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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 209-136-7 | CAS number: 556-67-2
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 73 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):
- 12.5
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 915 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The following correction was made to the NOAEC (inhalation): Correction for experimental exposure duration (6 h/d to 8 h/d): 0.75. Correction for respiratory volume (worker): 6.7m3/10m3. Therefore, the corrected NOAEC for repeated-dose systemic effects via the inhalation route is: 1820 mg/m3*(6 h/8 h)*(6.7 m3/10 m3) = 915 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 1
- Justification:
- Default (chronic study)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (inhalation rat to inhalation human)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 5
- Justification:
- Default
- AF for the quality of the whole database:
- 1
- Justification:
- Default
- AF for remaining uncertainties:
- 1
- Justification:
- Default (no remaining uncertainties)
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:
- 73 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 12.5
- Dose descriptor:
- NOAEC
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 1
- Justification:
- Default (chronic study)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (inhalation rat to inhalation human)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 5
- Justification:
- Default
- AF for the quality of the whole database:
- 1
- Justification:
- Default
- AF for remaining uncertainties:
- 1
- Justification:
- Default (no remaining uncertainties)
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:
- 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
The DNELs used for risk characterisation for workers are therefore:
DNEL (long-term, inhalation): 73 mg/m3
DNEL (long-term, dermal): Not calculated as dermal absorption is <1% and no hazard has been identified in dermal studies.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 13 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):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 325 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The following correction was made to the NOAEC (inhalation): Correction for experimental exposure duration (6 h/d to 24 h/d). Correction for dosing frequency (5 days/7 days). Therefore, the corrected NOAEC for repeated-dose systemic effects via the inhalation route is: 1820 mg/m3*(6 h/24 h)*(5/7) = 325 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 1
- Justification:
- Default (chronic study)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (inhalation rat to inhalation human)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 10
- Justification:
- Default
- AF for the quality of the whole database:
- 1
- Justification:
- Default
- AF for remaining uncertainties:
- 1
- Justification:
- Default (no remaining uncertainties)
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:
- 13 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor:
- NOAEC
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 1
- Justification:
- Default (chronic study)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (inhalation rat to inhalation human)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 10
- Justification:
- Default
- AF for the quality of the whole database:
- 1
- Justification:
- Default
- AF for remaining uncertainties:
- 1
- Justification:
- Default (no remaining uncertainties)
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:
- 3.7 mg/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):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 373.75 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The DNEL for systemic effects via the oral route is determined on the basis of route-to-route extrapolation from the inhalation combined chronic toxicity and carcinogenicity study conducted using a protocol comparable to OECD test guideline 453. The following correction was made to the NOAEC (inhaled): Correction for dosing frequency: 5 days/7 days. Correction for respiratory volume rat (24 hour): 1.15 m3/kg bw. Therefore, the corrected NOAEL for repeated dose systemic effects via the oral route is: 1820 mg/m3*(1.15 m3/kg)*5/7 = 373.75 mg/kg bw/day.
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 1
- Justification:
- Default (chronic study)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (inhalation rat to oral human)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 10
- Justification:
- Default
- AF for the quality of the whole database:
- 1
- Justification:
- Default
- AF for remaining uncertainties:
- 1
- Justification:
- Default (no remaining uncertainties)
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
Repeated dose toxicity is the critical systemic endpoints for workers and consumers. In both cases however, respiratory tract irritation following repeated exposures gives the lowest DNELs, so this is the overall critical endpoint for risk characterisation. D4 is not classified as mutagenic, carcinogenic or sensitising.
The DNELs used for risk characterisation for consumers are therefore:
DNEL (long-term, oral): 3.7 mg/kg/day
DNEL (long-term, inhalation): 13 mg/m3
DNEL (long-term, dermal): Not calculated as dermal absorption is <1% and no hazard has been identified in dermal studies.
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.
