Registration Dossier
Registration Dossier
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EC number: 204-727-6 | CAS number: 125-12-2
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 13.22 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Dose descriptor starting point:
- NOAEL
- Value:
- 15 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Explanation for the modification of the dose descriptor starting point:
Taking NOAEL of 15 mg/kg/day from a repeat dose toxicity rat study as a starting point, and assuming 100% absorption, critical exposures levels are as follows:
For workers: DNEL= 13.22mg/m3
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 26.45 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Dose descriptor starting point:
- NOAEL
- Value:
- 15 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
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:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.15 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):
- 100
- Dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.3 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEL
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
A.- ACUTE TOXICITY:
Oral exposure. Systemic effects
Starting point for acute oral effects is NOAEL=15 mg/kg/day derived from repeat dose toxicity report. Assessment factors are to be applied as follows:
(1) the allometric scaling factor for the rat is 4;
(2) a default factor of 2.5 accounts for additional interspecies differences;
(3) for intraspecies differences (workers) the default factor is 5, for consumers is 10
Dermal exposure. Systemic effects
Starting point for systemic effects is oral repeat dose toxicity test were NOAEL= 15 mg/kg/day. Assessment factors are to be applied as follows:
(4) the allometric scaling factor for the rat is 4;
(5) a default factor of 2.5 accounts for additional interspecies differences;
(6) for intraspecies differences (workers) the default factor is 5,
Inhalatory exposure. Systemic effects
Taking acute oral toxicity as a starting point, and assuming 100% absorption, critical exposures levels are as follows:
For workers: DNEL= 13.22mg/m3
B.- REPEAT DOSE TOXICITY:Systemic effects
Dermal exposure
Dermal risk assessment is based on the oral NOAEL of 15 mg/kg/day from the repeat dose toxicity test. The worst case (100% absorption) was assumed.
The following adjustment factors are applied for the identification of the reference MOS:
(1) for duration adjustment a factor of 2 is used,
(2) the allometric scaling factor for the rat is 4;
(3) a default factor of 2.5 accounts for additional interspecies differences;
(4) for intraspecies differences (workers) the default factor is 5,
This gives a reference MOS of 100 for workers (2x 4 x 2.5 x 5). DNELsyst.Dermal route is established in 1.15 mg/kg/day (workers).
Oral exposure
Starting point is NOAEL of 15 mg/kg/day from a repeat dose toxicity rat study. Assuming 100% absorption and the AF described above, critical exposure levels are as follows:
Workers: 15/100= 0.15 mg/kg/day
Inhalatory exposure
The same starting point is taken as previous calculations.
For workers: DNEL= 13.22 mg/ m3
C. SKIN IRRIRATION
The substance is not classified as skin irritant according to CLP but is R38 based on D. 67/548 criteria
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 13.04 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 1.15
- Modified dose descriptor starting point:
- LOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 13.04 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 1.15
- Modified dose descriptor starting point:
- NOAEC
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:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.075 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Modified dose descriptor starting point:
- LOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.15 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Modified dose descriptor starting point:
- NOAEL
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:
- 0.075 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- LOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.152 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
Oral exposure. Systemic effects
Starting point for acute oral effects is NOAEL=15 mg/kg/day derived from repeat dose toxicity report. Assessment factors are to be applied as follows:
(1) the allometric scaling factor for the rat is 4;
(2) a default factor of 2.5 accounts for additional interspecies differences;
(3) for intraspecies differences the factor for consumers is 10
For consumers: DNEL= 0.15 mg/kg/day
Dermal exposure. Systemic effects
Starting point for systemic effects is oral repeat dose toxicity test were NOAEL= 15 mg/kg/day. Assessment factors are to be applied as follows:
(4) the allometric scaling factor for the rat is 4;
(5) a default factor of 2.5 accounts for additional interspecies differences;
(6) for intraspecies differences the factor for consumers is 10
For consumers: DNEL= 0.15 mg/kg/day
Inhalatory exposure. Systemic effects
Taking acute oral toxicity as a starting point, and assuming 100% absorption, critical exposures levels are as follows:
For consumers: DNEL= 13.04mg/ m3
B.- REPEAT DOSE TOXICITY:Systemic effects
Dermal exposure
Dermal risk assessment is based on the oral NOAEL of 15 mg/kg/day from the repeat dose toxicity test. The worst case (100% absorption) was assumed.
The following adjustment factors are applied for the identification of the reference MOS:
(1) for duration adjustment a factor of 2 is used,
(2) the allometric scaling factor for the rat is 4;
(3) a default factor of 2.5 accounts for additional interspecies differences;
(4) for intraspecies differences (consumers) the default factor is 10,
This gives a reference MOS of 200 for consumers (2 x 4 x 2.5 x 10). DNELsyst. Dermal route is established in 1.35 mg/kg/day (consumers).
Oral exposure
Starting point is NOAEL of 15 mg/kg/day from a repeat dose toxicity rat study. Assuming 100% absorption and the AF described above, critical exposure levels are as follows:
Consumers: 15/200= 0.075 mg/kg/day
Inhalatory exposure
Same starting point is taken as previous calculations.
For consumers: DNEL= 13.04mg/ m3
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