Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 204-814-9 | CAS number: 126-96-5
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 116.4 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 232.7 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Modified dose descriptor starting point:
- NOAEC
Local effects
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.32 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.64 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEL
Workers - Hazard for the eyes
Additional information - workers
A.- ACUTE TOXICITY:
Oral exposure. Systemic effects
Starting point for acute oral effects is NOAEL=132 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
For workers: DNEL= 2.64 mg/kg/day
Dermal exposure. Systemic effects
Starting point for systemic effects is oral repeat dose toxicity test were NOAEL= 132 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,
For workers: DNEL= 2.64 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 workers: DNEL= 232.7mg/m3
B.- SKIN IRRITATION
No effects on skin irritation have been reported. Therefore this hazard is of no concern.
C.- REPEAT DOSE TOXICITY: Systemic effects
Dermal exposure
Dermal risk assessment is based on the oral NOAEL of 132 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 1.32 mg/kg/day (workers).
Oral exposure
Starting point is NOAEL of 132 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: 132/100= 1.32 mg/kg/day
Inhalatory exposure
The same starting point is taken as previous calculations.
For workers: DNEL= 116.4mg/m3
C.- REPRODUCTIVE
Oral exposure
Starting point is NOAELmaternal tox.= 665.5 mg/kg/day The same NOEAL was stablished for reproductive effects.
The following adjustment factors are applied for the identification of the reference MOS:
(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,
Overall the reference MOS is 50 (4 x 2.5 x 5). The respective critical dermal exposure level at the workplace is identified as DNEL =13.31 mg /kg/day for workers.
For DNELdevelopment=23.7mg/kg/bw.
Dermal exposure
Same starting point and same AF were used for deriving DNELs. Worst case of 100% absorption was assumed.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 57.4 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 1.15
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 114.8 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
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.66 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.32 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 via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.66 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.32 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
Additional information - General Population
A.- ACUTE TOXICITY:
Oral exposure.Systemic effects
Starting point for acute oral effects is NOAEL=132 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= 1.32 mg/kg/day
Dermal exposure. Systemic effects
Starting point for systemic effects is oral repeat dose toxicity test were NOAEL= 132 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= 1.32 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= 114.8mg/ m3
B.- SKIN IRRITATION
No effects on skin irritation have been reported. Therefore this hazard is of no concern.
C.- REPEAT DOSE TOXICITY: Systemic effects
Dermal exposure
Dermal risk assessment is based on the oral NOAEL of 132 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 0.66 mg/kg/day (consumers).
Oral exposure
Starting point is NOAEL of 132 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: 132/200= 0.66 mg/kg/day
Inhalatory exposure
Same starting point is taken as previous calculations.
For consumers: DNEL= 57.4mg/ m3
C.- REPRODUCTIVE
Oral exposure
Starting point is NOAELmaternal tox= 665.5 mg/kg/day Thesame NOEAL was stablished for reproductive effects.
The following adjustment factors are applied for the identification of the reference MOS:
(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 (consumers) the default factor is 10,
Overall the reference MOS is 50 (4 x 2.5 x 10). The respective critical dermal exposure level at the workplace is identified as DNEL =6.65 mg /kg/day for workers.
For DNELdevelopment=11.85mg/kg/bw.
Dermal exposure
Same starting point and same AF were used for deriving DNELs. Worst case of 100% absorption was assumed.
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.
