Registration Dossier
Registration Dossier
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EC number: 700-916-7 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 9.4 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 705.26 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- There is no relevant reliable long-term inhalation study available
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:
- DNEL (Derived No Effect Level)
- Value:
- 1.3 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 400 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)
- Most sensitive endpoint:
- skin irritation/corrosion
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
The hazard assessment of the target substance is based on the read-across substance, thermocracked kerosene (CAS 68333-23-3). The NOAEL for systemic effects is established from the dermal subacute (28-D; 5d/wk.) study in rats (Koschier, F.J., 1992).
Relevant dose descriptor NOAEL = 400 mg/kg/day, subacute, dermal exposure, rat (BP, 1992).
Modification of the dose descriptor according to ECHA Guidance R.8 (November 2012) Example B. 3.
100 % dermal absorption for rats
100 % inhalation absorption regardless of species
Corrected inhalatory NOAEC = dermal NOAEL * (1/ sRVrat 8h) * (ABSdermal-rat/ ABSinh-human) * (sRVhuman8h/ wRV) ABS – absorption
sRVrat – respiratory volume under standard conditions = 0.38 m3/kg/d
sRVhuman- respiratory volume under standard conditions = 6.7 m3 (8h)
wRV - respiratory volume light activity for worker = 10 m3 (8h)
Corrected inhalatory NOAEC= 400 * (1/0.38) * (100/100) * (6.7 / 10)
Corrected inhalatory NOAEC = 705.26 mg/m3
Assessment factors according to ECHA 2012 Guidance R.8 Characterization of dose response to human health
Interspecies - remaining differences 2.5
Intraspecies differences for workers 5
Exposure duration - subacute to chronic 6
Issues related to dose responses - the starting point for the DNEL calculation is a derived NOAEL - default assessment factor 1 Quality of whole database - default assessment factor 1
Overall AF 2.5 * 5 * 6 * 1 * 1 = 75
DNEL worker inhalation= 705.26 mg/m3/ 75 = 9.40 mg/m3
Long-term - systemic - dermal
The hazard assessment of the target substance is based on the read-across substance, thermocracked kerosene (CAS 68333-23-3). The NOAEL for systemic effects is established from the dermal subacute (28-D; 5d/wk.) study in rats (Koschier, F.J., 1992).
Relevant dose descriptor NOAEL = 400 mg/kg/day, subacute, dermal exposure, rat by BP, 1992.
Modification of the dose descriptor according to ECHA Guidance R.8 (November 2012) Example B. 2.
100 % dermal absorption is assumed for both species
Corrected dermal NOAEL = dermal NOAEL * (ABSdermal-rat/ ABSdermal-human)
Corrected dermal NOAEL = 400 * (100/100)
Corrected dermal NOAEL = 400 mg/kg bw/day
Assessment factors according to ECHA 2012 Guidance R.8 Characterization of dose response to human health
Interspecies - allometric scaling - rat 4
Interspecies - remaining differences 2.5
Intraspecies differences – worker 5
Exposure duration - subacute to chronic 6
Issues related to dose responses - the starting point for the DNEL calculation is a derived NOAEL- default assessment factor 1 Quality of whole database - default assessment factor 1
Overall AF 4 * 2.5 * 5 * 6 * 1 * 1 = 300
DNEL worker by dermal route = 400 mg/kg bw/day / 300 = 1.30 mg/kg bw/day
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 7.02 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 052.63 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- There is no relevant reliable long-term inhalation study available
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.67 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 400 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)
- Most sensitive endpoint:
- skin irritation/corrosion
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:
- 0.67 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 400 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- There is no relevant reliable long-term oral study available
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
The hazard assessment of the target substance is based on the read-across substance, thermocracked kerosene (CAS 68333-23-3). The NOAEL for systemic effects is established from the dermal subacute (28-D; 5d/wk.) study in rats (Koschier, F.J., 1992).
Relevant dose descriptor
NOAEL = 400 mg/kg/day, subacute, dermal exposure, rat by (Koschier, F.J., 1992).
