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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 217-533-1 | CAS number: 1879-09-0
- 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:
- 0.14 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 10.58 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Modification of the dose descriptors is necessary, because the routes of exposure are different between animals (oral) and humans (inhalation). For this purpose the default respiratory volume for the rat corresponding to the daily duration of human exposure is considered in the first step, followed by a correction for the difference between respiratory rates of workers under standard conditions and under light activity in the second step. NAECcorr_inh = oral NOAEL (6 x 1/0.38 m3/kg bw x 6.7 m3/10 m3 = 10.58 mg/m3. Oral absorption in rats is assumed to be 100%, based on the toxicokinetic evaluation. For the purposes of risk assessment, absorption in humans is also taken as 100%. Therefore, NAECcorr_inh = 70.5 x 100/100 = 10.58 mg/m3.
- Justification:
- Default assessment factor when the starting point for the DNEL calculation is a NOAEC (Chapter R.8: Characterisation of dose [concentration]-response for human health)
- Justification:
- Default assessment factor for extrapolation from subacute to chronic
- Justification:
- No allometric scaling required for inhalation route.
- Justification:
- Default assessment factor
- Justification:
- Default assessment factor of 5 for workers
- Justification:
- Default assessment factor for good/standard quality of database (Chapter R.8: Characterisation of dose [concentration]-response for human health)
- Justification:
- It is considered that there are sufficient safety factors built into the extrapolations utilised to justify omission of this “uncertain” assessment factor.
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
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:
- 0.02 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 6 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No data on skin absorption is available. The substance is considered to be dermally toxic and a skin irritant on the basis of the results noted in rabbits. Rats are largely unaffected by the substance, whereas rabbits demonstrate a toxic response to the substance when applied dermally. The studies carry no definitive explanation of this difference of toxicity observed, and it is concluded that this is a species specific effect. Assessment of the literature, specifically: Skin Permeability In Vivo: Comparison in Rat, Rabbit, Pig and Man; Journal of Investigative Dermatology (1972) 58, 114–123; doi:10.1111/1523-1747.ep12538909 Accepted 26 October 1971. This paper details that in a comparative percutaneous absorption study undertaken in rats, rabbits, miniature swine and man, the results obtained indicated that skin permeability decreases in the following order: rabbit, rat, pig and man. It may be therefore that the permeability of rabbit skin is much greater for the substance than it is in the rat, and the toxic response is proliferated by rabbit skin to a greater extent. As a worst case, assume that oral absorption in rats is 100% and dermal absorption in humans is considered to be 100%. Therefore dose descriptor after route to route extrapolation is 6 x 100/100 = 6 mg/kg bw/day. This is considered to give an appropriate assessment factor for long term exposure. In practise, exposure would be precluded by the acute dermal toxicity labelling of the substance.
- Justification:
- Default assessment factor when the starting point for the DNEL calculation is a NOAEL (Chapter R.8: Characterisation of dose [concentration]-response for human health)
- Justification:
- Default assessment factor for extrapolation from subacute to chronic
- Justification:
- Allometric scaling factor for rat = 4
- Justification:
- Default assessment factor
- Justification:
- Default assessment factor of 5 for workers
- Justification:
- Default assessment factor for good/standard quality of database (Chapter R.8: Characterisation of dose [concentration]-response for human health)
- Justification:
- It is considered that there are sufficient safety factors built into the extrapolations utilised to justify omission of this “uncertain” assessment factor.
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
On the basis of the results noted in the rabbit studies, classification under the CLP Regulation (EC No 1272/2008 is as follows:
Acute toxicity, Category 1
H310: Fatal in contact with skin
No data on skin absorption is available. The substance is considered to be dermally toxic and a skin irritant on the basis of the results noted in rabbits.Rats are largely unaffected by the substance, whereas rabbits demonstrate a toxic response to the substance when applied dermally. The studies carry no definitive explanation of this difference of toxicity observed, and it is concluded that this is a species specific effect.
Assessment of the literature, specifically:
Skin Permeability In Vivo: Comparison in Rat, Rabbit, Pig and Man;Journal of Investigative Dermatology(1972)58, 114–123; doi:10.1111/1523-1747.ep12538909 Accepted 26 October 1971.
This paper details that in a comparative percutaneous absorption study undertaken in rats, rabbits, miniature swine and man, the results obtained indicated that skin permeability decreases in the following order: rabbit, rat, pig and man. It may be therefore that the permeability of rabbit skin is much greater for the substance than it is in the rat, and the toxic response is proliferated by rabbit skin to a greater extent.
