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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
- 23.5 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):
- 37.5
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 881.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
in accordance with ECHA REACH TG R8 and ECETOC technical report 110. Inhalation long-term systemic DNEL based on NOAEL (OECD 407) in rats
- AF for dose response relationship:
- 1
- Justification:
- in accordance with ECETOC technical report 110
- AF for differences in duration of exposure:
- 3
- Justification:
- in accordance with ECHA REACH TG R8 and ECETOC technical report 110. Increasing exposure duration does not result in an increase in incidence and severity of adverse effects, based on comparable results from animal studies after repeated oral treatment lasting 14-days, 28 days and about 63 days. A reduced AF of 3 for exposure duration is considered sufficiently conservative.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- In accordance with ECHA REACH TG R8; Allometric scaling is not applied, AF not used for inhalation route.
- AF for other interspecies differences:
- 2.5
- Justification:
- In accordance with ECHA REACH TG R8 and ECETOC technical report 110.
- AF for intraspecies differences:
- 5
- Justification:
- ECHA REACH TGD
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH TGD and ECETOC technical report 110
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH TGD and ECETOC technical report 110
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 6.7 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):
- 150
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The bioavailability of dermal routes are considered equal.
NOAEL (dermal) derived according to ECHA Guidance TGD R8: "Guidance on information requirements and chemical safety assessment", Appendix R.8-2, Example B.5.
Corrected NOAEL(dermal) = NOAEL(oral,rat) * Absorption(oral, rat)/Absorption (dermal, human)
= 1000 mg/kg bw * 100% / 100%
= 1000 mg/kg bw- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 3
- Justification:
- NOAEL of 1000 mg/kg bw was obtained in the 14-day study, in the 28-day study and in reproduction toxicity screening test, in which animals were treated longer than 60 days. It is not likely, that the NOAEL will be far lower than 1000 mg/kg bw for the sub-chronic and chronic toxicity. No toxicologically significant changes noted in hematology, coagulation, clinical chemistry and urinalysis parameters. There were no test item-related effects in absolute and relative organ weights, gross and histopathology parameters in both the sexes in all studies.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- According to ECHA REACH TGD R8 and ECETOC technical report 110; Allometric scaling from
rat to human => factor of 2.5 for remaining interspecies differences not taken but included into intraspecies variability consideration. - AF for other interspecies differences:
- 1
- Justification:
- According to ECHA REACH TGD R8 and ECETOC technical report 110, factor of 2.5 for remaining
interspecies differences not taken but included into intraspecies variability consideration. - AF for intraspecies differences:
- 5
- Justification:
- According to ECHA REACH TGD R8 and ECETOC technical report 110; German Ausschuss für
Gefahrstoffe- AGS 2010 - AF for the quality of the whole database:
- 1
- Justification:
- According to ECHA REACH TGD R8 and ECETOC technical report 110: Good /standard quality of
database. - AF for remaining uncertainties:
- 2.5
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
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
General population will not get in contact with the substance registered.
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.
