Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
9.98 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
30
Modified dose descriptor starting point:
NOAEC
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:
1.17 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
300
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

1.   Relevant Toxicology Data, exposure pattern and route

 

The calculation of the DNEL is based on the results of a Combined Repeated Oral Dose and reproduction Toxicity study (OECD 422) in rats. A NOAEL for systemic toxicity was established at 350 mg/kg bw.

2. Mode of action

No non-threshold mode of action is associated with the test substance. In particular, the test substance has no genotoxic potential.

 

3. Correction of dose descriptor

NOAEL (oral) is converted into a NOAEL(corrected)in accordance to Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose[concentration]-response for human health, ECHA, May 2008.

Dermal: NOAEL (oral) = 350 mg/kg bw =>NAEC(corrected) = 350mg/kg

Inhalation: NOAEL (oral) = 350 mg/kg bw =>NAEC(corrected) = 299.6 mg/m3

Assumption: Absorption oral = absorption dermal = 1/2 absorption inhalation.

 

4. Application of assessment factors

The following assessment factors were chosen:

Dermal:

Intraspecies differences account for a factor of 4. Since a subchronic study in the rat was assigned as key study,

a factor of 5 for intraspecies difference

a factor of 6 for exposure duration was used.

a factor of 2.5 for an additional factor for residual interspecies differences

a factor of 1 for the quality of dataset.

 

 

Inhalation:

Intraspecies differences account for a factor of 1

a factor of 6 for exposure duration was used.

a factor of 5 for interspecies differences

a factor of 1 for the quality of dataset. . 

 

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.54 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
60
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.58 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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.58 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

General Population - Hazard for the eyes

Additional information - General Population

1.   Relevant Toxicology Data, exposure pattern and route

 

The calculation of the DNEL is based on the results of a Combined Repeated Oral Dose and reproduction Toxicity study (OECD 422) in rats. A NOAEL for systemic toxicity was established at 350 mg/kg bw.

2. Mode of action

No non-threshold mode of action is associated with the test substance. In particular, the test substance has no genotoxic potential.

 

3. Correction of dose descriptor

NOAEL (oral) is converted into a NOAEL(corrected)in accordance to Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose[concentration]-response for human health, ECHA, May 2008.

Dermal: NOAEL (oral) = 350 mg/kg bw =>NAEC(corrected) = 350mg/kg

Inhalation: NOAEL (oral) = 350 mg/kg bw =>NAEC(corrected) = 299.6 mg/m3

Assumption: Absorption oral = absorption dermal = 1/2 absorption inhalation.

 

4. Application of assessment factors

The following assessment factors were chosen:

Dermal:

Intraspecies differences account for a factor of 4. Since a subchronic study in the rat was assigned as key study,

a factor of 10 for intraspecies difference

a factor of 6 for exposure duration was used.

a factor of 2.5 for an additional factor for residual interspecies differences

a factor of 1 for the quality of dataset.

 

 

Inhalation:

Intraspecies differences account for a factor of 1

a factor of 6 for exposure duration was used.

a factor of 10 for interspecies differences

a factor of 1 for the quality of dataset. .