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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 237-198-5 | CAS number: 13684-56-5
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.6 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):
- 12.5
- Dose descriptor starting point:
- NOAEL
- Value:
- 3.2 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 8 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The NOAEL of 3.2 mg/kg bw/d from the 2-year rat study is modified for activity (*6.7/10), breathing rate (*1/0.38), relative absorption (*80/100) and differences in exposure pattern (*7/5) to give a modified starting point (inhalation NOAEC) of 8 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- Default factor according to REACH Guidance; starting point is a NOAEL
- AF for differences in duration of exposure:
- 1
- Justification:
- Default factor according to REACH Guidance; NOAEL is from a study of chronic duration
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not required: already accounted for
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor according to REACH Guidance
- AF for intraspecies differences:
- 5
- Justification:
- Default factor according to REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- Default factor according to REACH Guidance; good quality database
- AF for remaining uncertainties:
- 1
- Justification:
- Default factor according to REACH Guidance; no remaining uncertainties
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:
- 1.1 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):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 3.2 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 56 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The starting point of 3.2 mg/kg bw/d is modified for the extent of oral and dermal absorption (*100/8) and differences in exposure pattern (*7/5) to give a modified starting point (dermal NOAEL) of 56 mg/kg bw/d.
- AF for dose response relationship:
- 1
- Justification:
- Default factor according to REACH Guidance; starting point is a NOAEL
- AF for differences in duration of exposure:
- 1
- Justification:
- Default factor according to REACH Guidance; starting point is from a study of chronic duration
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default factor according to REACH Guidance; starting point is from a rat study
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor according to REACH Guidance
- AF for intraspecies differences:
- 5
- Justification:
- Default factor according to REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- Default factor according to REACH Guidance; database is of good quality
- AF for remaining uncertainties:
- 1
- Justification:
- Default factor according to REACH Guidance; no remaining uncertainties
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.1 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):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 3.2 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 3 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The NOAEL of 3.2 mg/kg bw/d from the 2-year rat study is modified for breathing rate (*1/1.15) and relative absorption (*80/100) to give a modified starting point (inhalation NOAEC) of 3 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- Default factor according to REACH Guidance; starting point is a NOAEL
- AF for differences in duration of exposure:
- 1
- Justification:
- Default factor according to REACH Guidance; NOAEL is from a study of chronic duration
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not required: already accounted for
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor according to REACH Guidance
- AF for intraspecies differences:
- 10
- Justification:
- Default factor according to REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- Default factor according to REACH Guidance; good quality database
- AF for remaining uncertainties:
- 1
- Justification:
- Default factor according to REACH Guidance; no remaining uncertainties
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:
- 0.4 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:
- 3.2 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 40 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The starting point of 3.2 mg/kg bw/d is modified for the extent of oral and dermal absorption (*100/8)
to give a modified starting point (dermal NOAEL) of 40 mg/kg bw/d.- AF for dose response relationship:
- 1
- Justification:
- Default factor according to REACH Guidance; starting point is a NOAEL
- AF for differences in duration of exposure:
- 1
- Justification:
- Default factor according to REACH Guidance; starting point is from a study of chronic duration
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default factor according to REACH Guidance; starting point is from a rat study
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor according to REACH Guidance
- AF for intraspecies differences:
- 10
- Justification:
- Default factor according to REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- Default factor according to REACH Guidance; database is of good quality
- AF for remaining uncertainties:
- 1
- Justification:
- Default factor according to REACH Guidance; no remaining uncertainties
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:
- 0.03 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:
- 3.2 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Not required: the starting point is derived from an oral study
- AF for dose response relationship:
- 1
- Justification:
- Default factor according to REACH Guidance; starting point is a NOAEL
- AF for differences in duration of exposure:
- 1
- Justification:
- Default factor according to REACH Guidance; starting point is from a study of chronic duration
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default factor according to REACH Guidance; starting point is from a rat study
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor according to REACH Guidance
- AF for intraspecies differences:
- 10
- Justification:
- Default factor according to REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- Default factor according to REACH Guidance; database is of good quality
- AF for remaining uncertainties:
- 1
- Justification:
- Default factor according to REACH Guidance; 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
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.
