Registration Dossier
Registration Dossier
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EC number: 221-518-5 | CAS number: 3130-19-6
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.09 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:
- 5 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 4.4 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NOEChuman= NOELrat× (1/0.38 m3/kg bw) × (6.7m3/10m3) × (oral absorption/inhalation absorption) = 5 mg/kg bw/day × 1/0.38 × 6.7/10 × 50/100
- AF for dose response relationship:
- 1
- Justification:
- Default - NOAEL defined
- AF for differences in duration of exposure:
- 2
- Justification:
- Default - subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scalling is required for inhalation
- AF for other interspecies differences:
- 1
- Justification:
- Addressed by modification of starting point
- AF for intraspecies differences:
- 5
- Justification:
- Default for workers
- AF for the quality of the whole database:
- 2
- Justification:
- Data from source substance
- AF for remaining uncertainties:
- 2.5
- Justification:
- default- remaining differences
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:
- 0.05 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:
- 5 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 10 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
NOELhuman= NOELrat× (oral absorption/dermal absorption) = 5 mg/kg bw/day × (50%/25%)
- AF for dose response relationship:
- 1
- Justification:
- Default - NOAEL defined
- AF for differences in duration of exposure:
- 2
- Justification:
- Default - subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default – rat to human
- AF for other interspecies differences:
- 1
- Justification:
- Addressed by modification of starting point
- AF for intraspecies differences:
- 5
- Justification:
- Default for workers
- AF for the quality of the whole database:
- 2
- Justification:
- Data from source substance
- AF for remaining uncertainties:
- 2.5
- Justification:
- Default- remaining differences
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Repeated dose toxicity studies with Uvicure S128 are not available, therefore read-across to the source substance 7-oxabicyclo[4.1.0]hept-3-ylmethyl 7-oxabicyclo[4.1.0]heptane-3-carboxylate (CAS Number:2386-87-0;EC Number:219-207-4) based on the presence of same functional groups and close structural similarity.
The oral repeat-dose 90-day study in rats with the source substance resulted in a NOAEL of 5 mg/kg bw/day and did identify a systemic effect in nasal epithelium, suggesting that effects observed in the target organ following oral dosing could potentially be elicited by systemic exposure. In addition, the substance is not acutely toxic, is neither a skin nor an eye irritant. Genotoxic potential was evidenced in available studies. The NOAEL of 5 mg/kg bw/day has been used as the starting point for long-term systemic DNELs derivation and is considered protective enough for workers.
The substance is a skin sensitiser, but no DNEL/DMEL can be derived, since skin sensitisation was tested in a M&K test. A qualitative assessment has been performed and according to Table R. 8-24 (Chapter R.8, ECHA Guidance on information requirements and chemical safety assessment), the substance is considered to be a moderate skin sensitiser.
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
No general public exposure is anticipated.
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