, dogs and mice, resulting in a NOAEL-value of 1000 mg/kg bw/day. Based on this value, the EC Scientific Committee on Food established a temporary Acceptable Daily Intake (ADI) of up to 10 mg/kg as the sum of methyl, ethyl and propyl paraben and their sodium salts. That ADI was temporary since the Committee asked for some additional information with regard to the reproductive effects and more data on the cell proliferation effect of the compounds in the rat forestomach.","endpoint":"repeated dose toxicity","ingredient":"s are marketed with the symbol (+) and therefore may also be added to","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":4,"route":"","species":"rat","study_id":"sccp_o_019_noael_001"}

sccp_o_019.pdf

SOURCE_SUBDIR=sccp_o_019; REPORT_TITLE=Extended Opinion on the Safety Evaluation of Parabens; OPINION_NUMBER=SCCP/0873/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=28 January 2005; VALUE_TEXT=1000; DOSE=A NOAEL value of 1000 mg/kg bw/day was accepted for all esters.; EFFECT=rabens used in cosmetic products Viewing the availability of the four above-mentioned official reports, the toxicity profile of the parabens will only be briefly summarised in the current report and more detailed sections will be dedicated to the specific potential problem areas. 3.2.1. General toxicology Based on acute, subacute and chronic toxicity studies in rats, dogs and mice, parabens have been proven to be practically non-toxic, not carcinogenic, not genotoxic nor co-carcinogenic, and not teratogenic. A NOAEL value of 1000 mg/kg bw/day was accepted for all esters. Parabens are not expected to accumulate in tissues and the ester linkage of the parabens is expected to be readily hydrolyzed [SCF 1994]. 3.2.2. Estrogenic effects of parabens In a number of in vitro studies, such as the recombinant yeast estrogen screen, parabens have proven being able to bind the estrogen receptor, to activate genes controlled by these receptors, and to stimulate cell growth and increase the level of immune reactive estrogen receptor pro; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"","citation":"","dose":"A NOAEL value of 1000 mg/kg bw/day was accepted for all esters.","duration":"subacute","effect":"rabens used in cosmetic products Viewing the availability of the four above-mentioned official reports, the toxicity profile of the parabens will only be briefly summarised in the current report and more detailed sections will be dedicated to the specific potential problem areas. 3.2.1. General toxicology Based on acute, subacute and chronic toxicity studies in rats, dogs and mice, parabens have been proven to be practically non-toxic, not carcinogenic, not genotoxic nor co-carcinogenic, and not teratogenic. A NOAEL value of 1000 mg/kg bw/day was accepted for all esters. Parabens are not expected to accumulate in tissues and the ester linkage of the parabens is expected to be readily hydrolyzed [SCF 1994]. 3.2.2. Estrogenic effects of parabens In a number of in vitro studies, such as the recombinant yeast estrogen screen, parabens have proven being able to bind the estrogen receptor, to activate genes controlled by these receptors, and to stimulate cell growth and increase the level of immune reactive estrogen receptor pro","endpoint":"repeated dose toxicity","ingredient":"s are marketed with the symbol (+) and therefore may also be added to","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":6,"route":"","species":"rat","study_id":"sccp_o_019_noael_006"}

sccp_o_019.pdf

SOURCE_SUBDIR=sccp_o_019; REPORT_TITLE=Extended Opinion on the Safety Evaluation of Parabens; OPINION_NUMBER=SCCP/0873/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=28 January 2005; VALUE_TEXT=0.4; DOSE=For the latter, a NOAEL value of 2 mg/kg bw/day was proposed.; EFFECT=SCCP/0873/05 Opinion on the safety evaluation of parabens 9 Therefore, it is the opinion of the SCCP that methyl and ethyl paraben can be safely used up to the maximum authorized concentration as actually established (0.4%). Propyl, butyl and isobutyl paraben Propyl paraben - The developmental rat study provided for propyl paraben failed to indicate a clear NOAEL value, but it suggested that the potency of propyl paraben is clearly lower than the potency of butyl paraben [Oishi 2002b]. For the latter, a NOAEL value of 2 mg/kg bw/day was proposed. This value was obtained in a study where the compound was orally administered to male Wistar rats for 17 days and the investigated reproductive parameters included testicular weight, aquaporin-1 immunoexpression, rete testis distention and efferent duct epithelial cell height [Fisher 1999]. - The LOAEL-value for propyl paraben in; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"","citation":"","dose":"For the latter, a NOAEL value of 2 mg/kg bw/day was proposed.","duration":"developmental","effect":"SCCP/0873/05 Opinion on the safety evaluation of parabens 9 Therefore, it is the opinion of the SCCP that methyl and ethyl paraben can be safely used up to the maximum authorized concentration as actually established (0.4%). Propyl, butyl and isobutyl paraben Propyl paraben - The developmental rat study provided for propyl paraben failed to indicate a clear NOAEL value, but it suggested that the potency of propyl paraben is clearly lower than the potency of butyl paraben [Oishi 2002b]. For the latter, a NOAEL value of 2 mg/kg bw/day was proposed. This value was obtained in a study where the compound was orally administered to male Wistar rats for 17 days and the investigated reproductive parameters included testicular weight, aquaporin-1 immunoexpression, rete testis distention and efferent duct epithelial cell height [Fisher 1999]. - The LOAEL-value for propyl paraben in","endpoint":"reproductive toxicity","ingredient":"s are marketed with the symbol (+) and therefore may also be added to","loael_value":"","noael_unit":"%","noael_value":"0.4","page":9,"route":"","species":"rat","study_id":"sccp_o_019_noael_010"}

