Registration Dossier
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EC number: 941-212-1 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.88 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 170
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- Overall assessment factor (AF):
- 300
- Modified dose descriptor starting point:
- NOAEL
- AF for differences in duration of exposure:
- 6
- AF for other interspecies differences:
- 10
- AF for intraspecies differences:
- 5
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Analogue Justification:
For the calculation of the DNELs read across has been carried out from Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated, Distilled (“Distilled Grade”). The studies for distilled grade are considered relevant for read across to distillation residue grade since the two substances:
•Contain the same constituents (cardanol, cardol, 2-methyl cardol, C13 and unidentified phenolics, C17 phenolics and polymeric species), generally in similar proportions.
•Have similar physico-chemical properties in terms of their water solubility, vapour pressure and octanol-water partition coefficient.
Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated, Distilled (“Distilled Grade”) has a higher proportion of lower molecular weight, more potentially toxicologically active components, (principally cardanol) and lower proportion of more inert polymeric species compared to Distillation Residue Grade. The relative typical proportions of the cardanol and polymeric species in Distilled and Distillation Residue Grades are 78% versus 35% and 2% versus 50% respectively. Therefore, it is considered that distilled grade has the potential to exert greater toxicity within the group of distilled, technical and distilled residue grades (see Section 3.1 - Technological Process) for endpoints relevant to human health and environmental effects. On this basis within the group of distilled, technical and distilled residue grades, the substance Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated, Distilled represents the potentially most (eco)toxicologically active form.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.2 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.25 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
- AF for differences in duration of exposure:
- 6
- AF for other interspecies differences:
- 10
- AF for intraspecies differences:
- 10
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.25 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
- AF for differences in duration of exposure:
- 6
- AF for other interspecies differences:
- 10
- AF for intraspecies differences:
- 10
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
Analogue Justification:
For the calculation of the DNELs read across has been carried out from Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated, Distilled (“Distilled Grade”). The studies for distilled grade are considered relevant for read across to distillation residue grade since the two substances:
•Contain the same constituents (cardanol, cardol, 2-methyl cardol, C13 and unidentified phenolics, C17 phenolics and polymeric species), generally in similar proportions.
•Have similar physico-chemical properties in terms of their water solubility, vapour pressure and octanol-water partition coefficient.
Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated, Distilled (“Distilled Grade”) has a higher proportion of lower molecular weight, more potentially toxicologically active components, (principally cardanol) and lower proportion of more inert polymeric species compared to Distillation Residue Grade. The relative typical proportions of the cardanol and polymeric species in Distilled and Distillation Residue Grades are 78% versus 35% and 2% versus 50% respectively. Therefore, it is considered that distilled grade has the potential to exert greater toxicity within the group of distilled, technical and distilled residue grades (see Section 3.1 - Technological Process) for endpoints relevant to human health and environmental effects. On this basis within the group of distilled, technical and distilled residue grades, the substance Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated, Distilled represents the potentially most (eco)toxicologically active form.
A well conducted oral study combining a repeat dose toxicity study with reproduction/developmental toxicity screening has been performed in the rat (Dhinsaet al,2005) using Cashew Nutshell Extract, Decarboxylated, Distilled (Distilled Grade). Sprague-Dawley rats (10/sex/dose) were administered 0, 15, 150 or 1000 mg/kg bw/day via gavage for up to 49 days. The study was conducted to OECD Guideline 422 and to GLP requirements.
Clinical signs, functional observations, bodyweight development and food and water consumption were monitored during the study. Haematology and blood chemistry were also evaluated prior to mating and termination on selected animals from each dose group. Following mating and subsequent gestation, offspring development was monitored up to Day 4post partum.All animals were subject to gross necropsy and histopathological examination.
Increased salivation was detected prior to dosing and up to 5 hours after dosing for animals of either sex treated with 1000 mg/kg bw/day from Day 9 onwards. One female treated with 150 mg/kg bw/day developed clinical signs consistent with inappropriate dosing on Day 5 and was subsequently terminated. One female treated with 1000 mg/kg bw/day had given birth to a number of pups of which the majority were found dead. Several clinical signs were observed in this animal, and the animal and litter were terminated. There were no toxicologically significant deaths during the study.
A slightly reduced bodyweight gain was observed for 1000 mg/kg bw/day males during the first two weeks of the study. Reduced bodyweight gain was also observed for 1000 mg/kg bw/day females during the later stages of the gestation period. Females treated with 1000 mg/kg bw/day showed elevated liver weights. No changes were noted in food consumption, efficiency or water consumption.
