Registration Dossier
Registration Dossier
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EC number: 485-230-3 | CAS number: 1455-42-1
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
The toxicokinetics of the test substance were assessed by expert judgement.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
SPG (spiroglycol; 3,9-bis[1,1-dimethyl-2-hydroxyethyl]-2,4,8,10-tetraoxo-spiro [5,5] undecane; CAS no 1455-42-1) has a molecular weight of 304 Daltons. It is a white solid at room temperature, melting point 200oC. The substance is of very low vapour pressure (2.1 x 10-8Pa at 25oC), is of limited solubility in water (168 mg/L) and has a log Pow of 1.63 at 30oC. It is stable at pH 4, 7 or 9. The particle size distribution indicates that 91% are < 100 μm, 13.8 % < 10.2 μm and 5.4% <5.4 μm.
The substance is not classified as acutely toxic to rats, either when given orally or when given by inhalation. The substance is not classifiable in terms of skin and eye irritancy and skin sensitisation potential. The substance was negative in a bacterial point mutation assay and an assay for chromosomal aberrations. In the 28 day repeated dose study, rats received oral doses of 0, 15, 150 or 1000 mg/kg bw/d by gavage. There were no relevant toxicity findings. The no observed adverse effect level was stated as 1000 mg/kg bw/d.
Absorption
As the amount of substance of respirable size is relatively low, few particles will reach the lung alveolus. Given the low vapour pressure of the substance, it is unlikely that vapour will be inhaled in significant quantities.
The substance has some water solubility and has a log P 1.63, thus it is likely to be absorbed orally and through the skin. However, the substance appears to be non-toxic, thus thein vivostudies do not confirm that absorption has taken place.
Distribution
The log P indicates that the substance is likely to distribute in body water and not to bioaccumulate.
Metabolism
As the substance is a glycol, it is likely to be converted to the acid and/or conjugated with glucuronic acid or sulphate.
Excretion
Some conjugates are likely to be of sufficiently high molecular weight to suggest that they may be excreted in the bile of rat. Otherwise, the substance and metabolites are likely to be excreted in urine.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.
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