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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 701-219-0 | CAS number: 15174-47-7
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- insufficient hazard data available (further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- insufficient hazard data available (further information necessary)
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:
- insufficient hazard data available (further information necessary)
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
Due to delays in the toxicological testing, suitable DNELS for hazard classification are not able to be determined at this time. The dossier will be updated upon receipt of the final report from the CRO.
According to ECHA communication CCH-D-2114453633-49-01/F (attached in Section 13 of the dossier) received on December 14, 2018, a 90-Day Repeated Dose Toxicity Study of (2E)-2-methyl-3-phenylacrylaldehyde (Cyprinal; CAS# 15174-47-7) by the oral route (gavage) in Wistar rats, commenced in 2019 at Charles River Laboratories Hungary Kft.(H-8200 Veszprém, Szabadságpuszta, hrsz. 028/1., Hungary; Test Facility Study No. 19/205-101P), and in-life phase was completed in March 2020.
However, due to high demand and the need for additional investigations (trackdowns), the CRO has been unable to complete the reporting phase of the study before the ECHA deadline (The ECHA communication states that the registrant is required to submit the requested information in an updated registration dossier by 21 June, 2021). The laboratory expects to finalize and complete these reports in the 3rd quarter of 2021.
The justification of the testing delay can be found in Section 13.2 of the dossier. OECD 408 (Oral route) in rats is conducted prior to the initiation of any repeated dose toxicity studies by inhalation or dermal route. Results of the OECD 408 study are awaited (see section 7.5.1 of the dossier). Any decision to conduct repeated exposure dermal and inhalation studies will be dependent on the outcome of this OECD 408 oral in accordance with the Regulatory requirements
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:
- 3.5 mg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 1
- Dose descriptor:
- other: NOAEL
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA AF; human health relevant NOAEL from well conducted study
- AF for differences in duration of exposure:
- 1
- Justification:
- Default ECHA AF for local exposure
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default ECHA AF for human study (allometric scaling)
- AF for other interspecies differences:
- 1
- Justification:
- Default ECHA AF for human study
- AF for intraspecies differences:
- 1
- Justification:
- Default ECHA AF for (healthy) worker
- AF for the quality of the whole database:
- 1
- Justification:
- Default ECHA AF; the human health effects data are reliable and consistent, the available information meets the tonnage driven data requirements, and confidence in the database is high.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.5 mg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 1
- Dose descriptor starting point:
- other: NOAEL
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA AF; human health relevant NOAEL from well-conducted study.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default ECHA AF for human study (allometric scaling)
- AF for other interspecies differences:
- 1
- Justification:
- Default ECHA AF for human study
- AF for intraspecies differences:
- 1
- Justification:
- Default ECHA AF for (healthy) worker
- AF for the quality of the whole database:
- 1
- Justification:
- Default ECHA AF; the human health effects data are reliable and consistent, the available information meets the tonnage driven data requirements, and confidence in the database is high.
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:
- insufficient hazard data available (further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- insufficient hazard data available (further information necessary)
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:
- insufficient hazard data available (further information necessary)
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:
- 3.5 mg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 1
- Dose descriptor:
- other: NOAEL
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA AF; human health relevant NOAEL from well-conducted study.
- AF for differences in duration of exposure:
- 1
- Justification:
- Default ECHA AF for local exposure
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default ECHA AF for human study (allometric scaling)
- AF for other interspecies differences:
- 1
- Justification:
- Default ECHA AF for human study.
- AF for intraspecies differences:
- 1
- Justification:
- Default ECHA AF for (healthy) worker
- AF for the quality of the whole database:
- 1
- Justification:
- Default ECHA AF; the human health effects data are reliable and consistent, the available information meets the tonnage driven data requirements, and confidence in the database is high.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.5 mg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 1
- Dose descriptor starting point:
- other: NOAEL
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA AF; human health relevant NOAEL from well-conducted study.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default ECHA AF for human study (allometric scaling)
- AF for other interspecies differences:
- 1
- Justification:
- Default ECHA AF for human study
- AF for intraspecies differences:
- 1
- Justification:
- Default ECHA AF for (healthy) worker
- AF for the quality of the whole database:
- 1
- Justification:
- Default ECHA AF; the human health effects data are reliable and consistent, the available information meets the tonnage driven data requirements, and confidence in the database is high.
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- insufficient hazard data available (further information necessary)
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
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.
