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Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.78 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor starting point:
NOAEC
Value:
39 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
19.6 mg/m³
Explanation for the modification of the dose descriptor starting point:

The following corrections were made to the starting point:

Correction for experimental exposure duration (6 h/d to 8 h/d): 6/8 (ECHA default)

Correction for respiratory volume (worker): 6.7 m3/kg/10 m3/kg (ECHA default)

Therefore the corrected NOAEC for repeated-dose systemic effects via the inhalation route is:

39*(6 h/ 8 h)*(6.7 m3/kg/10 m3/kg) = 19.6 mg/m3

AF for dose response relationship:
1
AF for differences in duration of exposure:
2
Justification:
Default (subchronic to chronic)
AF for interspecies differences (allometric scaling):
1
Justification:
Default (rat inhalation to human inhalation)
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
5
Justification:
Default
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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 block-specific approach is not relevant for workers. Please refer to 'Toxicological information.Whole substance' for these endpoints.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor starting point:
NOAEC
Value:
1 115 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
199 mg/m³
Explanation for the modification of the dose descriptor starting point:

The DNEL for systemic effects via the inhalation route is determined from the inhalation NOAEC for alpha-pinene (1115 mg/m³) from the 90-day study in rats. The following corrections were made to the starting point:

Correction for exposure duration (6 h/d to 24 h/d) (ECHA default)

Correction for dosing frequency: 5 days/7 days (ECHA default)

Therefore the corrected NOAEC for repeated-dose systemic effects via the inhalation route is:

1115*(6/24)*(5/7) = 199 mg/m³

AF for dose response relationship:
1
AF for differences in duration of exposure:
2
Justification:
Default (subchronic to chronic)
AF for interspecies differences (allometric scaling):
1
Justification:
Default (rat inhalation to human inhalation)
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
10
Justification:
Default, general population
AF for the quality of the whole database:
1
Justification:
Default
AF for remaining uncertainties:
1
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:
DNEL (Derived No Effect Level)
Value:
4.8 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Dose descriptor starting point:
NOAEC
Value:
1 115 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
969.6 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The DNEL for systemic effects via the oral route is determined from the inhalation NOAEC for alpha-pinene (1115 mg/m³) from the 90-day study in rats.

NOTE: It is not possible to select appropriate units for the NOAEC under 'Dose descriptor starting point above'

The following corrections were made to the starting point:

Correction respiratory volume rat (24 hour) 1/1.15 m³/kg bw (ECHA default)

Correction for dosing frequency: 5 days/7 days (ECHA default)

Therefore the corrected NOAEL for repeated-dose systemic effects via the oral route is:

1115*(1/1.15) = 969.6 mg/kg bw/day

AF for dose response relationship:
1
AF for differences in duration of exposure:
2
Justification:
Default (subchronic to chronic)
AF for interspecies differences (allometric scaling):
4
Justification:
Default (rat inhalation to human dermal)
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
10
Justification:
Default
AF for the quality of the whole database:
1
Justification:
Default
AF for remaining uncertainties:
1
Justification:
Default
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 block-specific approach is not relevant for the dermal route or eye hazard. Please refer to 'Toxicological information.Whole substance' for these endpoints.