sccp_o_019.pdf

SOURCE_SUBDIR=sccp_o_019; REPORT_TITLE=Extended Opinion on the Safety Evaluation of Parabens; OPINION_NUMBER=SCCP/0873/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=28 January 2005; VALUE_TEXT=2; DOSE=For the latter, a NOAEL value of 2 mg/kg bw/day was proposed.; LOAEL_VALUE=10 mg/kg bw/day; EFFECT=SCCP/0873/05 Opinion on the safety evaluation of parabens 9 Therefore, it is the opinion of the SCCP that methyl and ethyl paraben can be safely used up to the maximum authorized concentration as actually established (0.4%). Propyl, butyl and isobutyl paraben Propyl paraben - The developmental rat study provided for propyl paraben failed to indicate a clear NOAEL value, but it suggested that the potency of propyl paraben is clearly lower than the potency of butyl paraben [Oishi 2002b]. For the latter, a NOAEL value of 2 mg/kg bw/day was proposed. This value was obtained in a study where the compound was orally administered to male Wistar rats for 17 days and the investigated reproductive parameters included testicular weight, aquaporin-1 immunoexpression, rete testis distention and efferent duct epithelial cell height [Fisher 1999]. - The LOAEL-value for propyl paraben in Wistar rats was shown to be 10 mg/kg bw/day [Oishi 2002a]. - The major adverse effects of concern caused by propyl paraben involve the male reproduct; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"","citation":"","dose":"For the latter, a NOAEL value of 2 mg/kg bw/day was proposed.","duration":"developmental","effect":"SCCP/0873/05 Opinion on the safety evaluation of parabens 9 Therefore, it is the opinion of the SCCP that methyl and ethyl paraben can be safely used up to the maximum authorized concentration as actually established (0.4%). Propyl, butyl and isobutyl paraben Propyl paraben - The developmental rat study provided for propyl paraben failed to indicate a clear NOAEL value, but it suggested that the potency of propyl paraben is clearly lower than the potency of butyl paraben [Oishi 2002b]. For the latter, a NOAEL value of 2 mg/kg bw/day was proposed. This value was obtained in a study where the compound was orally administered to male Wistar rats for 17 days and the investigated reproductive parameters included testicular weight, aquaporin-1 immunoexpression, rete testis distention and efferent duct epithelial cell height [Fisher 1999]. - The LOAEL-value for propyl paraben in Wistar rats was shown to be 10 mg/kg bw/day [Oishi 2002a]. - The major adverse effects of concern caused by propyl paraben involve the male reproduct","endpoint":"reproductive toxicity","ingredient":"s are marketed with the symbol (+) and therefore may also be added to","loael_value":"10 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"2","page":9,"route":"","species":"rat","study_id":"sccp_o_019_noael_011"}

