Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
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:
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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

The 90-day oral toxicity study in rats with Tinuvin 326 was performed according to GLP Testing guidelines and was selected as the most relevant study for DNEL calculation. The dose descriptor chosen was the NOAEL of 1000 mg/kg.

 

Oral NOAEL

 

Factor for standard respiratory volume rat

Factor for standard respiratory volume man and 8-h exposure

 

Corrected NOAEL

 

1000 mg/kg/day

 

 

1/0.38 m3/kg/d

 

6.7 m3(8h) / 10 m3(8h)

 

1763 mg/ m3

(1) Oral Route

 

 

 

Oral NOAEL

 

Sum of assessment factors applicable

 

DNELoral

 

Workers

 

1000 mg/kg/day

 

4 x 5 x 2 x 2.5 = 100

 

10 mg/kg

 

(2)  Inhalation route / systemic exposure

 

 

Corrected NOAEL

Sum of assessment factors applicable

DNELinhalative

 

Workers

 

1763 mg/ m3

 

5 x 2 x 2.5 = 25

 

70 mg/m3

 

In case future considerations have to consider inhalation exposure, a general dust limit value of 3 mg/m3 should be applied.

The dermal route is typically covered by oral route information in the absence of data for this administration route.

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:
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

General Population - Hazard via oral 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

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

The 90-day oral toxicity study in rats with the substance was performed according to GLP Testing guidelines and was selected as the most relevant study for DNEL calculation. The dose descriptor chosen was the NOAEL of 1000 mg/kg.

 

Oral NOAEL

Factor for standard respiratory volume rat

Corrected NOEL

 

1000 mg/kg/day

 

 

1/1.15 m3/kg/d

 

870 mg/ m3

 

(1) Oral Route

 

 

 

Oral NOAEL

 

Sum of assessment factors applicable

 

DNELoral

General population

 

1000 mg/kg/day

 

4 x 10 x 2 x 2.5 = 200

 

5 mg/kg

 

 

 

(2) Inhalation route / systemic exposure

 

 

 

Corrected NOAEL

Sum of assessment factors applicable

DNELinhalative

General population

 

870 mg/ m3

 

10 x 2 x 2.5 = 50

 

17 mg/m3

 

In case future considerations have to consider inhalation exposure, a general dust limit value of 3 mg/m3 should be applied.

The dermal route is typically covered by oral route information in the absence of data for this administration route.