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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 204-798-3 | CAS number: 126-71-6
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- 50 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: OEL method of German Bundesanstalt für Arbeitsschutz und Arbeitsmedizin (BAuA)
- Overall assessment factor (AF):
- 28
- Dose descriptor starting point:
- other: NAEL (rat)
- Value:
- 170 mg/kg bw/day
- Modified dose descriptor starting point:
- other: OEL (human)
- Value:
- 42 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Only oral route is available.
- AF for differences in duration of exposure:
- 1.4
- Justification:
- AF=2: Extrapolation to chronic exposure based on sub-chronic toxicty study. AF=0.7: Correction for exposure time 7 days in the study, 5 days exposure at the workplace.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Extrapolation is based on toxicological equivalence of a concentration of a chemical in the air of experimental animals and humans; animals and humans breathe at a rate depending on their caloric requirements.
- AF for intraspecies differences:
- 5
- Justification:
- Default assessment factor for workers.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
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:
- 4.25 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):
- 40
- Dose descriptor starting point:
- other: NAEL (rat)
- Value:
- 170 mg/kg bw/day
- Modified dose descriptor starting point:
- other: NAEL (rat)
- Value:
- 170 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Only oral route is available.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- Justification:
- Extrapolation to chronic exposure based on sub-chronic toxicty study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default assessment factor for allometric scaling in case of rat to human extrapolation.
- AF for other interspecies differences:
- 1
- Justification:
- A factor for remaining differences has not been applied, because there is no indication for interspecies differences in addition to the differences covered by the default interspecies factor.
- AF for intraspecies differences:
- 5
- Justification:
- Default assessment factor for workers.
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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
Long-term – inhalation, systemic effects (based on 90 day repeated dose oral toxicity study with rats as evaluated by the German Bundesanstalt für Arbeitsschutz und Arbeitsmedizin (BAuA) in 2007)
In 2007 the German Bundesanstalt für Arbeitsschutz und Arbeitsmedizin (BAuA) has evaluated Triisobutyl phosphate to estimate an OEL (Begründung zu Triisobutylphosphat in TRGS 900 Ausgabe: Januar 2006 zuletzt geändert und ergänzt: März 2007). In this evaluation the study of Monsanto (1990) was also evaluated and assessed. The BAuA concluded that the observed effects, seen at the highest dose level of 5000 mg/kg diet, could not conclusively be determined as toxicological relevant. The observed effect of changes in cholesterol and the number of leucocytes are not associated with changes in white blood cell counts. Additionally the slight increase inmean corpuscular hemoglobin content and concentration did not result in other effects on red blood cells. In addition no correlation was found between the observed changes in blood parameters and the results of the clinical and histopathological assessments. The BAuA therefore, decided that the dosis of 5000 mg/kg diet can be assumed to be a marginal LOEL which will only be slightly above the actual NOAEL. According to the BauA it can thus be assumed that for the estimation of an OEL, a NAEL of 2500 mg/kg diet, which corresponds to 170 mg/kg bw for male and 210 mg/kg bw for female rats, can be used. To derive an OEL for triisobutyl phosphate based on a 13 week exposure study in rats with a NAEL of 170 mg/kg bw/day, assessment factors were taken into account by the BauA as shown in the table below. Using the total assessment factors of 28 a OEL of 6 mg/kg bw/day is derived. The BAuA assumes a body weight of 70 kg for a worker and a inhalation volume of 10 m³ in 8 hours. Thus the OEL of 6 mg/kg bw/day corresponds to an air concentration of 42 mg/m³ triisobutyl phosphate. Additionally, the BAuA adopts the “preferred value approach” in its estimation of the OEL and the resulting OEL value thus becomes 50 mg/m³.
Description | Value | Remark |
Step 1) Relevant dose-descriptor | NAEL: 170 mg/kg bw/day | The effects observed at the highest tested dose in a 90 day repeated dose study re considered not conclusively toxicologically relevant acc to BAuA. Therefore the dose of 5000 mg/kg diet is considered a marginal LOEL. Which is assumed to be only slightly above the NOAEL. According to the BAuA in this case a NAEL of 2500 mg/kg diet. This corresponds to a dose of 170 mg/kg bw/day in male rats |
Modified dose-descriptor | 170 / 1 = 170 mg/kg bw/day | |
Step 2) Assessment factors |
|
|
Interspecies | 4 | Assessment factor for allometric scaling in case of rat to human extrapolation. A factor for remaining differences has not been applied, because there is no indication for interspecies differences in addition to the differences covered by the default interspecies factor. |
Intraspecies | 5 | Default assessment factor for worker |
Exposure duration | 2 | Default assessment factor for the extrapolation sub-chronic to chronic exposure |
Correction factor for exposure time | 0.7 | 7 days in the study; 5 days exposure at workplace |
OEL (mg/kg bw/day) | 170 / (4 x 5 x 2 x 0.7) = 6.07 | |
OEL human | 42 mg/m³ | Assuming a bodyweight of 70 kg for a worker and inhalation volume of 10 m³ in 8 hours |
OEL | 50 mg/m³ | Using the preferred value approach |
Long-term - inhalation, local effects
No data are available based on which a DNEL for local effects can be derived. There are also no data to suggest that the substance may cause local effects by inhalation exposure.