sccp_o_019.pdf

SOURCE_SUBDIR=sccp_o_019; REPORT_TITLE=Extended Opinion on the Safety Evaluation of Parabens; OPINION_NUMBER=SCCP/0873/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=28 January 2005; VALUE_TEXT=2; DOSE=nt duct epithelial cell height [Fisher 1999]. - The LOAEL-value for propyl paraben in Wistar rats was shown to be 10 mg/kg bw/day [Oishi 2002a]. - The major adverse effects of concern caused by propyl paraben involve the male reproductive system.; LOAEL_VALUE=10 mg/kg bw/day; EFFECT=nt duct epithelial cell height [Fisher 1999]. - The LOAEL-value for propyl paraben in Wistar rats was shown to be 10 mg/kg bw/day [Oishi 2002a]. - The major adverse effects of concern caused by propyl paraben involve the male reproductive system. It must not be forgotten, however, that the majority of cosmetic products will be used by females. Especially the cumulative cosmetic exposure value of 17.79 g/day is a clear overestimation for the normal male population. Butyl and isobutyl paraben - For butyl paraben a NOAEL value in Cjr:CD-1 mice (oral study) of 2 mg/kg bw/day has been proposed [Oishi 2002b]. - Very recently, a developmental study on butyl paraben became available. In that study, it was shown that the maternal NOAEL of butyl paraben was 100 mg/kg bw/day and that the compound did not have the potential to cause developmental toxicity in the Sprague- Dawley rat. It is known that potent estrogens interfere with the development of the reproductive system, placental function, embryonic growth, embryo viability and mainten; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"","citation":"","dose":"nt duct epithelial cell height [Fisher 1999]. - The LOAEL-value for propyl paraben in Wistar rats was shown to be 10 mg/kg bw/day [Oishi 2002a]. - The major adverse effects of concern caused by propyl paraben involve the male reproductive system.","duration":"developmental","effect":"nt duct epithelial cell height [Fisher 1999]. - The LOAEL-value for propyl paraben in Wistar rats was shown to be 10 mg/kg bw/day [Oishi 2002a]. - The major adverse effects of concern caused by propyl paraben involve the male reproductive system. It must not be forgotten, however, that the majority of cosmetic products will be used by females. Especially the cumulative cosmetic exposure value of 17.79 g/day is a clear overestimation for the normal male population. Butyl and isobutyl paraben - For butyl paraben a NOAEL value in Cjr:CD-1 mice (oral study) of 2 mg/kg bw/day has been proposed [Oishi 2002b]. - Very recently, a developmental study on butyl paraben became available. In that study, it was shown that the maternal NOAEL of butyl paraben was 100 mg/kg bw/day and that the compound did not have the potential to cause developmental toxicity in the Sprague- Dawley rat. It is known that potent estrogens interfere with the development of the reproductive system, placental function, embryonic growth, embryo viability and mainten","endpoint":"reproductive toxicity","ingredient":"s are marketed with the symbol (+) and therefore may also be added to","loael_value":"10 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"2","page":9,"route":"oral","species":"rat","study_id":"sccp_o_019_noael_012"}

sccp_o_019.pdf

SOURCE_SUBDIR=sccp_o_019; REPORT_TITLE=Extended Opinion on the Safety Evaluation of Parabens; OPINION_NUMBER=SCCP/0873/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=28 January 2005; VALUE_TEXT=unclear:strogenic effects of the parabens and more importantly with the newly discovered effects on the male reproductive system, as described under point 3.3 of this opinion, the European Food Safety Authority reviewed the safe use of parabens in food. The Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food came to the conclusion that the ADI remained unchanged for methyl, ethyl paraben and their sodium salts, but that for propyl paraben no ADI could be established, by lack of a clear NOAEL value.; EFFECT=strogenic effects of the parabens and more importantly with the newly discovered effects on the male reproductive system, as described under point 3.3 of this opinion, the European Food Safety Authority reviewed the safe use of parabens in food. The Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food came to the conclusion that the ADI remained unchanged for methyl, ethyl paraben and their sodium salts, but that for propyl paraben no ADI could be established, by lack of a clear NOAEL value.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"","citation":"","dose":"","duration":"","effect":"strogenic effects of the parabens and more importantly with the newly discovered effects on the male reproductive system, as described under point 3.3 of this opinion, the European Food Safety Authority reviewed the safe use of parabens in food. The Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food came to the conclusion that the ADI remained unchanged for methyl, ethyl paraben and their sodium salts, but that for propyl paraben no ADI could be established, by lack of a clear NOAEL value.","endpoint":"reproductive toxicity","ingredient":"s are marketed with the symbol (+) and therefore may also be added to","loael_value":"","noael_unit":"","noael_value":"unclear:strogenic effects of the parabens and more importantly with the newly discovered effects on the male reproductive system, as described under point 3.3 of this opinion, the European Food Safety Authority reviewed the safe use of parabens in food. The Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food came to the conclusion that the ADI remained unchanged for methyl, ethyl paraben and their sodium salts, but that for propyl paraben no ADI could be established, by lack of a clear NOAEL value.","page":8,"route":"","species":"","study_id":"sccp_o_019_noael_009"}

