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EC number: 245-509-0 | CAS number: 23235-61-2
- 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:
- 2.4 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 37.5
- Dose descriptor starting point:
- LOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 88 mg/m³
- Explanation for the modification of the dose descriptor starting point:
In the absence of an inhalation study, a corrected inhalation starting point is derived based on the oral LOAEL of 100 mg/kg bw/d. The oral LOAEL is corrected for breathing rate (/0.38) and activity (*0.67) and assuming inhalation absorption is twice oral absorption, resulting in a corrected inhalation LOAEC of 88 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- Default value
- AF for differences in duration of exposure:
- 1
- Justification:
- Not required. Although the starting point is from a PNDT study (technically sub-acute in duration), exposure covers the sensitive period. Increased risk would not be expected from a study of longer duration, therefore an assessment factor is not required. It is noted that this approach is protective compared to using the NOAEL of 1000 mg/kg bw/d from the 90-day study.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not required: already considered
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value: starting point derived from a rat study
- AF for intraspecies differences:
- 5
- Justification:
- Default value (workers)
- AF for the quality of the whole database:
- 1
- Justification:
- Default value
- AF for remaining uncertainties:
- 3
- Justification:
- AF used to take into account the use of a LOAEC as a starting point
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:
- 0.7 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Dose descriptor starting point:
- LOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
A study of repeated dose dermal toxicity is not available. Dermal absorption and oral absorption are assumed (worst case) to be equivalent. A corrected dermal LOAEL of 100 mg/kg bw/d is therefore derived.
- AF for dose response relationship:
- 1
- Justification:
- Default value
- AF for differences in duration of exposure:
- 1
- Justification:
- Not required. Although the starting point is from a PNDT study (technically sub-acute in duration), exposure covers the sensitive period. Increased risk would not be expected from a study of longer duration, therefore an assessment factor is not required. It is noted that this approach is protective compared to using the NOAEL of 1000 mg/kg bw/d from the 90-day study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value: starting point derived from a rat study
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value
- AF for intraspecies differences:
- 5
- Justification:
- Default value (workers)
- AF for the quality of the whole database:
- 1
- Justification:
- Default value
- AF for remaining uncertainties:
- 3
- Justification:
- AF used to take into account the use of a LOAEC as a starting point
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
Di-TMP is not classified for acute toxicity, is not a skin or eye irritant and is not a skin sensitiser. A NOAEL of 1000 mg/kg bw/d is reported for a 90-day oral toxicity study in the rat. A LOAEL of 100 mg/kg bw/d is reported for a rat PNDT study, based on apparently increased incidences of misshapen scapula in all treated groups. The relationship of this finding to treatment with diTMP and toxicological significance of this finding is unclear at present; it is therefore considered to be treatment-related and potentially adverse.
Based on the results of the Extended Once Generation Reproductive Toxicity study (OECD443), it is concluded that the No-Observed-Adverse-Effect-Level (NOAEL) for both systemic and reproductive toxicity in the Sprague Dawley rat is 1000 mg/kg/day.
The LOAEL of 100 mg/kg bw/d from the PNDT study is used as a starting point for DNEL derivation.
Worker DNEL Values
Inhalation DNELs
Systemic inhalation DNELs
Long-term systemic inhalation DNEL
A starting point (LOAEC) of 88 mg/m3is derived following correction of the oral LOAEL for breathing rate (/0.38) and activity (*0.67), and assuming that inhalation absorption is twice oral absorption. Applying individual assessment factors of 1 (for dose-response relationship), 1 (for duration of exposure), 1 (for allometric scaling), 2.5 (for other interspecies differences), 5 (for intraspecies differences), 1 (for database quality) and 3 (for remaining uncertainties) results in an overall assessment factor of 37.5. Applying the overall assessment factor to the corrected starting point results in a DNEL of 2.4 mg/m3. Although the starting point is from a PNDT study (technically sub-acute in duration), exposure covers the sensitive period. Increased risk would not be expected from a study of longer duration, therefore an assessment factor for study duration is not required. It is noted that this approach is protective compared to using the alternative NOAEL of 1000 mg/kg bw/d from the 90 -day study.
Short-term systemic inhalation DNEL
diTMP is not classified for acute toxicity. A short-term systemic DNEL is not derived in the absence of any hazard.
