Registration Dossier
Registration Dossier
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EC number: 411-290-7 | CAS number: 131538-00-6
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.94 mg/m³
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other:
- Overall assessment factor (AF):
- 18
- Dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 52.89 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.
Starting point: NOAEL of 30 mg/kg bw/day in a One Generation Reproduction 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
= 30 mg/kg bw/day * 1/0.38 m3/kg/8h * 100 /100 * 6.7 m3(8h)/10 m3(8h)
= 30 mg/kg bw/day * 1/0.38 m3/kg/8h * 1 * 6.7 m3 (8h)/10 m3(8h)
= 30 /0.38 * 1* (6.7/10) = 52.89 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 a NOAEL
- AF for differences in duration of exposure:
- 6
- AF for interspecies differences (allometric scaling):
- 1
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 3
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- 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:
- 0.42 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other:
- Overall assessment factor (AF):
- 72
- Dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Kinetics (metabolism, distribution and excretion) are considered to be similar for oral and dermal intake in the absence of evidence of the opposite.Correction dermal NOAEL: 30 mg/kg bw/day x 100/100a= 30 mg/kg bw/day (a% oral/dermal absorption)
- AF for dose response relationship:
- 1
- Justification:
- Value is a NOAEL
- AF for differences in duration of exposure:
- 6
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 3
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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:
- low hazard (no threshold derived)
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:
- 1.76 mg/m³
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other:
- Overall assessment factor (AF):
- 30
- Dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 52.89 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.
Starting point: NOAEL of 30 mg/kg bw/day in a One Generation Reproduction Toxicity Study in rat.
Conversion of an oral NOAEL into a corrected NOAEC:
The corrected inhalatory NOAEC (8 hours exposure/day) = oral NOAEL * 1/sRVrat * ABSoral-rat /ABSinhal-human * sRVhuman/wRV
= 30 mg/kg bw/day * 1/0.38 m3/kg/8h * 100 /100 * 6.7 m3 (8h)/10 m3 (8h)
= 30 mg/kg bw/day * 1/0.38 m3/kg/8h * 1 * 6.7 m3 (8h)/10 m3 (8h)
= 30 /0.38 * 1* (6.7/10) = 52.89 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.
- Justification:
- Value is a NOAEL
- AF for differences in duration of exposure:
- 6
- AF for interspecies differences (allometric scaling):
- 1
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 5
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- 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:
- 0.25 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other:
- Overall assessment factor (AF):
- 120
- Dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Kinetics (metabolism, distribution and excretion) are considered to be similar for oral and dermal intake in the absence of evidence of the opposite.Correction dermal NOAEL: 30 mg/kg bw/day x 100/100a= 30 mg/kg bw/day (a% oral/dermal absorption).
- AF for dose response relationship:
- 1
- Justification:
- Value is NOAEL
- AF for differences in duration of exposure:
- 6
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 5
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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:
- low hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.25 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other:
- Overall assessment factor (AF):
- 120
- Dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Value is a NOAE
- AF for differences in duration of exposure:
- 6
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 5
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other:
- Overall assessment factor (AF):
- 60
- Dose descriptor starting point:
- LOAEL
- Value:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
GST has harmonized classification for acute oral toxicity, cat. 4. The lower limit for this classification (300 mg/ kg bw) is considered a LOAEL.
- AF for dose response relationship:
- 3
- Justification:
- Value is a LOAEL
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 5
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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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