Registration Dossier
Registration Dossier
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EC number: 207-529-8 | CAS number: 479-27-6
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Dose descriptor starting point:
- NOAEC
- Value:
- 75 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Inhalation –
Starting point.NOAEC 394 mg/m3(local), NOAEC 75 mg/m3(systemic).
Assessment factors:
Rote to route
Duration
Allometric
Population
Data base
Residual differences
Overall AF
1
12
1
5 (10)
1
2.5
150
Inhal to inhal
Sub-acute to chronic (6) and 5 days to sub-acute (2)
Not needed for inhal
Workers (Public)
Klimisch 1
(300 Public)
Long-term DNEL for Workers inhal systemic = 75/150 = 0.5 mg/m3
Long-term DNEL for Workers inhal local = 394/150 = 2.63 mg/m3
Long-term DNEL for Public inhal systemic = 75/300 = 0.25 mg/m3
Long-term DNEL for Public inhal local = 394/300 = 1.3 mg/m3
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 12.5 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 12.5
- Dose descriptor starting point:
- NOAEC
- Explanation for the modification of the dose descriptor starting point:
Inhalation – LC50 >877 mg/m3 (highest dose), No effects at lowest dose, 156 mg/m3 (NOAEC).
Starting point. NOAEC 156 mg/m3.
Assessment factors:
Rote to route
Duration
Allometric
Population
Data base
Residual differences
Overall AF
1
1
1
5 (10)
1
2.5
12.5
Inhal to inhal
Acute to acute
Not needed for inhal
Workers (Public)
Klimisch 1
(25 Public)
Short-term DNEL for Workers inhal systemic and local = 156/12.5 = 12.5 mg/m3
Short-term DNEL for Public inhal systemic and local = 156/25 = 6.2 mg/m3
- AF for dose response relationship:
- 1
- AF for interspecies differences (allometric scaling):
- 1
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 1
- AF for remaining uncertainties:
- 2.5
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.63 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Dose descriptor:
- NOAEC
- Value:
- 394 mg/m³
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 12.5 mg/m³
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 12.5
- Dose descriptor starting point:
- NOAEC
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.25 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):
- 30
- Dose descriptor starting point:
- NOAEL
- Explanation for the modification of the dose descriptor starting point:
Dermal.
Starting point. Provisional results from 28-day oral study indicate effects seen at 75, 150 and 300 mg/kg bw/day but effects not reported for low dose, 37.5 mg/kg bw/day. Therefore, as a starting point the 37.5 mg/kg bw/day for the acute (28-day repeat dose) study is estimated to be the oral NOAEL.
There are no repeat dose data for dermal dose. For acute dosing, no signs of systemic poisoning were observed and no skin changes were seen when the substance was dermally dosed at 2000 mg/kg (single dose). However, signs of intoxication were seen when orally dosed at 200 mg/kg bw (single dose), 10-fold less, which would imply that the substance does not penetrate the skin to become bioavailable. As such, a dermal absorption factor of 10% is assumed.
Assessment factors:
Rote to route
Duration
Allometric
Population
Data base
Residual differences
Overall AF
0.1
6
4
5
1
2.5
30
Oral to dermal
Sub-acute to chronic
Rat to Human
Workers
Klimisch 1
Long-term DNEL for Workers dermal systemic and local = 37.5/30 = 1.25 mg/kg bw
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
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.25 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Dose descriptor starting point:
- NOAEC
- Value:
- 75 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Inhalation –
Starting point.NOAEC 394 mg/m3(local), NOAEC 75 mg/m3(systemic).
Assessment factors:
Rote to route
Duration
Allometric
Population
Data base
Residual differences
Overall AF
1
12
1
5 (10)
1
2.5
150
Inhal to inhal
Sub-acute to chronic (6) and 5 days to sub-acute (2)
Not needed for inhal
Workers (Public)
Klimisch 1
(300 Public)
Long-term DNEL for Workers inhal systemic = 75/150 = 0.5 mg/m3
Long-term DNEL for Workers inhal local = 394/150 = 2.63 mg/m3
Long-term DNEL for Public inhal systemic = 75/300 = 0.25 mg/m3
Long-term DNEL for Public inhal local = 394/300 = 1.3 mg/m3
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 6.2 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEC
- Value:
- 156 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Inhalation – LC50 >877 mg/m3 (highest dose), No effects at lowest dose, 156 mg/m3 (NOAEC).
