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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 305-673-7 | CAS number: 94944-95-3
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 106 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):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 150 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 2 645 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Route to route extrapolation taking into account an oral absorption of 100% and inhalation absorption of 10%
The corrected NOAEC = oral NOAEL *1/0.38*100/10*6.7/10= 2645 mg/m3
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- Justification:
- NOAEL taken from chronic study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- included in the derivation of the inhalation NOAEC
- AF for other interspecies differences:
- 2.5
- Justification:
- study in rat
- AF for intraspecies differences:
- 5
- Justification:
- worker exposure
- AF for the quality of the whole database:
- 2
- Justification:
- starting point is a study with a hydrolysis product
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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:
- 15 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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 150 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Based on the NOAEL of a chronic study with the hydrolysis product ethylene glycol. Route-to route extrapolation is based on 100% absorption after oral intake and 10% after dermal application.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- Justification:
- chronic study on ethylene glycol
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat study
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor
- AF for intraspecies differences:
- 5
- Justification:
- worker exposure
- AF for the quality of the whole database:
- 2
- Justification:
- database with data on structural analogue and hydrolysis products
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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)
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:
- DNEL (Derived No Effect Level)
- Value:
- 53 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):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 150 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 2 645 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Route to route extrapolation taking into account an oral absorption of 100% and inhalation absorption of 10%
The corrected NOAEC = oral NOAEL *1/0.38*100/10*6.7/10= 2645 mg/m3
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- Justification:
- based on chronic study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- factor already included in the derivation of the NOAEC
- AF for other interspecies differences:
- 2.5
- Justification:
- study in rat
- AF for intraspecies differences:
- 10
- Justification:
- consumer exposure
- AF for the quality of the whole database:
- 2
- Justification:
- study on hydrolysis product
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 7.5 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 150 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Based on the NOAEL of a chronic study with the hydrolysis product ethylene glycol. Route-to route extrapolation is based on 100% absorption after oral intake and 10% after dermal application.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- Justification:
- chronic study with ethylene glycol
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- study in rats
- AF for other interspecies differences:
- 2.5
- Justification:
- default value
- AF for intraspecies differences:
- 10
- Justification:
- consumer exposure
- AF for the quality of the whole database:
- 2
- Justification:
- based on data from studies with structural analogue and hydrolysis products
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
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