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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-389-7 | CAS number: 106-36-5
Toxicological Summary
Administrative data
Workers - 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:
- DNEL (Derived No Effect Level)
- Value:
- 23.3 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10.2
- Dose descriptor:
- NOAEC
- AF for dose response relationship:
- 1
- Justification:
- See Discussion
- AF for differences in duration of exposure:
- 3.4
- Justification:
- See Discussion
- Justification:
- Local effects - allometric scaling not relevant
- AF for other interspecies differences:
- 1
- Justification:
- See Discussion
- AF for intraspecies differences:
- 3
- Justification:
- See Discussion
- AF for the quality of the whole database:
- 1
- Justification:
- See Discussion
- AF for remaining uncertainties:
- 1
- Justification:
- See Discussion
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 79.3 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 3
- Dose descriptor starting point:
- NOAEC
- AF for dose response relationship:
- 1
- Justification:
- See Discussion
- Justification:
- Local effects - allometric scaling not relevant
- AF for other interspecies differences:
- 1
- Justification:
- See Discussion
- AF for intraspecies differences:
- 3
- Justification:
- See Discussion
- AF for the quality of the whole database:
- 1
- Justification:
- See Discussion
- AF for remaining uncertainties:
- 1
- Justification:
- See Discussion
Workers - 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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
The repeated dose toxicological study identified a local effect in the upper respiratory tract as the key effect driving LOEC for propyl-propionate. There were no significant systemic effects in any of the studies available on this substance or the others in the category. Therefore the only DNEL considered appropriate is that for Local effects, via inhalation (short term and long term).
The starting point for the DNEL derivation is the LOEC of 50 ppm (238 mg/m3) for local effects in the 28 -day repeated dose inhalation study on propyl propionate.
For Workers, this is converted to take into consideration exposure differences and differences in respiratory rate.
Adjusted starting point = 238 * 6/8 * 6.7/10 = 120 mg/m3
Assessment factors to be used:
Intra species variation (Worker): 3 (taken from ECETOC report on assessment factors and consistent with the approach taken by SCOEL in setting OELs for irritants)
Allometric scaling - N/A due to local effect
Other differences - according to the guidance either a factor of 1 or of 2.5 is appropriate depending on the nature of the effects. In this case the effect is in the upper respiratory tract and involved the degeneration of the olfactory epithelia. This is an irritant effect.
Irritating effects on the respiratory epithelium, and atrophy/degeneration of the nasal and olfactory epithelium are critical effects consistently observed with various ester derivatives (butyl acrylate, methyl acrylate, methylmethacrylate, methyl acetate, ethyl acrylate, lactate esters). These effects are thought to be related to a mechanism common between esters which involves hydrolysis by unspecific carboxylesterases located in the nasal/olfactory epithelium to release corresponding acids and alcohols. However, there are well-known differences in the anatomy and physiology of the nasal and olfactory epithelia between rats and humans. Although some variability in the experimental results of carboxylesterase activity exists, depending on the methodology and the substrate used, there is a general trend supporting lower nasal esterase activity towards esters from human tissues compared to those from rat tissues. (Ref. Frederick C. B. et al. Use of a hybrid computational fluid dynamics and physiologically based inhalation model for interspecies dosimetry comparisons of ester vapours. Toxicol Appl Pharmacol. 183(1): 23-40, 2002). The respiratory local effects should therefore be of a lower concern in the human situation. These effects are thought to be overpredictive in the rat model as compared to humans, because of the morphological and physiological differences.
Therefore the factor for other differences will be 1
Dose response: 1
Database quality: 1
Duration of exposure:
For acute/short term effects: 1 - the LOEC is from a 28 day study.
For Chronic effects: 3.4 this is taken from the publication of Batke, M., et al., Evaluation of time extrapolation factors based on the database RepDose. Toxicol. Lett. (2011), doi:10.1016/j.toxlet.2011.05.1030.
