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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 248-580-6 | CAS number: 27619-97-2
Toxicological information
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.08 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 15 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor is a NOAEL from an OECD 422 oral gavage study in rats. An assessment factor of 1 is appropriate per REACH guidance R.8.4.3.1.
- AF for differences in duration of exposure:
- 2
- Justification:
- The observed adverse outcomes in an OECD 422 were adverse effects resulting from systemic exposure. There is no longer term exposure data to predict effects with chronic expsoure. Accordingly, a default assessment factor of 2 is utlized for study duration adjustment per REACH guidance R8.4.3.2.1.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- This factor is included in the convertion of the oral dose to inhalation dose above.
- AF for other interspecies differences:
- 2.5
- Justification:
- The histopathological effects produced by the test substance are indicative of systemic toxicity. Since toxicodynamic interactions related to systemic toxicity are not understood, an assessment factor of 2.5 is appropriate for remaining interspecies differences per REACH guidance R.8.4.3.1.
- AF for intraspecies differences:
- 5
- Justification:
- The substance is not metabolized by mammals, so there can be no metabolic differences between species. Any kinetic differences would be related to clearance rates, most likely the glomular filtration rate. The default factor of 5 for workers is appropriate according to REACH guidance in R.8.4.3.1.
- AF for the quality of the whole database:
- 1
- Justification:
- A robust database exists for the substance . An assessment factor of 1 is appropriate per REACH guidance R.8.4.3.1.
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
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.15 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 15 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 15 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Assume 100% bioavailability (i.e., no adjustment). No adjustment for study duration since the rats were dosed daily.
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor is a NOAEL from an OECD 422 oral gavage study in rats. An assessment factor of 1 is appropriate per REACH guidance R.8.4.3.1.
- AF for differences in duration of exposure:
- 2
- Justification:
- The observed adverse outcomes in an OECD 422 were adverse effects resulting from systemic exposure. There is no longer term exposure data to predict effects with chronic exposure. Accordingly, a default assessment factor of 2 is utilized for study duration adjustment per REACH guidance R8.4.3.2.1.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- A default assessment factor of 4 is applied per REACH guidance R.8.4.3.1 since mode of action for the systemic effects is not known. A default value of 4 is used.
- AF for other interspecies differences:
- 2.5
- Justification:
- The histopathological effects produced by the test substance are indicative of systemic toxicity. Since toxicodynamic interactions related to systemic toxicity are not understood, an assessment factor of 2.5 is appropriate for remaining interspecies differences per REACH guidance R.8.4.3.1.
- AF for intraspecies differences:
- 5
- Justification:
- The substance is not metabolized by mammals, so there can be no metabolic differences between species. Any kinetic differences would be related to clearance rates, most likely the glomular filtration rate. The default factor of 5 for workers is appropriate according to REACH guidance in R.8.4.3.1.
- AF for the quality of the whole database:
- 1
- Justification:
- A robust database exists for the substance . An assessment factor of 1 is appropriate per REACH guidance R.8.4.3.1.
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
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:
- 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:
- 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:
- DNEL (Derived No Effect Level)
- Value:
- 0.075 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 15 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor is a NOAEL from an OECD 422 oral gavage study in rats. An assessment factor of 1 is appropriate per REACH guidance R.8.4.3.1.
- AF for differences in duration of exposure:
- 2
- Justification:
- The observed adverse outcomes in an OECD 422 were adverse effects resulting from systemic exposure. There is no longer term exposure data to predict effects with chronic expsoure. Accordingly, a default assessment factor of 2 is utlized for study duration adjustment per REACH guidance R8.4.3.2.1.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- A default assessment factor of 4 is applied per REACH guidance R.8.4.3.1 since mode of action for the systemic effects is not known. A default value of 4 is used.
- AF for other interspecies differences:
- 2.5
- Justification:
- The clinical chemical and histopathological effects produced by the test substance are indicative of systemic toxicity. Since toxicodynamic interactions related to systemic toxicity are not understood, an assessment factor of 2.5 is appropriate for remaining interspecies differences per REACH guidance R.8.4.3.1.
- AF for intraspecies differences:
- 10
- Justification:
- The substance is not metabolized by mammals, so there can be no metabolic differences between species. Any kinetic differences would be related to clearance rates, most likely the glomular filtration rate. The default factor of 10 for general population is appropriate according to REACH guidance in R.8.4.3.1.
- AF for the quality of the whole database:
- 1
- Justification:
- A robust database exists for the substance . An assessment factor of 1 is appropriate per REACH guidance R.8.4.3.1.
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
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.
