Registration Dossier

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
DNEL 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
DNEL 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
DNEL 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
DNEL 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
DNEL 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.