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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 225-967-8 | CAS number: 5187-23-5
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 26.4 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:
- 750 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 661 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The NOAEL of 750 mg/kg bw/d from the 91-day oral rat study is corrected for activity (*6.7/10), breathing rate (*1.0/0.38) and relative absorption (*1/2) to derive a corrected inhalation NOAEC of 661 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- The starting point is a NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Extrapolation from a subchronic study to chronic exposure
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not required; already accounted for in correction of the endpoint
- AF for other interspecies differences:
- 2.5
- Justification:
- Standard factor
- AF for intraspecies differences:
- 5
- Justification:
- Standard factor (workers)
- AF for the quality of the whole database:
- 1
- Justification:
- Standard factor; good quality database
- AF for remaining uncertainties:
- 1
- Justification:
- No significant 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:
- 7.5 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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 750 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 750 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
In the absence of dermal absorption data, dermal absorption is considered to be equivalent to oral absorption.
- AF for dose response relationship:
- 1
- Justification:
- The starting point is a NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Extrapolation from a sub-chronic study to chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The starting point is derived from a study in the rat
- AF for other interspecies differences:
- 2.5
- Justification:
- Standard factor
- AF for intraspecies differences:
- 5
- Justification:
- Standard factor (workers)
- AF for the quality of the whole database:
- 1
- Justification:
- Standard factor: high quality database
- AF for remaining uncertainties:
- 1
- Justification:
- Standard factor: no significant uncertainties remaining.
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:
- low hazard (no threshold derived)
Additional information - workers
The starting point for DNEL derivation is the NOAEL of 750 mg/kg bw/d from the 91 -day rat study.
Inhalation DNELs
For the long-term inhalation DNEL, the NOAEL of 750 mg/kg bw/d from the 91-day oral rat study is corrected for activity (*6.7/10), breathing rate (*1.0/0.38) and relative absorption (*1/2) to derive a corrected inhalation NOAEC of 661 mg/m3.
Dermal DNELs
In the absence of dermal absorption data, dermal absorption is considered to be equivalent to oral absorption. The corrected starting point for the long-term dermal DNEL is therefore a NOAEL of 750 mg/kg bw/d. CTF is not classified for skin irritation or skin sensitisation. In the absence of any hazard, derivation of a local dermal DNEL value is not required.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 6.5 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):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 750 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 326 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The NOAEL of 750mg/kg bw/d from the 91-day oral rat study is corrected for breathing rate (*1.0/1.15) and relative absorption (*1/2) to derive a corrected inhalation NOAEC of 326 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- The starting point is a NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Extrapolation from a sub-chronic study to chronic exposure
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not required; already accounted for in correction of the starting point
- AF for other interspecies differences:
- 2.5
- Justification:
- Standard factor
- AF for intraspecies differences:
- 10
- Justification:
- Standard factor (general population)
- AF for the quality of the whole database:
- 1
- Justification:
- Standard factor; good quality database
- AF for remaining uncertainties:
- 1
- Justification:
- Standard factor; no significant uncertainties remaining
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:
- 3.8 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 750 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 750 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The starting point is the NOAEL of 750 mg/kg bw/d from the 91 -day oral rat study. In the absence of dermal absorption data, dermal absorption is considered to be equivalent to oral absorption. The corrected starting point is therefore a NOAEL of 750 mg/kg bw/d.
- AF for dose response relationship:
- 1
- Justification:
- The starting point is a NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Extrapolation from a sub-chronic study to chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Standard factor: starting point is derived from a study in the rat
- AF for other interspecies differences:
- 2.5
- Justification:
- Standard factor
- AF for intraspecies differences:
- 10
- Justification:
- Standard factor: general population
- AF for the quality of the whole database:
- 1
- Justification:
- Standard factor: high quality database
- AF for remaining uncertainties:
- 1
- Justification:
- Standard factor: no significant uncertainties remaining
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:
- 3.8 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 750 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Modification of the starting point is not required.
- AF for dose response relationship:
- 1
- Justification:
- The starting point is a NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Extrapolation from a sub-chronic study to chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Standard factor: strarting point is from a study in the rat
- AF for other interspecies differences:
- 2.5
- Justification:
- Standard factor
- AF for intraspecies differences:
- 10
- Justification:
- Standard factor (general population)
- AF for the quality of the whole database:
- 1
- Justification:
- Standard factor: good quality database
- AF for remaining uncertainties:
- 1
- Justification:
- Standard factor: no significant uncertainties remaining
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
The starting point for DNEL derivation is the NOAEL of 750 mg/kg bw/d from the 91 -day rat study.
Inhalation DNELs
For the long-term inhalation DNEL, the NOAEL of 750 mg/kg bw/d from the 91-day oral rat study is corrected for breathing rate (*1.0/1.15) and relative absorption (*1/2) to derive a corrected inhalation NOAEC of 326 mg/m3.
Dermal DNELs
In the absence of dermal absorption data, dermal absorption is considered to be equivalent to oral absorption. The corrected starting point for the long-term dermal DNEL is therefore a NOAEL of 750 mg/kg bw/d. CTF is not classified for skin irritation or skin sensitisation. In the absence of any hazard, derivation of a local dermal DNEL value is not required.
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.
