Registration Dossier
Registration Dossier
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EC number: 947-945-3 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.961 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 60
- Modified dose descriptor starting point:
- other: NOAEL
- Value:
- 297.674 mg/m³
- AF for intraspecies differences:
- 5
- Justification:
- Worker
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.814 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 60
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 168.83 mg/kg bw/day
- AF for intraspecies differences:
- 5
- Justification:
- Worker
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
Toxicokinetics
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.
Acute toxicity :
Based on the available studies, cardanol is seen to be non toxic by the oral, inhalation and dermal route.
Skin & eye irritation :
On the basis of the available studies, cardanol is classified as a skin and eye irritant.
Skin sensitizer :
Available data and weight of evidence suggests that cardanol is sensitizing to skin
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.223 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- other: NOAEL
- Value:
- 146.809 mg/m³
- AF for intraspecies differences:
- 10
- Justification:
- General Population
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.407 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 168.83 mg/kg bw/day
- AF for intraspecies differences:
- 10
- Justification:
- General Population
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.703 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 84.415 mg/kg bw/day
- AF for intraspecies differences:
- 10
- Justification:
- General Population
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
DNEL derivation
Cardanol does not exhibits acute toxicity by the oral, inhalation and dermal route of exposure and thus is not classified for acute toxicity. The chemical was found to be irritating to skin and eye. Available data also indicate that the chemical does not exhibit genotoxicity and is not a reproductive toxin as well as not a developmental toxin within the dose levels mentioned in the respective end points.
In the absence of local effects following short-term or long-term exposure, no dose-response data are available and a quantitative dose descriptor is not derived. DNEL values for local exposure are therefore not calculated.
In the absence of acute systemic toxicity, no dose-response data are available and a quantitative dose descriptor is not derived. DNEL values for acute systemic effects are therefore not calculated.
A standard approach to deriving DNEL values in this case has been to use the developmental toxicity dataset and apply assessment factors as described in ECHA guidance documents. The critical endpoint is considered to be the NOAEL of 337.66 mg/kg bw/d in oral category.
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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