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Registration Dossier
Diss Factsheets
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EC number: 220-666-8 | CAS number: 2855-13-2
- 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:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.073 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 30
- Dose descriptor:
- LOAEC
- Value:
- 2.2 mg/m³
- AF for dose response relationship:
- 10
- Justification:
- An assessment factor of 10 is assumed to be sufficient as corrosive properties are usually steep effects.
- AF for differences in duration of exposure:
- 1
- Justification:
- A factor of 1 is used, because for local effects in the respiratory tract there is no substancial difference in LOAEC following acute and subacute exposure by inhalation; ECHA Guidance R8 Chapter 8.4.3.1.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No factor for allometric scaling is needed in case of inhalation exposure. Furthermore, the factor for remaining uncertainties is not needed as the rat is a more sensitive species for inhalation exposure and an obligatory nose breather and as the rat’s ventilation frequency is higher
- AF for other interspecies differences:
- 1
- Justification:
- No factor for other interspecies differencs was given, because the local effect in the respiratory tract is not triggered by other toxikokinetic or toxikodynamic differences.
- AF for intraspecies differences:
- 3
- Justification:
- Using a reduced factor of 3 is justified because the critical effect is a local effect that is hardly, if at all, determined by toxicodynamics and kinetics. Absorption,distribution and elimination play no or only a minor role. Local effects are largely concentration-dependent whereas exposure time and enzyme polymorphisms are of minor importance in such cases.Due to the fact that the local effects are driven by local exposure peaks and are not supposed to worsen with time and considering the rat is over-predictive in this case, a joint assessment factor of 3 is applied for intraspecies differences and exposure duration correction.
- AF for the quality of the whole database:
- 1
- Justification:
- The data are based on a good/standard quality database, which is complete, consistent contains standard information.
- AF for remaining uncertainties:
- 1
- Justification:
- There are no other differences between species to be considered for the observed local effects in the respiratory tract.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.073 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
Derivation of corrected starting points, overall assessment factors and DNEL´s for workers: Oral exposure for workers is not considered to be a relevant exposure pathway. Hence DNEL´s for oral exposure of workers are not derived.
Because of the corrosive and skin sensitizing properties of the substance, derivation of DNELs is not possible for local effects after dermal exposure. Therefore, a qualitative assessment is needed for local dermal exposure (high hazard).
As the substance is corrosive and sensitizing the caustic properties represent the primary effect. Thus, derivation of an inhalation DNEL after long-term inhalation exposure is not warranted because the local effects occur already at lower concentrations than systemic effects. All workers have to protect themselves by wearing protective clothes. Systemic exposure is not relevant.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- 0.3 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 59 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 59 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Based on a EOGRTS study in rats (NOAEL = 80 mg/kg bw/day) assuming a worst case 100% dermal absorption.
- AF for dose response relationship:
- 1
- Justification:
- Starting point is a NOAEL. Thus standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD
- AF for differences in duration of exposure:
- 2
- Justification:
- An assessment factor 2 is suggested by the ECHA TGD for exposure duration from subchronic (90 day) to chronic (see section R.8.4.3.1, Table R. 8-5) (ECHA, Nov 2012).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- An allometric scaling factor of 4 is suggested by the ECHA TGD (see section 8.4.3.1 of TGD; ECHA, Nov 2012) for interspecies differences.
- AF for other interspecies differences:
- 2.5
- Justification:
- A factor 2.5 is suggested by the ECHA TGD for remaining interspecies differences (ECHA, Nov 2012)
- AF for intraspecies differences:
- 10
- Justification:
- For intraspecies variability, the default assessment factor for general population for systemic effects is 10 (ECHA, Nov 2012).
- AF for the quality of the whole database:
- 1
- Justification:
- Because of good/standard quality of the database the standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD
- AF for remaining uncertainties:
- 1
- Justification:
- No further assessment factors are considered to be necessary.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.3 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):
- 200
- DNEL extrapolated from long term DNEL
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
The use of the substance isophorone diamine is restricted only to industrial and professional applications. Hence there is no need to derive DNEL´s for general population (consumers).
An indirect exposure of man via the environment might occur through ingestion of foodstuff or drinking water. Therefore, a systemic oral long-term DNEL for general population is derived and will be used to assess any possible risk that could result from indirect exposure of man via the environment.
As a worst case assumption an absorption rate of 100% is assumed by ingestion of the compound.
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