Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

A close analogue of the registered substance is not acutely toxic via the oral or dermal routes (LD50 > 2000 mg/kg) andoral administration of the same analogue to rats by gavage, at dose levels of 50, 300 and 1000 mg/kg bw/day in a 28-day repeated dose study (OECD 407) was well tolerated and the NOAEL was reported as 1000 mg/kg bw/day (equivalent to 404 mg a.i./kg bw/day). Similar results were reported with the same analogue test item when doses of 43, 160 and 600 mg a.i./kg bw/day were administered to rats during a combined repeated dose toxicity study with reproduction/developmental toxicity screening (OECD 422) and the NOAEL was reported as 600 mg a.i./kg bw/day.Moreover, no evidence of skin irritation/corrosion, serious eye damage/irritation or skin sensitisation was found during performance of appropriate studies.In the absence of systemic or local effects by the oral or dermal route DNELs could not be derived.

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

A close analogue of the registered substance is not acutely toxic via the oral or dermal routes (LD50 > 2000 mg/kg) andoral administration of the same analogue to rats by gavage, at dose levels of 50, 300 and 1000 mg/kg bw/day in a 28-day repeated dose study (OECD 407) was well tolerated and the NOAEL was reported as 1000 mg/kg bw/day (equivalent to 404 mg a.i./kg bw/day). Similar results were reported with the same analogue test item when doses of 43, 160 and 600 mg a.i./kg bw/day were administered to rats during a combined repeated dose toxicity study with reproduction/developmental toxicity screening (OECD 422) and the NOAEL was reported as 600 mg a.i./kg bw/day.Moreover, no evidence of skin irritation/corrosion, serious eye damage/irritation or skin sensitisation was found during performance of appropriate studies. In the absence of systemic or local effects by the oral or dermal route DNELs could not be derived.