Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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EC number: 605-318-9 | CAS number: 163206-31-3
Toxicological information
Toxicological Summary
Administrative data
Workers - 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:
- DNEL (Derived No Effect Level)
- Value:
- 0.005 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 30
- Dose descriptor:
- LOAEC
- Value:
- 0.3 mg/m³
- AF for dose response relationship:
- 3
- Justification:
- Starting point for the DNEL calculation is a LOAEC. Thus, the default assessment factor for dose response relationship from LOAEL to NOAEL is 3 according to Guidance Document R.8.4.3.1 (ECHA, Nov. 2012).
- AF for differences in duration of exposure:
- 2
- Justification:
- An assessment factor 2 is suggested by Guidance Document R.8 (ECHA, Nov. 2012) for exposure duration from subchronic to chronic.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- According to the Guidance Document R.8 (ECHA, Nov. 2012) allometric scaling should not be applied if the effects are not dependent on metabolic rate or systemic absorption, e.g. in the case of local effects. In case of this substance none of the available studies (acute and short term repeated dose toxicity, Irritation/Corrosion, Sensitisation) give indications of systemic bioavailability, since no systemic toxicity (or sensitisation potential) was observed. Instead, a particle-related portal of entry toxicity as toxicological mode of action is assumed. Therefore AF 1 is chosen.
- AF for other interspecies differences:
- 1
- Justification:
- A factor of 2.5 is suggested by Guidance Document R.8 (ECHA, Nov. 2012) for remaining interspecies differences, but justified deviations are possible. The available repeated inhalation pilot study with the substance supports local particle-related portal of entry toxicity as toxicological mode of action. For local effects on the respiratory tract it should be taken into account that rodents like the rat are in general more sensitive compared to humans as the rat’s ventilation frequency is higher. In fact, the relevance of local particle-related effects seen in the lungs of animals for humans is currently not clear and is subject to continued scientific debate (cp. Guidance on the application of the CLP criteria, ECHA, Nov. 2012). However, it is not indicated that humans are more susceptible against these kinds of effects, therefore a factor of 1 is applied.
- AF for intraspecies differences:
- 5
- Justification:
- For intraspecies variability in workers the default assessment factor is 5 according to Guidance Document R.8 (ECHA, Nov. 2012)
- AF for the quality of the whole database:
- 1
- Justification:
- The default assessment factor to be applied for good/standard quality of the data base is 1.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.025 mg/m³
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
Workers - 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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - 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:
- DNEL (Derived No Effect Level)
- Value:
- 0.001 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 60
- Dose descriptor:
- LOAEC
- Value:
- 0.3 mg/m³
- AF for dose response relationship:
- 3
- Justification:
- Starting point for the DNEL calculation is a LOAEC. Thus, the default assessment factor is 3 for extrapolation of LOAEC to NOAEC according to Guidance Document R.8 (ECHA, Nov. 2012).
- AF for differences in duration of exposure:
- 2
- Justification:
- An assessment factor 2 is suggested by Guidance Document R.8 (ECHA, Nov. 2012) for exposure duration from subchronic to chronic.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- According to the Guidance Document R.8 (ECHA, Nov. 2012) allometric scaling should not be applied if the effects are not dependent on metabolic rate or systemic absorption, e.g. in the case of local effects. In case of this substance none of the available studies (acute and short term repeated dose toxicity, Irritation/Corrosion, Sensitisation) give indications of systemic bioavailability, since no systemic toxicity (or sensitisation potential) was observed. Instead, a particle-related portal of entry toxicity as toxicological mode of action is assumed. Therefore AF 1 is chosen.
- AF for other interspecies differences:
- 1
- Justification:
- A factor 2.5 is suggested by Guidance Document R.8 (ECHA, Nov. 2012) for remaining interspecies differences, but justified deviations are possible. The available repeated inhalation pilot study with the substance supports local particle-related portal of entry toxicity as toxicological mode of action. For local effects on the respiratory tract it should be taken into account that rodents like the rat are in general more sensitive compared to humans as the rat’s ventilation frequency is higher. In fact, the relevance of local particle-related effects seen in the lungs of animals for humans is currently not clear and is subject to continued scientific debate (cp. Guidance on the application of the CLP criteria, ECHA, Nov. 2012). However, it is not indicated that humans are more susceptible against these kinds of effects, therefore a factor of 1 is applied.
- AF for intraspecies differences:
- 10
- Justification:
- For intraspecies variability in the general population the default assessment factor is 10 according to Guidance Document R.8 (ECHA, Nov. 2012)
- AF for the quality of the whole database:
- 1
- Justification:
- The default assessment factor to be applied for good/standard quality of the database is 1.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.004 mg/m³
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
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
The use of the test substance is restricted only to industrial applications. A direct use of this substance is not known. The exposure of consumers to this substance is unlikely to occur via consumer products, because no consumer product is known to contain this substance. Furthermore, because there is no release into the environment, an indirect exposure of the general population via the environment does not occur.
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.