Modification of the dose descriptor according to ECHA Guidance R.8 (November 2012) Example B. 3.
100 % dermal absorption for mouse
100 % inhalation absorption regardless of species
Corrected inhalatory NOAEC = dermal NOAEL * (1/ sRVrat 8h) * (ABSdermal-rat/ ABSinh-human)
ABS – absorption
sRVrat – respiratory volume under standard conditions = 0.38 m3/kg/d
Corrected inhalatory NOAEC= 400 * (1/0.38) * (100/100)
Corrected inhalatory NOAEC = 1052.63 mg/m3
Assessment factors according to ECHA 2012 Guidance R.8 Characterization of dose response to human health
Interspecies - remaining differences 2.5
Intraspecies differences - general population 10
Exposure duration - subacute to chronic 6
Issues related to dose responses - the starting point for the DNEL calculation is a derived NOAEL - default assessment factor 1
Quality of whole database - default assessment factor 1
Overall AF 2.5*10*6*1*1 = 150
DNEL general population inhalation= 1052.63 mg/m3/ 150 = 7.02 mg/m3
Long-term - systemic - dermal
The hazard assessment of the target substance is based on the read-across substance, thermocracked kerosene (CAS 68333-23-3). The NOAEL for systemic effects is established from the dermal subacute (28-D; 5d/wk.) study in rats (Koschier, F.J., 1992).
Relevant dose descriptor
NOAEL = 400 mg/kg/day, subacute, dermal exposure, rat byKoschier, F.J., 1992.
Modification of the dose descriptor according to ECHA Guidance R.8 (November 2012) Example B. 2.
100 % dermal absorption regardless of species.
Corrected dermal NOAEL = dermal NOAEL * (ABSdermal-rat/ ABSdermal-human)
Corrected dermal NOAEL = 400 * (100/100)
Corrected dermal NOAEL = 400 mg/kg bw/day
Assessment factors according to ECHA 2012 Guidance R.8 Characterization of dose response to human health
Interspecies - allometric scaling - rat 4
Interspecies - remaining differences 2.5
Intraspecies differences – general population 10
Exposure duration - subacute to chronic 6
Issues related to dose responses - the starting point for the DNEL calculation is a derived NOAEL- default assessment factor 1
Quality of whole database - default assessment factor 1
Overall AF 4 * 2.5 * 10 * 6 * 1 * 1 = 600
DNEL general population by dermal route = 400 mg/kg bw/day / 600 = 0.67 mg/kg bw/day
Long-term - systemic - oral
The hazard assessment of the target substance is based on the read-across substance, thermocracked kerosene (CAS 68333-23-3). The NOAEL for systemic effects is established from the dermal subacute (28-D; 5d/wk.) study in rats (Koschier, F.J., 1992).
Relevant dose descriptor
NOAEL = 400 mg/kg/day, subacute, dermal exposure, rat byKoschier, F.J., 1992.
Modification of the dose descriptor according to ECHA Guidance R.8 (November 2012) Example B. 6.
100 % oral absorption regardless of species
100 % dermal absorption for mouse
Corrected oral NOAEL = dermal NOAEL * (ABSdermal-rat/ ABSoral-human)
Corrected oral NOAEL = 400 * (100/100)
Corrected oral NOAEL = 400 mg/kg bw/day
Assessment factors according to ECHA 2012 Guidance R.8 Characterization of dose response to human health
Interspecies - allometric scaling - rat 4
Interspecies - remaining differences 2.5
Intraspecies differences – general population 10
Exposure duration - subacute to chronic 6
Issues related to dose responses - the starting point for the DNEL calculation is a derived NOAEL- default assessment factor 1
Quality of whole database - default assessment factor 1
Overall AF 4 * 2.5 * 10 * 6 * 1 * 1 = 600
DNEL general population by oral route = 400 mg/kg bw/day / 600 = 0.67 mg/kg bw/day
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