Total Factor = 10.2 (Chronic) and 3 (Acute)
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:
- DNEL (Derived No Effect Level)
- Value:
- 15.9 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 20.4
- Dose descriptor:
- NOAEC
- AF for dose response relationship:
- 1
- Justification:
- See Discussion
- AF for differences in duration of exposure:
- 3.4
- Justification:
- See Discussion
- Justification:
- Local effects - allometric scaling not relevant
- AF for other interspecies differences:
- 1
- Justification:
- See Discussion
- AF for intraspecies differences:
- 6
- Justification:
- See Discussion
- AF for the quality of the whole database:
- 1
- Justification:
- See Discussion
- AF for remaining uncertainties:
- 1
- Justification:
- See Discussion
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 54.2 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 6
- Dose descriptor starting point:
- NOAEC
- AF for dose response relationship:
- 1
- Justification:
- See Discussion
- Justification:
- Local effects - allometric scaling not relevant
- AF for other interspecies differences:
- 1
- Justification:
- See Discussion
- AF for intraspecies differences:
- 6
- Justification:
- See Discussion
- AF for the quality of the whole database:
- 1
- Justification:
- See Discussion
- AF for remaining uncertainties:
- 1
- Justification:
- See Discussion
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
The repeated dose toxicological study identified a local effect in the upper respiratory tract as the key effect driving the LOEC for propyl-propionate. There were no significant systemic effects in any of the studies available on this substance or the others in the category. Therefore the only DNEL considered appropriate is that for Local effects, via inhalation (short term and long term).
The starting point for the DNEL derivation is the LOEC of 50 ppm (238 mg/m3) for local effects in the 28 -day inhalation study on propyl-propionate.
For General Population, this is converted to take into consideration exposure differences and differences in respiratory rate.
Adjusted starting point = 238 * 6/24 = 59.5 mg/m3
Assessment factors to be used:
Intra species variation (General Pop): 6 (taken from ECETOC report on assessment factors and consistent with the approach taken by SCOEL in setting OELs for irritants)
Allometric scaling - N/A due to local effect
Other differences - according to the guidance either a factor of 1 or of 2.5 is appropriate depending on the nature of the effects. In this case the effect is in the upper respiratory tract and involved the degeneration of the olfactory epithelia. This is an irritant effect.
Irritating effects on the respiratory epithelium, and atrophy/degeneration of the nasal and olfactory epithelium are critical effects consistently observed with various ester derivatives (butyl acrylate, methyl acrylate, methylmethacrylate, methyl acetate, ethyl acrylate, lactate esters). These effects are thought to be related to a mechanism common between esters which involves hydrolysis by unspecific carboxylesterases located in the nasal/olfactory epithelium to release corresponding acids and alcohols. However, there are well-known differences in the anatomy and physiology of the nasal and olfactory epithelia between rats and humans. Although some variability in the experimental results of carboxylesterase activity exists, depending on the methodology and the substrate used, there is a general trend supporting lower nasal esterase activity towards esters from human tissues compared to those from rat tissues. (Ref. Frederick C. B. et al. Use of a hybrid computational fluid dynamics and physiologically based inhalation model for interspecies dosimetry comparisons of ester vapours. Toxicol Appl Pharmacol. 183(1): 23-40, 2002). The respiratory local effects should therefore be of a lower concern in the human situation. These effects are thought to be overpredictive in the rat model as compared to humans, because of the morphological and physiological differences.
Therefore the factor for other differences will be 1
Dose response: 1
Database quality: 1
Duration of exposure:
For acute/short term effects: 1 - the NOEL is from a 90-day study.
For Chronic effects: 3.4 this is taken from the publication of Batke, M., et al., Evaluation of time extrapolation factors based on the database RepDose. Toxicol. Lett. (2011), doi:10.1016/j.toxlet.2011.05.1030.
Total Factor = 20.4 (Chronic) and 6 (Acute)
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