Registration Dossier
Registration Dossier
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EC number: 701-308-4 | 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:
- 35.2 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):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 881 mg/m³
- Explanation for the modification of the dose descriptor starting point:
A repeat dose toxicity study via the inhalation route of exposure is not available. Therefore, the NOAEL from a repeat-dose toxicity study via the oral route was used.
NOAEC = oral NOAEL x (1/0.38m3/kg bw/day)x(abs oral/abs inhal) x 0.67
= 1000 x 2.63 x 0.5 x 0.67
= 881.0
DNEL = PoD/AF
= 881/25
= 35.2 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- As the dose descriptor is the NOAEL, the default assessment factor is 1.
- AF for differences in duration of exposure:
- 2
- Justification:
- To account for using PoD taken from a subchronic study to calculate a chronic DNEL.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is usually not applied in the derivation of the inhalation DNEL
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor
- AF for intraspecies differences:
- 5
- Justification:
- To account for intraspecies differences in an occupational setting.
- AF for the quality of the whole database:
- 1
- Justification:
- The database has a good quality, taking into account completeness, consistency and the standard information requirements, therefore the default factor of 1 applies.
- AF for remaining uncertainties:
- 1
- Justification:
- Not applicable.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 35.2 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):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 881 mg/m³
- Explanation for the modification of the dose descriptor starting point:
A repeat dose toxicity study via the inhalation route of exposure is not available. Therefore, the NOAEL from a repeat-dose toxicity study via the oral route was used.
NOAEC = oral NOAEL x (1/0.38m3/kg bw/day)x(abs oral/abs inhal) x 0.67
= 1000 x 2.63 x 0.5 x 0.67
= 881.0
DNEL = PoD/AF
= 881/25
= 35.2 mg/m3
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:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10 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:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
A repeat dose toxicity study via the dermal route of exposure is not available. Therefore, the NOAEL from a repeat-dose toxicity study via the oral route was used .
Dermal N(L)OAEC = oral (N(L)OAEL*( ABSoral/ABSdermal)
= 1000 x (1/1)
DNEL = PoD/AF
= 1000/100
= 10 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- As the dose descriptor is the NOAEL, the default assessment factor is 1.
- AF for differences in duration of exposure:
- 2
- Justification:
- To account for using PoD taken from a subchronic study to calculate a chronic DNEL.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling to account for differences in allometry in using the rat as a test model.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor
- AF for intraspecies differences:
- 5
- Justification:
- To account for intraspecies differences in an occupational setting.
- AF for the quality of the whole database:
- 1
- Justification:
- The database has a good quality, taking into account completeness, consistency and the standard information requirements, therefore the default factor of 1 applies.
- AF for remaining uncertainties:
- 1
- Justification:
- Not applicable.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10 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:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Dermal N(L)OAEC = oral (N(L)OAEL*( ABSoral/ABSdermal)
= 1000 x (1/1)
DNEL = PoD/AF
= 1000/100
= 10 mg/kg bw/day
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
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:
- 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
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
A no hazard conclusion has been identified on the basis that the substance does not enter the public domain.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
The substance does not enter the public domain and therefore DNEL values have not been calculated for the general population
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