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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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: 287-820-4 | CAS number: 85586-18-1
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.52 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 528.6 mg/m³
- Explanation for the modification of the dose descriptor starting point:
No indication that route to route extrapolation is not a valid approach for this substance.
- AF for dose response relationship:
- 1
- Justification:
- ECHA Default
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA Default subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling already considered in dose descriptor conversion (route to route extrapolation)
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default for worker expsoure
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA Default
- AF for remaining uncertainties:
- 2
- Justification:
- route to route extrapolation
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:
- 1 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No indication that route to route extrapolation is not a valid approach for this substance. For the purposes of this chemical safety assessment, the dermal BMDL10 long-term is considered to be equivalent to the systemic BMDL of 100 mg/kg/day (i. e. 100 % dermal adsorption is assumed).
- AF for dose response relationship:
- 1
- Justification:
- ECHA Default
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA Default subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA Default for rat
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default for worker expsoure
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA default
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA default
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high 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:
- no hazard identified
Additional information - workers
Oral to Inhalation Dose Descriptor Correction - NOAEC Long-term Systemic
Route-to-route extrapolation of the 28-day repeated dose toxicity study NOAEL via the oral route, to the inhalation route, was conducted in accordance with ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8).
The route to route extrapolation from rat oral toxicity dose to rat inhalation toxicity dose of 1/2 was not accounted for in the above equation, but applied as an assessment factor as remaining uncertainties.
Inhalatory NOAEClong-term= Systemic NOAELlong-termx (1/sRVrat) x (sRVhuman/wRV)
| Symbol | Parameter | Value/Reference |
| Input | ||
| Systemic NOAELlong-term | Oral system NOAEL from 28-day repeat dose rat test | 300 mg/kg bw/day |
| sRVrat | standard Respiratory Volume - rat | 0.38 m3/kg/day |
| sRVhuman | standard Respiratory Volume - human | 6.7 m3 |
| wRV | worker Respiratory Volume | 10 m3 |
| Output | ||
| Inhalatory NOAEClong-term | Inhalatory NOAEClong-termestimate | 528.6 mg/m3 |
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.87 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):
- 300
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 260.87 mg/m³
- Explanation for the modification of the dose descriptor starting point:
No indication that route to route extrapolation is not a valid approach for this substance.
- AF for dose response relationship:
- 1
- Justification:
- ECHA default
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA default subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling already considered in dose descriptor conversion (route to route extrapolation)
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default for remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default for general public
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA default
- AF for remaining uncertainties:
- 2
- Justification:
- route to route extrapolation
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:
- 0.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No indication that route to route extrapolation is not a valid approach for this substance.
- AF for dose response relationship:
- 1
- Justification:
- ECHA default
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA default subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default for rats
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default for remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default for general public
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA default
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA default
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high 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:
- 0.29 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No indication that route to route extrapolation is not a valid approach for this substance.
- AF for dose response relationship:
- 1
- Justification:
- ECHA default
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA default subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default for rats
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default for remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default for general public
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA default
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA default
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
Oral to Inhalation Dose Descriptor Correction - NOAEC Long-term Systemic
Route-to-route extrapolation of the 28-day repeated dose toxicity study NOAEL via the oral route, to the inhalation route, was conducted in accordance with ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8).
Inhalatory NOAEClong-term= Systemic NOAELlong-termx (1/sRVrat)
The route to route extrapolation from rat oral toxicity dose to rat inhalation toxicity dose of 1/2 was not accounted for in the above equation, but applied as an assessment factor as remaining uncertainties.
| Symbol | Parameter | Value/Reference |
| Input | ||
| Systemic NOAELlong-term | Oral system NOAEL from 28-day repeat dose rat test | 300 mg/kg bw/day |
| sRVrat | standard Respiratory Volume - rat | 1.15 m3/kg/day |
| Output | ||
| Inhalatory NOAEClong-term | Inhalatory NOAEClong-termestimate | 260.87 mg/m3 |
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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