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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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EC number: - | 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:
- 2.47 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 370.26 mg/m³
- Explanation for the modification of the dose descriptor starting point:
A NOAEL of 300 mg/kg bw /day was the lowest NOAEL determined for the source substances in repeated-dose studies. This NOAEL was derived in a sub-acute repeated dose oral toxicity study in rats (Longobardi 2013). This value was converted into the corrected inhalatory NOAEC taking into account the standard respiratory factor of 1/0.38 m³/kg/day, the absorption rates (oral 50 %, inhalation 100 %; in accordance with ECHA Guidance R.8 the absorption rate of the starting route is half that of the end route), the standard respiratory volume in humans/ worker respiratory volume (6.7 m³ (8 h) / 10 m³ (8 h)) and the correction factor between human and experimental exposure conditions of workers (5 working days vs. 7 days continuous exposure) of 1.4.
NOAEC corrected = 300 mg/kg bw/day * 1/0.38 m³/kg/day * 50/100 * (6.7 m³/10 m³) * 1.4 = 370.26 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 6
- Justification:
- sub-acute (28 d) to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scaling should be applied in case of oral-to-inhalation extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- default; no substance and route specific information on toxicokinetic and toxicodynamic is available for animals and humans
- AF for intraspecies differences:
- 5
- Justification:
- default for workers
- AF for the quality of the whole database:
- 2
- Justification:
- due to read across
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:
- 7 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- other: NOAEC
- Value:
- 4 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
A NOAEL of 300 mg/kg bw /day was the lowest NOAEL determined for the source substances in repeated-dose studies. This NOAEL was derived in a sub-acute repeated dose oral toxicity study in rats (Longobardi 2013). This value was converted into the corrected dermal NOAEC taking into account the absorption rates (oral 100 %, dermal 10 %) and the correction factor between human and experimental exposure conditions workers (5 working days vs. 7 days continuous exposure) of 1.4.
NOAEC corrected = 300 mg/kg bw/day * 100/10 * 1.4 = 4200 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 6
- Justification:
- sub-acute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- default; no substance and route specific information on toxicokinetic and toxicodynamic is available for animals and humans
- AF for intraspecies differences:
- 5
- Justification:
- default for workers
- AF for the quality of the whole database:
- 2
- Justification:
- due to read across
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:
- 0.43 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 130.43 mg/m³
- Explanation for the modification of the dose descriptor starting point:
A NOAEL of 300 mg/kg bw /day was the lowest NOAEL determined for the source substances in repeated-dose studies. This NOAEL was derived in a sub-acute repeated dose oral toxicity study in rats (Longobardi 2013). This value was converted into the corrected inhalatory NOAEC taking into account the standard respiratory factor of 1/1.15 m³/kg/day, the absorption rates (oral 50 %, inhalation 100 %; in accordance with ECHA Guidance R.8 the absorption rate of the starting route is half that of the end route).
NOAEC corrected = 300 mg/kg bw/day * 1/1.15 m³/kg/day * 50/100 = 130.43 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 6
- Justification:
- sub-acute (28 d) to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scaling should be applied in case of oral-to-inhalation extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- default; no substance and route specific information on toxicokinetic and toxicodynamic is available for animals and humans
- AF for intraspecies differences:
- 10
- Justification:
- default for general population
- AF for the quality of the whole database:
- 2
- Justification:
- due to read across
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:
- 2.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 1 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- other: NOAEC
- Value:
- 3 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
A NOAEL of 300 mg/kg bw /day was the lowest NOAEL determined for the source substances in repeated-dose studies. This NOAEL was derived in a sub-acute repeated dose oral toxicity study in rats (Longobardi 2013). This value was converted into the corrected dermal NOAEC taking into account the absorption rates (oral 100 %, dermal 10 %).
NOAEC corrected = 300 mg/kg bw/day * 100/10 = 3000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 6
- Justification:
- sub-acute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- default; no substance and route specific information on toxicokinetic and toxicodynamic is available for animals and humans
- AF for intraspecies differences:
- 10
- Justification:
- Default for general population
- AF for the quality of the whole database:
- 2
- Justification:
- due to read across
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:
- 0.25 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 1 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
An oral NOAEL of 300 mg/kg bw /day was the lowest NOAEL determined for the source substances in repeated-dose studies. This NOAEL was derived in a sub-acute repeated dose oral toxicity study in rats (Longobardi 2013).
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 6
- Justification:
- sub-acute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- default; no substance and route specific information on toxicokinetic and toxicodynamic is available for animals and humans
- AF for intraspecies differences:
- 10
- Justification:
- Default for general population
- AF for the quality of the whole database:
- 2
- Justification:
- due to read across
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
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.