sccp_o_019.pdf

SOURCE_SUBDIR=sccp_o_019; REPORT_TITLE=Extended Opinion on the Safety Evaluation of Parabens; OPINION_NUMBER=SCCP/0873/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=28 January 2005; VALUE_TEXT=100; DOSE=Butyl and isobutyl paraben - For butyl paraben a NOAEL value in Cjr:CD-1 mice (oral study) of 2 mg/kg bw/day has been proposed [Oishi 2002b]. - Very recently, a developmental study on butyl paraben became available.; EFFECT=lve the male reproductive system. It must not be forgotten, however, that the majority of cosmetic products will be used by females. Especially the cumulative cosmetic exposure value of 17.79 g/day is a clear overestimation for the normal male population. Butyl and isobutyl paraben - For butyl paraben a NOAEL value in Cjr:CD-1 mice (oral study) of 2 mg/kg bw/day has been proposed [Oishi 2002b]. - Very recently, a developmental study on butyl paraben became available. In that study, it was shown that the maternal NOAEL of butyl paraben was 100 mg/kg bw/day and that the compound did not have the potential to cause developmental toxicity in the Sprague- Dawley rat. It is known that potent estrogens interfere with the development of the reproductive system, placental function, embryonic growth, embryo viability and maintenance of pregnancy [Daston et al. 1997]. Although indirectly, these parameters could be responsive indicators of estrogenicity. This leads to the suggestion that butyl paraben did not have a strong estrogenic poten; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"","citation":"","dose":"Butyl and isobutyl paraben - For butyl paraben a NOAEL value in Cjr:CD-1 mice (oral study) of 2 mg/kg bw/day has been proposed [Oishi 2002b]. - Very recently, a developmental study on butyl paraben became available.","duration":"developmental","effect":"lve the male reproductive system. It must not be forgotten, however, that the majority of cosmetic products will be used by females. Especially the cumulative cosmetic exposure value of 17.79 g/day is a clear overestimation for the normal male population. Butyl and isobutyl paraben - For butyl paraben a NOAEL value in Cjr:CD-1 mice (oral study) of 2 mg/kg bw/day has been proposed [Oishi 2002b]. - Very recently, a developmental study on butyl paraben became available. In that study, it was shown that the maternal NOAEL of butyl paraben was 100 mg/kg bw/day and that the compound did not have the potential to cause developmental toxicity in the Sprague- Dawley rat. It is known that potent estrogens interfere with the development of the reproductive system, placental function, embryonic growth, embryo viability and maintenance of pregnancy [Daston et al. 1997]. Although indirectly, these parameters could be responsive indicators of estrogenicity. This leads to the suggestion that butyl paraben did not have a strong estrogenic poten","endpoint":"reproductive toxicity","ingredient":"s are marketed with the symbol (+) and therefore may also be added to","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":9,"route":"oral","species":"rat","study_id":"sccp_o_019_noael_013"}

