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EC number: 241-749-5 | CAS number: 17766-26-6
- 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:
- 7.1 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 176.3 mg/m³
- Explanation for the modification of the dose descriptor starting point:
For the derivation of all DNELs a NOAEL of 200 mg/kg bw/day obtained in a subchronic oral repeated dose (90 days) study in rats (0, 50, 200 and 400/500 mg/kg bw) was chosen as dose descriptor starting point.
For workers:
Corrected inhalatory NOAEC = oralNOAEL x 1/sRVanimal x ABS oral-rat / ABS inh-human x sRVhuman/wRV
The standard respiratory volume (sRV) for the 8 h exposure is 0.38 m³/kg bw for rats and 6.7 m³ (per person) in humans. The default 8-h respiratory volume of a worker (wRV) is 10 m³ taking increased activity into account. It is assumed, that the oral absorption rate is 50% of that of the inhalation absorption.
This results in the following equation:
Corrected inhalatory NOAEC = 200 mg/kg bw/d x (1/0.38 m³/kg bw) x (0.5 / 1) x (6.7 m³ / 10 m³) = 176.3 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- The descriptor starting point is a NOAEL. The dose response relationship is considered unremarkable.
- AF for differences in duration of exposure:
- 2
- Justification:
- Dose descriptor starting point is the NOAEL of a subchronic study.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Respiratory interspecies differences are fully covered by the factors used for route to route extrapolation.
- AF for other interspecies differences:
- 2.5
- Justification:
- There is no evidence for species differences in the general mode of action or kinetics. However, standard AF is applied.
- AF for intraspecies differences:
- 5
- Justification:
- Default value for workers according to ECHA REACH Guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- The data base is adequat and of good quality (taking into account reliability and consistency across different studies and endpoints).
- AF for remaining uncertainties:
- 1
- Justification:
- No further remaining uncertainties.
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:
- hazard unknown (no further information necessary)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2 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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
For the derivation of all DNELs a NOAEL of 200 mg/kg bw/day obtained in a subchronic oral repeated dose (90 days) study in rats (0, 50, 200 and 400/500 mg/kg bw) was chosen as dose descriptor starting point.
For workers:
Corrected dermal NOAEL = oralNOAEL x (ABS oral-rat / ABS dermal-rat) x (ABS dermal-rat / ABS dermal-human)
It is assumed that oral and dermal absorption rates are equal.
This results in the following equation:
Corrected dermal NOAEL = 200 mg/kg x 1 / 1 = 200 mg/kg
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor starting point is based on a NOAEL.
- AF for differences in duration of exposure:
- 2
- Justification:
- Dose descriptor starting point is the NOAEL of a subchronic study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default allometric scaling factor for differences between rats and humans.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value according to ECHA REACH Guidance
- AF for intraspecies differences:
- 5
- Justification:
- There is no evidence for species differences in the general mode of action or kinetics. However, standard AF is applied.
- AF for the quality of the whole database:
- 1
- Justification:
- The data base is adequat and of good quality (taking into account reliability and consistency, across different studies and endpoints).
- AF for remaining uncertainties:
- 1
- Justification:
- No further remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- low 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
In general, the calculation of a DNEL is based on the observed effect level which has to be modified as described in “Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of dose [concentration]-response for human health” (ECHA, November 2012). Dermal and inhalative intakes are the possible exposure routes for workers.
The establishment of an acute toxicity DNEL set for effects occurring after a single exposure of a few minutes up to 24 hours is unnecessary for TMT, as the long-term DNEL is sufficient to ensure, that these effects do not occur. Anhydrous TMT has a very low vapour pressure (5.45E-14 Pa at 25°C) at room temperature and as a consequence, the inhalation via vapours can be considered negligible. In addition, anhydrous TMT is a very hygroscopic solid and is therefore only transported and used for preparation of a commercial solution. The development of dust is not possible because the substance is delivered in tight bags.Thus, peak exposure significantly higher than the average daily exposure and the long-term DNEL are very unlikely. Based on the available data it is not possible to derive DNELs for local effects, since local irritation on skin and eyes are the leading effects which do not provide dose-response data. Therefore, a qualitative assessment is conducted and appropriate risk management measures will be identified.
As starting point for derivation of the DNEL, a NOAEL of 200 mg/kg bw/day (for systemic effects) was used which was found in a subchronic toxicity study performed according to OECD guideline 408 (2015 -0078 -DGT). In this GLP guideline study TMT 55 was administered via gavage at concentrations of 50, 200 and 500/400 mg anhydrous TMT/kg bw/day for 90 days. A NOAEL of 200 mg/kg bw/day for male rats was derived based on mortality and histopathological findings in the kidneys at the highest dose tested. This NOAEL was selected as relevant dose descriptor.
Inhalation
For calculation of the DNEL for long-term inhalative systemic effects, the dose descriptor has to be converted into a corrected starting point by route-to-route extrapolation.
It is assumed, that the oral absorption rate is 50% of that of the inhalation absorption.
Besides this, the interspecies difference between rat and human has to be taken into account. Therefore, the no observed effect level has to be corrected by the risk assessor 6.7 / 0.38*10 regarding breathing volume and frequency. Thus, the corrected starting point for workers was 176.3 mg anhydrous TMT/m³/day for inhalation.
Subsequently assessment factors (AF) are listed, which have to be taken into account for the final DNEL calculation: remaining interspecies-differences (2.5), intraspecies differences (5), duration extrapolation: subchronic - chronic (2).
The DNEL is calculated according to the formula DNEL = (corrected starting point) /(overall AF). Thus, the resulting DNEL for long-term inhalative systemic effects is 7.1 mg anhydrous TMT/m³ for workers.
Dermal
For calculation of the DNEL for long-term dermal systemic effects, the dose descriptor has to be converted into a corrected starting point by route-to-route extrapolation. It is assumed, that oral and dermal absorption rates are equal, since the skin absorption potential (0.055 mg/cm²/h) is assigned to a high dermal absorption of 80% based on the QSAR results for anhydrous TMT taking into account the respective molecular weight, log Pow and water solubility (for details refer to IUCLID chapter 7.1 toxicokinetics, metabolism and distribution). Thus the corrected starting point for workers was 200 mg anhydrous TMT/kg bw/day for the dermal route.
Subsequently, following assessment factors are taken into account for the final DNEL calculation: interspecies differences (4), remaining interspecies-differences (2.5), intraspecies differences (5) and duration extrapolation: subchronic - chronic (2).
As a consequence, the resulting DNEL for long-term dermal systemic effects is 2 mg anhydrous TMT/kg bw/day for workers.
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
TMT is only handled in industrial or professional settings (for details refer to IUCLID section 3.5 or to CSR section 2). Since exposure for the general public is precluded, DNELs for the general population are not relevant and thus not derived.
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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