Registration Dossier
Registration Dossier
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EC number: 250-792-9 | CAS number: 31765-95-4
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.53 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):
- 62.5
- Dose descriptor starting point:
- NOAEL
- Value:
- 125 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 220.4 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NOAEC(corrected) = NOAEL(oral) × [ABS(oral, rat) / ABS(inhalation, human)] × [sRV(human)/sRV(rat)] × [1/wRV]
NOAEL(oral) = 125 mg/kg/day
ABS(oral, rat) = 100 % (default value)
ABS(inhalation, human) = 100 % (default value)
sRV(human) = 6.7 m3/kg/day (according to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, ECHA, 2012)
sRV(rat) = 0.38 m3/kg/day (according to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, ECHA, 2012)
wRV = 10 m3 (according to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, ECHA, 2012)
- AF for dose response relationship:
- 1
- Justification:
- starting point is NOAEL
- AF for differences in duration of exposure:
- 4.5
- Justification:
- the administration period is between sub-acute and sub-chronic study (49 days)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not used for inhalation exposure
- AF for other interspecies differences:
- 2.5
- Justification:
- default value
- AF for intraspecies differences:
- 5
- Justification:
- workers
- AF for the quality of the whole database:
- 1
- Justification:
- adequate reliable study performed according to the guideline and GLP
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainty
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:
- 5.56 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):
- 225
- Dose descriptor starting point:
- NOAEL
- Value:
- 125 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 250 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
NOAEL(corrected) = NOAEL(oral) × ABS(oral, rat) / ABS(dermal, human)
NOAEL(oral) = 125 mg/kg/day
ABS(oral, rat) = 100 % (default value)
ABS(dermal, human) = 10 % (according to Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7c: Endpoint specific guidance, ECHA, 2017)
- AF for dose response relationship:
- 1
- Justification:
- starting point is NOAEL
- AF for differences in duration of exposure:
- 4.5
- Justification:
- the administration period is between sub-acute and sub-chronic study (49 days)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- study in rats
- AF for other interspecies differences:
- 2.5
- Justification:
- default value
- AF for intraspecies differences:
- 5
- Justification:
- workers
- AF for the quality of the whole database:
- 1
- Justification:
- adequate reliable study performed according to the guideline and GLP
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainty
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
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:
- 0.966 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):
- 112.5
- Dose descriptor starting point:
- NOAEL
- Value:
- 125 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 108.7 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NOAEC(corrected) = NOAEL(oral) × [ABS(oral, rat) / ABS(inhalation, human)] × 1/sRV(rat)
NOAEL(oral) = 125 mg/kg/day
ABS(oral, rat) = 100 % (default value)
ABS(inhalation, human) = 100 % (default value)
sRV(rat) = 1.15 m3/kg/day (according to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, ECHA, 2012)
- AF for dose response relationship:
- 1
- Justification:
- starting point is NOAEL
- AF for differences in duration of exposure:
- 4.5
- Justification:
- the administration period is between sub-acute and sub-chronic study (49 days)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not used for inhalation exposure
- AF for other interspecies differences:
- 2.5
- Justification:
- default value
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- adequate reliable study performed according to the guideline and GLP
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainty
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:
- 2.78 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):
- 450
- Dose descriptor starting point:
- NOAEL
- Value:
- 125 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 250 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
NOAEL(corrected) = NOAEL(oral) × ABS(oral, rat) / ABS(dermal, human)
NOAEL(oral) = 125 mg/kg/day
ABS(oral, rat) = 100 % (default value)
ABS(dermal, human) = 10 % (according to Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7c: Endpoint specific guidance, ECHA, 2017)
- AF for dose response relationship:
- 1
- Justification:
- starting point is NOAEL
- AF for differences in duration of exposure:
- 4.5
- Justification:
- the administration period is between sub-acute and sub-chronic study (49 days)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- study in rats
- AF for other interspecies differences:
- 2.5
- Justification:
- default value
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- adequate reliable study performed according to the guideline and GLP
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainty
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
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:
- 0.278 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):
- 450
- Dose descriptor starting point:
- NOAEL
- Value:
- 125 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- starting point is NOAEL
- AF for differences in duration of exposure:
- 4.5
- Justification:
- the administration period is between sub-acute and sub-chronic study (49 days)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- study in rats
- AF for other interspecies differences:
- 2.5
- Justification:
- default value
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- adequate reliable study performed according to the guideline and GLP
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainty
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.
