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EC number: 701-247-3
CAS number: -
A GLP guideline study with p-toluenesulphonic acid (CAS No. 104-15-4)
reported no adverse effects to male and female rats exposed orally for
28 days. The highest dose was 500 mg/kg bw/day (>490 mg/kg bw/day based
on >98% active ingredient). Therefore the NOAEL was set at 500 mg/kg
The NOAEL in the definitive 28 -day oral
study of toluene-4-sulphonic acid is 500 mg/kg bw/day. A preliminary
dose-finding study indicated mortality of females at 1250 mg/kg bw. And
while this is a valid study there were no adverse effects observed at
the highest dose tested. Therefore a read-across is included to view a
derived NOAEL for a related substance. Hydrotropes are the salt form of
the sulphonic acids.
studies with the salts (hydrotropes) provide valid read-across for the
acids. The specific cation is not expected to have an appreciable effect
on fate, ecotoxicity or mammalian toxicity and therefore the dataset for
the entire hydrotropes category can be applied broadly.
aromatic sulphonic acids are almost completely ionized in watery
environments even at low pH. The
salts of these acids are the hydrotropes (or “sulphonates”) which
include ammonium, calcium, potassium and sodium cations. In
principle the salts get dissociated when in contact with water, so
forming back to the acids. Because
of their close chemical similarities and because much of the production
of the aromatic sulphonic acids goes to manufacturing the salts, the
extensive dataset for the hydrotropes can also be used as a source of
read-across for endpoints in an aromatic sulphonic acid dossier. This
is particularly relevant for studies that are conducted in water (e.g.,
ecotoxicity and biodegradation) as well as for mammalian toxicity
studies where the relatively high acidity of the acid form has an
immediate and harsh local effect, whereas the salt form provides an
indication of potential systemic toxicity beyond the site of application
or initial contac
There are a total of 6 oral repeated dose
studies for the hydrotrope sodium xylene sulphonate (CAS No. 1300-72-7).
The key study is a 90-day oral study, conducted in 1968, is generally
comparable to the OECD 408 guideline study. In that study, the highest
dose for female rats - 4092 mg active ingredient (a.i.) per kilogram
body weight - resulted in a loss in relative weight of the spleen. The
2nd highest dose for females - 763 mg a.i. per kilogram body weight -
had no measureable adverse effects and therefore establishes the repeat
dose oral NOAEL for the test substance. The highest oral dose for male
rats - 3534 mg a.i. per kilogram body weight - had no measurable adverse
effects. No adverse effects were reported in a 90 day mouse study with
the same substance.
Classification for STOT is relevant
where significant toxic effects are seen from single or repeated dose
studies. No such significant toxicity is seen in all available studies
No classification for STOT is
warrented at present under 67/548/EEC or Regulation 1272/2008.
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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