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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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: - | 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:
- 3.5 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):
- 75
- Modified dose descriptor starting point:
- other: NAEC human worker
- Value:
- 262.762 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NAEC (rat - human worker)= [(NOEL/4) x 70]/10 * 1.4*0.5; NOEL= 214.5 mg/kg bw day( Dystar 1986); 4= allometric scaling factor for rat; 70 kg/bw: mean human body weight; 10 mg/m^3 air default worker breating volume; 1.4 Correction for differences between human and experimental exposure conditions; 0.5 Correction for bioavailability
- AF for dose response relationship:
- 1
- Justification:
- sufficient data about curve of dose/response
- AF for differences in duration of exposure:
- 6
- Justification:
- sub acute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- NAEC human worker
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- NAEC human worker
- AF for the quality of the whole database:
- 1
- Justification:
- GLP compliant with OECD and EU guidelines.
- AF for remaining uncertainties:
- 1
- Justification:
- 100% absorption for the inhalative route for animals and humans is assumed.
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)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 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):
- 300
- Dose descriptor starting point:
- NOAEL
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Repeated oral study is the best way to assess the dermal route in absence of a repeated dermal study
- AF for dose response relationship:
- 1
- Justification:
- good data about curve dose/response
- AF for differences in duration of exposure:
- 6
- Justification:
- sub acute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human standard
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- human standard to human worker
- AF for the quality of the whole database:
- 1
- Justification:
- P compliant with international guideline
- AF for remaining uncertainties:
- 1
- Justification:
- assuming 100% of absorption
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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
The substance doesn't react easely with other substances , environment and human body. An acute exposure via all three route (oral, dermal, inhalation) don't represent an hazard for standard value. And also for long term exposure , all DNEL value are very high for all route of exposure.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.62 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
- Modified dose descriptor starting point:
- other: NAEC g.p.
- Value:
- 93.84 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NAEC(oral rat - Human gen. population)= NOAEL 214.5 mg/kg bw X [1/4 ((assessment factor interspecies) X 70 kg (human body weight) X 1/20 m^3 (24h human breathing volume) *0.5 (Correction for bioavailability)
=93.84 mg/m^3
- AF for dose response relationship:
- 1
- Justification:
- sufficient data about curve of dose/response
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute 28 days to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- NAEC human g.p.
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- human general population
- AF for the quality of the whole database:
- 1
- Justification:
- GLP compliance with international guidelines
- AF for remaining uncertainties:
- 1
- Justification:
- 100% absorption for the inhalative route for animals and humans is assumed.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 75.072 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):
- 2.5
- DNEL extrapolated from long term DNEL
- Modified dose descriptor starting point:
- other: NAEC human g.p.
- Value:
- 187.68 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NAEC human general population (Human gen. population)= NOAEL 214.5 mg/kg bw X [1/4 ((assessment factor interspecies) X 70 kg (human body weight) X 1/20 m^3 (24h human breathing volume)]=187.68 mg/m^3
- AF for dose response relationship:
- 1
- Justification:
- sufficient data about curve of dose/response
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- NAEC human g.p.
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences
- AF for intraspecies differences:
- 1
- Justification:
- NAEC human g.p.
- AF for the quality of the whole database:
- 1
- Justification:
- GLP compliance with international guideline
- AF for remaining uncertainties:
- 1
- Justification:
- 100% absorption for the inhalative route for animals and humans is assumed.
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:
- 0.357 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 214.5 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
repeated oral study is the best way to assess the dermal route in absence of a repeated dermal study
- AF for dose response relationship:
- 1
- Justification:
- good data about curve dose/response
- AF for differences in duration of exposure:
- 6
- Justification:
- sub acute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human standard
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- human standard to human general population
- AF for the quality of the whole database:
- 1
- Justification:
- GLP compliant with international guideline
- AF for remaining uncertainties:
- 1
- Justification:
- assuming 100 % absorption
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:
- 0.357 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 214.5 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
oral rat repeated dose toxicity study
- AF for dose response relationship:
- 1
- Justification:
- sufficient data about curve of dose/response
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- human standard to human general population
- AF for the quality of the whole database:
- 1
- Justification:
- GLP compliant with OECD and EU guidelines
- AF for remaining uncertainties:
- 1
- Justification:
- assuming 100 % absorption
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
The substance doesn't react easely with other substances , environment and human body. An acute exposure via all three route (oral, dermal, inhalation) don't represent an hazard for standard value. And also for long term exposure , all DNEL value are very high for all route of exposure and also for all population category.
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.
