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EC number: 279-348-2 | CAS number: 79915-74-5
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 9.8 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC guidance (Technical Report No. 110, October 2010)
- Overall assessment factor (AF):
- 18
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 176.32 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Kinetics (metabolism, distribution and excretion) are considered to be similar for oral and inhalation intake in the absence of evidence of the opposite.
Calculation dose descriptor starting point:
Starting point: NOAEL of 100 mg/kg bw/day in a 28-day repeated dose toxicity study in rat.
Conversion of an oral NOAEL into a corrected NOAEC:
For workers (8h exposure/day), the corrected inhalatory NOAEC = oral NOAEL * 1/sRVrat * ABSoral-rat /ABSinhal-human * sRVhuman/wRV
= 100 * 1/0.38 m3/kg/8h * ABSoral-rat /ABSinhal-human * 6.7 m3(8h)/10 m3(8h)
= 100 * 1/0.38 m3/kg/8h * 1 * 6.7 m3(8h)/10 m3(8h)
= 100 /0.38 * 1* (6.7/10) = 176.32 mg/m3.
With ABS: Absorption, sRV: Standard Respiratory Volume; wRV: Worker Respiratory Volume; ABSoral-rat /ABSinhal-human= 100/100= 1, assuming no differences in inhalation absorption between rats and humans.
- AF for dose response relationship:
- 1
- Justification:
- Value is NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Extrapolation from subacute study to chronic exposure worker
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No correction for caloric demand for inhalation; included in dose descriptor starting point.
- AF for other interspecies differences:
- 1
- Justification:
- No remaining differences.
- AF for intraspecies differences:
- 3
- Justification:
- Difference in sensitivity among workers.
- AF for the quality of the whole database:
- 1
- Justification:
- Reliable studies used.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.2 mg/kg bw/day
- Most sensitive endpoint:
- sensitisation (skin)
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- other: ECETOC guidance (Technical Report No. 110, October 2010)
- Overall assessment factor (AF):
- 60
- Dose descriptor starting point:
- other: EC 1.6: 22%
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 132 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Corrected NOAEL = 22 % x 250 µg/cm2 = 5500 µg/cm2
The above is based on 22 µl of test substance applied onto 1 cm2area of a mouse ear, and a test substance density of 1.
Modification of the DNEL from µg/cm2to mg/kg bw/day:
Average mouse body weight: 30 g (TNO report V98.390)
Average total body surface mouse: 36 cm2 (TNO report V98.390)
Dose is applied on approximately 1 cm2of body surface.
5500 µg/cm2/day = 5.5 / (0.03/0.72) = 132 mg/kg bw/day
- AF for dose response relationship:
- 2
- Justification:
- Value is a LOAEL.
- AF for differences in duration of exposure:
- 1
- Justification:
- Duration of exposure is not a relevant parameter for skin sensitizing effect.
- AF for interspecies differences (allometric scaling):
- 10
- Justification:
- Specific assessment factor for skin sensitization.
- AF for other interspecies differences:
- 1
- Justification:
- No remaining differences.
- AF for intraspecies differences:
- 3
- Justification:
- Difference in sensitivity among workers.
- AF for the quality of the whole database:
- 1
- Justification:
- Reliable studies used.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
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:
- 2.9 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC guidance (Technical Report No. 110, October 2010)
- Overall assessment factor (AF):
- 30
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 86.96 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Kinetics (metabolism, distribution and excretion) are considered to be similar for oral and inhalation intake in the absence of evidence of the opposite. For the general population (24h exposure/day), the corrected inhalatory NOAEC = oral NOAEC * 1/sRVrat * ABSoral-rat /ABSinhal-human
= 100 * 1/1.15 m3/kg * ABSoral-rat /ABSinhal-human
= 100 * 1/1.15 m3/kg * 1 = 86.96 mg/m3
With ABS: Absorption, sRV: Standard Respiratory Volume; ABSoral-rat /ABSinhal-human= 100/100= 1, assuming no differences in inhalation absorption between rats and humans.
- AF for dose response relationship:
- 1
- Justification:
- Value is NOAEL.
- AF for differences in duration of exposure:
- 6
- Justification:
- Extrapolation from subacute study to chronic exposure general population.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No correction for caloric demand for inhalation; is included in dose descriptor starting point.
- AF for other interspecies differences:
- 1
- Justification:
- No remaining differences.
- AF for intraspecies differences:
- 5
- Justification:
- Difference in sensitivity within general population.
- AF for the quality of the whole database:
- 1
- Justification:
- Reliable studies used.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - 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:
- sensitisation (skin)
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- other: ECETOC guidance (Technical Report No. 110, October 2010)
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- other: EC 1.6 = 22%
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 132 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Corrected NOAEL = 22 % x 250 µg/cm2 = 5500 µg/cm2
The above is based on 22 µl of test substance applied onto 1 cm2area of a mouse ear, and a test substance density of 1.
Modification of the DNEL from µg/cm2to mg/kg bw/day:
Average mouse body weight: 30 g (TNO report V98.390)
Average total body surface mouse: 36 cm2(TNO report V98.390)
Dose is applied on approximately 1 cm2of body surface.
5500 µg/cm2/day = 5.5 / (0.03/0.72) = 132 mg/kg bw/day
- AF for dose response relationship:
- 2
- Justification:
- Value is LOAEL.
- AF for differences in duration of exposure:
- 1
- Justification:
- Duration of exposure is not a relevant parameter for skin sensitizing effect.
- AF for interspecies differences (allometric scaling):
- 10
- Justification:
- Specific assessment factor for skin sensitization.
- AF for other interspecies differences:
- 1
- Justification:
- No remaining differences.
- AF for intraspecies differences:
- 5
- Justification:
- Difference in sensitivity within general population.
- AF for the quality of the whole database:
- 1
- Justification:
- Reliable studies used.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
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:
- 0.83 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC guidance (Technical Report No. 110, October 2010)
- Overall assessment factor (AF):
- 120
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Value is NOAEL.
- AF for differences in duration of exposure:
- 6
- Justification:
- Extrapolation from subacute study to chronic exposure.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Correction for caloric demand from rat to human.
- AF for other interspecies differences:
- 1
- Justification:
- No remaining differences.
- AF for intraspecies differences:
- 5
- Justification:
- Difference in sensitivity among general population.
- AF for the quality of the whole database:
- 1
- Justification:
- Reliable studies used.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.83 mg/kg bw/day
DNEL related information
- DNEL extrapolated from long term DNEL
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.
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