Registration Dossier
Registration Dossier
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EC number: 944-390-9 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 35.3 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 12.5
- Dose descriptor starting point:
- NOAEL
- Value:
- 150 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 441 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The oral rat chronic toxicity study with ethane-1,2 -diol is considered as the most relevant study to derive a systemic DNEL for the inhalation route. Based on the available toxicokinetic data, absorption via the inhalation route (end route) is lower (60%) as compared to the oral route (starting route, 100%).
The NOAEL of 150 mg/kg bw/d was modified acc. to ECHA guidance IR&CSA chapter R.8 (150 * 1/0.38 * 100/60 * 6.7/10 = 441 mg/m³).
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 1
- Justification:
- No time extrapolation factor is needed since a chronic toxicity study is available.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Respiratory interspecies differences are fully covered by the factors used for route to route extrapolation.
- AF for other interspecies differences:
- 2.5
- Justification:
- Recommended AF for other interspecies differences.
- AF for intraspecies differences:
- 5
- Justification:
- The default value for the relatively homogenous group "worker" is used.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 176.5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 1
- Explanation for the modification of the dose descriptor starting point:
The worker DNEL(inhalation-systemic, long term) of 35.3 mg/m³ was used as starting point and corrected by a factor of 5 to account for acute/short term exposure.
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 9 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Dose descriptor:
- other: not relevant, as IOEL was used as DNEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 9 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 1
- Dose descriptor starting point:
- other: not relevant, as IOEL was used as DNEL
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3 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):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 150 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 1
- Justification:
- No time extrapolation factor is needed since a chronic toxicity study is available.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling from rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Recommended AF for other interspecies differences.
- AF for intraspecies differences:
- 5
- Justification:
- The default value for the relatively homogenous group "worker" is used.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short 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
- DNEL extrapolated from long term DNEL
- Explanation for the modification of the dose descriptor starting point:
The worker DNEL(dermal-systemic, long term) of 3 mg/kg bw/d was used as starting point and corrected by a factor of 5 to account for acute/short term exposure.
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
The reaction mass consists of the two main components 2-hydroxyethyl formate and ethylene diformate, which rapidly hydrolyse to formic acid and ethane-1,2-diol. Thus, the read-across from the two hydrolysis products to the reaction mass is justified.
The reaction mass is classified as corrosive as a consequence of the corrosive properties of formic acid. Therefore, it can be assumed that effects due to local toxicity (NOAEClocal= 61 mg/m3) outweigh those of systemic toxicity (NOAECsystemic= 244 mg/m3).
In contrast to formic acid, ethane-1,2-diol is not classified for corrosivity. Thus, the systemic toxicity of ethane-1,2-diol (NOAELsystemic= 150 mg/kg bw/d) outweighs its local toxicity and it can be assumed that ethane-1,2- diol is responsible for the systemic toxicity of the reaction mass.
Based on these considerations, systemic DNELs for the reaction mass are derived from ethane-1,2-diol (starting point: NOAEL=150 mg/kg bw/d) and local DNELs (inhalation route) from formic acid (applying the IOEL of 9 mg/m3). The IOEL (indicative occupational exposure limit value) for formic acid is published in the Commission Directive 2006/15/EC. As the IOEL covers the same exposure route and duration and no more recent information, which also includes the data represented in this IUCLID dossier, exists than the one used for the setting of the IOEL, the use of the IOEL as DNEL for local effects via inhaltion is considered to be adequate.
Reference
ECHA (2012): Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health
General Population - Hazard via inhalation 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
Local 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 via dermal 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
Local 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
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:
- hazard unknown but no further hazard information necessary as no exposure expected
Additional information - General Population
General
General population is not intended to be exposed to the reaction mass via inhalation or dermal route. Therefore, no DNEL (long-term, inhalation and dermal exposure) is derived for general population. As the reaction mass has no bioaccumulation potential no risk assessment for secondary poisoning is required for the general population.
References
(not included as endpoint study record)
- ECHA (2010) Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health. Version 2. ECHA-2010 -G-19 –EN.
- ECHA (2011) Guidance on information requirements and chemical safety assessment. Part B: Hazard assessment. Version 2
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