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Diss Factsheets
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EC number: 939-409-2 | CAS number: 1329-99-3
- 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:
- 7.056 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):
- 125
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 882 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- All data were based on oral repeated dose toxicity studies; there were no inhalation repeated toxicity dose studies.
- AF for dose response relationship:
- 1
- Justification:
- Started from NOAEC
- AF for differences in duration of exposure:
- 2
- Justification:
- Started from subchronic toxicity
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling was already applied in modification from NOAEL to NOAEC
- AF for other interspecies differences:
- 2.5
- Justification:
- Remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- Default ECHA factor
- AF for the quality of the whole database:
- 2
- Justification:
- Additional uncertainty by read across
- AF for remaining uncertainties:
- 2.5
- Justification:
- Additional safety factor for the lower female reproductive NOAEL of 200 mg/kg based on read-across with a-methylstyrene
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:
- 1 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):
- 500
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- All data were based on oral repeated dose toxicity studies; there were no dermal repeated dose toxicity studies.
- AF for dose response relationship:
- 1
- Justification:
- Started from NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Started from subchronic toxicity
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default ECHA factor for rat
- AF for other interspecies differences:
- 2.5
- Justification:
- Remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- Default ECHA factor
- AF for the quality of the whole database:
- 2
- Justification:
- Additional uncertainty by read across
- AF for remaining uncertainties:
- 2.5
- Justification:
- Additional safety factor for the lower female reproductive NOAEL of 200 mg/kg based on read-across with a-methylstyrene
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
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
Weight of evidence for Depanol I was obtained from subchronic and chronic toxicity testing with d-limonene in rats and subchronic toxicity testing in mice. The three studies were conducted according to older standards, however in combination they covered all needed study parameters. In addition, other studies are available for d-limonene demonstrating its safety. In all studies, NOAEL was above 500 mg/kg bw, taking into account that the kidney findings in male rats were not of relevance for humans. Supporting information was also available from 6-month dog studies, confirming that the nephropathology was specific to male rats.
Two year carcinogenicity studies were available in rats and mice with d-limonene. In rats, hyperplasia and adenomas were seen in male rats associated with cytoplasmic alfa 2µ-globulin granules in the renal tubuli. In mice, no hyperplasia or tumours were observed. These findings in male rats have meanwhile been accepted not to be relevant for humans.
For the reproductive toxicity, read across from source chemical alpha-methylstyrene tested in an OECD 422 study, demonstrated systemic toxicity at 200 mg/kg bw, without reproductive toxicity. At the dose of 1000 mg/kg, maternal toxicity was more extensive, and loss of offspring in two dams and lower body weight and viability of pups were observed at 1000 mg/kg bw. These effects however were considered to be secondary to maternal systemic toxicity.
No teratogenicity was observed for source chemicals alpha-methylstyrene (in rats) and for d-limonene (in rats, mice and rabbits). Some foetal toxicity was observed with both source chemicals at maternally toxic doses in rats, which was considered a secondary effect, however in mice and rabbits there was no foetal toxicity even at maternally toxic doses. Developmental NOAEL was at least 591 mg/kg bw.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.74 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):
- 250
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 435 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- All data were based on oral repeated dose toxicity studies; there were no inhalation repeated dose toxicity studies.
- AF for dose response relationship:
- 1
- Justification:
- Started from NOAEC
- AF for differences in duration of exposure:
- 2
- Justification:
- Started from subchronic toxicity
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling was already applied in modification from NOAEL to NOAEC
- AF for other interspecies differences:
- 2.5
- Justification:
- Remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- Default ECHA factor
- AF for the quality of the whole database:
- 2
- Justification:
- Additional safety factor for read-across
- AF for remaining uncertainties:
- 2.5
- Justification:
- Additional safety factor for the lower female reproductive NOAEL of 200 mg/kg based on read-across with a-methylstyrene
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
General Population - 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
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 1 000
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- All data were based on oral repeated dose toxicity studies; there were no dermal repeated dose toxicity studies.
- AF for dose response relationship:
- 1
- Justification:
- Started from NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Started from subchronic toxicity
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default ECHA factor for rat
- AF for other interspecies differences:
- 2.5
- Justification:
- Remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- Default ECHA factor
- AF for the quality of the whole database:
- 2
- Justification:
- Additional safety factor for read-across
- AF for remaining uncertainties:
- 2.5
- Justification:
- Additional safety factor for the lower female reproductive NOAEL of 200 mg/kg based on read-across with a-methylstyrene
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral 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
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 1 000
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- All data were based on oral repeated dose toxicity studies.
- AF for dose response relationship:
- 1
- Justification:
- Started from NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Started from subchronic toxicity
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default ECHA factor for rat
- AF for other interspecies differences:
- 2.5
- Justification:
- Remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- Default ECHA factor
- AF for the quality of the whole database:
- 2
- Justification:
- Additional safety factor for read-across
- AF for remaining uncertainties:
- 2.5
- Justification:
- Additional safety factor for the lower female reproductive NOAEL of 200 mg/kg based on read-across with a-methylstyrene
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
Weight of evidence for Depanol I was obtained from subchronic and chronic toxicity testing with d-limonene in rats and subchronic toxicity testing in mice. The three studies were conducted according to older standards, however in combination they covered all needed study parameters. In addition, other studies are available for d-limonene demonstrating its safety. In all studies, NOAEL was above 500 mg/kg bw, taking into account that the kidney findings in male rats were not of relevance for humans. Supporting information was also available from 6-month dog studies, confirming that the nephropathology was specific to male rats.
Two year carcinogenicity studies were available in rats and mice with d-limonene. In rats, hyperplasia and adenomas were seen in male rats associated with cytoplasmic alfa 2µ-globulin granules in the renal tubuli. In mice, no hyperplasia or tumours were observed. These findings in male rats have meanwhile been accepted not to be relevant for humans.
For the reproductive toxicity, read across from source chemical alpha-methylstyrene tested in an OECD 422 study, demonstrated systemic toxicity at 200 mg/kg bw, without reproductive toxicity. At the dose of 1000 mg/kg, maternal toxicity was more extensive, and loss of offspring in two dams and lower body weight and viability of pups were observed at 1000 mg/kg bw. These effects however were considered to be secondary to maternal systemic toxicity.
No teratogenicity was observed for source chemicals alpha-methylstyrene (in rats) and for d-limonene (in rats, mice and rabbits). Some foetal toxicity was observed with both source chemicals at maternally toxic doses in rats, which was considered a secondary effect, however in mice and rabbits there was no foetal toxicity even at maternally toxic doses. Developmental NOAEL was at least 591 mg/kg bw.
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.