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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 204-399-4 | CAS number: 120-47-8
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:
- 173 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):
- 10
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 763 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- No study on long-term inhalation toxicity available
- AF for dose response relationship:
- 1
- Justification:
- Default value for NOAEL as starting point for DNEL calculation
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic to chronic exposure
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is not necessary for the inhalation route
- AF for other interspecies differences:
- 1
- Justification:
- No default additional interspecies factor is used, since no species differences in the metabolism of the test substance were observed.
- AF for intraspecies differences:
- 5
- Justification:
- Default value for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Default value for good quality of database, also taking into account completeness and consistency.
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
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:
- 32.85 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):
- 40
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 314 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No study on long-term dermal toxicity available
- AF for dose response relationship:
- 1
- Justification:
- Default value for NOAEL as starting point for DNEL calculation
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic to chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling rat to human
- AF for other interspecies differences:
- 1
- Justification:
- No default additional interspecies factor is used, since no species differences in the metabolism of the test substance were observed.
- AF for intraspecies differences:
- 5
- Justification:
- Default value for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Default value for good quality of database, also taking into account completeness and consistency.
Acute/short term exposure
- Hazard assessment conclusion:
- no DNEL required: short term exposure controlled by conditions for long-term
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
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 43.47 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):
- 20
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 869.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- No study on long-term inhalation toxicity available
- AF for dose response relationship:
- 1
- Justification:
- Default value for NOAEL as starting point for DNEL calculation
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic exposure
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is not necessary for the inhalation route
- AF for other interspecies differences:
- 1
- Justification:
- No default additional interspecies factor is used, since no species differences in the metabolism of the test substance were observed.
- AF for intraspecies differences:
- 10
- Justification:
- Default value for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Default value for good quality of database, also taking into account completeness and consistency.
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
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:
- 16.42 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):
- 80
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 314 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No study on long-term dermal toxicity available
- AF for dose response relationship:
- 1
- Justification:
- Default value for NOAEL as starting point for DNEL calculation
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic to chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling rat to human
- AF for other interspecies differences:
- 1
- Justification:
- No default additional interspecies factor is used, since no species differences in the metabolism of the test substance were observed.
- AF for intraspecies differences:
- 10
- Justification:
- Default value for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Default value for good quality of database, also taking into account completeness and consistency.
Acute/short term exposure
- Hazard assessment conclusion:
- no DNEL required: short term exposure controlled by conditions for long-term
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:
- 12.5 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):
- 80
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default value for NOAEL as starting point for DNEL calculation
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic to chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling rat to human
- AF for other interspecies differences:
- 1
- Justification:
- No default additional interspecies factor is used, since no species differences in the metabolism of the test substance were observed.
- AF for intraspecies differences:
- 10
- Justification:
- Default value for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Default value for good quality of database, also taking into account completeness and consistency.
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.
