Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

DN(M)ELs for workers:Other Lubricant Base Oils(IP 346 < 3%)

  

 

Effect

Route

DNEL

Dose Descriptor

Modified Dose Descriptor and Assessment Factors

Acute Exposure

Systemic

Dermal

(a)

 

 

Inhalation

(a)

 

 

Local

Dermal

(a)

 

 

Inhalation

(a)

 

 

Long-Term Exposure

Systemic

Dermal

(a)

 

 

Inhalation

(a)

 

 

Local

Dermal

(a)

 

 

Inhalation

5.4 mg/m3/8h [aerosol]

500 mg/m3(NOAEC based on respiratory effects such as focal infiltrations or inflammatory cells, focal hyperplasia, squamous metaplasia of the nasal mucosa)

 

Dose descriptor was modified to correct starting point of 251 mg/m3/8h by adjustment for duration of exposure and level of activity. Then AF of 45 was applied for inter- and intraspecies and total duration differences.

a)    No hazard identified for this route (data available)

DN(M)ELs for workers:Other Lubricant Base Oils (IP 346 ≥3%)

 

 

Effect

Route

DNEL

Dose Descriptor

Modified Dose Descriptor and Assessment Factors

Acute Exposure

Systemic

Dermal

(a)

 

 

Inhalation

(a)

 

 

Local

Dermal

(a)

 

 

Inhalation

(a)

 

 

Long-Term Exposure

Systemic

(c)

Dermal

1.0 mg/kg/8h

30 mg/kg (LOAEL based on systemic effects in dermal rat study read-across from Untreated Distillate Aromatic Extracts: change in adrenals and bone marrow toxicity in males)

Dose descriptor was modified to correct starting point of 23 mg/kg/8 hr by adjustments for dermal absorption and LOAEL to NOAEL. Then AF of 24 was applied for inter- and intraspecies differences and for total duration.

Inhalation

2.7 mg/m3/8 h [aerosol]

30 mg/kg (LOAEL based on systemic effects in dermal rat study read-across from Untreated Distillate Aromatic Extracts: change in adrenals and bone marrow toxicity in males)

Dose descriptor was modified to correct starting point of 41mg/kg/8 hr by adjustments for dermal absorption, dermal to inhalation route and level of activity, LOAEL to NOAEL. Then AF of 15 was applied for inter- and intraspecies differences and for total duration.

Local

Dermal

(a) for 13-wk exposures and

(b) for chronic exposures (dermal carcinogen)

 

 

Inhalation

5.4 mg/m3/8h [aerosol]

500 mg/m3(NOAEC based on respiratory effects such as focal infiltrations or inflammatory cells, focal hyperplasia, squamous metaplasia of the nasal mucosa read-across from other Lubricant Base oil <3%)

Dose descriptor was modified to correct starting point of 251 mg/m3/8h by adjustment for duration of exposure and level of activity. Then AF of 45 was applied for inter- and intraspecies and total duration differences.

a) No hazard identified for this route (data available)

b) No-threshold effect and/or no dose-response information available

c) Long-term systemic effects include non-reproductive effects and developmental/reproductive effects. Lowest DNEL is shown.

General Population - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

DN(M)ELs for general population:Other Lubricant Base Oils(IP 346 < 3%)

 

 

Effect

Route

DNEL

Dose Descriptor

Modified Dose Descriptor and Assessment Factors

Acute Exposure

Systemic

 

Dermal

(a)

 

 

Inhalation

(a)

 

 

Local

Dermal

(a)

 

 

Inhalation

(a)

 

 

Long-Term Exposure

Systemic

Dermal

(a)

 

 

Inhalation

(a)

 

 

Oral

(a)

 

 

Local

Dermal

(a)

 

 

Inhalation

1.2 mg/m3/24h [aerosol]

500 mg/m3(NOAEC based on respiratory effects such as focal infiltrations or inflammatory cells, focal hyperplasia, squamous metaplasia of the nasal mucosa)

Dose descriptor was modified to correct starting point of 89.3 mg/m3/24h by adjustment for duration of exposure and level of activity. Then AF of 75 was applied for inter- and intraspecies and total duration differences.

a) No hazard identified for this route (data available)


DN(M)ELs for general population:Other Lubricant Base Oils (IP 346 ≥3%)

 

 

Effect

Route

DNEL

Dose Descriptor

Modified Dose Descriptor and Assessment Factors

Acute Exposure

Systemic

 

Dermal

(a)

 

 

Inhalation

(a)

 

 

Local

Dermal

(a)

 

 

Inhalation

(a)

 

 

Long-Term Exposure

Systemic

Dermal

(a)

 

 

Inhalation

(a)

 

 

Oral

0.74 mg/kg/24 h (b)

125 mg/kg (LOAEL based on systemic effects in oral rat study read-across from Untreated Distillate Aromatic Extracts: change in adrenals and bone marrow toxicity in males)

Dose descriptor was modified to correct starting point of 30 mg/kg/24 h by adjustments for LOAEL to NOAEL and duration of exposure. Then AF of 40 was applied for inter- and intraspecies differences and for total duration.

Local

Dermal

(a)

 

 

Inhalation

(a)

 

 

a) No DNEL needed since no exposure expected

b) This substance is not used by the general population. This value is for indirect exposure assessment only.