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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 202-708-7 | CAS number: 98-86-2
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.23 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
- Dose descriptor starting point:
- LOAEL
- Value:
- 75 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 93 mg/m³
- Explanation for the modification of the dose descriptor starting point:
According to ECHA Guidance R.8 (version 2.1, figure R8-3): Conversion of an oral rat N(L)OAEL into a corrected inhalatory N(L)OAEC to assess human inhalatory exposure
For workers (in case of 8h exposure/d):
corrected inhalatory N(L)OAEC = oral N(L)OAEL * (1/sRVrat) * (ABSoral-rat/ABSinh-human) * (sRVhuman/wRV)
For workers, an additional correction is applied for differences between human and experimental exposure conditions (EXPCOND): 1,4 (5/7 d/wk)
corrected inhalatory LOAEC = 75 * (1/0.38) * (1/2) * (6.7/10) * 1.4
corrected inhalatory LOAEC = 93 mg/m3
- AF for dose response relationship:
- 3
- Justification:
- A LOAEL is used as starting point
- AF for differences in duration of exposure:
- 2
- Justification:
- Extrapolation from subchronic to chronic exposure (default value = 2)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- no allometric scaling factor as inhalation data given as external concentration.
- AF for other interspecies differences:
- 2.5
- Justification:
- default value
- AF for intraspecies differences:
- 5
- Justification:
- default value for worker
- AF for the quality of the whole database:
- 1
- Justification:
- good quality
- AF for remaining uncertainties:
- 1
- Justification:
- not necessary
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:
- 0.35 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
- Dose descriptor starting point:
- LOAEL
- Value:
- 75 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 105 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
On the assumption that, in general, dermal absorption will not be higher than oral absorption, no default factor (i.e. factor 1) was introduced when performing oral-to-dermal extrapolation. (see ECHA Guidance R.8, R.8.4.2)
For workers, an additional correction is applied for differences between human and experimental exposure conditions (EXPCOND): 1,4 (5/7 d/wk)
- AF for dose response relationship:
- 3
- Justification:
- A LOAEL is used as starting point
- AF for differences in duration of exposure:
- 2
- Justification:
- Extrapolation from subchronic to chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value for rat (see R.8 Table R. 8-3)
- AF for other interspecies differences:
- 2.5
- Justification:
- default value
- AF for intraspecies differences:
- 5
- Justification:
- default value for worker
- AF for the quality of the whole database:
- 1
- Justification:
- Good quality
- AF for remaining uncertainties:
- 1
- Justification:
- not necessary
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:
- 0.22 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
- Dose descriptor starting point:
- LOAEL
- Value:
- 75 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 33 mg/m³
- Explanation for the modification of the dose descriptor starting point:
According to ECHA Guidance R.8 (version 2.1, figure R8-3): Conversion of an oral rat N(L)OAEL into a corrected inhalatory N(L)OAEC to assess human inhalatory exposure
For consumer (in case of 24h exposure/d):
corrected inhalatory N(L)OAEC = oral N(L)OAEL * (1/sRVrat) * (ABSoral-rat/ABSinh-human) * (ABSinh-rat/ ABSinh-human)
corrected inhalatory N(L)OAEC = 75 * (1/1.15) * (ABSoral-rat/ABSinh-human)
corrected inhalatory N(L)OAEC = 75 * (1/1.15) * (1/2) = 33 mg/m3
- AF for dose response relationship:
- 3
- Justification:
- A LOAEL is used as starting point
- AF for differences in duration of exposure:
- 2
- Justification:
- Extrapolation from subchronic to chronic exposure (default value = 2)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- no allometric scaling factor as inhalation data given as external concentration.
- AF for other interspecies differences:
- 2.5
- Justification:
- default value
- AF for intraspecies differences:
- 10
- Justification:
- default value for consumer
- AF for the quality of the whole database:
- 1
- Justification:
- good quality
- AF for remaining uncertainties:
- 1
- Justification:
- not necessary
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:
- 0.125 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
- Dose descriptor starting point:
- LOAEL
- Value:
- 75 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 75 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
On the assumption that, in general, dermal absorption will not be higher than oral absorption, no default factor (i.e. factor 1) was introduced when performing oral-to-dermal extrapolation. (see ECHA Guidance R.8, R.8.4.2)
- AF for dose response relationship:
- 3
- Justification:
- A LOAEL is used as starting point
- AF for differences in duration of exposure:
- 2
- Justification:
- Extrapolation from subchronic to chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value for rat (see R.8 Table R. 8-3)
- AF for other interspecies differences:
- 2.5
- Justification:
- default value
- AF for intraspecies differences:
- 10
- Justification:
- default value for consumer/general population
- AF for the quality of the whole database:
- 1
- Justification:
- good quality
- AF for remaining uncertainties:
- 1
- Justification:
- not necessary
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:
- 0.125 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
- Dose descriptor starting point:
- LOAEL
- Value:
- 75 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 75 mg/kg bw/day
- AF for dose response relationship:
- 3
- Justification:
- A LOAEL is used as starting point
- AF for differences in duration of exposure:
- 2
- Justification:
- Extrapolation from subchronic to chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value for rat (see R.8 Table R. 8-3)
- AF for other interspecies differences:
- 2.5
- Justification:
- default value
- AF for intraspecies differences:
- 10
- Justification:
- default value for consumer/general population
- AF for the quality of the whole database:
- 1
- Justification:
- good quality
- AF for remaining uncertainties:
- 1
- Justification:
- not necessary
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.
