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EC number: 203-180-0
CAS number: 104-15-4
No fertility studies are reported for the aromatic sulphonic acids.
These substances are very corrosive as was demonstrated in skin and eye
irritation studies, in the acute oral studies, and in the single
repeated dose oral study. For animal welfare, long-term exposures to
corrosive substances are not recommended. There are however studies for
the chemically related hydrotrope substances that looked at reproductive
organs and development of offspring. Hydrotropes are the salt form of
the sulphonic acids and therefore are used as read-across for this
endpoint. The 90-day oral rat and oral mouse studies and the 2-year
chronic dermal rat and mouse studies with the closely related compound
sodium xylene sulfonate (CAS No. 1300-72-7) included examination of sex
organs of both sexes. No treatment related effects on reproductive
organs were reported at doses roughly equivalent to those in the
developmental toxicity study. The 1994 study with calcium xylene
sulphonate (CAS No. 28088-63-3) did not follow a specific guideline but
was fully documented and conducted in accordance with GLP requirements.
No adverse effects were reported. The NOAEL for both maternal and
foetal toxicity was the highest dose tested - 3000 mg/kg bw /day which
is equivalent to 936 mg active ingredient per kilogram body weight per
day. The conclusion of the study was no indications of developmental
toxicity including teratogenesis.
Short description of key information:
In the developmental toxicity study, thirty (30) female rats received 0,
150, 1500 or 3000 mg test substance per kilogram body weight by oral
gavage on days 6 to 15 of gestation. Clinical symptoms were noted daily
through day 20. Body weight and food consumption were recorded every
three days through day 20. All females were macroscopically examined on
day 20. The uteri were removed, weighed and examined for number of
corpora lutea, implant sites, and number and location of fetuses and
resorptions. Fetuses were inspected on total number, sex, weight and
external, visceral (one-half) and skeletal (one-half) defects. One death
occurred at the 1500 mg/kg/day dose but it was considered a gavage
injury. There were no abnormal clinical observations or necropsy
findings. There were no effects on body weight or body weight gain.
There was a significant increase in food consumption for the 3000
mg/kg/day dose during gestation interval (day) 12-16 but this was
considered normal biological variation and not a direct effect of the
test substance. All indices were comaparable to the corresponding
controls. The NOAEL based on active ingredient of the test substance is
936 mg/kg bw/day.
No classification as a repeated dose toxin is indicated according to the
general classification and labeling requirements for dangerous
substances and preparations (Directive 67-548-EEC) or the
classification, labeling and packaging (CLP) regulation (EC) No
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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