sccp_o_019.pdf

SOURCE_SUBDIR=sccp_o_019; REPORT_TITLE=Extended Opinion on the Safety Evaluation of Parabens; OPINION_NUMBER=SCCP/0873/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=28 January 2005; VALUE_TEXT=1000; DOSE=For the major metabolite, p- hydroxybenzoic acid, no effect was present. d) Dietary administration of methyl and ethyl paraben to juvenile male rats had no effect on sex hormones and reproductive organs at dosage levels up to 1000 mg/kg bw/day.; LOAEL_VALUE=10 mg/kg bw/day; EFFECT=However, for methyl, ethyl and propyl paraben, such activity was not detectable in vivo using uterotrophic assays (oral and s.c.) in mice and rats. On the contrary, for butyl and isobutyl paraben (not used in food), a positive effect was seen after s.c. injection. For the major metabolite, p- hydroxybenzoic acid, no effect was present. d) Dietary administration of methyl and ethyl paraben to juvenile male rats had no effect on sex hormones and reproductive organs at dosage levels up to 1000 mg/kg bw/day. Thus the NOAEL for methyl and ethyl paraben is 1000 mg/kg bw/day. For propyl paraben impaired spermatogenesis, reduced testosterone levels and reduced sperm cell count numbers were observed and a LOAEL of 10 mg/kg bw/day was established. e) The EFSA report came to the conclusion that the ADI of up to 10 mg/kg remains in place for the sum of methyl and ethyl paraben and their sodium salts on the basis of a NOAEL of 1000 mg/kg. For propyl paraben on the other hand, this ADI was not considered appropriate. An ADI for the propyl es; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"","citation":"","dose":"For the major metabolite, p- hydroxybenzoic acid, no effect was present. d) Dietary administration of methyl and ethyl paraben to juvenile male rats had no effect on sex hormones and reproductive organs at dosage levels up to 1000 mg/kg bw/day.","duration":"","effect":"However, for methyl, ethyl and propyl paraben, such activity was not detectable in vivo using uterotrophic assays (oral and s.c.) in mice and rats. On the contrary, for butyl and isobutyl paraben (not used in food), a positive effect was seen after s.c. injection. For the major metabolite, p- hydroxybenzoic acid, no effect was present. d) Dietary administration of methyl and ethyl paraben to juvenile male rats had no effect on sex hormones and reproductive organs at dosage levels up to 1000 mg/kg bw/day. Thus the NOAEL for methyl and ethyl paraben is 1000 mg/kg bw/day. For propyl paraben impaired spermatogenesis, reduced testosterone levels and reduced sperm cell count numbers were observed and a LOAEL of 10 mg/kg bw/day was established. e) The EFSA report came to the conclusion that the ADI of up to 10 mg/kg remains in place for the sum of methyl and ethyl paraben and their sodium salts on the basis of a NOAEL of 1000 mg/kg. For propyl paraben on the other hand, this ADI was not considered appropriate. An ADI for the propyl es","endpoint":"reproductive toxicity","ingredient":"s are marketed with the symbol (+) and therefore may also be added to","loael_value":"10 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"1000","page":5,"route":"oral","species":"rat","study_id":"sccp_o_019_noael_002"}

sccp_o_019.pdf

SOURCE_SUBDIR=sccp_o_019; REPORT_TITLE=Extended Opinion on the Safety Evaluation of Parabens; OPINION_NUMBER=SCCP/0873/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=28 January 2005; VALUE_TEXT=1000; DOSE=ile male rats had no effect on sex hormones and reproductive organs at dosage levels up to 1000 mg/kg bw/day.; LOAEL_VALUE=10 mg/kg bw/day; EFFECT=ile male rats had no effect on sex hormones and reproductive organs at dosage levels up to 1000 mg/kg bw/day. Thus the NOAEL for methyl and ethyl paraben is 1000 mg/kg bw/day. For propyl paraben impaired spermatogenesis, reduced testosterone levels and reduced sperm cell count numbers were observed and a LOAEL of 10 mg/kg bw/day was established. e) The EFSA report came to the conclusion that the ADI of up to 10 mg/kg remains in place for the sum of methyl and ethyl paraben and their sodium salts on the basis of a NOAEL of 1000 mg/kg. For propyl paraben on the other hand, this ADI was not considered appropriate. An ADI for the propyl ester could not be established because of the lack of a clear NOAEL. 3.1.3. The Danish Institute of Food and Veterinary Research, Anonymous 2004 In September 2004, the Danish Institute of Food and Veterinary Research issued a report entitled "Note on Parabens in Food, Cosmetics and Consumer Products". This document refers to the EFSA report for a full overview of the available toxicity data on par; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"","citation":"","dose":"ile male rats had no effect on sex hormones and reproductive organs at dosage levels up to 1000 mg/kg bw/day.","duration":"","effect":"ile male rats had no effect on sex hormones and reproductive organs at dosage levels up to 1000 mg/kg bw/day. Thus the NOAEL for methyl and ethyl paraben is 1000 mg/kg bw/day. For propyl paraben impaired spermatogenesis, reduced testosterone levels and reduced sperm cell count numbers were observed and a LOAEL of 10 mg/kg bw/day was established. e) The EFSA report came to the conclusion that the ADI of up to 10 mg/kg remains in place for the sum of methyl and ethyl paraben and their sodium salts on the basis of a NOAEL of 1000 mg/kg. For propyl paraben on the other hand, this ADI was not considered appropriate. An ADI for the propyl ester could not be established because of the lack of a clear NOAEL. 3.1.3. The Danish Institute of Food and Veterinary Research, Anonymous 2004 In September 2004, the Danish Institute of Food and Veterinary Research issued a report entitled \"Note on Parabens in Food, Cosmetics and Consumer Products\". This document refers to the EFSA report for a full overview of the available toxicity data on par","endpoint":"reproductive toxicity","ingredient":"s are marketed with the symbol (+) and therefore may also be added to","loael_value":"10 mg/kg bw/day","noael_unit":"mg/kg","noael_value":"1000","page":5,"route":"","species":"rat","study_id":"sccp_o_019_noael_003"}

