Registration Dossier
Registration Dossier
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EC number: 201-044-5 | CAS number: 77-62-3
Endpoint summary
Administrative data
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics, other
- Remarks:
- Written assessment
- Type of information:
- other: Written assessment
- Adequacy of study:
- other information
- Study period:
- January 2018
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Written assessment
- Justification for type of information:
- At the current level of registration, a written assessment is suitable.
- Objective of study:
- other: Written assessment of ADME
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Written assessment based on available study data.
- Details on absorption:
- See attached background material below.
- Details on distribution in tissues:
- See attached background material below.
- Details on excretion:
- See attached background material below.
- Details on metabolites:
- See attached background material below.
- Bioaccessibility (or Bioavailability) testing results:
- See attached background material below.
- Conclusions:
- In conclusion, there is no evidence that the substance is significantly absorbed via the dermal route or the inhalation route. The results of an oral repeated dose toxicity study indicate that the substance may be absorbed orally. It is likely that the following ingestion, the substance undergoes conjugation with glucuronic acid and sulfate within the gastrointestinal tract. Following absorption, the fatty acids are transported to the tissues of the body including the liver where they undergo oxidation in the cells. These solubilised metabolites are then most probably excreted in the urine in conjugated form. Consequently, the substance is considered to have low bioaccumulation potential.
- Executive summary:
In conclusion, there is no evidence that the substance is significantly absorbed via the dermal route or the inhalation route. The results of an oral repeated dose toxicity study indicate that the substance may be absorbed orally. It is likely that the following ingestion, the substance undergoes conjugation with glucuronic acid and sulfate within the gastrointestinal tract. Following absorption, the fatty acids are transported to the tissues of the body including the liver where they undergo oxidation in the cells. These solubilised metabolites are then most probably excreted in the urine in conjugated form. Consequently, the substance is considered to have low bioaccumulation potential.
Reference
Description of key information
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
- Absorption rate - oral (%):
- 100
- Absorption rate - dermal (%):
- 100
- Absorption rate - inhalation (%):
- 100
Additional information
100% absorption is assumed for all routes as a worst case assessment. The substance is considered to be of low bioaccumulation potential.
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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