Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 200-300-3 | CAS number: 56-93-9
- 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
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:
- 0.88 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
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 22.04 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Long term inhalation studies are not available. The long term systemic inhalation DNEL has been derived from the oral 90 d Repeated Dose Toxicity Study. For derivation of the dose descriptor starting point a factor of 2 has been included for route-to-route extrapolation from oral to inhalative.
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA AF for NOAEL used as starting point. The original NOAEL is reliable. No adjustment is required.
- AF for differences in duration of exposure:
- 2
- Justification:
- ECHA default - see guidance.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- default corrections for respiratory rate and respiratory volume have been included in route-to-route extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default - see guidance.
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default - see guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- The available studies were conducted according to modern regulatory standards and were adequately reported. On this basis the quality of the database is not considered to contribute to uncertainty and it is therefore not necessary to apply an additional factor.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.75 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 22.04 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- An acute toxicity hazard leading to a classification according to CLP Regulation (EC) No 1272/2008 acute toxicity Category 4 for the inhalation route has been identified. However, a reliable dose descriptor for acute systemic effects could not be derived from the available inhalation study. Considering high peak exposure the DNEL for acute toxicity was set for a reference period of 15 minutes at twice the value of the long-term DNEL.
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.25 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):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 25 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Long term dermal studies are not available. The long term systemic dermal DNEL has been derived from the oral 90 d Repeated Dose Toxicity Study.
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA AF for NOAEL used as starting point. The original NOAEL is reliable. No adjustment is required.
- AF for differences in duration of exposure:
- 2
- Justification:
- ECHA default - see guidance.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default - see guidance.
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default - see guidance.
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default - see guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- The available studies were conducted according to modern regulatory standards and were adequately reported. On this basis the quality of the database is not considered to contribute to uncertainty and it is therefore not necessary to apply an additional factor.
- AF for remaining uncertainties:
- 1
- Justification:
- The available studies were conducted according to modern regulatory standards and were adequately reported. On this basis the quality of the database is not considered to contribute to uncertainty and it is therefore not necessary to apply an additional factor.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 25 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- An acute toxicity hazard leading to a classification according to CLP Regulation (EC) No1272/2008 acute toxicity Category 3 for the dermal route has been identified. However, a reliable dose descriptor for acute systemic effects could not be derived from the available dermal studies. Considering high peak exposure the DNEL for acute toxicity was set for a reference period of 15 minutes at twice the value of the long-term DNEL.
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - workers
General considerations
Short-term data
Data on acute toxicity are available for the oral, inhalation and dermal route. BTMAC is classified for acute oral and dermal toxicity Hazard Category 3 as well as inhalation toxicity Hazard Category 4.
BTMAC is not classified for skin or eye irritation, nor for skin sensitization.
Long-term data
Data relevant for long-term toxicity are available from an oral sub-chronic toxicity study and a developmental toxicity study, both in rats.
Selection of the relevant dose descriptors:
NOAEL = 25 mg/kg bw/day: 90 d Repeated Dose Toxicity Study, rat, oral (gavage)
NOAEL = 20 mg/kg bw/d: Prenatal Developmental Toxicity Test, rat, oral (gavage)
Hazard for the eyes
An additional hazard was listed for acute eye effects, since 3 of 6 animals in the acute eye irritation study died after dosing, even though no eye irritation was observed.
Modification of the relevant dose descriptors to the correct starting point:
Oral absorption
No data exist on differences in bioavailability following oral or dermal exposure between experimental animals and humans, and a similar bioavailability is assumed by default.
Oral to inhalatory
For inhalatory exposure as a worst case assumption a 100% absorption is assumed in absence of any experimental data (Guidance on Information Requirements and Chemical Safety Assessment, R8).
Extrapolation oral to inhalation: AF 2
Oral to dermal
For chemical safety assessment a dermal absorption rate of 100% is assumed as a worst case value (Guidance on Information Requirements and Chemical Safety Assessment, R8).