Haematological assessments revealed elevated platelet counts for animals of either sex treated with 1000 mg/kg bw/day. Elevated haemoglobin, erythrocyte and haematocrit was also evident for males treated at 1000 mg/kg bw/day. No such effects were detected at 150 and 15 mg/kg bw/day. An increase in aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase levels were observed for 1000 mg/kg bw/day animals of either sex, together with elevated inorganic phosphorus, bilirubin and urea, and reduced cholesterol levels.
Open field arena observations revealed increased salivation for individual animals of either sex treated with 1000 mg/kg bw/day from Week 3.
Groups of alveolar macrophages were seen with a higher incidence for females treated with 1000 mg/kg bw/day. A higher incidence of sinus histiocytosis and/or foamy histiocytes was observed in relation to treatment with 1000 mg/kg bw/day. Hyperkeratosis, frequently associated with acanthosis was seen in the forestomach of animals of either sex treated with 1000 mg/kg bw/day. Focal ulceration of the forestomach epithelium was also seen in one high dose female. Mucosal hypertrophy was seen in three males at the top dose group. A low incidence of mucosal hypertrophy was observed in females in all dose groups.
Reproductive and developmental parameters were similar for treated animals and controls.
The observation of changes in the lungs, mesenteric lymph nodes, stomach and duodenum in rats treated with 1000 mg/kg bw/day resulted in a systemic NOAEL of 150 mg/kg bw/day being identified. No adverse effects on reproduction or development were noted, therefore, an arbitrary NOAEL of 1000 mg/kg bw/day has been identified for these endpoints from this study.
Information on the toxicokinetics and toxicodynamics of Cashew Nutshell Extract, Decarboxylated, Distilled (Distilled Grade) are not available, therefore assessment (uncertainty) factors for interspecies and intraspecies variation cannot be specifically derived, and therefore, default factors as prescribed in the ECHA guidance will be used.
A sub-acute (short-term) No Observed Adverse Effect Level (NOAEL) of 150 mg/kg bw/day has been identified from a 28 day repeat dose oral study combined with a reproductive screening test.
Oral
General population
Long-term
A safety assessment factor of 10 will be applied to account for interspecies (rat to human) variation, as per the ECHA Guidance (ECHA, 2008).
A safety assessment factor of 10 will be applied to account for intraspecies variation (between humans in the general population, to include sensitive sub-populations) as per the ECHA Guidance.
In the absence of any long-term repeat dose studies, a safety assessment factor of 6 will be applied to account for use of a sub-acute NOAEL for a chronic DNEL, as per the ECHA Guidance.
Derived No Effect Level (DNELLong-term) for oral exposure = 150/10/10/6 = 0.25 mg/kg bw/day
Worker
Long-term
A safety assessment factor of 10 will be applied to account for interspecies (rat to human) variation, as per the ECHA Guidance (ECHA, 2008).
A safety assessment factor of 5 will be applied to account for intraspecies variation (between workers, therefore not including sensitive sub-populations), as per the ECHA guidance.
In the absence of any long-term repeat dose studies, a safety assessment factor of 6 will be applied to account for use of a sub-acute NOAEL for a chronic DNEL, as per the ECHA Guidance.
Derived No Effect Level (DNELLong-term) for oral exposure = 150/10/5/6 = 0.5 mg/kg bw/day
Dermal
Data obtained indicate that in 2 out of 4 tests, Cashew Nutshell Extract, Decarboxylated, Distilled (Distilled Grade) samples are irritating to the skin and sensitising. A sub-acute or chronic dermal study is not available.
The United Kingdom Interdepartmental Group on Health Risks from Chemicals document entitled ‘Guidelines on route-to-route extrapolation of toxicity data when assessing health risks of chemicals’ (IGHRC, 2006) states that oral to dermal extrapolation is common for industrial chemical and pesticide exposure. This document assumes that dermal bioavailability is less than oral (i.e. less substance will be absorbed via the skin due to its barrier properties), therefore, using the oral data is precautionary, providing that the skin is not compromised by the substance being a severe irritant and causing increased absorption through a more permeable barrier. Although a skin irritant and sensitiser, Cashew Nutshell Extract, Decarboxylated, Distilled (Distilled Grade) is not considered to be a ‘severe irritant’, therefore, equivalent bioavailability can be assumed for oral and dermal exposure to provide a precautionary DNEL. The approach used in the IGHRC document is that used in the ECHA Guidance and is widely referenced.
A sub-acute (short-term) NOAEL of 150 mg/kg bw/dayhas been identified from a 28 day repeat dose oral study combined with a reproductive screening test.
General population
Long-term
A safety assessment factor of 10 will be applied to account for interspecies (rat to human) variation, as per the ECHA Guidance (ECHA, 2008).
A safety assessment factor of 10 will be applied to account for intraspecies variation (between in the general population, to include sensitive sub-populations) as per the ECHA Guidance.