Long-term –dermal, systemic effects (based on 90 day repeated dose oral toxicity study with rats.
Description | Value | Remark |
Step 1) Relevant dose-descriptor | NAEL: 170 mg/kg bw/day | The effects observed at the highest tested dose in a 90 day repeated dose study re considered not conclusively toxicologically relevant acc to BAuA. Therefore the dose of 5000 mg/kg diet is considered a marginal LOEL. Which is assumed to be only slightly above the NOAEL. According to the BAuA in this case a NAEL of 2500 mg/kg diet. This corresponds to a dose of 170 mg/kg bw/day in male rats |
Step 2) Modification of starting point | 1
| Ratio of dermal to oral absorption (default value, as proposed in the REACH guidance (R.8.4.2)
|
Modified dose-descriptor | 170 mg/kg bw/day | |
Step 3) Assessment factors |
|
|
Interspecies | 4 | Assessment factor for allometric scaling |
Intraspecies | 5 | Default assessment factor for worker |
Exposure duration | 2 | Default assessment factor for the extrapolation sub-chronic to chronic exposure |
Dose response | 1 |
|
Quality of database | 1 |
|
DNEL | Value | |
| 170 / (4 x 5 x 2 x 1 x 1) = 4.25 mg/kg bw/day |
Long-term - dermal, local effects
No data are available based on which a DNEL for local effects can be derived. As the substance is not irritating to skin upon exposure for 4 hours under semiocclusive conditions, no local effects are expected by repeated dermal exposure. The substance is classified as sensitising to skin. However, it is not possible to derive a DNEL on the basis of the available data.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.89 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- Overall assessment factor (AF):
- 5.6
- Dose descriptor starting point:
- other: OEL worker
- Value:
- 50 mg/m³
- Modified dose descriptor starting point:
- other: OEL worker
- Value:
- 50 mg/m³
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 4.2
- Justification:
- AF=3: Default assessment factor for the extrapolation from 8h to 24h exposure. AF=1.4: Extrapolation from 5 days exposure for workers to 7 days exposure for consumers
- AF for interspecies differences (allometric scaling):
- 1
- AF for other interspecies differences:
- 0.7
- Justification:
- Lower mean respiration volume for general population (6.7 m3 respiratory volume for 8h with no activity divided by 10 m3 respiratory volume for 8h with light activity).
- AF for intraspecies differences:
- 2
- Justification:
- Default assessment factor from workers to general population
- AF for the quality of the whole database:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.13 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- Overall assessment factor (AF):
- 80
- Modified dose descriptor starting point:
- other: NAEL
- Value:
- 170 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Only oral route is available.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- Justification:
- Extrapolation to chronic exposure based on sub-chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default assessment factor for allometric scaling in case of rat to human extrapolation.
- AF for other interspecies differences:
- 1
- Justification:
- A factor for remaining differences has not been applied, because there is no indication for interspecies differences in addition to the differences covered by the default interspecies factor.
- AF for intraspecies differences:
- 10
- Justification:
- Default assessment factor
- AF for the quality of the whole database:
- 1
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:
- 2.13 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- Overall assessment factor (AF):
- 80
- Modified dose descriptor starting point:
- other: NAEL
- Value:
- 170 mg/kg bw/day
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- Justification:
- Extrapolation to chronic exposure based on sub-chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default assessment factor for allometric scaling in case of rat to human extrapolation.
- AF for other interspecies differences:
- 1
- Justification:
- A factor for remaining differences has not been applied, because there is no indication for interspecies differences in addition to the differences covered by the default interspecies factor.
- AF for intraspecies differences:
- 10
- Justification:
- Default assessment factor
- AF for the quality of the whole database:
- 1
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
In 2007 the German Bundesanstalt für Arbeitsschutz und Arbeitsmedizin (BAuA) has evaluated Triisobutyl phosphate to estimate an OEL (Begründung zu Triisobutylphosphat in TRGS 900 Ausgabe: Januar 2006 zuletzt geändert und ergänzt: März 2007).In this evaluation the study of Monsanto (1990) was also evaluated and assessed. The BAuA concluded that the observed effects, seen at the highest dose level in the 90-day repeated dose study of 5000 mg/kg diet, could not conclusively be determined as toxicological relevant. The observed effect of changes in cholesterol and the number of leucocytes are not associated with changes in white blood cell counts. Additionally the slight increase in mean corpuscular hemoglobin content and concentration did not result in other effects on red blood cells. In addition no correlation was found between the observed changes in blood parameters and the results of the clinical and histopathological assessments. The BAuA therefore, decided that the dosis of 5000 mg/kg diet can be assumed to be a marginal LOEL which will only be slightly above the actual NOAEL. According to the BauA it can thus be assumed that for the estimation of an OEL, a NAEL of 2500 mg/kg diet, which corresponds to 170 mg/kg bw for male and 210 mg/kg bw for female rats, can be used. To derive an OEL for triisobutyl phosphate based on a 13 week exposure study in rats with a NAEL of 170 mg/kg bw/day, assessment factors were taken into account by the BauAas shown in the table below.Using the total assessment factors of 28 a OEL of 6 mg/kg bw/day is derived. The BAuA assumes a body weight of 70 kg for a worker and a inhalation volume of 10 m³ in 8 hours. Thus the OEL of 6 mg/kg bw/day corresponds to an air concentration of 42 mg/m³ triisobutyl phosphate. Additionally, the BAuA adopts the “preferred value approach” in its estimation of the OEL and the resulting OEL value thus becomes 50 mg/m³.
