Registration Dossier
Registration Dossier
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EC number: 941-379-0 | CAS number: -
Toxicological Summary
Administrative data
Workers - 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
Workers - 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:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
| Effect | Route | DNEL | Dose Descriptor | Modified Dose Descriptor and Assessment Factors | |
| Acute Exposure | Systemic | Dermal | (a) | ||
| Inhalation | (a) | ||||
| Local | Dermal | (b) | |||
| Inhalation | (a) | ||||
| Long-Term Exposure | Systemic | Dermal | (a) | ||
| Inhalation | (a) | ||||
| Local | Dermal | (b) | |||
| Inhalation | (a) |
a) No hazard identified for this route (data available)
b) The data do not allow setting a DNEL.
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
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 19 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: REACH guidance with modification of some factors
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 750 mg/kg bw/day
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
| Effect | Route | DNEL | Dose Descriptor | Modified Dose Descriptor and Assessment Factors | |
| Acute Exposure | Systemic | Dermal | (a) | ||
| Inhalation | (a) | ||||
| Local | Dermal | (b) | |||
| Inhalation | (a) | ||||
| Long-Term Exposure | Systemic | Dermal | (a) | ||
| Inhalation | (a) | ||||
| Oral | 19 mg/kg/24h | 750 mg/kg (NOAEL – 21-week daily oral gavage study based on significant decrease in body weight for females (deemed biologically meaningful) | No modification of dose descriptor was needed since study incorporated daily exposures. A total assessment factor of 40 was applied for inter- and intraspecies differences and for overall duration of exposure. | ||
| Local | Dermal | (b) | |||
| Inhalation | (a) |
a) No hazard identified for this route (data available)
b) The data do not allow setting a DNEL.
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