Registration Dossier
Registration Dossier
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EC number: 915-748-1 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.7 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:
- NOAEC
- Value:
- 200 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 352.6 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The following correction was made to the NOAEC (oral): Correction respiratory volume rat (8 hour) 1/0.38 m³/kg bw/day, Correction for respiratory volume (worker): 6.7 m³/10 m³. Therefore the corrected NOAEC for repeated-dose systemic effects via the inhalation route is: 200 mg/kg bw/day*(1/0.38) *(6.7 m³/10 m³) = 352.6 mg/m³.
- AF for dose response relationship:
- 1
- Justification:
- A clear NOAEL was established.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default (sub-acute to chronic)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (oral rat to inhaled human)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 5
- Justification:
- Default
- AF for the quality of the whole database:
- 1
- Justification:
- The available studies were conducted according to appropriate OECD test guidelines and in compliance with GLP.
- AF for remaining uncertainties:
- 1
- 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:
- 0.7 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
DNEL for systemic effects via dermal route was determined from 28-day oral NOAEL = 200 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- A clear NOAEL was established.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default (sub-acute to chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default Default (oral rat to dermal human)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 5
- Justification:
- Default
- AF for the quality of the whole database:
- 1
- Justification:
- The available studies were conducted according to appropriate OECD test guidelines and in compliance with GLP.
- AF for remaining uncertainties:
- 1
- 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
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.2 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:
- NOAEC
- Value:
- 200 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 173.9 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The following correction was made to the NOAEL (oral): Correction respiratory volume rat (24 hour) 1/1.15 m³/kg bw. Therefore the corrected NOAEC for repeated-dose systemic effects via the inhalation route is: 200*(1/1.15) = 173.9 mg/m³.
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 6
- Justification:
- Default (sub-acute to chronic)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (oral rat to inhaled human)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 10
- Justification:
- Default
- 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:
- no hazard identified
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:
- 0.3 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
DNEL for systemic effects via oral route determined from 28-day oral NOAEL = 200 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- A clear NOAEL was established.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default (sub-acute to chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (oral rat to oral human)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 10
- Justification:
- Default
- AF for the quality of the whole database:
- 1
- Justification:
- The available studies were conducted according to appropriate OECD test guidelines and in compliance with GLP.
- AF for remaining uncertainties:
- 1
- 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
General Population - Hazard via inhalation route, Infrequent DNELs
Systemic effects
Hazard assessment conclusion
DNEL (Derived No Effect Level) = 6.9 mg/m³
Route of original study: Oral
DNEL derivation method: ECHA REACH Guidance
Overall assessment factor (AF) = 25
Dose descriptor starting point: NOAEC = 200 mg/m³
Modified dose descriptor starting point: NOAEC = 173.9 mg/m³
Explanation for the modification of the dose descriptor starting point
The following correction was made to the NOAEC (oral): Correction respiratory volume rat (24 hour)
1/1.15 m³/kg bw/day. Therefore the corrected NOAEC for repeated-dose systemic effects via the inhalation route is: 200 mg/kg bw/day*(1/1.15) = 173.9 mg/m³.
Assessment Factors
AF for dose response relationship = 1 (Default)
AF for differences in duration of exposure = 1 (Default, infrequent exposure)
AF for interspecies differences (allometric scaling) = 1 (Default, oral rat to inhaled human)
AF for other interspecies differences = 2.5 (Default)
AF for intraspecies differences = 10 (Default, general population)
AF for the quality of the whole database = 1 (Default)
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