There is a repeated dose oral toxicity study available for the substance itself (K1) study . A NOAEL of 6 mg/kg bw/day was established in this study and was selected as starting point for deriving the long-term systemic inhalation DNEL and the long-term systemic dermal DNEL on the basis of being the lowest dose. Long-term local DNELs (inhalation and dermal) were not derived as it is considered that the derivation from long term systemic effects provides a suitable margin of safety for use. Acute toxicity DNEL’s were not derived. Chapter R.8: Characterisation of dose [concentration]-response for human health, APPENDIX R. 8-8 Acute toxicity states that if an acute toxicity hazard (leading to C&L) has been identified, a DNEL for acute toxicity is only established for the effects of peak exposures if these peaks could be significantly higher than the average daily exposure and the long-term DNEL is insufficient to limit them. As high peak exposures are not anticipated during the use of the substance, no derivation of a DNEL is required. The long term DNEL is considered appropriate to address this species specific risk.
In practice, occupational protection for workers does not allow a direct exposure of workers to the test item at a concentration causing irritation, due to PPE as standard in the workplace. The RMMs installed to protect workers are sufficient to prevent any hazard from local dermal exposure. It is considered that the derivation from long term systemic effects provides a suitable margin of safety for use.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.035 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 5.22 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Modification of the dose descriptors is necessary, because the routes of exposure are different between animals (oral) and humans (inhalation). For this purpose, the oral dose for the rat is converted to the corresponding air concentration using a standard breathing volume for the rat (1.15 m3/kg for 24 hrs exposure of general public). NAECcorr_inh = oral NOAEL (6) x 1/1.15 m3/kg bw = 5.22 mg/m3. Oral absorption in rats is assumed to be 100%, based on the toxicokinetic evaluation. For the purposes of risk assessment, absorption in humans is also taken as 100% Therefore, NAECcorr_inh = 5.22 x 100/100 = 5.22 mg/m3.
- Justification:
- Default assessment factor when the starting point for the DNEL calculation is a NOAEC (Chapter R.8: Characterisation of dose [concentration]-response for human health)
- Justification:
- Default assessment factor for extrapolation from subacute to chronic
- Justification:
- No allometric scaling required for inhalation route.
- Justification:
- Default assessment factor
- Justification:
- Default assessment factor of 10 for general population
- Justification:
- Default assessment factor for good/standard quality of database (Chapter R.8: Characterisation of dose [concentration]-response for human health)
- Justification:
- It is considered that there is sufficient safety factors built into the extrapolations utilised to justify omission of this “uncertain” assessment factor.
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
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
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.01 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 6 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
As worst case, assume that oral absorption in rats is 100% and dermal absorption in humans is 100%. Therefore dose descriptor after route to route extrapolation is 6 x 100/100 = 6 mg/kg bw/day.
- Justification:
- Default assessment factor when the starting point for the DNEL calculation is a NOAEL (Chapter R.8: Characterisation of dose [concentration]-response for human health)
- Justification:
- Default assessment factor for extrapolation from subacute to chronic
- Justification:
- Allometric scaling factor for rat = 4
- Justification:
- Default assessment factor
- Justification:
- Default assessment factor for general population
- Justification:
- Default assessment factor for good/standard quality of database (Chapter R.8: Characterisation of dose [concentration]-response for human health)
- Justification:
- It is considered that there are sufficient safety factors built into the extrapolations utilised to justify omission of this “uncertain” assessment factor.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Dermal to Dermal
- Justification:
- Default assessment factor when the starting point for the DNEL calculation is a NOAEC (Chapter R.8: Characterisation of dose [concentration]-response for human health)
- Justification:
- Not applied for dermal; see below
- Justification:
- Default assessment factor
- Justification:
- Default assessment factor of 10 for the general public
- Justification:
- Default assessment factor
- Justification:
- It is considered that there are sufficient safety factors built into the extrapolations utilised to justify omission of this “uncertain” assessment factor.
