Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 813-845-2 | CAS number: 13780-04-6
Toxicological information
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 34.6 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):
- 42.5
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 472 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NOAEC: ((841/4) x 70)/10; NOAEL=841 mg/kg bw/day; 4 = allometric scaling factor rat; 70 kg/bw= standard human body weight; 10 m^3/person= default human breathing volume for workers in 8 h.
- AF for dose response relationship:
- 1
- Justification:
- No scaling needed
- AF for differences in duration of exposure:
- 3.4
- Justification:
- ERASM Project: lower factor found based on RepDose study (factor 3.4 instead of 6 from subacute to chronic exposure)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scaling needed because the starting point (NOAEC) has just been corrected for the human evaluation.
- AF for other interspecies differences:
- 2.5
- Justification:
- Toxicocinetic and toxicodynamic differences
- AF for intraspecies differences:
- 5
- Justification:
- Human Worker
- AF for the quality of the whole database:
- 1
- Justification:
- GLP compliant, recent data on the registered substance
- AF for remaining uncertainties:
- 1
- Justification:
- 100% adsorption for inhalative route for animal and humanis assumed
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
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:
- 49.5 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):
- 170
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 8 410 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
10% adsorption for dermal route compaired to oral route is assumed. NOAEL is corrected for route to route extrapolation.
- AF for dose response relationship:
- 1
- Justification:
- No scaling needed
- AF for differences in duration of exposure:
- 3.4
- Justification:
- ERASM Project: lower factor found based on RepDose study (factor 3.4 instead of 6 from subacute to chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat
- AF for other interspecies differences:
- 2.5
- Justification:
- Toxicocinetic and toxicodynamic differences
- AF for intraspecies differences:
- 5
- Justification:
- Human worker
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
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:
- high hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.7 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):
- 85
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 736 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NOAEC= ((841 /4) x 70) /20; NOAEL = 841 mg/kg bw/day on rat; 4 = allometric scaling factor rat; 70 kg/bw= standard human body weight; 20 m^3/person= default human breathing volume for general population 24h.
- AF for dose response relationship:
- 1
- Justification:
- No scaling needed
- AF for differences in duration of exposure:
- 3.4
- Justification:
- ERASM Project: lower factor found based on RepDose study (factor 3.4 instead of 6 from subacute to chronic exposure)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scaling needed because the starting point (NOAEC) has just been corrected for the human evaluation.
- AF for other interspecies differences:
- 2.5
- Justification:
- Toxicocinetic and toxicodynamic differences
- AF for intraspecies differences:
- 10
- Justification:
- General population
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
- Justification:
- 100% adsorption for inhalative route for animal and humanis assumed
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
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:
- 24.7 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):
- 340
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 8 410 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
10% adsorption for dermal route compaired to oral route is assumed. NOAEL is corrected for route to route extrapolation.
- AF for dose response relationship:
- 1
- Justification:
- No scaling needed
- AF for differences in duration of exposure:
- 3.4
- Justification:
- ERASM Project: lower factor found based on RepDose study (factor 3.4 instead of 6 from subacute to chronic exposure)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat
- AF for other interspecies differences:
- 2.5
- Justification:
- Toxicocinetic and toxicodynamic differences
- AF for intraspecies differences:
- 10
- Justification:
- General population
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
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:
- 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):
- 340
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 841 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No modification necessary
- AF for dose response relationship:
- 1
- Justification:
- No scaling needing
- AF for differences in duration of exposure:
- 3.4
- Justification:
- ERASM Project: lower factor found based on RepDose study (factor 3.4 instead of 6 from subacute to chronic exposure)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat
- AF for other interspecies differences:
- 2.5
- Justification:
- Toxicocinetic and toxicodynamic differences
- AF for intraspecies differences:
- 10
- Justification:
- General population
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
- Justification:
- 100% adsorption for oral route for animal and human is assumed
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
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.
