Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 130 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
12
Modified dose descriptor starting point:
NOAEC

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 130 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
12
Dose descriptor starting point:
NOAEC

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.67 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
150
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:
no hazard identified

Additional information - workers

The Acute/Short-term Worker DNEL of 1130 mg/m3 (140 ppm) is based on the rat acute 4 hr inhalation study with a NOAEL of > 2.6 gm/m3. Following conversion to a human equivalent concentration of 108 ppm a total Assessment Factor of 12.5 (2.5 x 5) was applied resulting in a value of 8.6 ppm. Since the Acute DNEL is for short-term exposure no Assessment Factor fore repeated-dose adverse effects is required. This value was corrected for exposure duration by 4 hr/15 minutes = 16 -fold because Acute/Short-term Worker DNELS are based on an exposure period of 15 minutes (ECHA RIP 3.2 Chaper R.8, Section R.8.1.2.5 page 16). Therefore, 8.6 ppm x 16 = approximately 140 ppm/15 minutes. The long-term systemic effects Worker inhalation DNEL is based on the 90 -day rat inhalation study with a NOAEL of 500 mg/m3 (62 ppm) and the application of a total Assessment Factor of 50 x plus correction of the rat inhalation to hhuman equivalent concentration resulting in a DNEL of 5.0 mg/m3 (0.62 ppm) 8 hr TWA. The Long-term exposure - systemic Worker dermal DNEL was derived from the rat oral O.E.C.D. 422 Testing Guideline study with a NOAEL of 1000 mg/kg/day. An Allometric scalling factor of four was used as per ECHA RIP 3.2 Guidance, Chapter R.8, Section R.8.4.3.1, Table R.8 -3, page 30. In addition, a total Assessment Factor of 150 x was applied resulting in a Worker dermal DNEL of 1.67 mg/kg/day. There were no local effects observed in repeated-dose rat studies upon which long-term exposure-local effects DNELs could be established.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
100
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
565 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
25
Modified dose descriptor starting point:
NOAEC

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:
0.835 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
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:
0.833 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
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

Acute General population oral and dermal DNELs are not required as per ECHA RIP 3.2 Guidance, Chapter R.8, Section R.8.1.2.5, page 16, DNEL acute for "Inhalation route only". An Acute Inhalation DNEL was based on the rat 4 hr acute inhalation study with a NOAEL of > 2.6 gn/m3. A total assessment Factor of 25 x (2.5 x 10) was applied with the exposure duration adjustment factor of 4 hr/15 minutes = 16 -fold. However, the General population is unlikely to encounter such high peak exposures that may occur during workplace maintenance opperations for vinyl neodecanoate. General population long-term - local effects DNELs cannot be derived due to lack of demonstrated hazard. The General population long-term exposure - systemic effects Inhalation DNEL was based on the rat 90 -day inhalation NOAEL of 500 mg/m3 (62 ppm) corrected to the human equivalent concentration and the application of a total Assessment Factor of 100 resulting in a DNEL of 2.5 mg/m3 (0.31 ppm) 24 hr TWA. The General population long-term exposure - systemic dermal DNEL is based on the rat oral O.E.C.D. 422 Testing Guideline study with a NOAEL of 1000 mg/kg/day. The General population - systemic oral DNEL is also based on the NOAEL of 1000 mg/kg/day from the rat oral O.E.C.D. 422 Testing Guideline study. An allometric scalling adjustment of 4 was applied as per ECHA RIP 3.2 Guidance, Chapter R.8, Section R.8.4.3.1, Table R.8 -3, page 30. The total Assment Factor was 300 x resulting in a long-term oral exposure - systemic DNEL of 0.833 mg/kg/day. Long-term exposure - local effects for the General population cannot be derived due to lack of identified hazard.