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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 211-681-0 | CAS number: 685-63-2
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:
- 0.663 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Dose descriptor starting point:
- NOAEC
- Value:
- 99.4 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 49.95 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Default (DNEL calculator)
The correction factors applied to starting point NOAEC value account for the difference of daily exposure time in rats (6hrs/day) compared to worker shift (8 hrs/day), and of respiratory volume.
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default (DNEL calculator)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 5
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Value:
- 362 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 12.5
- Dose descriptor starting point:
- NOAEC
- Value:
- 1 800 mg/m³
- Value:
- 4 525.6 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- inhalation study
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
- AF for the quality of the whole database:
- 1
- Justification:
- Reliable study
- AF for remaining uncertainties:
- 1
- Justification:
- Default
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.325 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Dose descriptor:
- NOAEC
- Value:
- 99.4 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Default value. A concentration-dependent response was observed.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default value. Local effects were observed in repeated-dose toxicity studies (14-day and 28-day)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default value. The exposure route is inhalation.
- AF for other interspecies differences:
- 2.5
- Justification:
- Findings consisted in alterations in the nasal cavity. A greater sensitivity in rats is usually observed compared to humans because of the physiological differences in the rat nasal cavity (in particular due to the larger epithelium surface in contact with incoming airflow). Furthermore, a difference of sensitivity was observed between two rat strains. There were no findings in the nasal cavity of Wistar rats treated similarly.
However, in the absence of information related to the mechanism leading to the nasal effects in Sprague-Dawley rats and whether metabolism is involved, a default assessment factor for residual interspecies differences is applied conservatively. - AF for intraspecies differences:
- 5
- Justification:
- Default value for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Default value. Effects on the nasal cavity were documented in a dose-range finding study (14-day) and a reliable 28-day study in Sprague-Dawley rats, not in Wistar rats treated for 28 days (males) and up to 47 days (females). Therefore the point of departure is considered conservative.
- AF for remaining uncertainties:
- 1
- Justification:
- Default value.
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:
- hazard unknown but no further hazard information necessary as no exposure expected
- Value:
- 94.1 µg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Dose descriptor starting point:
- NOAEC
- Value:
- 99.4 mg/m³
- Value:
- 28.23 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Default value (DNEL calculator) by route to route extrapolation, although negligible skin exposure is expected under industrial workplace conditions.
- AF for dose response relationship:
- 1
- Justification:
- Default value (DNEL calculator)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default value (DNEL calculator)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value (DNEL calculator)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value (DNEL calculator)
- AF for intraspecies differences:
- 5
- Justification:
- Default value (DNEL calculator)
- AF for the quality of the whole database:
- 1
- Justification:
- Default value (DNEL calculator)
- AF for remaining uncertainties:
- 1
- Justification:
- Default value (DNEL calculator)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
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:
- DNEL (Derived No Effect Level)
- Value:
- 118.3 µg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Dose descriptor starting point:
- NOAEC
- Value:
- 99.4 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 17.75 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Default (DNEL calculator)
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default (DNEL calculator)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 10
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator)
- AF for remaining uncertainties:
- 1
- Justification:
- Default (DNEL calculator)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
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:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
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:
- 39.8 µg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Dose descriptor starting point:
- NOAEC
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 23.9 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default (DNEL calculator)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 10
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator)
- AF for remaining uncertainties:
- 1
- Justification:
- Default (DNEL calculator)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
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.