DERIVATION OF DNELs
DNELs long term systemic effects
Uncertainties
|
AF
|
Justification
|
Allometric scaling (inhalation)
|
1 |
No allometric scaling rat to humans for inhalation - differences in respiratory volume are already included in route-to-route extrapolation (ECHA 2008).
|
Allometric scaling (dermal)
|
4 |
Allometric scaling rat to humans AF 4 (ECHA 2008).
|
Remaining interspecies differences
|
2.5 |
Default AF for remaining interspecies differences
|
Intraspecies differences
|
5 |
Default AF for workers
|
Differences in duration of exposure (90 d repeated dose toxicity study)
|
2 |
Default assessment factor for extrapolation from subchronic to chronic
|
Differences in duration of exposure (prenatal developmental toxicity study) |
1 |
No time extrapolation is required since the susceptible window is fully covered. |
Dose response and endpoint specific/severity
|
1 |
The NOAELs are reliable. No adjustment is required.
|
Quality of whole database
|
1 |
The studies were conducted according to modern regulatory standards and were adequately reported. On this basis the quality of the database is not considered to contribute uncertainty and it is therefore not necessary to apply an additional factor. |
Remaining uncertainties
|
1 |
No uncertainties remain. |
DNELs derived from oral repeated dose toxicity NOAEL (90-d study, rat, OECD Guideline 408)
Worker-DNEL long-term for dermal route (systemic): 0.25 mg/kg bw/d
Start value: 25 mg/kg bw/d
Route of original study: oral
Dose descriptor starting point after route-to-route extrapolation: 25 mg/kg bw/d
Overall AF 4*2.5*5*2*1*1*1 = 100
Worker-DNEL long-term for inhalation route (systemic): 0.88 mg/m³
Start value: 25 mg/kg bw/d
Route of original study: oral
Dose descriptor starting point after route-to-route extrapolation: 22.04 mg/m³
For workers the corrected inhalatory NOEC is calculated according to the following equation:
corrected inhalatory NOAEC = oral NOAEL x 1/sRVratx ABSoral-rat/ ABSinh-humanx sRVhuman/ wRV
= 25 x 1/0.38 x 50/100 x 6.7/10
The corrected inhalatory NOAECworker (8h) is therefore:
= 22.04 mg/m³ (8h-TWA)
Overall AF: 1*2.5*5*2*1*1*1 = 25
This DNEL does not address the potential for local irritation. The risk characterisation will consider whether specific risk management measures are necessary to protect against local effects.
DNELs derived from oral prenatal developmental toxicity NOAEL (rat, OECD Guideline 414)
Worker-DNEL long-term for dermal route (systemic): 0.4 mg/kg bw/d
Start value: 20 mg/kg bw/d
Route of original study: oral
Dose descriptor starting point after route-to-route extrapolation: 20 mg/kg bw/d
Overall AF 4*2.5*5*1*1*1*1 = 50
Worker-DNEL long-term for inhalation route (systemic): 1.41 mg/m³
Start value: 20 mg/kg bw/d
Route of original study: oral
Dose descriptor starting point after route-to-route extrapolation: 17.63 mg/m³
For workers the corrected inhalatory NOEC is calculated according to the following equation:
corrected inhalatory NOAEC = oral NOAEL x 1/sRVratx ABSoral-rat/ ABSinh-humanx sRVhuman/ wRV
= 20 x 1/0.38 x 50/100 x 6.7/10
The corrected inhalatory NOAECworker (8h) is therefore:
= 17.63 mg/m³ (8h-TWA)
Overall AF: 1*2.5*5*1*1*1*1 = 12.5
This DNEL does not address the potential for local irritation. The risk characterisation will consider whether specific risk management measures are necessary to protect against local effects.
The DNELs for developmental toxicity were higher than those for repeated dose toxicity. Thus, the repeated dose toxicity-DNELs are also protective for development.
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 DNEL derived for general population, as no consumer exposure is anticipated. Substance is used as a catalyst only in industrial settings.
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.