Registration Dossier
Registration Dossier
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EC number: 444-860-9 | CAS number: 474510-57-1
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.71 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:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 53 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Modification of the starting point (R.8 Figure R.8 -3):
Corrected inhalatory N(L)OAEC = oral N(L)OAEL*(1/sRVrat)*ABSoral-rat/ABSinh-human)*(sRVhuman/wRV)
= oral N(L)OAL*(1/0.38 m3/kg/d)*(1/1)*6.7m3(8h)/10 m3 (8h))
ABS: Absorption
sRV: standard Respiratory Volume
wRV: worker Respiratory Volume
ABSoral-rat: 1 [-]: worst case default
ABSinh-human: 1 [-]: worst case default
- AF for dose response relationship:
- 1
- Justification:
- No issues in relevance or reliability of dose response: REACH guidance R.8 (default)
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute (28 day) to chronic: REACH guidance R.8 (default)
- Justification:
- Not relevant for corrected inhalation DNEL: REACH guidance R.8 (default)
- AF for other interspecies differences:
- 2.5
- Justification:
- Interspecies remaining differences: REACH guidance R.8 (default)
- AF for intraspecies differences:
- 5
- Justification:
- Worker: REACH guidance R.8 (default)
- AF for the quality of the whole database:
- 1
- Justification:
- No significant reduction in relevance or reliability across the database: REACH guidance R.8 (default)
- Justification:
- No 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:
- 0.1 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):
- 30
- Dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No absorption data is available, therefore a worst case modification factor of 1 is used: REACH guidance R.8 (default)
- AF for dose response relationship:
- 1
- Justification:
- No issues in relevance or reliability of dose response: REACH guidance R.8 (default)
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute (28 day) to chronic: REACH guidance R.8 (default)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling factor Rat to Human: REACH guidance R.8 (default)
- AF for other interspecies differences:
- 2.5
- Justification:
- Interspecies remaining differences: REACH guidance R.8 (default)
- AF for intraspecies differences:
- 5
- Justification:
- Worker: REACH guidance R.8 (default)
- AF for the quality of the whole database:
- 1
- Justification:
- No significant reduction in relevance or reliability across the database: REACH guidance R.8 (default)
- Justification:
- No 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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
1. Identification of relevant dose descriptor
In an OECD 422 study performed in rats, the substance did not cause mortalities. Gastric erosions, decreased body weight and lowered motor activity were recorded at the highest concentration of 90 mg/kg bw. The NOAEL is considered to be 30 mg/kg bw/d.
2. Mode of action
No non-threshold mode of action is associated with the test substance. In particular, the test substance has no genotoxic potential.
Calculation of DNEL bases upon Guidance Document on Dermal Absorption, European Commission, 2004 and Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, may 2008
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.17 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:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 26 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Modification of the starting point (R.8 Figure R.8 -3):
Corrected inhalatory N(L)OAEC = oral N(L)OAEL*(1/sRVrat)*ABSoral-rat/ABSinh-human)*(sRVhuman/wRV)
= oral N(L)OAL*(1/0.38 m3/kg/d)*(1/1)*6.7m3(8h)/10 m3 (8h))
ABS: Absorption
sRV: standard Respiratory Volume
wRV: worker Respiratory Volume
ABSoral-rat: 1 [-]: worst case default
ABSinh-human: 1 [-]: worst case default
- AF for dose response relationship:
- 1
- Justification:
- No issues in relevance or reliability of dose response: REACH guidance R.8 (default)
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute (28 day) to chronic: REACH guidance R.8 (default)
- Justification:
- Not relevant for corrected inhalation DNEL: REACH guidance R.8 (default)
- AF for other interspecies differences:
- 2.5
- Justification:
- Interspecies remaining differences: REACH guidance R.8 (default)
- AF for intraspecies differences:
- 10
- Justification:
- General population: REACH guidance R.8 (default)
- AF for the quality of the whole database:
- 1
- Justification:
- No significant reduction in relevance or reliability across the database: REACH guidance R.8 (default)
- Justification:
- No 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
General Population - Hazard via dermal 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No absorption data is available, therefore a worst case modification factor of 1 is used: REACH guidance R.8 (default)
- AF for dose response relationship:
- 1
- Justification:
- No issues in relevance or reliability of dose response: REACH guidance R.8 (default)
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute (28 day) to chronic: REACH guidance R.8 (default)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling factor Rat to Human: REACH guidance R.8 (default)
- AF for other interspecies differences:
- 2.5
- Justification:
- Interspecies remaining differences: REACH guidance R.8 (default)
- AF for intraspecies differences:
- 10
- Justification:
- General population: REACH guidance R.8 (default)
- AF for the quality of the whole database:
- 1
- Justification:
- No significant reduction in relevance or reliability across the database: REACH guidance R.8 (default)
- Justification:
- No 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
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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- No issues in relevance or reliability of dose response: REACH guidance R.8 (default)
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute (28 day) to chronic: REACH guidance R.8 (default)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling factor Rat to Human: REACH guidance R.8 (default)
- AF for other interspecies differences:
- 2.5
- Justification:
- Interspecies remaining differences: REACH guidance R.8 (default)
- AF for intraspecies differences:
- 10
- Justification:
- General population: REACH guidance R.8 (default)
- AF for the quality of the whole database:
- 1
- Justification:
- No significant reduction in relevance or reliability across the database: REACH guidance R.8 (default)
- Justification:
- No remaining uncertainties.
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
1. Identification of relevant dose descriptor
In an OECD 422 study performed in rats, the substance did not cause mortalities. Gastric erosions, decreased body weight and lowered motor activity were recorded at the highest concentration of 90 mg/kg bw. The NOAEL is considered to be 30 mg/kg bw/d.
2. Mode of action
No non-threshold mode of action is associated with the test substance. In particular, the test substance has no genotoxic potential.
Calculation of DNEL bases upon Guidance Document on Dermal Absorption, European Commission, 2004 and Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, may 2008
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.
