Registration Dossier

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:
2015
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
Name:
Unnamed
Type:
Constituent
Radiolabelling:
no

Test animals

Species:
other: Not applicable
Strain:
other: Not applicable
Sex:
not specified
Details on test animals 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:
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.