Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Link to relevant study record(s)

Description of key information

Key value for chemical safety assessment

Additional information

The test substance is a white powder with a molecular weight of 558.96 g/mol. The logPow value is 13 and the solubility in water is 20 µg/l (20°C, pH 6). The vapour pressure was estimated to 1.333E-10 Pa.

According to the physico-chemical properties (molecular weight, logPow) the test substance is expected not to be absorbed through the gastrointestinal tract (ECHA R7c). This is supported by an absorption study conducted according to the Levine technique (Geigy Chemicals Corporation, 1965 and 1966), which was performed to analyse the absorption potential of the test substance along the gastro intestinal tract.14C labelled test material was injected into the gut lumen of rats for 3 hours. The test compound was detected to be poorly absorbed. Further support is given by an acute oral toxicity study. TIF: RAIf (SPF) rats were administered a dose of 3000 mg/kg body weight per gavage (Ciba-Geigy, 1980). No mortalities and no treatment related clinical signs occurred and the LD50 oral was set to be > 3000 mg/kg body weight. Additionally, a subacute study in Tif: RAIf (SPF) rats (Ciba-Geigy, 1983) supports the assumption, that the test substance is not absorbed through the gastro intestinal tract. The test material was administered via the diet in doses of 97 – 1010 mg/kg bw for male rats and 91 - 897 mg/kg bw for female rats for 28 days. No test material related effects were observed. Furthermore, in two independent subchronic studies conducted in Sprague-Dawley rats (Geigy Pharmaceuticals, 1974) and beagle dogs (Geigy Pharmaceuticals, 1974) the test substance was administered in the diet in doses up to 1297.3 mg/kg body weight in rats and 818 mg/kg body weight in dogs, respectively. In both studies no test material related adverse effects were observed.

The dermal uptake of the test substance is unlikely due to its physico-chemical parameters. The test substance did not exhibit any acute dermal toxicity (Ciba-Geigy, 1992), skin irritative / corrosive (Ciba-Geigy, 1981), eye irritative (Ciba-Geigy Ltd, 1981) or skin sensitisation properties (Ciba-Geigy, 1982), respectively.

The acute inhalative toxicity study (Ciba-Geigy, 1973) did not reveal signs for bioavailability via the respiratory pathway. Tif. RAI rats were exposed using a nose-only system to a technically maximal achievable analytical substance concentration of 1 mg/l for 4 hours and did not show any clinical sign of toxic effects of the test substance. As the test substance is a solid and its vapour pressure is estimated to be 1.333E-10 Pa, absorption via inhalation is unlikely. No information is available about dustiness of the test substance. However, in light of its low water solubility, there is a likelihood of deposition in the lung if exposure to particulate aerosols should occur.