Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8.31 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
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:
12.1 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEL
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:
medium hazard (no threshold derived)

Additional information - workers

1. Relevant Toxicology Data, exposure pattern and route

The oral repeat dose toxicity of an analog of this substance was evaluated with rats at doses as high as 160 mg/kg/day for up to 52 consecutive days in accordance with OECD 422. Substance-related toxicity was limited to morbundity, adverse clinical signs, and epithelial hyperplasia, hyperkeratosis, and inflammation of the stomach. The NOAEL for systemic toxicity was 160 mg/kg/day. The NOEL for portal of entry irritation and related secondary effects parental toxicity was 40 mg/kg/day. This study was determined to be suitable for read across to fill the data gap for EC 283-392-8.  

2. Mode of action

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

 

3. Correction of dose descriptor

NOAELoralis converted into a NOAELcorrectedin accordance to Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose [concentration] - response for human health, ECHA, May 2008.

NOAELoral= 160 mg/kg/d

NOAELcorrected= 1600 mg/kg/d for dermal exposure, dermal absorption of 10% was justified (see Toxicokinetic Statement).

NOAELcorrected= NOAELrat-oral÷ 0.38 m3/kg*(ABSrat-oral÷ ABShuman-inhalation)*6.7÷10.3 (sRV human 8h/wRV 8h) = 273.9 mg/m3for inhalation exposure.

Purity of the test material is 91%, and it was taken into account when calculating DNEL.

 

4. Application of assessment factors

Dermal route: The following assessment factors were chosen: interspecies difference (4 for allometric scale, 1 for remaining difference), intraspecies difference (5 for workers), duration extrapolation (6 for subacute to chronic exposure duration), and quality of the data (1 for a reliable study).

Inhalation route: The following assessment factors were chosen: interspecies difference (1), intraspecies difference (5 for workers), duration extrapolation (6 for subacute to chronic exposure duration), and quality of the data (1 for a reliable study).

 

 

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.11 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
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:
6.1 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
240
Modified dose descriptor starting point:
NOAEL
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:
0.24 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
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population

1. Relevant Toxicology Data, exposure pattern and route

The oral repeat dose toxicity of an analog of this substance was evaluated with rats at doses as high as 160 mg/kg/day for up to 52 consecutive days in accordance with OECD 422. Substance-related toxicity was limited to morbundity, adverse clinical signs, and epithelial hyperplasia, hyperkeratosis, and inflammation of the stomach. The NOAEL for systemic toxicity was 160 mg/kg/day. The NOEL for portal of entry irritation and related secondary effects parental toxicity was 40 mg/kg/day. This study was determined to be suitable for read across to fill the data gap for EC 283-392-8.  

  

2. Mode of action

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

 

3. Correction of dose descriptor

NOAELoralis converted into a NOAELcorrectedin accordance to Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose [concentration] - response for human health, ECHA, May 2008.

NOAELoral= 160 mg/kg/d

NOAELcorrected= 1600 mg/kg/d for dermal exposure, dermal absorption of 10% was justified (see Toxicokinetic Statement).

NOAELcorrected= NOAELrat-oral÷ 1.15 m3/kg*(ABSrat-oral÷ ABShuman-inhalation) =139.1 mg/m3for inhalation exposure.

Purity of the test material is 91%, and it was taken into accound when calculating DNEL.

 

4. Application of assessment factors

Dermal route: The following assessment factors were chosen: interspecies difference (4 for allometric scale, 1 for remaining difference), intraspecies difference (10 for general population), duration extrapolation (6 for subacute to chronic exposure duration), and quality of the data (1 for a reliable study).

Inhalation route: The following assessment factors were chosen: interspecies difference (1), intraspecies difference (10 for general population), duration extrapolation (6 for subacute to chronic exposure duration), and quality of the data (1 for a reliable study).

Oral route: The following assessment factors were chosen: interspecies difference (4 for allometric scale, 2.5 for remaining difference), intraspecies difference (10 for general population), duration extrapolation (6 for subacute to chronic exposure duration), and quality of the data (1 for a reliable study).