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EC number: 240-210-1
CAS number: 16066-35-6
Short description of key information on bioaccumulation potential result: Given the high polarity and water solubility , the substance is expected to be rapidly excreted and minimally absorbed into systemic circulationShort description of key information on absorption rate: No data available. Not required under REACH.
oral administration, p-toluene sulphonic acid is rapidly absorbed. In
dogs were given 17.4 mg of radiolabelled 35S sodium tosylated/kg body
weight, maximum radioactivity was measured in the blood after just 30
minutes (Dreifuss et al., 1971).
rats and dogs which were given oral doses of p-toluene sulphonate as
sultamicillin tosylate (100 mg/kg and 50 mg/kg body weight,
respectively), maximum serum concentrations were measured 2 hours after
administration (Kano et al., 1985)
situ studies of intestinal absorbtion with Sprague-Dawley rats showed
that at pH 7.5 /thus, in dissociated form) PTSA was not absorbed after
10 minutes (Ho et al., 1982)
dispoersion of PTSA in the tissues also occurs rapidly. Its half life in
the plasma of both dogs and rats was found to be 75 minutes (Dreufuss et
al., 1971; Ho et al., 1982). Studies with sultamicillin tosylate
produced a half life value in dogs of 60 minutes and in ratd of 100
minutes (Kano et al., 1985).
distribution of PTSA in the tissues following intravenous injection (no
information on dose size) has been studies.. The highest concentration
after 35 minutes were found in urine and kidneys (Ho et al., 1982).
Following adinistration as Sultamicillin tosylate to rats, its
concentration was measured after 2 and 6 hours. After 6 hours, p-toluene
sulphonate was no longer detectable in any tissues apart from the kidney
(1.2 ug/g), heart (0.1 ug/g) and serum (0.3 ug/ml) (Kano et al., 1985)
can be seen from these studies, elimination is very rapid and occurs
mainly via the kidneys. Within four days, following oral administration
of 34.8 mg of PTSA/kg body weight to rats, 82% was escreted in the urine
and 13% in the faeces. For dogs, which were given 17.4 mg PTSA/kg body
weight, the respective values were 84,5% and 17.5%. In both cases by far
the greater part of the administerd dose was eliminated after just one
day (Dreyfuss et al., 1971).
rats, within 24 hours sultamicillin tosylate (200 mg/kg bw) was eliminated
to 87% in the animal's urine and to 1.2% in the faeces (Kano et al., 1985).
Analyses of urine and faeces showed that in both cases the substance had been
eliminated unaltered. The excretion profiles for dogs which were administerd
17.4 mg sodium tosilate-35S/kg bw i.p. or p.o. and for rats which where administerd
34.8 mg/kg of the same substance p.o. were found to be very similar (Dreyfuss
et al., 1971) . After 5 days, excretion of labelled sodium tosilate in the
dogs was below the detection limit. In rats, too, even at a dose of 200 mg/kg,
after 4 days 95% of the dose has been excreted (Dreyfuss et al., 1971).
when p-toluene sulphonate was administerd to rats in the form of sultamicillin
tosylate in dayli doses of 100 mg/kg bw over a period of 21 days, no accumulation
of p-toluene sulphonate in the animal was found. The highest p-toluene suklphonate
concentrations were found in the kidneys (14 ug/g) and serum (2.9 ug/ml) 4
hours following administration of the last dose, while the concentration in
other tissues was under 1 ug/g. These concentrations were of the same order
of magnitude as those found 4 hours after administration of a single dose
of the substance. 24 hours afteradministration of the final dose, p-toluene
sulohinate was no longer detectable in the animals' organs (Kano et al., 1985)
dermal adsorption it can be evaluated the result of a model build to
evaluate the dermal penetration for hydrotopes.
multiple homogeneous layer model was used to derive an estimate of
dermal penetration for hydrotropes. The mathematical model simulates the
uptake of a chemical substance through the skin into a central sink
compartment below the skin. The model uses the substance's diffusion and
partitioning coefficients and calculates the total (cumulative) fraction
of the substance that enters the stratum corneum for a specific exposure
duration. The model does not include any metabolism and the model is
believed to represent an upper bound estimate of the potential uptake of
the substance through the skin.
penetration simulations based on a mechanistic model of the process of
uptake of chemical substances in skin predicts that the dermal
penetration of a generic hydrotrope is less than 0.6% of the applied
amount (over a wide range of exposure scenarios). Simulations show that
for an exposure extending to 23 hours, the dermal uptake does not exceed
2.8% of the applied amount, regardless of the applied amount
(concentration) within the range of 0.0002% to 10%. 10% is considered an
upper bound of the concentration of hydrotropes in consumer products.
polarity of the aromatic sulfonic acids is less than hydrotopes, the low
Kow can help in supporting a very low penetration of acids too. The
dermal pathway is in any case not included in the exposure scenarios
because of the corrosivity of the substance.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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