Registration Dossier

Diss Factsheets

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

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