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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 940-417-3 | CAS number: -
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:
- 87.5 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):
- 60
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 5 250 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- NOAEL of 750 mg/kg bw from the repeated dose toxicity was taken; 525 mg/m3 as corresponding NOAEC for a worker (70 mg bw; 10m3 as respiration volume for 8 h working
- AF for dose response relationship:
- 3
- Justification:
- The obtained NOAEL of 750 mg/kg bw is near to the presumed LOAEL of 1000 mg/kg bw in the adaptation phase; the hemolytic effect of the registration substance and its read-across substances is strongest in the first few days of the treatment.
- AF for differences in duration of exposure:
- 1
- Justification:
- The registration substance induces hemolysis and liver enlargement; the hemolytic effect is dependent on the dose in the adapation phase and less dependent afterwards on the treatment duration. No AF from subacute to chronic is considered to be necessary. Furhter, the registration substance is not bioaccumulating.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default value
- AF for other interspecies differences:
- 1
- Justification:
- No additional AF is needed for the hemolytic effect, since humans are considered to be less sensitive towards to hemoltic effect of the presumed metabolite 2-butoxyacetic acid.
- AF for intraspecies differences:
- 5
- Justification:
- default value
- AF for the quality of the whole database:
- 1
- Justification:
- The database based on the grouping of chemicals covers all endpoints. The obtained results are consistent, the mode of action as well as the kinetic profile of the registration substance can be reliably derived. No additional AF is needed.
- AF for remaining uncertainties:
- 1
- Justification:
- The applied read-across is robust, since the scientifical rationale is based on structural similarity, identical mode of action as well as on the consistent toxicity profiles. No additional AF is needed.
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:
- 12.5 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):
- 60
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 750 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No resorption difference is assumed for oral or dermal routes.
- AF for dose response relationship:
- 3
- Justification:
- The obtained NOAEL of 750 mg/kg bw is near to the presumed LOAEL of 1000 mg/kg bw in the adaptation phase; the hemolytic effect of the registration substance and its read-across substances is strongest in the first few days of the treatment.
- AF for differences in duration of exposure:
- 1
- Justification:
- The registration substance induces hemolysis and liver enlargement; the hemolytic effect is dependent on the dose in the adapation phase and less dependent afterwards on the treatment duration. No AF from subacute to chronic is considered to be necessary. Furhter, the registration substance is not bioaccumulating.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default value
- AF for other interspecies differences:
- 1
- Justification:
- No additional AF is needed for the hemolytic effect, since humans are considered to be less sensitive towards to hemoltic effect of the presumed metabolite 2-butoxyacetic acid.
- AF for intraspecies differences:
- 5
- Justification:
- default value
- AF for the quality of the whole database:
- 1
- Justification:
- The database based on the grouping of chemicals covers all endpoints. The obtained results are consistent, the mode of action as well as the kinetic profile of the registration substance can be reliably derived. No additional AF is needed.
- AF for remaining uncertainties:
- 1
- Justification:
- The applied read-across is robust, since the scientifical rationale is based on structural similarity, identical mode of action as well as on the consistent toxicity profiles. No additional AF is needed.
Acute/short term exposure
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:
- low hazard (no threshold derived)
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
DNEL related information
General Population - Hazard via dermal route
Systemic 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
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:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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.
