Registration Dossier

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:
DNEL (Derived No Effect Level)
Value:
10 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEL
DNEL value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
DNEL value:
1 000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default value in accordance with ECHA guidance- Chapter R.8
AF for differences in duration of exposure:
2
Justification:
DNEL is based on 90 days oral study
AF for interspecies differences (allometric scaling):
4
Justification:
DNEL is based on study conducted in rats
AF for other interspecies differences:
2.5
Justification:
Default value in accordance with ECHA guidance- Chapter R.8
AF for intraspecies differences:
5
Justification:
DNEL is calculated for workers
AF for the quality of the whole database:
1
Justification:
Default value in accordance with ECHA guidance- Chapter R.8
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

No adverse effects upon which DNELs for workers could be based have been seen in any of the available toxicity studies. In accordance with ECHA Guidance Document Chapter R.8, therefore, DNELs for acute effects have not been derived. The physico-chemical properties of the substance demonstrate that there is negligible potential for inhalation exposure to the substance; consequently, no inhalation DNELs have been derived. Based on an absence of toxicity in the available studies, a long-term dermal DNEL for systemic effects in workers of 10 mg/kg bw/day is proposed based on the 90-day oral toxicity study in rats in which a NOAEL of 1,000 mg/kg bw/day was identified (the highest dose tested).

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:
DNEL (Derived No Effect Level)
Value:
5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Dose descriptor starting point:
NOAEL
DNEL value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
DNEL value:
1 000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default value in accordance with ECHA guidance- Chapter R.8
AF for differences in duration of exposure:
2
Justification:
DNEL is based on 90 days oral study
AF for interspecies differences (allometric scaling):
4
Justification:
DNEL is based on study conducted in rats
AF for other interspecies differences:
2.5
Justification:
Default value in accordance with ECHA guidance- Chapter R.8
AF for intraspecies differences:
10
Justification:
DNEL is calculated for general population
AF for the quality of the whole database:
1
Justification:
Default value in accordance with ECHA guidance- Chapter R.8
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:
DNEL (Derived No Effect Level)
Value:
5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Dose descriptor starting point:
NOAEL
DNEL value:
1 000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default value in accordance with ECHA guidance- Chapter R.8
AF for differences in duration of exposure:
2
Justification:
DNEL is based on 90 days oral study
AF for interspecies differences (allometric scaling):
4
Justification:
DNEL is based on study conducted in rats
AF for other interspecies differences:
2.5
Justification:
Default value in accordance with ECHA guidance- Chapter R.8
AF for intraspecies differences:
10
Justification:
DNEL is calculated for general population
AF for the quality of the whole database:
1
Justification:
Default value in accordance with ECHA guidance- Chapter R.8
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

No adverse effects upon which DNELs for general population could be based have been seen in any of the available toxicity studies. In accordance with ECHA Guidance Document Chapter R.8, therefore, DNELs for acute effects have not been derived. The physico-chemical properties of the substance demonstrate that there is negligible potential for inhalation exposure to the substance; consequently, no inhalation DNELs have been derived.

Based on an absence of toxicity in the available studies, a long-term oral DNEL for systemic effects in the general population and a long-term dermal DNEL for systemic effects in the general population, each of 5.0 mg/kg bw/day are proposed based on the 90-day oral toxicity study in rats in which a NOAEL of 1,000 mg/kg bw/day was identified (the highest dose tested).