Registration Dossier
Registration Dossier
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EC number: 700-918-8 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DMEL (Derived Minimum Effect Level)
- Value:
- 3.25 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:
- DMEL (Derived Minimum Effect Level)
- Value:
- 234 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:
- low hazard (no threshold derived)
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
Long-term - systemic - inhalation
Hazard assessment of the target substance is based on the most hazardous and critical constituent, benzene.
In accordance with REACH guidance (Appendix R.8-13), a science-based Binding Occupational Exposure Limit value (BOELV) can be used in place of a formal DN(M)EL provided no new scientific information exists which challenges the validity of the BOELV. While information regarding the NOAEC for effects on human bone marrow post-date the BOELV, a DNEL based on these bone marrow (threshold) findings would be higher (and hence offer less protection) than the BOELV. The BOELV will therefore be used as the basis of the DN(M)EL for long-term systemic effects associated with benzene, including haematotoxicity and carcinogenicity.
Relevant dose descriptor
Binding exposure limit value for benzene (BOELVbenzene 3.25 mg/m3) is used without modifications.
DNEL chronic systemic by inhalation route = 3.25 mg/m³
Long-term - systemic - dermal
Hazard assessment of the target substance is based on the most hazardous and critical constituent, benzene.
Relevant dose descriptor
The dermal NOAEL is extrapolated from the BOELVbenzene(3.25 mg/m3).
Modification of the dose descriptor according to ECHA Guidance R.8 (November 2012) Example B. 4.
Route of exposure (inhalation vs dermal); benzene bioavailability via inhalation is assumed to be 50 % while dermal absorption is only 0.1 % (Modjtahedi and Maibach, 2008).
Corrected dermal NOAEL = BOELVbenzene* wRV8h* ABSinh-human/ ABSoral-human
ABS - absorption
wRV8h-worker
respiratory volume (wRV) is 50% greater than the resting standard
respiratory volume of
0.2 L/min/kg bw; wRV8-hour=
(0.2 L/min/kg bw x 1.5 x 60 min x 8 h) / 1000 = 0.144 m3/kg bw
Corrected dermal NOAEL= 3.25* 0.144 * (50/0.1) = 234 mg/kg bw/day
Assessment factors
As the Binding exposure limit value (BOELV) is based on worker life-time exposure no assessment factor is needed.
DNEL worker chronic systemic by dermal route = 234 mg/kg bw/day
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DMEL (Derived Minimum Effect Level)
- Value:
- 3.25 µg/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:
- DMEL (Derived Minimum Effect Level)
- Value:
- 234 µg/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:
- DMEL (Derived Minimum Effect Level)
- Value:
- 0.234 µg/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
Long-term - systemic - inhalation
Hazard assessment of the target substance is based on the most hazardous component i.e. benzene. The value, DMEL 3.25 µg/m3, is based on the approach used by WHO (2000) which combined estimates of excess risk for leukaemia calculated by Crump (1994) for four models into a geometric mean estimate. The same four models were used for the derivation of this DMEL but estimates of excess risk for acute myelogenous or acute monocytic leukaemia (AMML) calculated by Crump (1994) were used instead of those for leukaemia. For three of the four models, excess risk estimates calculated by Crump (1994) were used. A more recent estimate of excess risk was available for one model (TCEQ, 2007) and this was used instead of the estimate calculated by Crump (1994). The value of 3.25 µg/m3 (1 ppb) is protective against haematotoxicity, genotoxicity and carcinogenicity and results in a geometric mean excess lifetime risk of AMLL of 0.9 x 10-5.
Relevant dose descriptor
DMEL benzene (3.25 µg/m3) is used without modifications.
DMEL chronic systemic by inhalation route =3.25 µg/m3
Long-term - systemic - dermal
Hazard assessment of the target substance is based on the most hazardous component, benzene.
Relevant dose descriptor
The dermal NOAEL is extrapolated from the inhalation DMELbenzene(3.25 µg/m3).
Modification of the dose descriptor according to ECHA Guidance R.8 (November 2012) Example B. 4.
Route of exposure (inhalation vs oral); bioavailability via inhalation is assumed to be 50 % while dermal absorption is only 0.1 % (Modjtahedi and Maibach, 2008).
Corrected dermal NOAEL = DMELbenzene* wRV8-h* ABSinh-rat/ ABSoral-human
ABS - absorption
wRV8-h-worker
respiratory volume (wRV) is 50% greater than the resting standard
respiratory volume of
0.2 L/min/kg bw; wRV8-hour=
(0.2 L/min/kg bw x 1.5 x 60 min x 8 h) / 1000 = 0.144 m3/kg bw
Corrected dermal NOAEL= 3.25 * 0.144 * (50/0.1) = 234 µg/kg bw/day
Assessment factors
As the DMEL is based on general population life-time exposure no assessment factor is needed.
DMEL chronic systemic by dermal route = 234 µg/kg bw/day
Long-term - systemic - oral
Hazard assessment of the target substance is based on the most hazardous component, benzene.
Relevant dose descriptor
The oral NOAEL is extrapolated from the inhalation DMELbenzene(3.25 µg/m3).
Modification of the dose descriptor according to ECHA Guidance R.8 (November 2012) Example B. 4.
Route of exposure (inhalation vs oral); bioavailability via inhalation is assumed to be 50 % while oral absorption is assumed to be 100 %.
Corrected oral NOAEL = DMELbenzene* wRV8-h* ABSinh-human/ ABSoral-human
ABS - absorption
wRV8-h-worker
respiratory volume (wRV) is 50% greater than the resting standard
respiratory volume of
0.2 L/min/kg bw; wRV8-hour=
(0.2 L/min/kg bw x 1.5 x 60 min x 8 h) / 1000 = 0.144 m3/kg bw
Corrected oral NOAEL= 3.25 * 0.144 * (50/100) = 0.234 µg/kg bw/day
Assessment factors
As the inhalation DMEL is based on general population life-time exposure no assessment factor is needed.
DMEL worker chronic systemic by oral route = 0.234 µg/kg bw/day
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