Registration Dossier
Registration Dossier
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EC number: 203-828-2 | CAS number: 111-05-7
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.35 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:
- LOAEL
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 176.3 mg/m³
- Explanation for the modification of the dose descriptor starting point:
In a 90 days toxicity study by oral route (OECD 408), groups of 20 rats were exposed daily to 100, 300, 1000 mg/kg bw per day for 90 days. The male gender seems to more sensitive than female. Taken into consideration the mortality and similar effects as those seen at the highest dose in a single male at 100 mg/kg, the No Observed Adverse Effect Level (NOAEL) was not determined in males (LOAEL systemic effects for males, 90d = 100 mg/kg). In females, the NOAEL corresponds to 300 mg/kg.
Step 1) Relevant dose-descriptor: LOAEL, rat = 100 mg/kg bw per day
Step 2) Modification of starting point - Conversion into inhalation NOAEC (in mg/m³) by using an 8-hour respiratory volume for the rat: 0.38 m³/kg bw - Correction for activity driven differences of respiratory volumes in workers compared to workers in rest: 6.7 m³/10 m³ - Correction for inhalation to oral absorption: no factor is added. Justification: the test substance has a low volatility (vapour pressure of less than 0.00005 Pa). - No difference in oral and inhalation absorption is expected between rats and human. LOAEC corrected = 100*1/0.38*6.7/10 = 176.3 mg/m³
- AF for dose response relationship:
- 3
- Justification:
- LOAEL value available
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- inhalation study
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
- Justification:
- workers
- AF for the quality of the whole database:
- 1
- Justification:
- GLP OECD study
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.33 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:
- LOAEL
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
In a 90 days toxicity study by oral route (OECD 408), groups of 10 rats were exposed daily to 100, 300, 1000 mg/kg bw per day for 90 days. The male gender seems to more sensitive than female. Taken into consideration the mortality and similar effects as those seen at the highest dose in a single male at 100 mg/kg, the No Observed Adverse Effect Level (NOAEL) was not determined in males (LOAEL systemic effects for males, 90d = 100 mg/kg). In females, the NOAEL corresponds to 300 mg/kg.
Step 1) Relevant dose-descriptor: LOAEL, rat = 100 mg/kg bw per day
Step 2) As no dermal penetration study is available, we will consider 100% absorption as a worst case. No difference in oral and dermal absorption is expected between rats and humans.
- AF for dose response relationship:
- 3
- Justification:
- LOAEL value available
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
- Justification:
- workers
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no DNEL required: short term exposure controlled by conditions for long-term
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
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