Registration Dossier
Registration Dossier
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EC number: 275-069-5 | CAS number: 70969-58-3
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
Additional information
From the toxicology studies, the observed effects following oral administration of a single dose (no systemic effects at 2000 mg/kg bw) suggests that the substance is either not readily absorbed following an oral dose, or that it undergoes extensive first-pass metabolism. Poor oral absorption is supported by toxicokinetics and metabolism studies with diisononyl hexahydrophthalate (full public report on1,2 -Cyclohexanedicarboxylic acid, 1,2-diisononyl ester (‘Hexamoll DINCH’),National Industrial Chemicals Notification and Assessment Scheme (NICNAS) of, August 2008). This substance is another ester of cyclohexane-1,2-dicarboxylic acid where the alcohol ester is isononanol rather than isobutanol. The NICNAS assessment reports that oral absorption becomes saturated at higher doses, resulting in the majority of the substance being recovered in faeces. The absorption that did occur was rapid (maximum after 1-2 hrs), with little indication of significant first pass metabolism. The majority of the substance was eliminated via the faeces unchanged with the level of metabolites in urine or bile representing only a small fraction of the administered dose. The substance was distributed to most bodily tissues within 1-8 hours with a plasma half-life of 4.4-11.9 hours (depending on the administered dose). The kinetics of elimination was biphasic. The main metabolites observed in metabolic studies in rats were the mono-ester and cyclohexanedicarboxylic acid together with the alcohol hydrolysed from the ester.
NICNAS notes that while diisononyl hexahydrophthalate is similar in structure to diisononyl phthalate, it lacks the aromatic ring structure of the phthalate. Aromatisation of various derivatives of cyclohexanecarboxylic acid has been observed in liver from rat, guinea pig, rabbits and mice (Svardal and Scheline, 1985). However, this aromatisation activity was dependent on the presence of the carboxylic acid group and 1,2-cyclohexanedicarboxylic acid (similar to the substance being notified) was unable to be aromatised. Thus the cyclohexane,1-2,dicarboxylic acid esters are not expected to be able to aromatise to form the equivalent phthalate ester or its metabolitesin-vivo.
Full public report on1,2-Cyclohexanedicarboxylic acid, 1,2-diisononyl ester (‘Hexamoll DINCH’),National Industrial Chemicals Notification and Assessment Scheme (NICNAS) of, August 2008
Svardal AM and Scheline RR (1985) The aromatization of cyclohexanecarboxylic acid to hippuric acid: substrate specificity and species differences.Mol Cell Biochem. 67(2):171-9.
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