Registration Dossier
Registration Dossier
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EC number: 223-445-4 | CAS number: 3896-11-5
Toxicological Summary
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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