Chemwatch: 4883-43
Version No: 3.1.1.1
Page 10 of 14
Fido's Herbal Shampoo
Issue Date: 12/20/2013
Print Date: 07/05/2016
damage to eyes). An exception has been made for C12 AS which is classified as Harmful (Xn) with the risk phrases R22
(Harmful if swallowed) and R38 and R41 (CESIO 2000). AS are not included in Annex 1 of list of dangerous substances of
Council Directive 67/548/EEC.
AS are readily absorbed from the gastrointestinal tract after oral administration. Penetration of AS through intact skin appears
to be minimal. AS are extensively metabolized in various species resulting in the formation of several metabolites. The
primary metabolite is butyric acid-4-sulfate. The major site of metabolism is the liver. AS and their metabolites are primarily
eliminated via the urine and only minor amounts are eliminated via the faeces. In rats about 70-90% of the dose was
eliminated via the urine within 48 hours after oral, intravenous or intraperitoneal administration of 1 mg of AS per rat. The
acute toxicity of AS in animals is considered to be low after skin contact or oral intake.
For a homologous series of AS (C8 to C16), maximum swelling of stratum corneum (the outermost layer of epidermis) of the
skin was produced by the C12 homologue. This is in accordance with the fact that the length of the hydrophobic alkyl chain
influences the skin irritation potential. Other studies have shown that especially AS of chain lengths C11, C12 and C13
remove most amino acids and soluble proteins from the skin during washing.
Concentrated samples of AS are skin irritants in rabbits and guinea pigs. AS are non-irritant to laboratory animals at a 0.1%
concentration. C12 AS is used in research laboratories as a standard substance to irritate skin and has been shown to induce
an irritant eczema. AS were found, by many authors, to be the most irritating of the anionic surfactants, although others have
judged the alkyl sulfates only as irritant as laurate (fatty acid soap).
A structure/effect relationship with regard to the length of the alkyl chain can also be observed on mucous membranes. The
maximum eye irritation occurs at chain lengths of C10 to C14 . In acute ocular tests, 10% C12 AS caused corneal damage to
the rabbit eyes if not irrigated. Another study showed that a 1.0% aqueous C12 AS solution only had a slight effect on rabbit
eyes, whereas 5% C12 AS caused temporary conjunctivitis, and 25% C12 AS resulted in corneal damage.
In a 13-week feeding study, rats were fed dietary levels of 0, 40, 200, 1,000 or 5,000 ppm of C12 AS. The only test material
related effect observed was an increase in absolute organ weights in the rats fed with the highest concentration which was
5,000 ppm. The organ weights were not further specified and no other abnormalities were found.
In a mutagenicity study, rats were fed 1.13 and 0.56% C12 AS in the diet for 90 days. This treatment did not cause
chromosomal aberrations in the bone marrow cells.
Mutagenicity studies with Salmonella typhimurium strains (Ames test) indicate no mutagenic effects of C12 AS ). The available
long-term studies in experimental animals (rats and mice) are inadequate to evaluate the carcinogenic potential of AS.
However, in studies in which animals were administered AS in the diet at levels of
up to 4% AS, there was no indication of increased risk of cancer after oral ingestion.
No specific teratogenic effects were observed in rabbits, rats or mice when pregnant animals were dosed with 0.2, 2.0, 300
and 600 mg C12 AS/kg body weight/day by gavage during the most important period of organogenesis (day 6 to 15 of
pregnancy for mice and rats and day 6 to 18 of pregnancy for rabbits). Reduced litter size, high incidence of skeletal
abnormalities and foetal loss were observed in mice at 600 mg C12 AS/kg/day, a dose level which also caused severe toxic
effects in the parent animals in all three species . An aqueous solution of 2% AS was applied (0.1 ml) once daily to the dorsal
skin (2 x 3 cm) of pregnant mice from day 1 to day 17 of gestation. A solution of 20% AS was tested likewise from day 1 to
day 10 of gestation. The
mice were killed on days 11 and 18, respectively. A significant decrease in the number of implantations was observed when
mice were treated with 20% AS compared to a control group which was dosed with water. No evidence of teratogenic effects
was noted.
When aqueous solutions of 2% and 20% AS (0.1 ml) were applied once per day to the dorsal skin (2 x 3 cm) of pregnant
ICR/Jc1 mice from day 12 to day 17 of gestation no effects on pregnancy outcome were detected. Treatment with 20% AS
resulted in growth retardation of suckling mice, but this effect disappeared after weaning. A 10% AS solution (0.1 ml) was
applied twice daily to the dorsal skin (2 x 3 cm) of pregnant lCR/Jc1 mice during the preimplantation period (days 0-3 of
gestation). A significant number of embryos collected on day 3 as severely deformed or remained at the morula stage. The
number of embryos in the oviducts was significantly greater for the mice dosed with AS as compared to the control mice. No
pathological changes were detected in the major organs of the dams
ISOTHIAZOLINONES,
MIXED
The following information refers to contact allergens as a gro