Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

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:
no hazard identified
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:
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

Analogue substances are not acutely toxic via the oral or dermal routes (LD50 > 2000 mg/kg) and oral administration of EC 631-848-7 to rats by gavage, at dose levels of 100, 300 and 1000 mg/kg bw/day, was well tolerated in a 28-day repeated dose oral toxicity (NOAEL 1000 mg/kg bw/day). Similar results were obtained during a reproductive/developmental screening study in which no analogue-related effects relevant to humans were reported after administration of 100, 250, 500 and 1000 mg/kg bw/day and the NOAEL for reproductive and developmental toxicity was considered to be 1000 mg/kg bw/day. Furthermore, no evidence of skin irritation/corrosion, serious eye damage/irritation or skin sensitisation was found during performance of appropriate studies.

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:
no hazard identified
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:
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

Analogue substances are not acutely toxic via the oral or dermal routes (LD50 > 2000 mg/kg) and oral administration of EC 631-848-7 to rats by gavage, at dose levels of 100, 300 and 1000 mg/kg bw/day, was well tolerated in a 28-day repeated dose oral toxicity (NOAEL 1000 mg/kg bw/day). Similar results were obtained during a reproductive/developmental screening study in which no analogue-related effects relevant to humans were reported after administration of 100, 250, 500 and 1000 mg/kg bw/day and the NOAEL for reproductive and developmental toxicity was considered to be 1000 mg/kg bw/day. Furthermore, no evidence of skin irritation/corrosion, serious eye damage/irritation or skin sensitisation was found during performance of appropriate studies