sccp_o_019.pdf

SOURCE_SUBDIR=sccp_o_019; REPORT_TITLE=Extended Opinion on the Safety Evaluation of Parabens; OPINION_NUMBER=SCCP/0873/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=28 January 2005; VALUE_TEXT=1000; DOSE=yl paraben impaired spermatogenesis, reduced testosterone levels and reduced sperm cell count numbers were observed and a LOAEL of 10 mg/kg bw/day was established. e) The EFSA report came to the conclusion that the ADI of up to 10 mg/kg remains in place for the sum of methyl and ethyl paraben and their sodium salts on the basis of a NOAEL of 100...; LOAEL_VALUE=10 mg/kg bw/day; EFFECT=yl paraben impaired spermatogenesis, reduced testosterone levels and reduced sperm cell count numbers were observed and a LOAEL of 10 mg/kg bw/day was established. e) The EFSA report came to the conclusion that the ADI of up to 10 mg/kg remains in place for the sum of methyl and ethyl paraben and their sodium salts on the basis of a NOAEL of 1000 mg/kg. For propyl paraben on the other hand, this ADI was not considered appropriate. An ADI for the propyl ester could not be established because of the lack of a clear NOAEL. 3.1.3. The Danish Institute of Food and Veterinary Research, Anonymous 2004 In September 2004, the Danish Institute of Food and Veterinary Research issued a report entitled "Note on Parabens in Food, Cosmetics and Consumer Products". This document refers to the EFSA report for a full overview of the available toxicity data on parabens, and focuses on the problems of endocrine disrupting potential, effects on the male reproductive system, skin penetration of parabens, breast cancer & paraben-containing cosmetic; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"","citation":"","dose":"yl paraben impaired spermatogenesis, reduced testosterone levels and reduced sperm cell count numbers were observed and a LOAEL of 10 mg/kg bw/day was established. e) The EFSA report came to the conclusion that the ADI of up to 10 mg/kg remains in place for the sum of methyl and ethyl paraben and their sodium salts on the basis of a NOAEL of 100...","duration":"","effect":"yl paraben impaired spermatogenesis, reduced testosterone levels and reduced sperm cell count numbers were observed and a LOAEL of 10 mg/kg bw/day was established. e) The EFSA report came to the conclusion that the ADI of up to 10 mg/kg remains in place for the sum of methyl and ethyl paraben and their sodium salts on the basis of a NOAEL of 1000 mg/kg. For propyl paraben on the other hand, this ADI was not considered appropriate. An ADI for the propyl ester could not be established because of the lack of a clear NOAEL. 3.1.3. The Danish Institute of Food and Veterinary Research, Anonymous 2004 In September 2004, the Danish Institute of Food and Veterinary Research issued a report entitled \"Note on Parabens in Food, Cosmetics and Consumer Products\". This document refers to the EFSA report for a full overview of the available toxicity data on parabens, and focuses on the problems of endocrine disrupting potential, effects on the male reproductive system, skin penetration of parabens, breast cancer & paraben-containing cosmetic","endpoint":"reproductive toxicity","ingredient":"s are marketed with the symbol (+) and therefore may also be added to","loael_value":"10 mg/kg bw/day","noael_unit":"mg/kg","noael_value":"1000","page":5,"route":"","species":"","study_id":"sccp_o_019_noael_004"}

