Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 285-206-0 | CAS number: 85049-36-1
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 6.96 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 75
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
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:
- 10 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
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
Acute toxicity
The guidance on dose/concentration response regarding human health (section R8.1.2.5 of chapter R.8 of the Guidance on Information Requirements and Chemical Safety Assessment) indicates that acute DNELs do not need to be calculated for substances that are not classified for an acute toxicity hazard. As this substance is not classified for acute toxicity hazards, no acute DNELs need to be calculated.
Local effects
Since no local effects were described, the DNELs are based on the systemic effects only.
LONG -TERM DNEL
The long-term DNEL is based on the most critical NOAEL seen in the repeated/ reproduction study with a NOAEL of 1000 mg/kg.
long-term DNEL for the inhalation route (systemic effects, route to-route extrapolation) =
1000 * (1/ sRV(a) * 0.67 (b) )
--------------------------------------------------------------------------------------------------------------------------- =
25 (c)
1000* (1/ 0.384) * 0.67
-------------------------------------------------------- = .6.96 mg/m325
(a) Standard respiratory volume (sRV) rat:0.384 m3/kg
(b) correction for worker respiratory volume (conservative default for route to route)
(c)interspecies (without allometric scaling) * intraspecies * correction for duration: (2.5 * 5 * 2 )
long-term DNEL for the dermal route (systemic effects, route to-route extrapolation)
1000 *1 (a) / 4*2.5*5 (b) *2 (c) = 10 mg/kg bw/day
(a) route to route extrapolation oral to dermal
(b) assessment factors (interspecies * intraspecies (4*2.5) * 5)
(c) Correction for duration from subacute to chronic (2)
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 23 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
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:
- 5 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
DNEL related information
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5 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
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
Acute toxicity
The guidance on dose/concentration response regarding human health (section R8.1.2.5 of chapter R.8 of the Guidance on Information Requirements and Chemical Safety Assessment) indicates that acute DNELs do not need to be calculated for substances that are not classified for an acute toxicity hazard. As this substance is not classified for acute toxicity hazards, no acute DNELs need to be calculated.
Local effects
Since no local effects were described, the DNELs are based on the systemic effects only.
LONG -TERM DNEL
The long-term DNEL is based on the most critical NOAEL seen in the repeated/ reproduction studywith a NOAEL of 1000 mg/kg.
long-term DNEL for the inhalation route (systemic effects, route to-route extrapolation) =
1000 * (1/ sRV(a))
--------------------------------------------------------------------------------------------------------------------------- =
2.5*10*2 (b)
1000* (1/ 1.15)
-------------------------------------------------------- = 23 mg /m3
50
(a) Standard respiratory volume (sRV) rat for general public (24h):1.15 m3/kg
(b) Interspecies (without allometric scaling) * intraspecies * correction for duration: (2.5 * 10 * 2 )
long-term DNEL for the dermal route (systemic effects, route to-route extrapolation)
1000 *1 (a) / 4*2.5*5 (b) *2 (c) = 5.01 mg/kg bw/day
(a) route to route extrapolation oral to dermal
(b) assessment factors (interspecies * intraspecies (4*2.5) * 10)
(c) Correction for duration from subchronic to chronic (2)
long-term DNEL for the oral route (systemic effects)
1000 / 4*2.5*5 (a) *2(b) = 5.01 mg/kg bw/day
(a) assessment factors (interspecies * intraspecies (4*2.5) * 10)
(b) Correction for duration from subchronic to chronic (2)
Endpoints are given using a read across.
Full read across report is attached below
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.
