Registration Dossier
Registration Dossier
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EC number: 688-124-7 | CAS number: 152261-43-3
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 44 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: see justification and comments
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 60 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- other: see justification and comments
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:
- 43 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- other: see justification and comments
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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
Based on the composition and reactivity of the UVCB substance assessed in this chemical safety report, the most relevant constituent for risk assessment is diethylene glycol. This compound makes 57% of the composition and is further released during polymerization resulting in approx. 80%.
Thus, the inhalative long-term DNEL of 44 mg/m3 is derived from the occupational exposure limit (OEL) of diethylene glycol (CAS 111-46-6, TRGS 900). The OEL goes back to a NOAEL of 50 mg/kg bw/day in a 225 day feeding study with rats. For the dermal DNEL a dermal study with ethylene glycol on dogs was selected for DNEL derivation as it is the most relevant repeated dose study performed in accordance to OECD TG 410 and GLP. In this study, the dermal NOAEL for ethylene glycol was established to be 4440 mg/kg bw/day. This value is taken in a 1:1 relation also for diethylene glycol since diethylene glycol can generate 2 molecules of ethylene glycol in a worst case assumption.
As the concentration of ethanol in the UVCB substance is much lower and the DNELs are higher, they are just given for the sake of completeness, but will not be further considered in the risk assessment.For ethanol, the DNEL systemic long-term inhalation is considered to correspond to the occupational exposure limit of 960 mg/m³. The long-term systemic DNEL for the dermal exposure route is 343 mg/kg/day (see ECHA dissemination site).
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- no hazard identified
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
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.
