Registration Dossier

Administrative data

Description of key information

A documentation and evaluation of available data on this endpoint is presented in:
Thiodiglycol, SIDS Initial Assessment Report for SIAM 19, final version 10/2006.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
500 mg/kg bw/day

Additional information

No data are available on the dermal or inhalation route.

In a 28 day oral study (BASF 1993) conducted according to OECD guideline 407, repeated exposure of rats by gavage to 1000 mg/kg bw/day thiodiglycol resulted in no effects of toxicological significance. Therefore this dose is considered as NOAEL. In a 90-day study (Angerhofer et al. 1997; comparable to the current OECD guideline 408), male and female Sprague-Dawley rats were treated by gavage with 0, 50, 500, or 5000 mg/kg bw/day thiodiglycol, 5 days per week. Ophthalmic examinations, haematology, clinical chemistry and histopathology revealed no significant treatment related effects. In the high dose group, the body weights of males and females were significantly reduced although the food consumption was not influenced except on day 1 (females) and day 3 (males) of the exposure period. The absolute and the relative kidney weights in males and females of the high dose group were significantly increased. Urine analysis including microscopic examination revealed in the high dose group the following significant effects: increase in urine volume (in males and females), decrease in urine pH (males and females), slight increase in specific gravity of the urine (males), reduction in triple phosphate (males; crystals per field determined), and granular casts in the urine (females).The only effect seen at 500 mg/kg bw/day was a significant decrease in urine pH in female rats, which is considered as adaptive rather than an adverse effect. The NOAEL for subchronic oral exposure to thiodiglycol, as determined from this study, is 500 mg/kg bw/day. The LOAEL is 5000 mg/kg bw/day due to effects on body & kidney weight and changes in urine parameters.

Justification for classification or non-classification

The criteria for classification according to EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 are not met.