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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

NOAEL (systemic toxicity) = >= 1000 mg/kg bw/day (No hazard identified); OECD 422; García (2018) 

Long-term systemic hazard assessment for this substance is based on a subacute toxicity study conducted on rats in accordance with OECD 422, under GLP (García 2018).  The substance was administered to 10 male and 10 female Hannover Wistar Rat (HsdHan®:WIST) by oral gavage at dose levels of 100, 350 and 1000 mg/kg/day. Males were treated continuously for two weeks before pairing up to necropsy, after a minimum of 37 consecutive days. Females were treated continuously for two weeks before pairing, throughout pairing and gestation, and until Day 13-15 of lactation (the day before sacrifice). Females were allowed to litter and rear their offspring, and litters were killed on Day 13-15 of lactation (the day before the corresponding female was killed). F1 generation received no direct administration of the test item; any exposure was in utero or via the milk.  Although there was no recovery phase, this is not a guideline requirement.  

The key findings in this study was, statistically lower mean values with respect to Control, in all test item administered males groups was observed in forelimb grip strength, as well as higher mean motor activity values with respect to Control were observed in general in all test item administered groups in males and females. Therefore, the No Observed Adverse Effect Level (NOAEL) for systemic toxicity was 1000 mg/kg bw/day for males and females, taking into account that findings observed in clinical pathology did not affect the general well-being, growth, development or life span as well as that the findings observed in grip strength or motor activity were not corroborated with clinical signs.

The hazard conclusion for reproductive and developmental toxicology were as follows: 

NOAEL(fertility) = >= 1000 mg/kg bw/day (No hazard identified); OECD 422; García (2018)

NOAEL(development) = >= 1000 mg/kg bw/day (No hazard identified); OECD 422; García (2018)

The No Observed Effect Level (NOEL) for reproductive / developmental toxicity was considered to be 1000 mg/kg/day, taking into account that there was no effect on estrous cycle, pre-coital interval, mating performance, fertility and gestation length or in the offspring on litter size, sex ratio, survival, clinical signs, body weights, ano-genital distances or macropathology.

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

NOAEL (systemic toxicity) = >= 1000 mg/kg bw/day (No hazard identified); OECD 422; García (2018) 

Long-term systemic hazard assessment for this substance is based on a subacute toxicity study conducted on rats in accordance with OECD 422, under GLP (García 2018).  The substance was administered to 10 male and 10 female Hannover Wistar Rat (HsdHan®:WIST) by oral gavage at dose levels of 100, 350 and 1000 mg/kg/day. Males were treated continuously for two weeks before pairing up to necropsy, after a minimum of 37 consecutive days. Females were treated continuously for two weeks before pairing, throughout pairing and gestation, and until Day 13-15 of lactation (the day before sacrifice). Females were allowed to litter and rear their offspring, and litters were killed on Day 13-15 of lactation (the day before the corresponding female was killed). F1 generation received no direct administration of the test item; any exposure was in utero or via the milk.  Although there was no recovery phase, this is not a guideline requirement.  

The key findings in this study was, statistically lower mean values with respect to Control, in all test item administered males groups was observed in forelimb grip strength, as well as higher mean motor activity values with respect to Control were observed in general in all test item administered groups in males and females. Therefore, the No Observed Adverse Effect Level (NOAEL) for systemic toxicity was 1000 mg/kg bw/day for males and females, taking into account that findings observed in clinical pathology did not affect the general well-being, growth, development or life span as well as that the findings observed in grip strength or motor activity were not corroborated with clinical signs.

The hazard conclusion for reproductive and developmental toxicology were as follows: 

NOAEL(fertility) = >= 1,000 mg/kg bw/day (No hazard identified); OECD 422; García (2018)

NOAEL(development) = >= 1,000 mg/kg bw/day (No hazard identified); OECD 422; García (2018)

The No Observed Effect Level (NOEL) for reproductive / developmental toxicity was considered to be 1000 mg/kg/day, taking into account that there was no effect on estrous cycle, pre-coital interval, mating performance, fertility and gestation length or in the offspring on litter size, sex ratio, survival, clinical signs, body weights, ano-genital distances or macropathology.