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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-104-6 | CAS number: 103-36-6
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.22 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):
- 150
- Dose descriptor starting point:
- NOAEL
- Value:
- 443.7 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 782.3 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NOAEL = 443.7 mg/kg bw/d
This NOAEL is calculated starting from the NOAEL available from a combined repeated dose / reproductive toxicity study in rats on the read-across substance benzyl cinnamate by taking into account a correction for the molecular weight.
NOAEL (benzyl cinnamate) = 600 mg/kg bw/d
MW (benzyl cinnamate) = 238.28 g/mol
MW (ethyl cinnamate) = 176.21 g/mol
NOAEL (ethyl cinnamate) = 600 * (176.21/238.28) = 443.7 g/mol
--> 443.7 mg/kg bw/d / 0.38 m3/kg bw * 6.7 m3/ 10 m3
NOAEC = 782.3 mg/m3
- AF for dose response relationship:
- 2
- Justification:
- default value for route-to-route extrapolation according to R.8.4.2.
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA REACH standard AF for sub-acute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not used for inhalation results
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH standard AF for "differences not related to calorimetric differences"
- AF for intraspecies differences:
- 5
- Justification:
- default value according to R.8.4.3.1
- AF for the quality of the whole database:
- 1
- Justification:
- no issues with the quality of the data base
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
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
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.479 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):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 443.7 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 443.7 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
NOAEL = 443.7 mg/kg bw/d
This NOAEL is calculated starting from the NOAEL available from a combined repeated dose / reproductive toxicity study in rats on the read-across substance benzyl cinnamate by taking into account a correction for the molecular weight.
NOAEL (benzyl cinnamate) = 600 mg/kg bw/d
MW (benzyl cinnamate) = 238.28 g/mol
MW (ethyl cinnamate) = 176.21 g/mol
NOAEL (ethyl cinnamate) = 600 * (176.21/238.28) = 443.7 g/mol
No specific information on dermal absorption was taken into account.
This approach starts from the assumption that dermal absorption will not be higher than oral absorption.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA REACH standard AF for sub-acute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA REACH standard AF for rat to human extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH standard AF for "differences not related to calorimetric differences"
- AF for intraspecies differences:
- 5
- Justification:
- ECHA REACH standard AF for intraspecies differences to workers
- AF for the quality of the whole database:
- 1
- Justification:
- no issues with the quality of the data base
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties 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
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.286 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):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 443.7 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 385.8 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NOAEL = 443.7 mg/kg bw/d
This NOAEL is calculated starting from the NOAEL available from a combined repeated dose / reproductive toxicity study in rats on the read-across substance benzyl cinnamate by taking into account a correction for the molecular weight.
NOAEL (benzyl cinnamate) = 600 mg/kg bw/d
MW (benzyl cinnamate) = 238.28 g/mol
MW (ethyl cinnamate) = 176.21 g/mol
NOAEL (ethyl cinnamate) = 600 * (176.21/238.28) = 443.7 g/mol
--> 443.7 mg/kg bw/d / 1.15 m3/kg bw
NOAEC = 385.8 mg/m3
- AF for dose response relationship:
- 2
- Justification:
- default value for route-to-route extrapolation according to R.8.4.2.
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA REACH standard AF for sub-acute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not used for oral results
- AF for other interspecies differences:
- 2.5
- Justification:
- differences not related to calorimetric differences
- AF for intraspecies differences:
- 10
- Justification:
- default value according to R.8.4.3.1
- AF for the quality of the whole database:
- 1
- Justification:
- no issues with the quality of the data base
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.74 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 443.7 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 443.7 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
NOAEL = 443.7 mg/kg bw/d
This NOAEL is calculated starting from the NOAEL available from a combined repeated dose / reproductive toxicity study in rats on the read-across substance benzyl cinnamate by taking into account a correction for the molecular weight.
NOAEL (benzyl cinnamate) = 600 mg/kg bw/d
MW (benzyl cinnamate) = 238.28 g/mol
MW (ethyl cinnamate) = 176.21 g/mol
NOAEL (ethyl cinnamate) = 600 * (176.21/238.28) = 443.7 g/mol
No specific information on dermal absorption was taken into account.
This approach starts from the assumption that dermal absorption will not be higher than oral absorption.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA REACH standard AF for sub-acute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA REACH standard AF for rat to human extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH standard AF for "differences not related to calorimetric differences"
- AF for intraspecies differences:
- 10
- Justification:
- ECHA REACH default AF for the general population
- AF for the quality of the whole database:
- 1
- Justification:
- no issues with the quality of the data base
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties 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:
- DNEL (Derived No Effect Level)
- Value:
- 0.74 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 443.7 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 443.7 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
NOAEL = 443.7 mg/kg bw/d
This NOAEL is calculated starting from the NOAEL available from a combined repeated dose / reproductive toxicity study in rats on the read-across substance benzyl cinnamate by taking into account a correction for the molecular weight.
NOAEL (benzyl cinnamate) = 600 mg/kg bw/d
MW (benzyl cinnamate) = 238.28 g/mol
MW (ethyl cinnamate) = 176.21 g/mol
NOAEL (ethyl cinnamate) = 600 * (176.21/238.28) = 443.7 g/mol
Oral absorption by rat and human are assumed to be equal.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA REACH standard AF for sub-acute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA REACH standard AF for rat to human extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH standard AF for "differences not related to calorimetric differences"
- AF for intraspecies differences:
- 10
- Justification:
- ECHA REACH standard AF for the general population
- AF for the quality of the whole database:
- 1
- Justification:
- no issues with the quality of the data base
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
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.
