Registration Dossier
Registration Dossier
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EC number: 203-632-7 | CAS number: 108-95-2
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8 mg/m³
Acute/short term exposure
- Hazard assessment conclusion:
- medium 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:
- DNEL (Derived No Effect Level)
- Value:
- 16 mg/m³
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.23 mg/kg bw/day
DNEL related information
- Overall assessment factor (AF):
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - workers
Worker-DNEL long-term for dermal route-systemic
Relevant dose-descriptor for the endpoint concerned:OEL of 8 mg/m3 (SCOEL/SUM/16, 2003)
Correction of starting point:
Route of exposure (inhalation versus dermal exposure): OEL of 8 mg/m3 is converted to 80 mg/person/day assuming a breathing volume of 10 m3 in workers.
Similar exposure conditions (occupational exposure during 8 h shift).
Average person weight of 65 kg
8 mg/m3 x 10 m3/d /65 kg= 1.23 mg/kg bw/d
Assessment factors relating to the extrapolation procedure:
Assessment factors have been included in derivation of OEL, therefore no further assessment factor
Overall assessment factor: 1
DNEL worker long-term dermal systemic = 1.23 mg/kg bw/day
Worker-DNEL long-term for inhalation route-systemic
Relevant dose-descriptor for the endpoint concerned: SCOEL (2003) used the 90 day NOAEC of 5 ppm (20 mg/m3) (Sandage, 1961). “Although this was a well-designed and wide-ranging study, the SCOEL felt that limited reporting of results, especially regarding irritation of the upper respiratory tract, was a difficulty. However, no significant systemic toxicity seems likely to have been produced in any of the three species at this level.”
This approach by SCOEL was supported by the Hoffmann et al. 2001 subacute inhalation study which specifically addressed local effects in the respiratory tract and concluded on a NOAEC of 96 mg/m3.
Assessment factors relating to the extrapolation procedure:
According to SCOEL, an uncertainty factor of 2 was applied to allow for the absence of human data, but taking into account a 24h/d exposure of monkeys. Taking into account the preferred value approach, an 8-hour TWA of 2 ppm (7.8 mg/m3) is recommended. [5ppm/2 =2 ppm, rounded]
DNEL worker long-term inhalation systemic = 7.8 mg/m3 (2 ppm)
Worker-DNEL acute for inhalation route-local
According to SCOEL, it was judged that ais required to protect against upper respiratory tract irritation. There are no human data to suggest a particular value for the, but on the basis of animal data a STEL (15 min) of 4 ppm was recommended.
DNEL worker acute inhalation local: 15.6 mg/m3 (4 ppm)
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.452 mg/m³
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- BMDL10
- Value:
- 52 mg/kg bw/day
- Modified dose descriptor starting point:
- BMCL10
- Value:
- 45.2 mg/m³
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
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:
- exposure based waiving
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.5 mg/kg bw/day
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- BMDL10
- Value:
- 52 mg/kg bw/day
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.5 mg/kg bw/day
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- BMDL10
- Value:
- 52 mg/kg bw/day
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - General Population
General population -DNEL long-term for inhalation route-systemic
Relevant dose-descriptor for the endpoint concerned: based on on BMDL10 of 52 mg/kg bw/day for reduced body weight gain in females
Correction of starting point:
route-to-route extrapolation general population: 1.15m3/kg bw/day = factor 1/1.15 => 52 mg/kg bw/day 1/1.15m3/kg bw/day = 45.2 mg/m3
Assessment factors relating to the extrapolation procedure:
Interspecies differences: 10
Intraspecies differences: 10
Overall assessment factor: 100
DNEL general population long-term inhalation systemic = 0.452 mg/m3
General population -DNEL long-term for dermal route-systemic
Relevant dose-descriptor for the endpoint concerned: based on on BMDL10 of 52 mg/kg bw/day for reduced body weight gain in females
Assessment factors relating to the extrapolation procedure:
Interspecies differences: 10
Intraspecies differences: 10
Overall assessment factor: 100
DNEL general population chronic dermal systemic: 0.5 mg/kg bw/day (equal to TDI of 0.5 from EFSA 2013)
General population-DNEL long-term for oral route-systemic
Relevant dose-descriptor for the endpoint concerned: based on on BMDL10 of 52 mg/kg bw/day for reduced body weight gain in females
Assessment factors relating to the extrapolation procedure:
Interspecies differences: 10
Intraspecies differences: 10
Overall assessment factor: 100
DNEL general population long-term oral systemic: 0.5 mg/kg bw/day (equal to TDI of 0.5 from EFSA 2013)
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