In the absence of any long-term repeat dose studies, a safety assessment factor of 6 will be applied to account for use of a sub-acute NOAEL for a chronic DNEL, as per the ECHA Guidance.
Derived No Effect Level (DNELLong-term) for dermal exposure = 150/10/10/6 = 0.25 mg/kg bw/day
Worker
Long-term
A safety assessment factor of 10 will be applied to account for interspecies (rat to human) variation, as per the ECHA Guidance (ECHA, 2008).
A safety assessment factor of 5 will be applied to account for intraspecies variation (between workers, therefore not including sensitive sub-populations), as per the ECHA guidance.
In the absence of any long-term repeat dose studies, a safety assessment factor of 6 will be applied to account for use of a sub-acute NOAEL for a chronic DNEL, as per the ECHA Guidance.
Derived No Effect Level (DNELLong-term) for dermal exposure = 150/10/5/6 = 0.5 mg/kg bw/day
It should be recognised that in addition to defining a dermal DNEL, consideration should be given to whether it would be more relevant to assess and control the risk(s) of dermal exposure.
Inhalation
A sub-acute or chronic inhalation study is not available. In order to derive an inhalation DNEL, data can be converted from oral studies.
A sub-acute (short-term) NOAEL of 150 mg/kg bw/day has been identified from a 28 day repeat dose oral study combined with a reproductive screening test.
General population
Long-term
To convert the rat NOAEL (NoObservedAdverse Effect Level) to human NAEL (No Adverse Effect Level) for interspecies variation (rat to human), a factor of 1.15 will be applied to account for the standard breathing volume of the rat for 24 hours, as per the ECHA Guidance (ECHA, 2008).
An adjustment of x10/100% (oral absorption/inhalation absorption) will be applied to account for assumed bioavailability via the inhalatory route compared with the oral route (i.e. low oral absorption as low toxicity seen via this route and has to pass into blood stream from the intestines versus high absorption straight from the lungs) (IGHRC, 2006).
A safety assessment factor of 10 will be applied to account for intraspecies variation (between humans in the general population, to include sensitive sub-populations) (ECHA, 2008).
In the absence of any long-term repeat dose studies, a safety assessment factor of 6 will be applied to account for use of a sub-acute NOAEL for a chronic DNEL, as per the ECHA Guidance.
Derived No Effect Level (DNELLong-term) for inhalation exposure = 150/1.15x0.1/10/6 = 0.2mg/m3
General population (consumers with 4 hours exposure per day)
Long-term
To convert the rat NOAEL (NoObservedAdverse Effect Level) to human NAEL (No Adverse Effect Level) for interspecies variation (rat to human), a factor of 0.19 will be applied to account for the standard breathing volume of the rat for 24 hours, as per the ECHA Guidance (ECHA, 2008).
An adjustment of x10/100%(oral absorption/inhalation absorption) will be applied to account for assumed bioavailability via the inhalatory route compared with the oral route (i.e. low oral absorption as low toxicity seen via this route and has to pass into blood stream from the intestines versus high absorption straight from the lungs) (IGHRC, 2006).
A safety assessment factor of 10 will be applied to account for intraspecies variation (between humans in the general population, to include sensitive sub-populations) (ECHA, 2008).
In the absence of any long-term repeat dose studies, a safety assessment factor of 6will be applied to account for use of a sub-acute NOAEL for a chronic DNEL, as per the ECHA Guidance.
Derived No Effect Level (DNELLong-term) for inhalation exposure = 150/0.19x0.1/10/6 = 1.32mg/m3
Worker
Long-term
To convert the rat NOAEL (NoObservedAdverse Effect Level) to human NAEL (No Adverse Effect Level) for interspecies variation (rat to human), a factor of 0.38 will be applied to account for the standard breathing volume of the rat for 8 hours, as per the ECHA Guidance (ECHA, 2008).
An additional conversion for workers of 6.7m3/10m3to account for caloric demand during light activity will be applied.
An adjustment of x10/100% (oral absorption/inhalation absorption) will be applied to account for assumed bioavailability via the inhalatory route compared with the oral route. (i.e. low oral absorption as low toxicity seen via this route and has to pass into blood stream from the intestines versus high absorption straight from the lungs) (IGHRC, 2006).
A safety assessment factor of 5 will be applied to account for intraspecies variation (between workers, therefore not including sensitive sub-populations) (ECHA, 2008).
In the absence of any long-term repeat dose studies, a safety assessment factor of 6will be applied to account for use of a sub-acute NOAEL for a chronic DNEL, as per the ECHA Guidance.
Derived No Effect Level (DNELLong-term) for inhalation exposure = 150/0.38x0.67x0.1/5/g = 0.88mg/m3
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.

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