Registration Dossier
Registration Dossier
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EC number: 618-460-1 | CAS number: 9010-89-3
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 80.4 mg/m³
DNEL related information
- DNEL derivation method:
- other: Read-across from hydrolysis product diethylene glycol (DEG, CAS 111-46-6)
- Modified dose descriptor starting point:
- other: DNEL for DEG (CAS 111-46-6)
- Value:
- 60 mg/m³
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:
- 142 mg/kg bw/day
DNEL related information
- DNEL derivation method:
- other: Read-across from hydrolysis product diethylene glycol (DEG, CAS 111-46-6)
- Modified dose descriptor starting point:
- other: DNEL for DEG (CAS 111-46-6)
- Value:
- 106 mg/kg bw/day
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:
- no hazard identified
Additional information - workers
See discussion in "general population" section below.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 16.1 mg/m³
DNEL related information
- DNEL derivation method:
- other: Read-across from hydrolysis product diethylene glycol (DEG, CAS 111-46-6)
- Modified dose descriptor starting point:
- other: DNEL for DEG (CAS 111-46-6)
- Value:
- 12 mg/m³
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:
- DNEL (Derived No Effect Level)
- Value:
- 71 mg/kg bw/day
DNEL related information
- DNEL derivation method:
- other: Read-across from hydrolysis product diethylene glycol (DEG, CAS 111-46-6)
- Modified dose descriptor starting point:
- other: DNEL for DEG (CAS 111-46-6)
- Value:
- 53 mg/kg bw/day
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
Polyesterol 90212 is not classified for local effects (skin/eye/respiratory irritation, sensitization). Therefore, local DNELs are not proposed.
No acute/short-term DNELs are proposed because the test substance is not classified based on test data for acute toxicity (in accordance with section ECHA's Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of dose [concentration]-response for human health, section R.8.1.2.5).
The systemic effects of Polyesterol 90212 were evaluated on the basis of read-across to its hydrolysis product diethylene glycol, resulting in a systemic oral NOAEL of 172 mg/kg bw/day.
The DNELs that were derived for DEG were adopted for Polyesterol 90212 by molar conversion. As DEG in total constitutes 74.6% of the polyesterol, the conversion of the DEG DNELs was conducted as follows: DNEL (Polyesterol 90212) = DNEL (DEG) * (100% / 74.6%).
Oral DNELs for the general population were not derived as exposure via the oral route is not expected.
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