Long-term – dermal, systemic effects (based on 90 day repeated dose oral toxicity study with rats)
Description | Value | Remark |
Step 1) Relevant dose-descriptor | NAEL: 170 mg/kg bw/day | The effects observed at the highest tested dose in a 90 day repeated dose study,are considered not conclusively toxicologically relevant acc to BAuA. Therefore the dose of 5000 mg/kg diet is considered a marginal LOEL. Which is assumed to be only slightly above the NOAEL. Therefore the NAEL is assumed to be 2500 mg/kg diet. This corresponds to a dose of 170 mg/kg bw/day in male rats. |
Step 2) Modification of starting point | 1 | Ratio of dermal to oral absorption (default value, as proposed in the REACH guidance (R.8.4.2) |
Modified dose-descriptor | 170 / 1=170 mg/kg bw/day | |
Step 3) Assessment factors |
|
|
Interspecies | 4 | Assessment factor for allometric scaling in case of rat to human extrapolation. A factor for remaining differences has not been applied, because there is no indication for interspecies differences in addition to the differences covered by the default interspecies factor. |
Intraspecies | 10 | Default assessment factor |
Exposure duration | 2 | Default assessment factor for the extrapolation sub-chronic to chronic exposure |
Dose response | 1 |
|
Quality of database | 1 |
|
DNEL | Value | |
| 170 / (4 x 10 x 2 x 1 x 1) = 2.13 mg/kg bw/day |
Long-term - dermal, local effects
No data are available based on which a DNEL for local effects can be derived. As the substance is not irritating to skin upon exposure for 4 hours under semiocclusive conditions, no local effects are expected by repeated dermal exposure. The substance is classified as sensitising to skin. However, it is not possible to derive a DNEL on the basis of the available data.
Long-term – inhalation, systemic effects (based on 90-day repeated dose oral toxicity study with rats)
Description | Value | Remark |
Step 1) Relevant dose-descriptor | OEL worker: 50 mg/m³ | Based on an triisobutyl phosphate evaluation by BAuA for the determination of a inhalation OEL value. |
Modified dose-descriptor | 50 mg/m³ | |
Step 3) Assessment factors |
|
|
Intraspecies | 2 | Default assessment factor for extrapolation from workers to the general population |
Exposure duration | 3 | Default assessment factor for the extrapolation from 8h to 24h exposure |
Dose response | 1 |
|
Quality of database | 1 |
|
Correction factor for exposure time | 1.4 | Extrapolation from 5 days exposure for workers to 7 days exposure for consumers |
Respiration volume | 0.67 | Lower mean respiration volume for general population (6.7 m³ respiratory volume for 8h with no activity divided by 10 m³ respiratory volume for 8h with light activity). |
DNEL
| Value | |
50 / (1 x 2 x 3 x 1.4 x 0.67) = 8.89 mg/m³ |
Long-term - inhalation, local effects
No data are available based on which a DNEL for local effects can be derived. There are also no data to suggest that the substance may cause local effects by inhalation exposure.
Long-term – oral, systemic effects (based on 90-day repeated dose oral toxicity study with rats)
Description | Value | Remark |
Step 1) Relevant dose-descriptor | NAEL: 170 mg/kg bw/day | The effects observed at the highest tested dose in a 90 day repeated dose study,are considered not conclusively toxicologically relevant acc to BAuA. Therefore the dose of 5000 mg/kg diet is considered a marginal LOEL. Which is assumed to be only slightly above the NOAEL. Therefore the NAEL is assumed to be 2500 mg/kg diet using a safety factor of 2. This corresponds to a dose of 170 mg/kg bw/day in male rats |
Step 2) Modification of starting point | - | - |
Step 3) Assessment factors |
|
|
Interspecies | 4 | Assessment factor for allometric scaling in case of rat to human extrapolation. A factor for remaining differences has not been applied, because there is no indication for interspecies differences in addition to the differences covered by the default interspecies factor. |
Intraspecies | 10 | Default assessment factor |
Exposure duration | 2 | Default assessment factor for the extrapolation sub-chronic to chronic exposure |
Dose response | 1 |
|
Quality of database | 1 |
|
DNEL | Value | |
| 170 / (4 x 10 x 2 x 1 x 1) = 2.13 mg/kg bw/day |
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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