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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 200-915-7 | CAS number: 75-91-2
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.2 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 12.5
- Dose descriptor starting point:
- NOAEC
- Value:
- 55.2 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 27.7 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Modification factor: Time scaling is required to adjust for 6h/d exposure to 8h/d working condition. Exposures were for 5 days a week so no adjustment is needed. In addition, worker ventilation rate needs to be accounted for.
55.2 mg/m3* (6h/d / 8 h/d) * (6.7m3/10m3) = 27.7 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- Standard for NOAEC as dose descriptor in terms of ECHA R.8 guidance
- AF for differences in duration of exposure:
- 1
- Justification:
- No adjustment – chronic study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling not required
- AF for other interspecies differences:
- 2.5
- Justification:
- Interspecies rat to human (ECHA R.8 value)
- AF for intraspecies differences:
- 5
- Justification:
- Intraspecies worker (ECHA R.8 value)
- AF for the quality of the whole database:
- 1
- Justification:
- Reliable studies available
- AF for remaining uncertainties:
- 1
- Justification:
- Not required
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 85.2 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 12.5
- Dose descriptor starting point:
- NOAEC
- Value:
- 66.3 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 066.1 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Time scaling to 15 minutes from 6 hours to account for acute exposures. In addition, worker ventilation rate needs to be accounted for.
66.3 mg/m3 * (6 h/0.25 h) * (6.7 m3/10 m3) = 1066.1 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- Standard for NOAEC as dose descriptor in terms of ECHA R.8 guidance
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling not required
- AF for other interspecies differences:
- 2.5
- Justification:
- Interspecies rat to human (ECHA R.8 value)
- AF for intraspecies differences:
- 5
- Justification:
- Intraspecies worker (ECHA R.8 value)
- AF for the quality of the whole database:
- 1
- Justification:
- Reliable studies available
- AF for remaining uncertainties:
- 1
- Justification:
- Not required
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.58 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 12.5
- Dose descriptor:
- NOAEC
- Value:
- 14.7 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Standard for NOAEC as dose descriptor in terms of ECHA R.8 guidance
- AF for differences in duration of exposure:
- 1
- Justification:
- No adjustment – chronic study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling not required.
- AF for other interspecies differences:
- 2.5
- Justification:
- Interspecies rat to human (ECHA R.8 value)
- AF for intraspecies differences:
- 5
- Justification:
- Intraspecies worker (ECHA R.8 value)
- AF for the quality of the whole database:
- 1
- Justification:
- Reliable studies available
- AF for remaining uncertainties:
- 1
- Justification:
- Not required
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 28.4 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 12.5
- Dose descriptor starting point:
- NOAEC
- Value:
- 22.1 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Standard for NOAEC as dose descriptor in terms of ECHA R.8 guidance
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling not required
- AF for other interspecies differences:
- 2.5
- Justification:
- Interspecies rat to human (ECHA R.8 value)
- AF for intraspecies differences:
- 5
- Justification:
- Intraspecies worker (ECHA R.8 value)
- AF for the quality of the whole database:
- 1
- Justification:
- Reliable studies available
- AF for remaining uncertainties:
- 1
- Justification:
- Not required
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.21 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Dose descriptor starting point:
- NOAEC
- Value:
- 55.2 mg/m³
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 8 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Modification factor: A dose unit conversion factor (from inhalation to dermal for an 8 hour exposure; 0.38 m3/kg) was included. Time scaling is required to adjust for 6h/d exposure to 8h/d working condition. Exposures were for 5 days a week so no adjustment is needed. In addition, worker ventilation rate needs to be accounted for.
55.2 mg/m3 * (6 h/d / 8 h/d) * 0.38m3/kg bw * (6.7 m3/10 m3) = 10.5 mg/kg bw
- AF for dose response relationship:
- 1
- Justification:
- Standard for NOAEC as dose descriptor in terms of ECHA R.8 guidance
- AF for differences in duration of exposure:
- 1
- Justification:
- No adjustment – chronic study
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 2.5
- Justification:
- Interspecies rat to human (ECHA R.8 value)
- AF for intraspecies differences:
- 5
- Justification:
- Intraspecies worker (ECHA R.8 value)
- AF for the quality of the whole database:
- 1
- Justification:
- Reliable studies available
- AF for remaining uncertainties:
- 1
- Justification:
- Not required
Acute/short term exposure
- Hazard assessment conclusion:
- no data available: testing technically not feasible
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no data available: testing technically not feasible
Acute/short term exposure
- Hazard assessment conclusion:
- no data available: testing technically not feasible
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - workers
DNEL derivation procedure detailed in document appended to Section 13.2.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.39 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEC
- Value:
- 55.2 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 9.8 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Modification factor: Time scaling is required to adjust for 6h/d exposure to 24 h/d. Exposures were for 5 days a week so adjustment to 7 days per week is required.
