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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 204-001-9 | CAS number: 112-73-2
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:
- 70 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):
- 10
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 700 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Assuming: human body weight of 70 kg; respiration volume of 10m3 for a shift; comparable resorption for oral and inhalation routes
- AF for dose response relationship:
- 1
- Justification:
- Clear dose responce relation obtained
- AF for differences in duration of exposure:
- 1
- Justification:
- Steady state within 9 day and efficient elimination demonstrated for the toxicant 2-butoxyactic acid in rats treated up to 28-days; no bioaccumulating effect observed in the subchronic and chronic studies with EGBE.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Extrapolation from rat to human
- AF for other interspecies differences:
- 1
- Justification:
- Hemolytic acitivity of 2-butoxyacetic acid as mode of action demonstrated; human less susceptible to the given mode of action demonstrated.
- AF for intraspecies differences:
- 2.5
- Justification:
- AF of 2.5 is considered to be appropriate as the susceptible population is identified; females are more susceptible to males. Use of 2.5 for intraspecies is also mentioned in TRGS 900 for EGBE that shares the 2-butoxyacetic acid as toxic metabolites with DEGDBE.
- AF for the quality of the whole database:
- 1
- Justification:
- Most of the studies used to assess the health hazard are scientifically well performed, Guideline studies and GLP studies; the applied read-across is based on the same toxicity mode of action and is considered to be very robust; no additional AF needed
- AF for remaining uncertainties:
- 1
- Justification:
- Any additional uncertainties not known
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
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10 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):
- 10
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Comparable resorption for oral and dermal routes is assumed
- AF for dose response relationship:
- 1
- Justification:
- Clear dose responce relation obtained
- AF for differences in duration of exposure:
- 1
- Justification:
- Steady state within 9 day and efficient elimination demonstrated for the toxicant 2-butoxyactic acid
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Extrapolation factor from rat to human
- AF for other interspecies differences:
- 1
- Justification:
- Hemolytic acitivity of 2-butoxyacetic acid as mode of action demonstrated; human less susceptible to the given mode of action demonstrated.
- AF for intraspecies differences:
- 2.5
- Justification:
- AF of 2.5 is considered to be appropriate as the susceptible population is identified; females are more susceptible to males. Use of 2.5 for intraspecies is also mentioned in TRGS 900 for EGBE that shares the 2-butoxyacetic acid as toxic metabolites with DEGDBE.
- AF for the quality of the whole database:
- 1
- Justification:
- Most of the studies used to assess the health hazard are scientifically well performed, Guideline studies and GLP studies; the applied read-across is based on the same toxicity mode of action and is considered to be very robust; no additional AF needed
- AF for remaining uncertainties:
- 1
- Justification:
- Any additional uncertainties not known
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
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.