sccp_o_019.pdf

SOURCE_SUBDIR=sccp_o_019; REPORT_TITLE=Extended Opinion on the Safety Evaluation of Parabens; OPINION_NUMBER=SCCP/0873/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=28 January 2005; VALUE_TEXT=1000; DOSE=Dosages of 103 and 1030 mg/kg bw/day failed to induce adverse effects [Oishi 2004].; EFFECT=n of parabens 8 Recently, methyl and ethyl paraben have been tested for effects on secretion of sex hormones and the Wistar rat male reproductive system. Dosages of 103 and 1030 mg/kg bw/day failed to induce adverse effects [Oishi 2004]. Taking together the above-mentioned studies, it is clear that butyl paraben shows the highest potency with regard to effects to the male reproductive system. This is in accordance with the results of the estrogenicity tests. It was also concluded that, in order to define an exact NOAEL for propyl paraben, additional studies were necessary [EFSA 2004, Anonymous 2004]. Very recently, a detailed developmental toxicity evaluation of butyl paraben given by oral gavage to Sprague-Dawley rats became available [Daston 2004]. Dosage levels of 0, 10, 100 and 1000 mg/kg bw/day were administered on gestation days 6-19 (sperm positive day being gestation day 0). Foetuses were evaluated on gestation day 20. The highest dosage level caused decreases in maternal weight gain (significant during gestation day 18; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"","citation":"","dose":"Dosages of 103 and 1030 mg/kg bw/day failed to induce adverse effects [Oishi 2004].","duration":"developmental","effect":"n of parabens 8 Recently, methyl and ethyl paraben have been tested for effects on secretion of sex hormones and the Wistar rat male reproductive system. Dosages of 103 and 1030 mg/kg bw/day failed to induce adverse effects [Oishi 2004]. Taking together the above-mentioned studies, it is clear that butyl paraben shows the highest potency with regard to effects to the male reproductive system. This is in accordance with the results of the estrogenicity tests. It was also concluded that, in order to define an exact NOAEL for propyl paraben, additional studies were necessary [EFSA 2004, Anonymous 2004]. Very recently, a detailed developmental toxicity evaluation of butyl paraben given by oral gavage to Sprague-Dawley rats became available [Daston 2004]. Dosage levels of 0, 10, 100 and 1000 mg/kg bw/day were administered on gestation days 6-19 (sperm positive day being gestation day 0). Foetuses were evaluated on gestation day 20. The highest dosage level caused decreases in maternal weight gain (significant during gestation day 18","endpoint":"reproductive toxicity","ingredient":"s are marketed with the symbol (+) and therefore may also be added to","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":8,"route":"oral","species":"rat","study_id":"sccp_o_019_noael_007"}

sccp_o_019.pdf

{"absorption_percent":"0.4%; 0.8%","basis":"4-Hydroxybenzoic acid, its salts and esters (\"parabens\") are currently authorised in Annex VI, entry 12 of the Cosmetics Directive (76/768/EEC) at a maximum use concentration of 0.4% (acid) for one ester and 0.8% for a mixture of esters. Between January 2005 and June 2008, the Scientific Committee on Consumer Products (SCCP) adopted four opinions on parabens: • The first opinion (SCCP/0874/05) addressed parabens and breast cancer: “Extended Opinion on parabens, underarm cosmetics and breast cancer” and concluded that according to the current knowledge, there is no evidence of a demonstrable risk for the development of breast cancer caused by the use of underarm cosmetics. • The second opinion “(SCCP/0873/05) was “An extended opinion on the Safety Evaluation of parabens\" with the following conclusions: “Methyl- and ethylparaben For the methyl and ethyl p-hydroxybenzoic acid esters, the maximum authorised concentrations remain unchanged. Propyl-, isopropyl-, butyl- and isobutylparaben...","concentration_tested":"4-Hydroxybenzoic acid, its salts and esters (\"parabens\") are currently authorised in Annex VI, entry 12 of the Cosmetics Directive (76/768/EEC) at a maximum use concentration of 0.4% (acid) for one ester and 0.8% for a mixture of esters.","page":5,"pdf":"sccs_o_041.pdf","row_type":"dermal_absorption_study"}

sccs_o_041.pdf

{"absorption_percent":"0.4%; 0.8%","basis":"4-Hydroxybenzoic acid, its salts and esters (\"parabens\") are currently authorised in Annex VI, entry 12 of the Cosmetics Directive (76/768/EEC) at a maximum use concentration of 0.4% (acid) for one ester and 0.8% for a mixture of esters. Between January 2005 and June 2008, the Scientific Committee on Consumer Products (SCCP) adopted four opinions on parabens: • The first opinion (SCCP/0874/05) addressed parabens and breast cancer: “Extended Opinion on parabens, underarm cosmetics and breast cancer” and concluded that according to the current knowledge, there is no evidence of a demonstrable risk for the development of breast cancer caused by the use of underarm cosmetics. • The second opinion “(SCCP/0873/05) was “An extended opinion on the Safety Evaluation of parabens\" with the following conclusions: “Methyl- and ethylparaben For the methyl and ethyl p-hydroxybenzoic acid esters, the maximum authorised concentrations remain unchanged. Propyl-, isopropyl-, butyl- and isobutylparaben...","concentration_tested":"4-Hydroxybenzoic acid, its salts and esters (\"parabens\") are currently authorised in Annex VI, entry 12 of the Cosmetics Directive (76/768/EEC) at a maximum use concentration of 0.4% (acid) for one ester and 0.8% for a mixture of esters.","page":5,"pdf":"sccs_o_041.pdf","row_type":"dermal_absorption_study"}

