Registration Dossier

Administrative data

Workers - 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

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.3 mg/kg bw/day
DNEL related information
Overall assessment factor (AF):
300
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available

Workers - Hazard for the eyes

Additional information - workers

The Derived No-Effect Levels (DNEL) were calculated using the recommendations of the ECHA "Guidance on information requirements and chemical safety assessment – Chapter R.8: Characterisation of dose [concentration]-response for human health" (May 2008).

The adverse effects selected for DNEL derivation were considered to bear a threshold mode of action.

-      Acute toxicity:

In the absence of any relevant toxic effect and in particular any acute toxicity hazard leading to Classification & Labelling, no specific DNEL was derived.

-      Irritation/Corrosion:

In the absence of irritation effects related to the test substance, no specific DNEL was derived.

-      Sensitization:

In the absence of skin sensitization effects related to the test substance, no specific DNEL was derived.

-      Repeat-dose toxicity:

Dermal exposure:

The study selected for dermal DNEL derivation is the OECD 407 and OECD 421-compliant studies in rats where no significant systemic toxicity was observed up to the highest tested dose, i.e. 1000 mg/kg b. w. /day.

-      Dose descriptor: NOAEL = 1000 mg/kg bw in rats

-      Corrected dose descriptor: No correction was applied (dermal NOAEL = oral NOAEL because both oral and dermal absorptions are considered negligible)

-      Assessment factors:

Interspecies differences = 4 (default value for rats)

Other toxicokinetic differences = 2.5 (default value for rats)

Intraspecies differences = 5 (default value for workers)

Differences in exposure duration = 6 (default value for subacute to chronic exposure extrapolation)

Dose-response issues = 1 (use of a NOAEL as a starting point)

Quality of the database = 1 (complete and reliable data)

=> Global assessment factor = 300

-      DNEL calculation:

Worker-DNEL long-term for dermal route, systemic effects = 1000 / 300 = 3.3 mg/kg bw

Inhalation exposure:

Exposure of humans via inhalation is unlikely (very low vapour pressure); handling of the registered substance does not produce vapour, aerosols or droplets. Furthermore, the most probable route of exposure is the dermal route since the substance is produced and commercialized as a liquid.

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:
DNEL (Derived No Effect Level)
Value:
1.66 mg/kg bw/day
DNEL related information
Overall assessment factor (AF):
600
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.66 mg/kg bw/day
DNEL related information
Overall assessment factor (AF):
600
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

The Derived No-Effect Levels (DNEL) were calculated using the recommendations of the ECHA "Guidance on information requirements and chemical safety assessment – Chapter R.8: Characterisation of dose [concentration]-response for human health" (May 2008).

The adverse effects selected for DNEL derivation were considered to bear a threshold mode of action.

-      Acute toxicity:

In the absence of any relevant toxic effect and in particular any acute toxicity hazard leading to Classification & Labelling, no specific DNEL was derived.

-      Irritation/Corrosion:

In the absence of irritation effects related to the test substance, no specific DNEL was derived.

-      Sensitization:

In the absence of skin sensitization effects related to the test substance, no specific DNEL was derived.

-      Repeat-dose toxicity:

Oral / Dermal exposure:

The study selected for dermal DNEL derivation is the OECD 407 and OECD 421-compliant studies in rats where no significant systemic toxicity was observed up to the highest tested dose, i.e. 1000 mg/kg b. w. /day.

-      Dose descriptor: NOAEL = 1000 mg/kg bw in rats

-      Corrected dose descriptor: No correction was applied (dermal NOAEL = oral NOAEL because both oral and dermal absorptions are considered negligible)

-      Assessment factors:

Interspecies differences = 4 (default value for rats)

Other toxicokinetic differences = 2.5 (default value for rats)

Intraspecies differences = 10 (default value for general population)

Differences in exposure duration = 6 (default value for subacute to chronic exposure extrapolation)

Dose-response issues = 1 (use of a NOAEL as a starting point)

Quality of the database = 1 (complete and reliable data)

=> Global assessment factor = 600

-      DNEL calculation:

General population-DNEL long-term for oral/dermal route, systemic effects = 1000 / 600 = 1.66 mg/kg bw

Inhalation exposure:

Exposure of humans via inhalation is unlikely (very low vapour pressure); handling of the registered substance does not produce vapour, aerosols or droplets. Furthermore, the most probable route of exposure is the dermal route since the substance is produced and commercialized as a liquid.