Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.6 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Modified dose descriptor starting point:
NOAEC
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
AF for intraspecies differences:
5
AF for the quality of the whole database:
2
AF for remaining uncertainties:
2.5
Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.75 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
600
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

This substance is of low acute toxicity following oral exposure. The substance is not expected to be irritating to the skin or to the eyes and does not possess any skin sensitisation potential. On these bases no acute DNELs are required.

Data evaluating the genotoxic potential of the substance lead to conclusions that the substance is not genotoxic.

A GLP-compliant OECD 422 study, under the worst condition of oral gavage, set a parental NOEL at 150 mg/kg bw/day and the systemic NOAEL at 450 mg/kg bw/day. The reproductive and developmental of offspring to day 4 of lactation toxicity NOAELs were also established by this OECD 422 study, at the limit dose of 1000 mg/kg bw/day. The systemic NOAEL of 450 mg/kg bw/day is considered the appropriate endpoint to caluculate long-term DNELs for workers exposure. An additional assessment factor of 2 was applied because the data on reproductive and developmental toxicity are limited to the above mentioned OECD 422 study and no data on chronic toxicity are available.

Taken together, all the availalbe toxicological information suggests that the substance should be at most minimally absorbed.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

The general population is not expected to be exposed to the substance.