sccs_o_041.pdf

{"absorption_percent":"0.4%; 0.8%","basis":"4-Hydroxybenzoic acid, its salts and esters (\"parabens\") are currently authorised in Annex VI, entry 12 of the Cosmetics Directive (76/768/EEC) at a maximum use concentration of 0.4% (acid) for one ester and 0.8% for a mixture of esters. Between January 2005 and June 2008, the Scientific Committee on Consumer Products (SCCP) adopted four opinions on parabens: • The first opinion (SCCP/0874/05) addressed parabens and breast cancer: “Extended Opinion on parabens, underarm cosmetics and breast cancer” and concluded that according to the current knowledge, there is no evidence of a demonstrable risk for the development of breast cancer caused by the use of underarm cosmetics. • The second opinion “(SCCP/0873/05) was “An extended opinion on the Safety Evaluation of parabens\" with the following conclusions: “Methyl- and ethylparaben For the methyl and ethyl p-hydroxybenzoic acid esters, the maximum authorised concentrations remain unchanged. Propyl-, isopropyl-, butyl- and isobutylparaben...","concentration_tested":"4-Hydroxybenzoic acid, its salts and esters (\"parabens\") are currently authorised in Annex VI, entry 12 of the Cosmetics Directive (76/768/EEC) at a maximum use concentration of 0.4% (acid) for one ester and 0.8% for a mixture of esters.","page":5,"pdf":"sccs_o_041.pdf","row_type":"dermal_absorption_study"}

sccs_o_041.pdf

{"absorption_percent":"3.5%","basis":"3.3.1.1 Dermal absorption in vitro The Norwegian Institute of Public Health published in 2003 a report (Paulsen and Alexander, 2003), briefly summarising the toxicity of the parabens and using in their calculation of the MoS a value of 3.5% dermal absorption, based on in vitro studies with human skin (Cross and Roberts 2000): This document was taken up in the 2005 SCCP opinion on parabens (SCCP/0873/05) and was considered to give a realistic value for dermal absorption. During the commenting period of the present opinion (SCCS/1348/10) however, the SCCS was informed that the value of 3.5% dermal absorption was based on a misinterpretation of the original study results contained in the applicant's dossier and should therefore not be used.","page":13,"pdf":"sccs_o_041.pdf","row_type":"dermal_absorption_study"}

sccs_o_041.pdf

{"absorption_percent":"3.5%","basis":"3.3.1.1 Dermal absorption in vitro The Norwegian Institute of Public Health published in 2003 a report (Paulsen and Alexander, 2003), briefly summarising the toxicity of the parabens and using in their calculation of the MoS a value of 3.5% dermal absorption, based on in vitro studies with human skin (Cross and Roberts 2000): This document was taken up in the 2005 SCCP opinion on parabens (SCCP/0873/05) and was considered to give a realistic value for dermal absorption. During the commenting period of the present opinion (SCCS/1348/10) however, the SCCS was informed that the value of 3.5% dermal absorption was based on a misinterpretation of the original study results contained in the applicant's dossier and should therefore not be used.","page":13,"pdf":"sccs_o_041.pdf","row_type":"dermal_absorption_study"}

sccs_o_041.pdf

{"absorption_percent":"3.5%","basis":"3.3.1.1 Dermal absorption in vitro The Norwegian Institute of Public Health published in 2003 a report (Paulsen and Alexander, 2003), briefly summarising the toxicity of the parabens and using in their calculation of the MoS a value of 3.5% dermal absorption, based on in vitro studies with human skin (Cross and Roberts 2000): This document was taken up in the 2005 SCCP opinion on parabens (SCCP/0873/05) and was considered to give a realistic value for dermal absorption. During the commenting period of the present opinion (SCCS/1348/10) however, the SCCS was informed that the value of 3.5% dermal absorption was based on a misinterpretation of the original study results contained in the applicant's dossier and should therefore not be used.","page":13,"pdf":"sccs_o_041.pdf","row_type":"dermal_absorption_study"}

sccs_o_041.pdf