Starting point. NOAEC 156 mg/m3.
Assessment factors:
Rote to route
Duration
Allometric
Population
Data base
Residual differences
Overall AF
1
1
1
5 (10)
1
2.5
12.5
Inhal to inhal
Acute to acute
Not needed for inhal
Workers (Public)
Klimisch 1
(25 Public)
Short-term DNEL for Workers inhal systemic and local = 156/12.5 = 12.5 mg/m3
Short-term DNEL for Public inhal systemic and local = 156/25 = 6.2 mg/m3
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.3 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Dose descriptor:
- NOAEC
- Value:
- 394 mg/m³
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 6.2 mg/m³
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEC
- Value:
- 156 mg/m³
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.625 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):
- 60
- Dose descriptor starting point:
- NOAEL
- Explanation for the modification of the dose descriptor starting point:
Dermal.
Starting point. Provisional results from 28-day oral study indicate effects seen at 75, 150 and 300 mg/kg bw/day but effects not reported for low dose, 37.5 mg/kg bw/day. Therefore, as a starting point the 37.5 mg/kg bw/day for the acute (28-day repeat dose) study is estimated to be the oral NOAEL.
There are no repeat dose data for dermal dose. For acute dosing, no signs of systemic poisoning were observed and no skin changes were seen when the substance was dermally dosed at 2000 mg/kg (single dose). However, signs of intoxication were seen when orally dosed at 200 mg/kg bw (single dose), 10-fold less, which would imply that the substance does not penetrate the skin to become bioavailable. As such, a dermal absorption factor of 10% is assumed.
Assessment factors:
Rote to route
Duration
Allometric
Population
Data base
Residual differences
Overall AF
0.1
6
4
5 (10)
1
2.5
30 (60)
Oral to dermal
Sub-acute to chronic
Rat to Human
Workers (Population)
Klimisch 1
Long-term DNEL for Workers dermal systemic = 37.5/30 = 1.25 mg/kg bw
Long-term DNEL for GP dermal systemic = 37.5/60 = 0.625 mg/kg bw
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:
- 0.062 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 37.5 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Oral
Starting point. There was an NOAEL reported of 5 mg/kg bw/day from a 14-day repeat dose study as effects were noted at 50 mg/kg bw/day.
Provisional results from 28-day study indicate effects seen at 75, 150 and 300 mg/kg bw/day but effects not reported for low dose, 37.5 mg/kg bw/day. Therefore, as a starting point the 37.5 mg/kg bw/day for the acute (28-day repeat dose) study is estimated to be the NOAEL.
Assessment factors:
Rote to route
Duration
Allometric
Population
Data base
Residual differences
Overall AF
1
6
4
5 (10)
1
2.5
300 (600)
Oral to oral
Sub-acute to chronic(6)
Rat to Human
Workers (GP)
Klimisch 1
Long-term DNEL for Workers oral systemic and local = 37.5/300 = 0.125 mg/kg bw
Long-term DNEL for GP oral systemic and local = 37.5/600 = 0.0625 mg/kg bw
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.67 mg/kg bw/day
- Most sensitive endpoint:
- acute 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
- Value:
- 67 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Oral – LD50 591 mg/kg and intoxication at 200 mg/kg bw (lowest dose).
Starting point. As there was not an NOEL established and effects were seen at 200 mg/kg bw (LOAEL), therefore a NOAEL of 3/10 of 200 mg/kg bw is estimated, 67 mg/kg bw.
Assessment factors:
Rote to route
Duration
Allometric
Population
Data base
Residual differences
Overall AF
1
1
4
5 (10)
1
2.5
50 (100)
Oral to oral
Acute to acute
Rat to Human
Workers (GP)
Klimisch 1
Default
Short-term DNEL for Workers oral systemic and local = 67/50 = 1.34 mg/kg bw
Short-term DNEL for GP oral systemic and local = 67/100 = 0.67 mg/kg bw
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
