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Diss Factsheets
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EC number: 938-708-5 | 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:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.345 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 30
- Dose descriptor:
- NOAEC
- AF for dose response relationship:
- 1
- Justification:
- When the starting point for the DNEL delineation is a NOAEC, the default AF is 1.
- AF for differences in duration of exposure:
- 6
- Justification:
- The default AF to be applied for the extrapolation of exposure duration subacute to chronic is 6.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- According to the ECHA TGD allometric scaling should not be applied for local effects, since local effects are independent of the basal metabolic rate, therefore AF 1 is chosen.
- AF for other interspecies differences:
- 1
- Justification:
- A factor 2.5 is suggested by the ECHA TGD for remaining interspecies differences, but justified deviations are possible. Rodents like the rat are in general more sensitive compared to humans as the rat’s ventilation frequency is higher. Therefore, as a general rule a AF of 1 for remaining interspecies differences provides sufficient protection.
- AF for intraspecies differences:
- 5
- Justification:
- The default AF to be applied for intraspecies differences in workers is 5.
- AF for the quality of the whole database:
- 1
- Justification:
- The default AF to be applied for good/standard quality of the database, taking into account completeness, consistency and the standard information requirements, is 1.
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:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Selection of the relevant starting point
Inhalation exposure is typically the most relevant route for assessing occupational hazard and risk in humans. Effects from repeated exposure of animals to TDI Trimer are limited to effects on the respiratory tract. In a subacute (4-week) inhalation study with aerosol exposure of TDI Trimer (Desmodur RC, 25 % in ethyl acetate) to rats a NOAEC of 20.6 mg/m3 was determined based on histopathological effects in the upper and lower respiratory tract (Pauluhn, 2012). These portal-of-entry effects were caused by deposits of the test article or its polymerized reaction products. As far as epithelial changes of the respiratory epithelium occurred they followed the typical anterior-posterior gradient of deposition intensity. Tissue inflammatory responses to deposited material did not occur. No indications of systemic toxicity were found in this study.
Therefore, a worker DNEL for long-term inhalation exposure - local effects have to be derived.
Derivation of the DNEL long-term inhalation exposure - local effects
Starting point: 20.6 mg/m3 (NOAEC from subacute inhalation study)
Correction of the starting point according to ECHA Guidance, Chapter R.8 (Dec. 2010), Figure R.8-2:
corrected NOAEC = 20.6 mg/m3 x (6 h/d : 8 h/d) x (6.7 m3 : 10 m3) = 10.35 mg/m3
According to ECHA Guidance, Chapter R.8 (Dec. 2010), Section R.8.4 a series of assessment factors (AF) were applied to the corrected NOAEC from the subacute rat inhalation study and are summarized in the table below:
Type of assessment |
Assessment factor (AF) |
For interspecies differences rat vs. human |
1 |
For remaining interspecies differences 2 |
1 |
For intraspecies differences in workers 3 |
5 |
For extrapolation of exposure duration |
6 |
For reliability of dose-response 4 |
1 |
For quality of whole database 5 |
1 |
Overall assessment factor |
30 |
1 According to the ECHA TGD allometric scaling should not be applied for local effects, since local effects are independent of the basal metabolic rate. In this case, substance deposition in the respiratory tract without any inflammatory response to deposited material was seen. Therefore AF 1 is chosen.
2 A factor 2.5 is suggested by the ECHA TGD for remaining interspecies differences, but justified deviations are possible. Rodents like the rat are in general more sensitive compared to humans as the rat’s ventilation frequency is higher. No interspecies differences are expected due to substance deposition in the respiratory tract. Therefore, as a general rule a AF of 1 for remaining interspecies differences provides sufficient protection.
3 The use of the default AF 5 is a conservative approach because for the substance deposits with respective consequences is not to assume that there are great intraspecies differences.
4 When the starting point for the DNEL delineation is a NOAEC, the default AF is 1.
5 The default AF to be applied for good/standard quality of the database, taking into account completeness, consistency and the standard information requirements, is 1.
Dividing the corrected NOAEC of 10.35 mg/m3 by the calculated overall AF of 30 results in a worker DNEL of 0.345 mg/m3 for long-term inhalation - local effects.
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:
- no hazard identified
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
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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