Registration Dossier
Registration Dossier
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EC number: 411-220-5 | CAS number: 134701-20-5 CG 27-145
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.8 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.8 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEC
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.2 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.2 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
1. Identification of relevant dose descriptor
The 90-day oral toxicity study in rats with the test substance was the most representative repeat-dose study performed and is considered as appropriate for DNEL derivation.
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.
3. Correction of dose descriptor
NOAEL (oral) is converted into a NOAEL(corrected)in accordance toGuidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose[concentration]-response for human health, ECHA, May 2008.
Workers: NOAEL (oral) = 50 mg/kg bw =>NOAEL(corrected)=88 mg/m3
4. Application of assessment factors
The following assessment factors were choosen: A correction for differences in metabolic rate per body weight was made by an allometric scaling factor of 4 (except for inhalation). Intraspecies differences account for a factor of 5. For exposure duration a factor of 2 is employed. Overall, an assessment factor of 40 was employed.
5.Selection of the critical DNEL(s)/DMELs and/or qualitative/semi-quantitative descriptor for critical health effects
DNEL- acute, inhalation, systemic:The acute DNELs could not be calculated directly but the long-term DNELs are sufficient to ensure that acute effects do not occur, provided high-peak acute exposure (especially for inhalation) can be avoided.
DNEL- acute, inhalation, local:
Not quantifiable. The long-term DNEL was considered appropriate to apply.
DNEL- acute, dermal, systemic: Not quantifiable; The acute DNELs could not be calculated directly but the long-term DNELs are sufficient to ensure that acute effects do not occur, provided high-peak acute exposure can be avoided. The skin irritation and sensitization potential supposed to be covered by the oral DNEL derived, in addition to the appropriate risk management measures to minimize skin contact.
DNEL- acute, dermal, local:
Not quantifiable
The long-term DNEL was considered appropriate to apply.
DNEL- long-term, inhalation, local:
Not quantifiable and not considered applicable.
DNEL- long-term, inhalation, systemic:
NOAEL (corrected) / Sum of assessment factors applicable
88 mg/kg bw / 10 = 8.8 mg/m3
DNEL- long-term, dermal, systemic:
NOAEL (oral) / Sum of assessment factors applicable
50 mg/kg bw / 40 = 1.25 mg/kg bw
The
dermal route is typically covered by oral route information in the
absence of data for this administration route.
DNEL- long-term, dermal, local:
Not quantifiable and not considered applicable.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.2 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 20
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.2 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 20
- Modified dose descriptor starting point:
- NOAEC
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.6 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 80
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.6 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 80
- Modified dose descriptor starting point:
- NOAEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.6 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 80
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.6 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 80
- Modified dose descriptor starting point:
- NOAEL
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
1. Identification of relevant dose descriptor
The 90-day oral toxicity study in rats with the test substance was the most representative repeat-dose study performed and is considered as appropriate for DNEL derivation.
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.
3. Correction of dose descriptor
NOAEL (oral) is converted into a NOAEL(corrected)in accordance to Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose[concentration]-response for human health, ECHA, May 2008.
General population: NOAEL (oral) = 50 mg/kg bw =>NOAEL(corrected)= 43.5 mg/m3
4. Application of assessment factors
The following assessment factors were choosen: A correction for differences in metabolic rate per body weight was made by an allometric scaling factor of 4 (except for inhalation). Intraspecies differences account for a factor of 10. For exposure duration a factor of 2 is employed. . Overall, an assessment factor of 80 was employed.
5.Selection of the critical DNEL(s)/DMELs and/or qualitative/semi-quantitative descriptor for critical health effects
DNEL- acute, inhalation, systemic:The acute DNELs could not be calculated directly but the long-term DNELs are sufficient to ensure that acute effects do not occur, provided high-peak acute exposure (especially for inhalation) can be avoided.
DNEL- acute, inhalation, local:
Not quantifiable. The long-term DNEL was considered appropriate to apply.
DNEL- acute, dermal, systemic: Not quantifiable; The acute DNELs could not be calculated directly but the long-term DNELs are sufficient to ensure that acute effects do not occur, provided high-peak acute exposure can be avoided.
DNEL- acute, dermal, local:
Not quantifiable.
The long-term DNEL was considered appropriate to apply.
DNEL- long-term, inhalation, local:
Not quantifiable and not considered applicable.
DNEL- long-term, inhalation, systemic:
NOAEL (corrected) / Sum of assessment factors applicable
43 mg/kg bw / 20 = 2.2 mg/m3
DNEL- long-term, dermal, systemic:
NOAEL (oral) / Sum of assessment factors applicable
50 mg/kg bw / 80 = 0.6 mg/kg bw
The
dermal route is typically covered by oral route information in the
absence of data for this administration route.
DNEL- long-term, dermal, local:
Not quantifiable and not considered applicable.
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