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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 690-526-2 | CAS number: 38632-47-2
- 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:
- DNEL (Derived No Effect Level)
- Value:
- 10 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):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 245 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- no additional AF necessary
- AF for differences in duration of exposure:
- 2
- Justification:
- extrapolation from subchronic animal data to chronic human situation; default value according to REACH guidance documents
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- included already in route-to-route extrapolation to derive dose descriptor starting point.
- AF for other interspecies differences:
- 2.5
- Justification:
- default value according to REACH guidance documents
- AF for intraspecies differences:
- 5
- Justification:
- default value according to REACH guidance documents
- AF for the quality of the whole database:
- 1
- Justification:
- no additional AF necessary
- AF for remaining uncertainties:
- 1
- Justification:
- no additional AF necessary
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
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 13.9 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 390 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- no additional AF necessary
- AF for differences in duration of exposure:
- 2
- Justification:
- extrapolation from subchronic animal data to chronic human situation; default value according to REACH guidance documents
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- extrapolation from rats to humans; default value according to REACH guidance documents
- AF for other interspecies differences:
- 2.5
- Justification:
- default value according to REACH guidance documents
- AF for intraspecies differences:
- 5
- Justification:
- default value according to REACH guidance documents
- AF for the quality of the whole database:
- 1
- Justification:
- no additional AF necessary
- AF for remaining uncertainties:
- 1
- Justification:
- no additional AF necessary
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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
PCMS is not irritating to the skin or eye and has no local effects in an acute inhalation study. PCMS is not sensitizing. Consequently local DNELs are not applicable for PCMS.
Long-term DNEL:
The point of departure for systemic toxicity is the comprehensive sub-chronic oral toxicity study in rats. In this study a NOAEL of 278 mg/kg/day was established.
Taking into account the REACH Guidance default assessment factors:
Intraspecies factor rat->humans: 4
Additional uncertainty: 2.5
Interspecies factor for worker: 5
Time-extrapolation sub-chronic-> chronic 2
The overall assessment factor will be 100.
Consequently, the long-term DNEL (worker, oral) will be 2.8 mg/kg/day.
The default absorption values of 50% and 100% are taken for oral and inhalation exposure, respectively. As outlined in the chapter toxicokinetic these values can be considered as conservative.
Dermal absorption is assumed to be low. Based on the “Guidance on information requirements and chemical safety assessment Chapter R.7c: Endpoint specific guidance” an absorption of 10% was chosen for the DNEL calculation (Footnote page 156).
Taking into account the above mentioned oral (50%) and inhalation (100%) absorption values, the default body weight for worker (70 kg) and a default respiratory volume of 10 m3, the long-term DNEL (worker, inhalation) will be: 10 mg/m3
Taking into account the above mentioned oral (50%) and dermal (10%) absorption values, the long-term DNEL (worker, dermal) will be: 13.9 mg/kg/day.
The available acute toxicity studies in rats indicate low systemic toxicity. PCMS is not irritating to the skin or eye and has no local effects in an acute inhalation study. PCMS is not sensitizing. Consequently, for exposure by inhalation, an acute exposure assessment factor of 2 might be applied to account for potential peak exposure within the day.
PCMS has developmental toxicity properties. In a comprehensive developmental toxicity test in rats a NOAEL for maternal and developmental toxicity of 232 mg/kg/day was established. The point of departure for developmental toxicity is 232 mg/kg/day.
Taking into account the REACH Guidance default assessment factors:
Intraspecies factor rat->humans: 4
Additional uncertainty: 2.5
Interspecies factor for worker: 5
The overall assessment factor will be 50
Consequently, the long-term developmental toxicity DNEL (worker, oral) will be 4.6 mg/kg/day. Since this value is higher than the systemic DNEL (long term, oral) calculated above it is considered that the systemic DNEL covers developmental toxicity and the lowest DNEL should be used for risk assessment.
Short-term DNEL:
The available acute toxicity studies in rats indicate low systemic toxicity. PCMS is not irritating to the skin or eye and has no local effects in an acute inhalation study. PCMS is not sensitizing. Consequently, an acute exposure assessment factor of 2 will be applied to account for potential peak exposure within the day.
General Population - Hazard via inhalation route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
The formulation containing PCMS is a tanning agent, which is used in industrial sites (tannery). The X-Tan formulation contains 35% PCMS as the active ingredient. PCMS hydrolyses rapidly at pH 7 and pH 9 to form the major hydrolysis product, hexamethylene diamine or insoluble poly urea. Hydrolysis is rapid with the hydrolysis half-life of X-Tan measured as 3.5 hours at pH 7 and 10 minutes at pH 9 respectively (see CSR Section 4.1.1.1). X-Tan is used in a buffered process which is regulated at, at least, pH 8 for 18-24 hours. During the industrial use as tanning agent, either X-Tan has reacted with peptide / amino acid of raw hide or X-Tan is completely hydrolysed during tanning process. The wet whites, leathers and waste water after the tanning process have been thoroughly tested. No PCMS / X-Tan can be detected. Therefore, the exposure of PCMS / X-Tan to general public can be excluded. DNELs for the general population are not applicable for X-Tan.
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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