Chemwatch : 4883-41 Version No : 5.1.1.1
Page 9 of 13 Fidos Black Gloss Shampoo ( Fido ' s Black Gloss Shampoo )
Issue Date : 12 / 22 / 2014 Print Date : 06 / 27 / 2016 manufacturers to remove 1,4-dioxane , though it is not required by federal law . The material may produce moderate eye irritation leading to inflammation . Repeated or prolonged exposure to irritants may produce conjunctivitis . * [ CESIO ]
COCAMIDOPROPYLBETAINE
The following information refers to contact allergens as a group and may not be specific to this product . Contact allergies quickly manifest themselves as contact eczema , more rarely as urticaria or Quincke ' s oedema . The pathogenesis of contact eczema involves a cell-mediated ( T lymphocytes ) immune reaction of the delayed type . Other allergic skin reactions , e . g . contact urticaria , involve antibody-mediated immune reactions . The significance of the contact allergen is not simply determined by its sensitisation potential : the distribution of the substance and the opportunities for contact with it are equally important . A weakly sensitising substance which is widely distributed can be a more important allergen than one with stronger sensitising potential with which few individuals come into contact . From a clinical point of view , substances are noteworthy if they produce an allergic test reaction in more than 1 % of the persons tested . Possible cross-reactions to several fatty acid amidopropyl dimethylamines were observed in patients that were reported to have allergic contact dermatitis to a baby lotion that contained 0.3 % oleamidopropyl dimethylamine . Stearamidopropyl dimethylamine at 2 % in hair conditioners was not a contact sensitiser when tested neat or diluted to 30 %. However , irritation reactions were observed . A 10-year retrospective study found that out of 46 patients with confirmed allergic eyelid dermatitis , 10.9 % had relevant reactions to oleamidopropyl dimethylamine and 4.3 % had relevant reactions to cocamidopropyl dimethylamine . Several cases of allergic contact dermatitis were reported in patients from the Netherlands that had used a particular type of body lotion that contained oleamidopropyl dimethylamine . In 12 patients tested with their personal cosmetics , containing the fatty acid amidopropyl dimethylamine cocamidopropyl betaine ( CAPB ), 9 had positive reactions to at least one dilution and 5 had irritant reactions . All except 3 patients , who were not tested , had 2 or 3 + reaction to the 3,3-dimethylaminopropylamine ( DMAPA , the reactant used in producing fatty acid amidopropyl dimethylamines ) at concentrations as low as 0.05 %. The presence of DMAPA was investigated via thin-layer chromatography in the personal cosmetics of 4 of the patients that had positive reactions . DMAPA was measured in the products at 50 - 150 ppm suggesting that the sensitising agent in CAPB-induced allergy is DMAPA , . The sensitisation potential of a 4 % aqueous liquid fabric softener formulation containing 0.5 % stearyl / palmitylamidopropyl dimethylamine was investigated using . The test material caused some irritation in most volunteers . After a rest period of 2 weeks , the subjects received challenge patches with the same concentration of test material on both arms . Patch sites were graded 48 and 96 h after patching . Eight subjects reacted at challenge , and 7 of the eight submitted to rechallenge with 4 % and 0.4 % aqueous formulations . No reactions indicative of sensitisation occurred at rechallenge . The test formulation containing stearyl / palmitylamidopropyl dimethylamine had no significant sensitisation potential . subjects . Most undiluted cationic surfactants satisfy the criteria for classification as Harmful ( Xn ) with R22 and as Irritant ( Xi ) for skin and eyes with R38 and R41 . The material may produce moderate eye irritation leading to inflammation . Repeated or prolonged exposure to irritants may produce conjunctivitis . The material may cause skin irritation after prolonged or repeated exposure and may produce a contact dermatitis ( nonallergic ). This form of dermatitis is often characterised by skin redness ( erythema ) and swelling the epidermis . Histologically there may be intercellular oedema of the spongy layer ( spongiosis ) and intracellular oedema of the epidermis .
Amphoteric surfactants are easily absorbed in the intestine and are excreted partly unchanged via the faeces . Metabolisation to CO2 and short-chained fatty acids also occur . No tendency to accumulation in the organism or storage of betaines in certain organs has been detected . Betaines generally have a low acute toxicity . E . g ., LD50 values for cocoamidopropylbetaine ( 30 % solution ) by oral administration have been determined to 4,910 mg / kg body weight in rats .
Betaines do not carry any net charge , and , therefore , they can only form hydrophobic bonds with proteins in the skin . This may be the explanation for the low protein denaturation potential of betaines as the ion-binding of other surfactants contributes to denaturation . In combination with anionic surfactants a positive synergistic effect with regard to skin compatibility is often found . Compared to a 20 % solution of C12 alkyl sulfate ( AS ; sodium lauryl sulfate ) alone , decreased erythema was observed for the combination of 20 % C12 AS and 10 % cocoamidopropyl betaine one hour after the removal of patches . The combination of cocoamidopropyl betaine and C12 AS also reduced swelling of the skin , and generally interactions between amphoterics and AS produce less swelling and result in milder skin reactions . Concentrated betaines are expected to be irritant to skin and eyes . Diluted solutions ( 3-10 %) are not irritant to skin , but they are mildly irritant to the eyes ( 4.5 %)
No evidence of delayed contact hypersensitivity was found in guinea pigs after topically administrated solutions of 10 % cocoamidopropyl betaine by using the Magnusson-Kligman maximization test . Various instances of contact allergy to cocoamidopropyl betaine have been reported . In all of the reports it was concluded that the observed skin reactions were due to the presence of 3-dimethylaminopropylamine which is an impurity in cocoamidopropyl betaine . This impurity is an intermediate in the synthesis of alkylamidopropyldimethylamines that are intermediates in the synthesis of the corresponding alkylamido betaines .
Cocoamidopropyl betaine was proven to be non-mutagenic to Salmonella typhimurium in the Ames Salmonella / microsome reverse mutation assay . Short-term genotoxicity tests have shown negative results of mutagenicity for lauryl betaine in various strains of Salmonella typhimurium
* [ Van Waters and Rogers ] ** [ Canada Colors and Chemicals Ltd .] Toxicokinetics , metabolism and distribution .