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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 238-098-4 | CAS number: 14228-73-0
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:
- 3.52 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):
- 75
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 264 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Starting NOAEL = 300 mg/kg bw/day. Converted to Dose descriptor starting point according to ECHA guidance (practical guide 14). 300/0.38 x 0.67x0.5 = 264 mg/m3 ; It is assumed that the oral absorption rate is 50% of that of the inhalation absorption.
- AF for dose response relationship:
- 1
- Justification:
- Toxicological findings showed a clear dose response with minimal to slight severity up to the highest dose in the key study
- AF for differences in duration of exposure:
- 6
- Justification:
- Subcute study used as the starting point.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not required due to route to route extrapolation method
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default
- 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:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
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
- Route of original study:
- Oral
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:
- Starting NOAEL = 300 mg/kg bw/day. Oral and dermal bioavailability are assumed to be equal (refer to TK section)
- AF for dose response relationship:
- 1
- Justification:
- Toxicological findings showed a clear dose response with minimal to slight severity up to the highest dose in the key study
- AF for differences in duration of exposure:
- 6
- Justification:
- Subcute study used as the starting point.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default
- 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:
- hazard unknown (no further information necessary)
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
Accroding to eye irritation test result, CHDM DGE was classified as non-irritant to eye. However, the skin test results showed that CHDM DGE was irritant (catagory 2). Based on these results, personal protective equipment will be proposed to prevent ocular contact.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.86 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):
- 150
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 130.4 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Starting NOAEL = 300 mg/kg bw/day. Converted to Dose descriptor starting point according to ECHA guidance (practical guide 14). 300/1.15 = 260.86 mg/m3 ; It is assumed that the oral absorption rate is 50% of that of the inhalation absorption.
- AF for dose response relationship:
- 1
- Justification:
- Toxicological findings showed a clear dose response with minimal to slight severity up to the highest dose in the key study
- AF for differences in duration of exposure:
- 6
- Justification:
- Subcute study used as the starting point.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not required due to route to route extrapolation method
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default
- 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:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
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
- Route of original study:
- Oral
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:
- Starting NOAEL = 300 mg/kg bw/day. Dermal and oral bioavailability are taken to be equal (refer to TK section).
- AF for dose response relationship:
- 1
- Justification:
- Toxicological findings showed a clear dose response with minimal to slight severity up to the highest dose in the key study
- AF for differences in duration of exposure:
- 6
- Justification:
- Subcute study used as the starting point.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default
- 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:
- hazard unknown (no further information necessary)
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:
- 0.5 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):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- not relevant
- AF for dose response relationship:
- 1
- Justification:
- Toxicological findings showed a clear dose response with minimal to slight severity up to the highest dose in the key study
- AF for differences in duration of exposure:
- 6
- Justification:
- Subcute study used as the starting point.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default
- 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:
- hazard unknown (no further information necessary)
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.