Local inhalation DNELs
diTMP is not classified as a skin or eye irritant and there is no evidence to suggest respiratory irritation. Long-term and short-term local inhalation DNELs are not derived in the absence of any hazard.
Dermal DNELs
Systemic dermal DNELs
Long-term systemic dermal DNEL
A corrected starting point (LOAEL) of 100 mg/kg bw/d is derived, assuming (worst case) that dermal absorption is equivalent to oral absorption. Applying individual assessment factors of 1 (for dose-response relationship), 1 (for duration of exposure), 4 (for allometric scaling), 2.5 (for other interspecies differences), 5 (for intraspecies differences), 1 (for database quality) and 3 (for remaining uncertainties) results in an overall assessment factor of 150. Applying the overall assessment factor to the corrected starting point results in a DNEL of 0.7 mg/kg bw/d. Although the starting point is from a PNDT study (technically sub-acute in duration), exposure covers the sensitive period. Increased risk would not be expected from a study of longer duration, therefore an assessment factor for study duration is not required. It is noted that this approach is protective compared to using the alternative NOAEL of 1000 mg/kg bw/d from the 90 -day.
Short-term systemic dermal DNEL
diTMP is not classified for acute toxicity. A short-term systemic DNEL is not derived in the absence of any hazard.
Local dermal DNELs
diTMP is not classified as a skin irritant or skin sensitiser. Long-term and short-term local dermal DNELs are not derived in the absence of any hazard.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.6 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Dose descriptor starting point:
- LOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 43 mg/m³
- Explanation for the modification of the dose descriptor starting point:
In the absence of an inhalation study, a corrected inhalation starting point is derived from the oral LOAEL of 100 mg/kg bw/d. The oral LOAEL is corrected for breathing rate (/1.15) and the extent of absorption, resulting in a corrected inhalation LOAEC of 43 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- Default value
- AF for differences in duration of exposure:
- 1
- Justification:
- Not required. Although the starting point is from a PNDT study (technically sub-acute in duration), exposure covers the sensitive period. Increased risk would not be expected from a study of longer duration, therefore an assessment factor for study duration is not required. It is noted that this approach is protective compared to using the alternative NOAEL of 1000 mg/kg bw/d from the 90-day study.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not required (already accounted for)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value (rat study used as the starting point)
- AF for intraspecies differences:
- 10
- Justification:
- Default value (general population)
- AF for the quality of the whole database:
- 1
- Justification:
- Default value
- AF for remaining uncertainties:
- 3
- Justification:
- Use of LOAEL as starting point
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.3 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Dose descriptor starting point:
- LOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
A study of repeated dose dermal toxicity is not available. Dermal absorption and oral absorption are assumed (worst case) to be equivalent. A corrected dermal LOAEL of 100 mg/kg bw/d is therefore derived.
- AF for dose response relationship:
- 1
- Justification:
- Default value
- AF for differences in duration of exposure:
- 1
- Justification:
- Not required. Although the starting point is from a PNDT study (technically sub-acute in duration), exposure covers the sensitive period. Increased risk would not be expected from a study of longer duration, therefore an assessment factor for study duration is not required. It is noted that this approach is protective compared to using the alternative NOAEL of 1000 mg/kg bw/d from the 90-day study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value: starting point derived from a rat study
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value
- AF for intraspecies differences:
- 10
- Justification:
- Default value (general population)
- AF for the quality of the whole database:
- 1
- Justification:
- Default value
- AF for remaining uncertainties:
- 3
- Justification:
- Use of LOAEL as starting point
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.3 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Dose descriptor starting point:
- LOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The starting point is derived from an oral study; correction is therefore not required.
- AF for dose response relationship:
- 1
- Justification:
- default value
- AF for differences in duration of exposure:
- 1
- Justification:
- Not required. Although the starting point is from a PNDT study (technically sub-acute in duration), exposure covers the sensitive period. Increased risk would not be expected from a study of longer duration, therefore an assessment factor for study duration is not required. It is noted that this approach is protective compared to using the alternative NOAEL of 1000 mg/kg bw/d from the 90-day study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value: starting point derived from a rat study
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value
- AF for intraspecies differences:
- 10
- Justification:
- Default value (general population)
- AF for the quality of the whole database:
- 1
- Justification:
- Default value
- AF for remaining uncertainties:
- 3
- Justification:
- Use of LOAEL as starting point
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
Di-TMP is not classified for acute toxicity, is not a skin or eye irritant and is not a skin sensitiser. A NOAEL of 1000 mg/kg bw/d is reported for a 90-day oral toxicity study in the rat. A LOAEL of 100 mg/kg bw/d is reported for a rat PNDT study, based on apparently increased incidences of misshapen scapula in all treated groups. The relationship of this finding to treatment with diTMP and toxicological significance of this finding is unclear at present; it is therefore considered to be treatment-related and potentially adverse.
