Chemwatch : 4883-43 Version No : 3.1.1.1
Page 9 of 14 Fido ' s Herbal Shampoo
Issue Date : 12 / 20 / 2013 Print Date : 07 / 05 / 2016 sodium , at a concentration of 25 %, was only a mild irritant . Concentrated C14-16- alpha-olefin sulfonates were severely irritating , but caused irreversible effects only if applied as undiluted powder . At concentrations below 10 % mild to moderate , reversible effects , were found . No data were available for alkane sulfonates
Alkyl sulfates and C14-18 alpha-olefin sulfonates were not skin sensitisers in animal studies . No reliable data were available for alkane sulfonates . Based on the similar chemical structure , no sensitisation is expected . However anecdotal evidence suggests that sodium lauryl sulfate causes pulmonary sensitisation resulting in hyperactive airway dysfunction and pulmonary allergy accompanied by fatigue , malaise and aching . Significant symptoms of exposure can persist for more than two years and can be activated by a variety of non-specific environmental stimuli such as a exhaust , perfumes and passive smoking . Absorbed sulfonates are quickly distributed through living systems and are readily excreted . Toxic effects may result from the effects of binding to proteins and the ability of sulfonates to translocate potassium and nitrate ( NO3- ) ions from cellular to interstitial fluids . Airborne sulfonates may be responsible for respiratory allergies and , in some instances , minor dermal allergies . Repeated skin contact with some sulfonated surfactants has produced sensitisation dermatitis in predisposed individuals
Repeat dose toxicity : After repeated oral application of alkyl sulfates with chain lengths between C12 and C18 , the liver was the only target organ for systemic toxicity . Adverse effects on this organ included an increase in liver weight , enlargement of liver cells , and elevated levels of liver enzymes . The LOAEL for liver toxicity ( parenchymal hypertrophy and an increase in comparative liver weight ) was 230 mg / kg / day ( in a 13 week study with C16-18 alkyl sulfate , sodium ). The lowest NOAEL in rats was 55 mg / kg / day ( in a 13 week study with C12-alkyl sulfate , sodium ). C14- and C14-16-alpha-olefin sulfonates produced NOAELs of 100 mg / kg / day ( in 6 month- and 2 year studies ). A reduction in body weight gain was the only adverse effect identified in these studies . No data were available with regard to the repeated dose toxicity of alkane sulfonates . Based on the similarity of metabolic pathways between alkane sulfonates , alkyl sulfates and alkyl-olefin sulfonates , the repeated dose toxicity of alkane sulfonates is expected to be similar with NOAEL and LOAEL values in the same range as for alkyl sulfates and alpha-olefin sulfonates , i . e . 100 and 200-250 mg / kg / day , respectively , with the liver as potential target organ .
Genotoxicity : Alkyl sulfates of different chain lengths and with different counter ions were not mutagenic in standard bacterial and mammalian cell systems both in the absence and in the presence of metabolic activation . There was also no indication for a genotoxic potential of alkyl sulfates in various in vivo studies on mice ( micronucleus assay , chromosome aberration test , and dominant lethal assay ). alpha-Olefin sulfonates were not mutagenic in the Ames test , and did not induce chromosome aberrations in vitro . No genotoxicity data were available for alkane sulfonates . Based on the overall negative results in the genotoxicity assays with alkyl sulfates and alpha-olefin sulfonates , the absence of structural elements indicating mutagenicity , and the overall database on different types of sulfonates , which were all tested negative in mutagenicity assays , a genotoxic potential of alkane sulfonates is not expected .
Carcinogenicity : Alkyl sulfates were not carcinogenic in feeding studies with male and female Wistar rats fed diets with C12-15 alkyl sulfate sodium for two years ( corresponding to doses of up to 1125 mg / kg / day ). alpha-Olefin sulfonates were not carcinogenic in mice and rats after dermal application , and in rats after oral exposure . No carcinogenicity studies were available for the alkane sulfonates .
Reproductive toxicity : No indication for adverse effects on reproductive organs was found in various oral studies with different alkyl sulfates . The NOAEL for male fertility was 1000 mg / kg / day for sodium dodecyl sulfate . In a study using alpha-olefin sulfonates in male and female rats , no adverse effects were identified up to 5000 ppm .
Developmental toxicity : In studies with various alkyl sulfates ( C12 up to C16-18- alkyl ) in rats , rabbits and mice , effects on litter parameters were restricted to doses that caused significant maternal toxicity ( anorexia , weight loss , and death ). The principal effects were higher foetal loss and increased incidences of total litter losses . The incidences of malformations and visceral and skeletal anomalies were unaffected apart from a higher incidence of delayed ossification or skeletal variation in mice at > 500 mg / kg bw / day indicative of a delayed development . The lowest reliable NOAEL for maternal toxicity was about 200 mg / kg / day in rats , while the lowest NOAELs in offspring were 250 mg / kg / day in rats and 300 mg / kg / day for mice and rabbits . For alpha-olefin sulfonates ( C14-16-alpha-olefin sulfonate , sodium ) the NOAEL was 600 mg / kg / day both for maternal and developmental toxicity . No data were available for the reproductive and developmental toxicity of alkane sulfonates . Based on the available data , the similar toxicokinetic properties and a comparable metabolism of the alkyl sulfates and alkane sulfonates , alkane sulfonates are not considered to be developmental toxicants . Although the database for category members with C < 12 is limited , the available data are indicating no risk as the substances have comparable toxicokinetic properties and metabolic pathways . In addition , longer-term studies gave no indication for adverse effects on reproductive organs with different alkyl sulfates
The material may produce moderate eye irritation leading to inflammation . Repeated or prolonged exposure to irritants may produce conjunctivitis . The material may produce severe 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 ) thickening of the epidermis . Histologically there may be intercellular oedema of the spongy layer ( spongiosis ) and intracellular oedema of the epidermis . Prolonged contact is unlikely , given the severity of response , but repeated exposures may produce severe ulceration . Alkyl sulfates ( AS ) anionic surfactants are generally classified according to Comité Européen des Agents de Surface et leurs Intermédiaires Organiques ( CESIO ) as Irritant ( Xi ) with the risk phrases R38 ( Irritating to skin ) and R41 ( Risk of serious