Decene, hydroformylation products, low boiling

Toxicological Summary

Workers - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

330 mg/m³

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

By inhalation

DNEL related information

DNEL derivation method:

other:

Overall assessment factor (AF):

6

Modified dose descriptor starting point:

NOAEC

Value:

1 985 mg/m³

Explanation for the modification of the dose descriptor starting point:

Not applicable

AF for dose response relationship:

1

Justification:

Starting point is a NOAEC

AF for differences in duration of exposure:

2

Justification:

Sub-chronic study

AF for interspecies differences (allometric scaling):

1

Justification:

Not typically applied in the derivation of an inhalation DNEL

AF for other interspecies differences:

1

AF for intraspecies differences:

3

AF for the quality of the whole database:

1

AF for remaining uncertainties:

1

Acute/short term exposure

DNEL related information

Local effects

Acute/short term exposure

DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

44 mg/kg bw/day

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Oral

DNEL related information

DNEL derivation method:

other:

Overall assessment factor (AF):

24

Modified dose descriptor starting point:

NOAEL

Value:

1 056 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

The systemic dermal dose is derived by read across from an oral toxicity study. Basis for dose descriptor: 13 week oral gavage study in rats with BP 8313 (hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics, 2-25%) Reference: BP 8313. Technical Dossier Concerning Toxicological Properties. 84/BP0004-011/245. Rationale for selection of dose descriptor: There were no systemic effects (other than alpha 2u-globulin-mediated male rat kidney nephropathy, an effect not relevant to humans) observed. 1056 mg/kg/day (approximately a limit dose for a study of this type) was the highest dose tested. Assessment factors: Additional Modification factor: no scientific rationale to modify the NOAEL; Interspecies factor: 4 (ECETOC, 2005 and more recent information. Allometric scaling is appropriate when extrapolating oral (gavage) to oral exposure); Intraspecies factor: 3 (ECETOC, 2005 and more recent information); Duration (subchronic to chronic): 2 (ECETOC, 2005 and more recent information. Extrapolation from subchronic to a chronic duration)

AF for dose response relationship:

1

Justification:

Starting point is a NOAEL

AF for differences in duration of exposure:

2

Justification:

Sub-chronic study

AF for interspecies differences (allometric scaling):

4

Justification:

Rat

AF for other interspecies differences:

1

AF for intraspecies differences:

3

AF for the quality of the whole database:

1

AF for remaining uncertainties:

1

Acute/short term exposure

DNEL related information

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:

no hazard identified

Additional information - workers

 The potential exposure to the test material indicates that long-term exposure DNELs need to be derived for workers and for the general population. No acute toxicity was noted in any of the toxicological studies conducted. Additionally, DNELs derived for chronic exposures are typically lower than those calculated for acute exposures and would therefore be protective of human for both the acute and chronic exposures. 

Dermal and inhalation are the relevant routes of exposure. Aspiration is a potential hazard, but a DNEL calculation is not appropriate for an aspiration hazard.

In instances where stable aerosol formation is expected, a value of 10 mg/m3 will be used as an operational control limit for inhalation exposure.

Workers are expected to have infrequent and short-term exposures; however, for calculation of the DNEL for REACH purposes it is assumed that workers have maximal repeated exposure for 8 hr/day for 5 day/wk. 

 

General Population - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

71 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):

10

Modified dose descriptor starting point:

NOAEC

Value:

705 mg/m³

Explanation for the modification of the dose descriptor starting point:

Not applicable

AF for dose response relationship:

1

Justification:

Starting point is a NOAEC

AF for differences in duration of exposure:

2

Justification:

Sub-chronic study

AF for interspecies differences (allometric scaling):

1

Justification:

Not typically applied in the derivation of an inhalation DNEL

AF for other interspecies differences:

1

AF for intraspecies differences:

5

AF for the quality of the whole database:

1

AF for remaining uncertainties:

1

Acute/short term exposure

DNEL related information

Local effects

Acute/short term exposure

DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

26 mg/kg bw/day

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Oral

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

40

Modified dose descriptor starting point:

NOAEL

Explanation for the modification of the dose descriptor starting point:

The systemic dermal dose is derived by read across from an oral toxicity study. Basis for dose descriptor: 13 week oral gavage study in rats with BP 8313 (hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics, 2-25%) Reference: BP 8313. Technical Dossier Concerning Toxicological Properties. 84/BP0004-011/245. Rationale for selection of dose descriptor: There were no systemic effects (other than alpha 2u-globulin-mediated male rat kidney nephropathy, an effect not relevant to humans) observed. 1056 mg/kg/day (approximately a limit dose for a study of this type) was the highest dose tested. Assessment factors: Additional Modification factor: no scientific rationale to modify the NOAEL; Interspecies factor: 4 (ECETOC, 2005 and more recent information. Allometric scaling is appropriate when extrapolating oral (gavage) to oral exposure); Intraspecies factor: 5 (ECETOC, 2005 and more recent information; general population); Duration (subchronic to chronic): 2 (ECETOC, 2005 and more recent information. Extrapolation from subchronic to a chronic duration)

AF for dose response relationship:

1

Justification:

Starting point is a NOAEL

AF for differences in duration of exposure:

2

Justification:

Sub-chronic study

AF for interspecies differences (allometric scaling):

4

Justification:

Rat

AF for other interspecies differences:

1

AF for intraspecies differences:

5

AF for the quality of the whole database:

1

AF for remaining uncertainties:

1

Acute/short term exposure

DNEL related information

General Population - Hazard via oral route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

26 mg/kg bw/day

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Oral

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

40

Modified dose descriptor starting point:

NOAEL

Value:

1 056 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

Not applicable

AF for dose response relationship:

1

Justification:

Starting point is a NOAEL

AF for differences in duration of exposure:

2

Justification:

Sub-chronic study

AF for interspecies differences (allometric scaling):

4

Justification:

Rat

AF for other interspecies differences:

1

AF for intraspecies differences:

5

AF for the quality of the whole database:

1

AF for remaining uncertainties:

1

Acute/short term exposure

DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:

no hazard identified

Additional information - General Population

The potential exposure to the test material indicates that long-term exposure DNELs need to be derived for general population. No acute toxicity was noted in any of the toxicological studies conducted. Additionally, DNELs derived for chronic exposures are typically lower than those calculated for acute exposures and would therefore be protective of human for both the acute and chronic exposures. 

 

Dermal and inhalation are the relevant routes of exposure. An oral DNEL was calculated for use in an indirect exposure assessment; the oral route is not expected to be a significant exposure route. Aspiration is a potential hazard, but a DNEL calculation is not appropriate for an aspiration hazard.

 

Consumers in the general population are expected to have infrequent and short-term exposures. However, for calculation of DNELs for REACH, it is assumed that consumers have a maximal repeated dose for 24 hr/day for 7 day/wk.