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Registration Dossier
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EC number: 214-192-0 | CAS number: 1112-55-6
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.493 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
- Value:
- 37 mg/m³
- Explanation for the modification of the dose descriptor starting point:
In a Screening for reproductive / developmental toxicity study, NOAEL of test item were determined to be 30 mg/kg/day in males and females for repeated dose toxicity. NOAEL of 30 mg/kg/day is selected as starting point.
- AF for dose response relationship:
- 1
- Justification:
- The value of 1 is the default for dose descriptor NOAEL.
- AF for differences in duration of exposure:
- 6
- Justification:
- The value of 6 is default for sub-acute study.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- The default value 4 for rat is not applicable as respiratory rates depend directly on caloric demand, hence value 1 is used.
- AF for other interspecies differences:
- 2.5
- Justification:
- The value of 2.5 is default for interspecies variability - remaining differences in case of no other specific susceptibility differences info available.
- AF for intraspecies differences:
- 5
- Justification:
- The default value is 5 for works according to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8.
- AF for the quality of the whole database:
- 1
- Justification:
- The default value is 1 according to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8.
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
This submission substance is classified as Category 4 for acute inhalation toxicity as the LC50 was 2270 mg/m3 (2.27 mg/L) in an acute inhalation toxicity test in compliance with OECD 403 and GLP.
Therefore low hazard determined.
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:
- 0.14 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):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Value:
- 42 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
In a Screening for reproductive / developmental toxicity study, NOAEL of test item were determined to
be 30 mg/kg/day in males and females for repeated dose toxicity. NOAEL of 30 mg/kg/day is selected as starting point.
- AF for dose response relationship:
- 1
- Justification:
- The value of 1 is default for dose descriptor NOAEL.
- AF for differences in duration of exposure:
- 6
- Justification:
- The value of 6 is default for sub-acute study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The default value is 4 for study animal rats.
- AF for other interspecies differences:
- 2.5
- Justification:
- The value of 2.5 is default for interspecies variability - remaining differences in case of no other specific susceptibility differences info available.
- AF for intraspecies differences:
- 5
- Justification:
- The default value is 5 for works according to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8.
- AF for the quality of the whole database:
- 1
- Justification:
- The default value is 1 for quality of whole database according to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
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:
- 87 µg/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
- Value:
- 13.1 mg/m³
- Explanation for the modification of the dose descriptor starting point:
In a Screening for reproductive / developmental toxicity study, NOAEL of test item were determined to be 30 mg/kg/day in males and females for repeated dose toxicity. NOAEL of 30 mg/kg/day is selected as starting point.
- AF for dose response relationship:
- 1
- Justification:
- The value of 1 is default for dose descriptor NOAEL.
- AF for differences in duration of exposure:
- 6
- Justification:
- The value of 6 is default for sub-acute study.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- The default value 4 for rat is not applicable as respiratory rates depend directly on caloric demand, hence value 1 is used.
- AF for other interspecies differences:
- 2.5
- Justification:
- The value of 2.5 is default for interspecies variability - remaining differences in case of no other specific susceptibility differences info available.
- AF for intraspecies differences:
- 10
- Justification:
- The default value is 10 for general population according to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8.
- AF for the quality of the whole database:
- 1
- Justification:
- The default value is 1 for quality of whole database according to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8.
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
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:
- 50 µg/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
- Value:
- 30 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
In a Screening for reproductive / developmental toxicity study, NOAEL of test item were determined to be 30 mg/kg/day in males and females for repeated dose toxicity. NOAEL of 30 mg/kg/day is selected as starting point.
- AF for dose response relationship:
- 1
- Justification:
- The value of 1 is default for dose descriptor NOAEL.
- AF for differences in duration of exposure:
- 6
- Justification:
- The value of 6 is default for sub-acute study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The default value is 4 for study animal rats.
- AF for other interspecies differences:
- 2.5
- Justification:
- The value of 2.5 is default for interspecies variability - remaining differences in case of no other specific susceptibility differences info available.
- AF for intraspecies differences:
- 10
- Justification:
- The default value is 10 for general population according to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8.
- AF for the quality of the whole database:
- 1
- Justification:
- The default value is 1 for quality of whole database according to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
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:
- 50 µg/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
- Value:
- 30 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
In a Screening for reproductive / developmental toxicity study, NOAEL of test item were determined to be 30 mg/kg/day in males and females for repeated dose toxicity. NOAEL of 30 mg/kg/day is selected as starting point.
- AF for dose response relationship:
- 1
- Justification:
- The value of 1 is default for dose descriptor NOAEL.
- AF for differences in duration of exposure:
- 6
- Justification:
- The value of 6 is default for sub-acute study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The default value is 4 for study animal rats.
- AF for other interspecies differences:
- 2.5
- Justification:
- The value of 2.5 is default for interspecies variability - remaining differences in case of no other specific susceptibility differences info available.
- AF for intraspecies differences:
- 10
- Justification:
- The default value is 10 for general population according to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8.
- AF for the quality of the whole database:
- 1
- Justification:
- The default value is 1 for quality of whole database according to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8.
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.
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