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Diss Factsheets
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EC number: 907-605-7 | CAS number: 68815-47-4
- 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:
- 0.42 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 37.5
- Dose descriptor:
- LOAEC
- AF for dose response relationship:
- 3
- Justification:
- adequate factor for steep dose-response funtion
- AF for differences in duration of exposure:
- 1
- Justification:
- no additional factor is required for time duration since the effect observed is not dependent on the time of exposure
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- local effects, starting point is inhalation concentration
- AF for other interspecies differences:
- 2.5
- Justification:
- according to ECHA Guidance
- AF for intraspecies differences:
- 5
- Justification:
- according to ECHA Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- adequate database, default according to ECHA Guidance
- AF for remaining uncertainties:
- 1
- Justification:
- adequate database, default according to ECHA Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.84 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL extrapolated from long term DNEL
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
Worker DNEL long-term for dermal route -systemic effects:
No repeated-dose toxicity with dermal application exist for the submission substance. The only effects observed in oral repeated dose studies were seen in the respiratory tract, with subsequent mortality at higher doses. As these effects possibly are attributable to inhalation uptake in these studies, no systemic effects were observed in these studies, which might serve as a basis for deriving a DNEL for dermal exposure. In addition, the substance is corrosive to the skin and any exposure to the skin has to be avoided. Respective RMM are expected to effectively prevent any significant dermal exposure.
Worker-DNEL long-term for inhalation route- local effects:
In a 13 week toxicity study (6 hours a day, 5 days a week) rats were exposed to an aerosol containing various concentrations of the submission substance (EHL, 1985, Report No. 85 -220). In this study a LOAEC of 15.8 mg/m³ was determined (analytically determined concentration of BHMT corrected for total concentration submission substance, findings: lesions in the respiratory tract).
Correction of starting point for DNEL derivation: no correction of the starting point is needed since the effect observed (irritation of respiratory tract) is not driven by the time of exposure (see various studies in IUCLID section 7.5.2)
Assessment factors applied were for:
· Interspecies differences: no allometric scaling, 2.5 (remaining differences)
· Intraspecies differences: 5
· Differences in duration of exposure: 1 ( no additional factor isrequired for time duration since the effect observed is not dependent on the time of exposure)
· Issues related to dose-response: 3 (starting point is LOAEC instead of NOAEC)
· Quality of whole database: 1 (no deficiencies)
Overall assessment factor: 75
Calculation DNEL = 15.8 mg/m³/37.5 resulting in the DNEL = 421 µg/m³≈0.4 mg/m³
Please note: Benchmark modeling, which was applied to these data, did not lead to an improved situation compared to extrapolation from LOAEL to NOAEL by the default factor of 3.
Worker-DNEL short-term for inhalation route- local effects:
No dose-response data exist for acute inhalation exposure, which would allow to derive a short-term DNEL. Effects after repeated application of the submission substance by inhalation to rats were restricted to the respiratory tract with target organs damaged by local irrititation being the nasal passages, the trachea and lungs. After repeated inhalation of HMD, a main component of the submission substance, effects observed in rats and mice are limited to effects on the upper respiratory tract caused by local irritation in the nasal passages and the larynx. Therefore, an acute DNEL inhalation for local effects was established from the WORKER DNEL LONG-TERM FOR INHALATION ROUTE, LOCAL EFFECTS by using a multiplying factor of 2 considering that the observed adverse effects are mainly driven by the exposure concentration of the submission substance with respect to its corrosive properties.
Calculation DNEL = 0.42 mg/m³ * 2 resulting in the DNEL = 842 µg/m³ ≈ 0.84 mg/m³
Concerning quantitative assessment of acute/short term exposure local and systemic effects:
Worker-DNELs for short term duration (short term event, peak exposure) for dermal route- local and systemic effects were not established as the available data are not sufficient for quantitfication. A qualitative risk assessment will be performed due to the identified short term toxicity hazard leading to Classification (i.e. Acute Tox. 4 (dermal and oral), Skin Corr. 1 A, Eye damage 1, Skin sens. 1B, STOT SE 3).
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
No DNELs for the general population were derived due to the fact, that the substance is not intended to be used by the general population, thus the submission substance reaches the end of the lifecycle without exposure of the 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.
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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