Registration Dossier
Registration Dossier
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EC number: 204-337-6 | CAS number: 119-61-9
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.7 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):
- 37.5
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 26.4 mg/m³
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.1 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):
- 150
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 15 mg/kg bw/day
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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
DNEL Long-term – dermal, systemic effects
Relevant dose descriptor for the endpoint concerned: LOAEL of 15 mg/kg bw/d in male and female rats in a 2 year carcinogenicity study (NTP, 2006)
Assessment factors relating to the extrapolation procedure:
Interspecies: 4 (allometric scaling) and 2.5 (remaining differences)
Intraspecies: 5 (worker)
Time extrapolation: no correction necessary (chronic study)
Route to route extrapolation: 1 (oral to dermal)
Dose-response: 3 (LOAEL to NOAEL)
Quality of whole database: sufficient (no correction necessary)
Overall assessment factor: 4 * 2.5 * 5 * 1 * 3 = 150
DNEL long-term– dermal, systemic effects: 15 mg/kg bw/d ÷ 150 = 0.1 mg/kg bw/d
DNEL Long-term–inhalation, systemic effects
Relevant dose descriptor for the endpoint concerned: LOAEL of 15 mg/kg bw/d in male and female rats in a 2 year carcinogenicity study (NTP, 2006)
Correction of starting point:
Bioavailability: complete absorption is assumed (no correction necessary)
Route of exposure (oral vs. inhalation exposure): complete absorption assumed (no correction necessary)
Differences in respiratory volumes: respiratory volume of the rat in 8 h corresponds to 0.38 m3/kg bw, additional correction for the higher standard respiratory volumes of workers compared to resting persons: correction factor = (1 ÷ 0.38) * (6.7 ÷ 10) = 1.76
Overall correction factor: 1.76
Corrected starting point: 15 * 1.76 = 26.4 mg/m3
Assessment factors relating to the extrapolation procedure:
Interspecies: 2.5 (remaining differences)
Intraspecies: 5 (worker)
Time extrapolation: no correction necessary
Dose-response: 3 (LOAEL to NOAEL)
Quality of whole database: sufficient (no correction necessary)
Overall assessment factor: 2.5 * 5 * 3 = 37.5
DNEL Long-term–inhalation, systemic effects: 26.4 mg/m3 ÷ 37.5 = 0.7 mg/m3
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.17 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
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 13 mg/m³
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.05 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
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 15 mg/kg bw/day
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
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.05 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
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 15 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
DNEL Long-term – dermal, systemic effects
Relevant dose descriptor for the endpoint concerned: LOAEL of 15 mg/kg bw/d in male and female rats in a 2 year carcinogenicity study (NTP, 2006)
Assessment factors relating to the extrapolation procedure:
Interspecies: 4 (allometric scaling) and 2.5 (remaining differences)
Intraspecies: 10 (general population)
Time extrapolation: no correction necessary (chronic study)
Route to route extrapolation: 1 (oral to dermal)
Dose-response: 3 (LOAEL to NOAEL)
Quality of whole database: sufficient (no correction necessary)
Overall assessment factor: 4 * 2.5 * 10 * 1 * 3 = 300
DNEL long-term– dermal, systemic effects: 15 mg/kg bw/d ÷ 300 = 0.05 mg/kg bw/d
DNEL Long-term–inhalation, systemic effects
Relevant dose descriptor for the endpoint concerned: LOAEL of 15 mg/kg bw/d in male and female rats in a 2 year carcinogenicity study (NTP, 2006)
Correction of starting point:
Bioavailability: complete absorption is assumed (no correction necessary)
Route of exposure (oral vs. inhalation exposure): complete absorption assumed (no correction necessary)
Differences in respiratory volumes: respiratory volume of the rat in 24 h corresponds to 1.15 m3/kg bw, correction factor 1 ÷ 1.15 = 0.87
Overall correction factor: 0.87
Corrected starting point: 15 * 0.87 = 13 mg/m3
Assessment factors relating to the extrapolation procedure:
Interspecies: 2.5 (remaining differences)
Intraspecies: 10 (general population)
Time extrapolation: no correction necessary
Dose-response: 3 (LOAEL to NOAEL)
Quality of whole database: sufficient (no correction necessary)
Overall assessment factor: 2.5 * 10 * 3 = 75
DNEL Long-term–inhalation, systemic effects: 13 mg/m3 ÷ 75 = 0.17 mg/m3
DNEL Long-term - oral, systemic effects
Relevant dose descriptor for the endpoint concerned: LOAEL of 15 mg/kg bw/d in male and female rats in a 2 year carcinogenicity study (NTP, 2006)
Correction of starting point:
Bioavailability: complete absorption is assumed (no correction necessary)
Route of exposure: similar to general population (no correction necessary)
Exposure conditions: oral uptake via food in humans compared to application via diet (no correction necessary)
Assessment factors relating to the extrapolation procedure:
Interspecies: 4 (allometric scaling) and 2.5 (remaining differences)
Intraspecies: 10 (general population)
Time extrapolation: no correction necessary
Dose-response: 3 (LOAEL to NOAEL)
Quality of whole database: sufficient (no correction necessary)
Overall assessment factor: 4 * 2.5 * 10 * 3 = 300
DNEL long-term– dermal, systemic effects: 15 mg/kg bw/d ÷ 300 = 0.05 mg/kg bw/d
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