Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
NOAEL
936 mg/kg bw/day
Additional information

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:

No effect

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
936 mg/kg bw/day
Additional 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.

Justification for classification or non-classification

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 1272/2008.