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Registration Dossier
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EC number: 203-905-0 | CAS number: 111-76-2
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 98 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 091 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: see discussion below and attached documentation to this record
- Overall assessment factor (AF):
- 9
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 9 824 mg/m³
- Explanation for the modification of the dose descriptor starting point:
An acute inhalation DNEL needs to be derived as the substance is classified for acute toxicity by the inhalation route. No suitable data is available, therefore a value for the systemic route therefore a value is derived by route to route extrapolation from the a LOAEL is based on the data from human poisoning incidents by the oral route. Of those values reported, the lowest estimated dose was 400mg/kg, which produced adverse but reversible symptoms. Route to route extrapolation can then be performed as shown:
Assume 5m3 inhaled over 4hrs exposure - half of normal workday exposure estimate of 10m3 over 8hrs, table R.8 -2, 57% absorption efficiency, 70kg worker = 9824mg/m3. (=400x70/5/0.57) (Inhalation absorption efficiency based on work of Johansson, 1986 - see chapter 7.1.1) Note that the theoretical inhalation figure used as the starting poin is above the saturated vapour concentration.
- AF for dose response relationship:
- 3
- Justification:
- LOAEL to NOAEL extrapolation
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not required, human data
- AF for other interspecies differences:
- 1
- Justification:
- not required, human data
- AF for intraspecies differences:
- 3
- Justification:
- See document attached to this record.
- AF for the quality of the whole database:
- 1
- Justification:
- default
- AF for remaining uncertainties:
- 1
- Justification:
- default
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 246 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
- Route of original study:
- Dermal
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:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 59 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 426 mg/m³
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- DNEL derivation method:
- other: see discussion below and attached documentation to this record
- Overall assessment factor (AF):
- 15
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 12 760 mg/m³
- Explanation for the modification of the dose descriptor starting point:
An acute inhalation DNEL needs to be derived as the substance is classified for acute toxicity by the inhalation route. No suitable data is available, therefore a value for the systemic route therefore a value is derived by route to route extrapolation from the a LOAEL is based on the data from human poisoning incidents by the oral route. Of those values reported, the lowest estimated dose was 400mg/kg, which produced adverse but reversible symptoms. Route to route extrapolation can then be performed as shown:
Assume 3.33m3 inhaled over 4hrs exposure - one sixth of consumer exposure estimate of 20m3 over 24hrs, table R-8.2, 57% absorption efficiency, 60kg consumer = 12760mg/m3. (=400x60/3.3/0.57) (Inhalation absorption efficiency based on work of Johansson, 1986 - see chapter 7.1.1) Note that this starting point is well in excess of the saturated vapour concentration.
- AF for dose response relationship:
- 3
- Justification:
- LOAEL->NOAEL
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not required, human data
- AF for other interspecies differences:
- 1
- Justification:
- not required, human data
- AF for intraspecies differences:
- 5
- Justification:
- See attached document
- AF for the quality of the whole database:
- 1
- Justification:
- default
- AF for remaining uncertainties:
- 1
- Justification:
- default
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 147 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
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:
- medium 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:
- 6.3 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- other: see discussion below and attached documentation to this record
- Overall assessment factor (AF):
- 10.9
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 69 mg/kg bw/day
- AF for dose response relationship:
- 3
- Justification:
- LOAEL to NOAEL. There is evidence to suggest that the NOAEL is only a little less than the LOAEL
- AF for differences in duration of exposure:
- 1
- Justification:
- No factor is used for study length as the data shows that the severity of effect does not increase from 90 days to lifetime exposure.
- AF for interspecies differences (allometric scaling):
- 7.2
- Justification:
- For the oral route, the LOAEL (69mg/kg from the NTP key repeat dose oral study in mice - see chapter 7.5.1) is equivalent to a human dose of 9.5mg/kg (based on extrapolation using the PBPK model - see chapter 7.1.1 of IUCLID). This accounts for toxicokinetic effects. This is converted into an allometric scaling factor of 7.25
- AF for other interspecies differences:
- 0.1
- Justification:
- based on lower sensitivity of humans to key effect of haemolysis. See IUCLID chapter 7.9.3.
- AF for intraspecies differences:
- 5
- Justification:
- See document attached to this record
- 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:
- DNEL (Derived No Effect Level)
- Value:
- 26.7 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: see discussion below and attached documentation to this record
- Overall assessment factor (AF):
- 15
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 400 mg/kg bw/day
- AF for dose response relationship:
- 3
- Justification:
- LOAEL to NOAEL
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not required, human data
- AF for other interspecies differences:
- 1
- Justification:
- not required, human data
- AF for intraspecies differences:
- 5
- Justification:
- See document attached to this record
- AF for the quality of the whole database:
- 1
- Justification:
- default
- AF for remaining uncertainties:
- 1
- Justification:
- default
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
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