Based on the results of the Extended Once Generation Reproductive Toxicity study (OECD443), it is concluded that the No-Observed-Adverse-Effect-Level (NOAEL) for both systemic and reproductive toxicity in the Sprague Dawley rat is 1000 mg/kg/day.
The LOAEL of 100 mg/kg bw/d from the PNDT study is used as a starting point for DNEL derivation.
General Population DNEL Values
Inhalation DNELs
Systemic inhalation DNELs
Long-term systemic inhalation DNEL
A starting point (LOAEC) of 43 mg/m3is derived following correction of the oral LOAEL for breathing rate (/1.15) and assuming that inhalation absorption is twice oral absorption. Applying individual assessment factors of 1 (for dose-response relationship), 1 (for duration of exposure), 1 (for allometric scaling), 2.5 (for other interspecies differences), 10 (for intraspecies differences), 1 (for database quality) and 3 (for remaining uncertainties) results in an overall assessment factor of 75. Applying the overall assessment factor to the corrected starting point results in a DNEL of 0.6 mg/m3. Although the starting point is from a PNDT study (technically sub-acute in duration), exposure covers the sensitive period. Increased risk would not be expected from a study of longer duration, therefore an assessment factor for study duration is not required. It is noted that this approach is protective compared to using the alternative NOAEL of 1000 mg/kg bw/d from the 90-day study.
Short-term systemic inhalation DNEL
diTMP is not classified for acute toxicity. A short-term systemic DNEL is not derived in the absence of any hazard.
Local inhalation DNELs
diTMP is not classified as a skin or eye irritant and there is no evidence to suggest respiratory irritation. Long-term and short-term local inhalation DNELs are not derived in the absence of any hazard.
Dermal DNELs
Systemic dermal DNELs
Long-term systemic dermal DNEL
A corrected starting point (LOAEL) of 100 mg/kg bw/d is derived, assuming (worst case) that dermal absorption is equivalent to oral absorption. Applying individual assessment factors of 1 (for dose-response relationship), 1 (for duration of exposure), 4 (for allometric scaling), 2.5 (for other interspecies differences), 10 (for intraspecies differences), 1 (for database quality) and 3 (for remaining uncertainties) results in an overall assessment factor of 300. Applying the overall assessment factor to the corrected starting point results in a DNEL of 0.3 mg/kg bw/d. Although the starting point is from a PNDT study (technically sub-acute in duration), exposure covers the sensitive period. Increased risk would not be expected from a study of longer duration, therefore an assessment factor for study duration is not required. It is noted that this approach is protective compared to using the alternative NOAEL of 1000 mg/kg bw/d from the 28-day study and an AF of 6 to cover study duration.
Short-term systemic dermal DNEL
diTMP is not classified for acute toxicity. A short-term systemic DNEL is not derived in the absence of any hazard.
Local dermal DNELs
diTMP is not classified as a skin irritant or skin sensitiser. Long-term and short-term local dermal DNELs are not derived in the absence of any hazard.
Oral DNELs
Systemic oral DNELs
Long-term systemic oral DNEL
Correction of the starting point is not required. Applying individual assessment factors of 1 (for dose-response relationship), 1 (for duration of exposure), 4 (for allometric scaling), 2.5 (for other interspecies differences), 10 (for intraspecies differences), 1 (for database quality) and 3 (for remaining uncertainties) results in an overall assessment factor of 300. Applying the overall assessment factor to the corrected starting point results in a DNEL of 0.3 mg/kg bw/d. Although the starting point is from a PNDT study (technically sub-acute in duration), exposure covers the sensitive period. Increased risk would not be expected from a study of longer duration, therefore an assessment factor for study duration is not required. It is noted that this approach is protective compared to using the alternative NOAEL of 1000 mg/kg bw/d from the 90 -day study.
Short-term systemic oral DNEL
diTMP is not classified for acute toxicity. A short-term systemic DNEL is not derived in the absence of any hazard.
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