Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 947-945-3 | CAS number: -
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- other: Based upon the weight of evidence of the physico-chemical parameters, bio-accumulation potential, that are likely to impact the toxico-kinetics of the chemical and also the acute toxicity test result by the oral and the dermal route
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Based upon the weight of evidence of the physico-chemical parameters, bio-accumulation potential, that are likely to impact the toxico-kinetics of the chemical and also the acute toxicity test result by the oral and the dermal route
Data source
Reference
- Reference Type:
- other: Based upon the weight of evidence of the physico-chemical parameters, bio-accumulation potential, that are likely to impact the toxico-kinetics of the chemical and also the acute toxicity test result by the oral and the dermal route
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
- Principles of method if other than guideline:
- Based upon the weight of evidence of the physico-chemical parameters, bio-accumulation potential, that are likely to impact the toxico-kinetics of the chemical and also the acute toxicity test result by the oral and the dermal route
- GLP compliance:
- no
Test material
- Reference substance name:
- Reaction mass of Cardanol diene and Cardanol monoene and Cardanol triene
- Cas Number:
- 37330-39-5
- Molecular formula:
- C(21)H(31-36)O
- IUPAC Name:
- Reaction mass of Cardanol diene and Cardanol monoene and Cardanol triene
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- other: Not applicable
- Strain:
- other: Not applicable
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- Not applicable
Administration / exposure
- Route of administration:
- other: Not applicable
- Vehicle:
- other: Not applicable
- Details on exposure:
- Not applicable
- Duration and frequency of treatment / exposure:
- Not applicable
Doses / concentrations
- Remarks:
- Doses / Concentrations:Not applicable
- No. of animals per sex per dose / concentration:
- Not applicable
- Control animals:
- other: Not applicable
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- The most likely route of absorption of Cardanol is through the dermal route. Absorption by the oral and inhalation route is highly unlikely considering the use of the chemical as well as the low vapour pressure of the chemical (0.0000195 Pa) respectively.
- Details on distribution in tissues:
- Considering the low water solubility of cardanol, any absorbed chemical shall be distributed through the body via the lipids and not through the blood considering the poor water solubility.
- Details on excretion:
- There is no reported data available on the excretion of absorbed cardanol but from the information available on the acute oral toxicity studies, where the LD50 value is > 5000 mg/kg bw, it is expected that the orally administered cardanol was excreted out of the living system of rats, by virtue of which they survived the entire duration of test with no abnormalities detected.
Metabolite characterisation studies
- Metabolites identified:
- not specified
- Details on metabolites:
- No data available
Any other information on results incl. tables
Based upon the data available on the important physico-chemical properties and results of the acute oral and dermal exposure; it can be concluded that cardanol shall have low bio-accumulation potential.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): other: low bio-accumulation potential based upon the properties of the chemicalBased upon the data available on the important physico-chemical properties and results of the acute oral and dermal exposure; it can be concluded that cardanol shall have low bio-accumulation potential.
- Executive summary:
There is no data available pertaining to the toxico-kinetics of cardanol. Therefore the absorption, distribution, metabolism and excretion (ADME) behavior have been derived based upon the properties of the chemical and results of the acute oral and dermal toxicity testing. It is also important to note that considering the use of cardanol as an industrial chemical, dermal absorption is the only likely route of absorption. However, in the acute toxicity testing by the dermal route, the LD50 was experimentally determined to be > 2000 mg/kg bw indicating no adverse effect by dermal absorption. The bio-concentration factor (BCF) values for the chemical are also < 500, indicating that the potential for bio-accumulation of cardanol is low
Thus, based on all the above considerations, it is concluded that cardanol shall have low bio-accumulation 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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
