Registration Dossier
Registration Dossier
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EC number: 204-688-5 | CAS number: 124-19-6
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 24.9 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):
- 50
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 242.8 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- no inhalatory study available - Oral readacross study used for route to route extrapolation
- AF for dose response relationship:
- 1
- Justification:
- corrected NOEC
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic default
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- route-route concentration no AS applied
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 5
- Justification:
- Worker – default
- AF for the quality of the whole database:
- 2
- Justification:
- read across
- AF for remaining uncertainties:
- 1
- Justification:
- none known
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:
- 7 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 409.7 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- no dermal study available - Oral read across study used for route to route extrapolation
- AF for dose response relationship:
- 1
- Justification:
- NOEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic to chronic default
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default - rat
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 5
- Justification:
- Worker – default
- AF for the quality of the whole database:
- 2
- Justification:
- due to read across starting point
- AF for remaining uncertainties:
- 1
- Justification:
- none known
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 systemic inhalatory NOEC calculated as described in guidance R.8 example B.3 assuming 50% and 100% absorption via oral and inhalatory routes respectively. The above factors were used to calculate a DNEL of 24.9 mg/m3.
Long term systemic dermal NOEL calculated as described in guidance R.8 example B.5 assuming 50% and 50% absorption via oral and dermal routes respectively. The above factors were used to calculate a DNEL of 7.0 mg/m3.
The material is not classified for acute systemic effects, therefore derivation of acute DNEL is not required. Long term DNELs are considered sufficient to ensure acute effects do not occur.
No local effects were observed, therefore no Local DNEL was derived.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 6.1 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):
- 100
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 612.9 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- no inhalatory study available - Oral read across study used for route to route extrapolation
- AF for dose response relationship:
- 1
- Justification:
- NOEC
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- route-route concentration AF not required
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 10
- Justification:
- General Population - default
- AF for the quality of the whole database:
- 2
- Justification:
- due to read across starting point
- AF for remaining uncertainties:
- 1
- Justification:
- none known
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:
- DNEL (Derived No Effect Level)
- Value:
- 3.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 400
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 409.7 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- no dermal study available - Oral read across study used for route to route extrapolation
- AF for dose response relationship:
- 1
- Justification:
- NOEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic to chronic default
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- AS rat default
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 10
- Justification:
- General Population - default
- AF for the quality of the whole database:
- 2
- Justification:
- due to read across starting point
- AF for remaining uncertainties:
- 1
- Justification:
- none known
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:
- 3.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 400
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 409.7 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- not required - oral 90d study
- AF for dose response relationship:
- 1
- Justification:
- NOEL
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic default
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default AS rat
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 10
- Justification:
- general population default
- AF for the quality of the whole database:
- 2
- Justification:
- read across
- AF for remaining uncertainties:
- 1
- Justification:
- none known
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
Long term systemic inhalatory NOEC calculated as described in guidance R.8 example B.3 assuming 50% and 100% absorption via oral and inhalatory routes respectively. The above factors were used to calculate a DNEL of 6.1 mg/m3.
Long term systemic dermal NOEL calculated as described in guidance R.8 example B.5 assuming 50% and 50% absorption via oral and dermal routes respectively. The above factors were used to calculate a DNEL of 3.5 mg/m3.
Long term systemic oral NOEL provided by 90d read across study. The above factors were used to calculate a DNEL of 3.5 mg/m3.
No local effects were observed, therefore no Local DNEL was derived.
The material is not classified for acute systemic effects, therefore derivation of acute DNEL is not required. Long term DNELs are considered sufficient to ensure acute effects do 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.
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