Registration Dossier
Registration Dossier
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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: 434-630-6 | CAS number: 60372-77-2
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 21.652 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):
- 12.5
- Dose descriptor starting point:
- NOAEL
- Value:
- 307 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 270.645 mg/m³
- Explanation for the modification of the dose descriptor starting point:
No available data on inhalatory study; DNEL is derived from oral study route.
Inhalatory N(L)OAEC=oral N(L)OAEL*(1/0.38 m3/kg/d)*0.67*(ABSoral/ABSinh)
ABSoral/ABSinh = 0.5
- AF for dose response relationship:
- 1
- Justification:
- Starting point NOAEL
- AF for differences in duration of exposure:
- 1
- Justification:
- Chronic sturdy
- AF for interspecies differences (allometric scaling):
- 2.5
- Justification:
- Default
- AF for other interspecies differences:
- 5
- Justification:
- Worker
- AF for intraspecies differences:
- 1
- Justification:
- Default
- AF for the quality of the whole database:
- 1
- Justification:
- Default
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:
- 6.14 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):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 307 mg/m³
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 307 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Starting point NOAEL
- AF for differences in duration of exposure:
- 1
- Justification:
- Default
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 5
- Justification:
- Worker
- AF for the quality of the whole database:
- 1
- Justification:
- Default
- AF for remaining uncertainties:
- 1
- Justification:
- Default
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:
- medium hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.339 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:
- 307 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 133.478 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- NOAEL
- AF for differences in duration of exposure:
- 1
- Justification:
- Chronic toxicity data
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 10
- Justification:
- General population
- AF for the quality of the whole database:
- 1
- Justification:
- Default
- AF for remaining uncertainties:
- 1
- Justification:
- Default
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:
- 3.07 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:
- 307 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 307 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Dermal N(L)OAEC=oral (N(L)OAEL*( ABSoral/ABSdermal). ABSoral/ABSdermal = 1 is used.
- AF for dose response relationship:
- 1
- Justification:
- Starting point NOAEL.
- AF for differences in duration of exposure:
- 1
- Justification:
- Chronic study data.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 10
- Justification:
- General population.
- AF for the quality of the whole database:
- 1
- Justification:
- Default
- AF for remaining uncertainties:
- 1
- Justification:
- Default
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:
- 3.07 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:
- 307 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 307 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Starting point NOAEL
- AF for differences in duration of exposure:
- 1
- Justification:
- Chronic study data
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rats
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 10
- Justification:
- General population
- AF for the quality of the whole database:
- 1
- Justification:
- Default
- AF for remaining uncertainties:
- 1
- Justification:
- Default
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
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