55.2 mg/m3 * (6 h/d / 24 h/d) * (5 d/w / 7 d/w) = 9.8 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- Standard for NOAEC as dose descriptor in terms of ECHA R.8 guidance
- AF for differences in duration of exposure:
- 1
- Justification:
- No adjustment – chronic study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling not required
- AF for other interspecies differences:
- 2.5
- Justification:
- Interspecies rat to human (ECHA R.8 value)
- AF for intraspecies differences:
- 10
- Justification:
- ECHA R.8 value
- AF for the quality of the whole database:
- 1
- Justification:
- Reliable studies available
- AF for remaining uncertainties:
- 1
- Justification:
- Not required
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 63.6 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEC
- Value:
- 66.3 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 591.2 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Modification factor: Time scaling to 15 minutes from 6 hours to account for acute exposures.
66.3 mg/m3 * 6 h/0.25 h =1591.2 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- Standard for NOAEC as dose descriptor in terms of ECHA R.8 guidance
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling not required
- AF for other interspecies differences:
- 2.5
- Justification:
- Interspecies rat to human (ECHA R.8 value)
- AF for intraspecies differences:
- 10
- Justification:
- ECHA R.8 value
- AF for the quality of the whole database:
- 1
- Justification:
- Reliable studies available
- AF for remaining uncertainties:
- 1
- Justification:
- Not required
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.1 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor:
- NOAEC
- Value:
- 14.7 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Standard for NOAEC as dose descriptor in terms of ECHA R.8 guidance
- AF for differences in duration of exposure:
- 1
- Justification:
- No adjustment – chronic study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling not required
- AF for other interspecies differences:
- 2.5
- Justification:
- Interspecies rat to human (ECHA R.8 value)
- AF for intraspecies differences:
- 10
- Justification:
- ECHA R.8 value
- AF for the quality of the whole database:
- 1
- Justification:
- Reliable studies available
- AF for remaining uncertainties:
- 1
- Justification:
- Not required
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 21.2 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEC
- Value:
- 22.1 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Standard for NOAEC as dose descriptor in terms of ECHA R.8 guidance
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling not required
- AF for other interspecies differences:
- 2.5
- Justification:
- Interspecies rat to human (ECHA R.8 value)
- AF for intraspecies differences:
- 10
- Justification:
- ECHA R.8 value
- AF for the quality of the whole database:
- 1
- Justification:
- Reliable studies available
- AF for remaining uncertainties:
- 1
- Justification:
- Not required
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.037 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEC
- Value:
- 55.2 mg/m³
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 2.8 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
A dose unit conversion factor (from inhalation to dermal for an 8h exposure; 0.38 m3/kg) was included. Time scaling is required to adjust for 6h/d exposure to 24 h/d exposure condition. Exposures were for 5 days a week so adjustment to 7 days a week is required.
55.2 mg/m3 * (6 h/d / 24 h/d) * 0.38 m3/kg bw * (5 d/w / 7 d/w) = 3.74 mg/kg bw
- AF for dose response relationship:
- 1
- Justification:
- Standard for NOAEC as dose descriptor in terms of ECHA R.8 guidance
- AF for differences in duration of exposure:
- 1
- Justification:
- No adjustment – chronic study
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 2.5
- Justification:
- Interspecies rat to human (ECHA R.8 value)
- AF for intraspecies differences:
- 10
- Justification:
- ECHA R.8 value
- AF for the quality of the whole database:
- 1
- Justification:
- Reliable studies available
- AF for remaining uncertainties:
- 1
- Justification:
- Not required
Acute/short term exposure
- Hazard assessment conclusion:
- no data available: testing technically not feasible
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no data available: testing technically not feasible
Acute/short term exposure
- Hazard assessment conclusion:
- no data available: testing technically not feasible
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.05 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):
- 400
- Dose descriptor starting point:
- NOAEL
- Value:
- 21 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Modification factor: 100% absorption is assumed for oral and dermal exposure therefore no adjustment is required.
21 mg/kg bw
- AF for dose response relationship:
- 1
- Justification:
- Standard for NOAEC as dose descriptor in terms of ECHA R.8 guidance
- AF for differences in duration of exposure:
- 4
- Justification:
- Subchronic/subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 2.5
- Justification:
- Interspecies rat to human (ECHA R.8 value)
- AF for intraspecies differences:
- 10
- Justification:
- ECHA R.8 value
- AF for the quality of the whole database:
- 1
- Justification:
- Reliable studies available
- AF for remaining uncertainties:
- 1
- Justification:
- Not required
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - General Population
DNEL derivation procedure detailed in document appended to Section 13.2.
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.
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