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.01 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 6 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Not required
- Justification:
- Default assessment factor when the starting point for the DNEL calculation is a NOAEC
- Justification:
- Default assessment factor for extrapolation from subacute to chronic
- Justification:
- Factor for allometric scaling for rat
- Justification:
- Default assessment factor
- Justification:
- Default assessment factor for general population
- Justification:
- Default assessment factor for good/standard quality of database (Chapter R.8: Characterisation of dose [concentration]-response for human health)
- Justification:
- It is considered that there is sufficient safety factors built into the extrapolations utilised to justify omission of this “uncertain” assessment factor
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 36.4 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 910 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Due to the nature of use of the products that contain the substance by consumers, it is considered appropriate to utilise an acute DNEL in place of the longer-term DNEL’s. The justification for this is that the products containing the substance would only be used sporadically, and as such would need to be assessed on these terms. Guidance R8 Appendix 8.8 details that if an acute toxicity hazard (leading to C&L) has been identified, a DNEL for acute toxicity can be established for the effects of peak exposures as these peaks can be significantly higher than the average daily exposure and the long-term DNEL may be insufficient to limit them. High peak exposures are usually assessed for the inhalation route only, however, on a case-by-case basis an ‘acute’ dermal or oral DNEL can be set for comparison with single exposure events. On the basis of the proposed dermal toxicity, assessment is performed for dermal exposure on a sporadic basis; comparison to acute DNEL’s is considered to be appropriate. A starting NAEC of 910 mg/kg is assumed as a worst case, as the data set provides for oral absorption in rats is assumed to be 100% and oral absorption in humans is assumed to be 100%. Therefore, NAECcorr_oral = 910 x 100/100 = 910 mg/kg.
- Justification:
- Default assessment factor when the starting point for the DNEL calculation is a NOAEC (Chapter R.8: Characterisation of dose [concentration]-response for human health)
- Justification:
- Not applied for oral; see below
- Justification:
- Default assessment factor
- Justification:
- Default assessment factor of 10 for the general public
- Justification:
- Default assessment factor
- Justification:
- It is considered that there are sufficient safety factors built into the extrapolations utilised to justify omission of this “uncertain” assessment factor.
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
On the basis of the results noted in the rabbit studies, classification under the CLP Regulation (EC No 1272/2008 is as follows:
Acute toxicity, Category 1
H310: Fatal in contact with skin
No data on skin absorption is available. The substance is considered to be dermally toxic and a skin irritant on the basis of the results noted in rabbits.Rats are largely unaffected by the substance, whereas rabbits demonstrate a toxic response to the substance when applied dermally. The studies carry no definitive explanation of this difference of toxicity observed, and it is concluded that this is a species specific effect.
Assessment of the literature, specifically:
Skin PermeabilityIn Vivo: Comparison in Rat, Rabbit, Pig and Man;Journal of Investigative Dermatology(1972)58, 114–123; doi:10.1111/1523-1747.ep12538909 Accepted 26 October 1971.
This paper details that in a comparative percutaneous absorption study undertaken in rats, rabbits, miniature swine and man, the results obtained indicated that skin permeability decreases in the following order: rabbit, rat, pig and man. It may be therefore that the permeability of rabbit skin is much greater for the substance than it is in the rat, and the toxic response is proliferated by rabbit skin to a greater extent.
There is a repeated dose oral toxicity study available for the substance itself (K1) study . A NOAEL of 6 mg/kg bw/day was established in this study and was selected as starting point for deriving the long-term systemic inhalation DNEL and the long-term systemic dermal DNEL on the basis of being the lowest dose. Long-term local DNELs (inhalation and dermal) were not derived as it is considered that the derivation from long term systemic effects provides a suitable margin of safety for use.
Due to the nature of use of the products that contain the substance by consumers, it is considered appropriate to utilise an acute DNEL in place of the longer-term DNEL’s. The justification for this is that the products containing the substance would only be used sporadically, and as such would need to be assessed on these terms.
Guidance R8 Appendix 8.8 details thatif an acute toxicity hazard (leading to C&L) has been identified, a DNEL for acute toxicity can be established for the effects of peak exposures as these peaks can be significantly higher than the average daily exposure and the long-term DNEL may be insufficient to limit them. High peak exposures are usually assessed for the inhalation route only, however, on a case-by-case basis an ‘acute’ dermal or oral DNEL can be set for comparison with single exposure events.
On the basis of the proposed dermal toxicity, assessment is performed for dermal exposure on a sporadic basis; comparison to acute DNEL’s is considered to be appropriate.
In practice, given the nature of use of the substance, it is unlikely that long term exposure to the substance by the general population is anticipated.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)