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Diss Factsheets
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EC number: 617-779-3 | CAS number: 85940-94-9
- 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
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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:
- 0.502 mg/m³
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 5
- Dose descriptor:
- NOAEC
- Value:
- 2.51 mg/m³
- AF for differences in duration of exposure:
- 1
- Justification:
- local effects on respiratory tract
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- local effects
- AF for other interspecies differences:
- 1
- Justification:
- 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 factor of 1 for remaining interspecies differences provides sufficient protection.
- AF for intraspecies differences:
- 5
- AF for the quality of the whole database:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 3
- Dose descriptor starting point:
- NOAEC
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:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Justification for the non-equivalence of the test material to the submission substance identity
HDI Trimer MEKO blocked is always produced and marketed as dissolved in solvent. Thus, the substance is expected to be handled and used in a form of a mixture of the registered substance in the solvent. It was concluded that testing the mixture for acute effects (acute toxicity studies, eye and skin irritation and sensitization) was more relevant than testing the registered substance as workers would be exposed to the mixture rather than to the pure substance. However, for long-term effects (repeat dose and reproductive studies), it has been concluded to test the registered substance instead of the mixture considering that the route of exposure is the inhalation route and the solvent could present inhalation long-term toxicity properties.
To conclude as a consequence in the endpoint study records, when toxicological studies were performed on the mixture, the test material was not ticked when requesting if equivalent to submission substance identity .
Discussion: DNELs
HDI Trimer MEKO-blocked is classified as a skin sensitizer.
The derivation of DNEL is assessed for workers only and by inhalation and dermal routes.
According to the physico-chemical and toxicological properties, HDI Trimer MEKO blocked is unlikely to be systemically absorbed at a significant rate. As determined in the long-term studies, only local effects were observed after HDI Trimer MEKO blocked exposure. Hence, extrapolation of the DNEL for systemic effects is not relevant.
1.DNEL for acute exposure-local effects
1.1Dermal route
A sensitization study was conducted according to the Guinea-Pig Maximisation Test and showed positive results. Considering that no dose response relationship was observed in this study, it is difficult to derive a threshold and to set a DNEL. Hence, only qualitative assessment can be performed following the approach described in the dossier to define the risk management measures (RMMs) and operational conditions (OCs).
1.2Inhalation
Derivation of an acute inhalation DNEL by extrapolation from a long-term inhalation DNEL
Cf 2.2 DNEL for long-term inhalation exposure
The DNEL for acute toxicity could be set for a reference period of 15 min at 3 times the value (default value) of the long term DNEL.
Acute inhalation DNEL extrapolated = 0.502*3 = 1.50 mg/m3
2.DNEL for long-term exposure-local effects
2.1 Dermal route
A sensitization study was conducted according to the Guinea-Pig Maximization Test and showed positive results. Considering that no dose response relationship was observed in this study, it is difficult to derive a threshold and to set a DNEL. Hence, only qualitative assessment can be performed following the approach described in the dossier to define the risk management measures (RMMs) and operational conditions (OCs).
2.2 Inhalation
The long-term DNEL inhalation exposure for local effects is derived from the repeated dose toxicity study by inhalation (90d) (L. Ma Hock, 2010)
In this long-term study, 3 concentrations have been tested: 5, 25 and 150 mg/m3.
At the clinical examination (mortality, clinical observation, BW, food consumption, rectal temperature, ophthalmology), no effect or changes has been observed.
At the clinical pathology, a statistically significant increase treatment related of absolute and relative weights has been observed in the lungs of both males and females at 150 mg/m3. The gross lesions have been observed in the mediastinal lymph nodes at 150 and 25 mg/m3.
At histopathology, only local effects have been observed in the respiratory tract.
Ø Nasal cavity: subepithelial lymphoid infiltrates in the septum of the nasal cavity
Ø Trachea: goblet cells and hyperplasia and inflammation of the respiratory epithelium and granuloma in the carina
Ø Lungs: granulomatus inflammation and lympho-reticular hyperplasia with development of granulomas in the BALT
Ø Mediastinal lymph nodes: lympho-reticular hyperplasia with development of multifocal granulomas
Moreover in hematology, an increase of neutrophil counts and total white blood cells is noticed, considered as a systemic effect in response to the inflammation and irritation of the respiratory tract after test substance exposure.
Table 1.2:Calculation of long-term DNEL by inhalation for local effects for HDI Trimer MEKO-blocked
Worker |
Local / Long-term DNEL / inhalation |
Step a : determination of the critical dose |
|
Key study |
Ma-Hock L., 90-day inhalation study in Wistar rats liquid aerosol |
Relevant dose descriptor |
NOAEC = 5.00 mg/m3 |
Step b : Correct starting point– factor for uncertainties |
|
Differences in absorption depending on route of exposure (route-route extrapolation, human/animal) |
- (local effects) |
Modification for exposure (experiment and human) |
6/8 |
Modification for respiratory volume |
6.7/10 |
Correct starting point = relevant dose descriptor / overall factor for uncertainties |
2.51 mg/m3 |
Step c : assessment factors |
|
Interspecies differences - Differences in metabolic rate per b.w. (allometric scaling) - Remaining differences
|
1(local effects) |
1(effects on respiratory tract) |
|
Intraspecies differences |
5 (worker, local effects) |
Duration extrapolation (sub-acute/sub-chronic/chronic) |
1(local effects on respiratory tract) |
Issues related to dose-response |
1(DNEL is derived from a NOAEC) |
Quality of whole database |
1 |
Overall assessment factor |
5 |
DNEL calculation |
0.502 mg/m3 |
Justification for the interspecies (remaining differences) assessment factor
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 factor of 1 for remaining interspecies differences provides sufficient protection.
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:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Additional information - General Population
The substance is not used in the public domain and exposure of consumers is thus not to be expected.
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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