9-Octadecen-1-ol, (Z)-, phosphate

Toxicological Summary

Workers - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

19.6 mg/m³

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Oral

DNEL related information

DNEL derivation method:

other: ECHA REACH Guidance and ECETOC Technical Report No. 110

Overall assessment factor (AF):

45

Modified dose descriptor starting point:

NOAEC

Value:

882 mg/m³

Explanation for the modification of the dose descriptor starting point:

There are no relevant experimental data on the repeated exposure by inhalation. A conservative approach is used assuming a 50 % absorption rate via the oral route (end route) as compared to the inhalation route (starting route).

AF for dose response relationship:

1

Justification:

The dose response relationship is considered unremarkable, therefore no additional factor is used.

AF for differences in duration of exposure:

6

Justification:

The default extrapolation factor for exposure duration is used: subacute (starting point) to chronic (end point).

AF for interspecies differences (allometric scaling):

1

Justification:

Respiratory interspecies differences are fully covered by the factors used for route to route extrapolation.

AF for other interspecies differences:

2.5

Justification:

Default factor according to ECHA guidance document.

AF for intraspecies differences:

3

Justification:

Intraspecies differences of workers are considered to be fully covered by the selected factor according to ECETOC Technical Report No. 110.

AF for the quality of the whole database:

1

Justification:

The quality of the whole data base is considered to be sufficient and uncritical.

AF for remaining uncertainties:

1

Justification:

The approach used for DNEL derivation is conservative. No further assessment factors are required.

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:

DNEL (Derived No Effect Level)

Value:

55.6 mg/kg bw/day

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Oral

DNEL related information

DNEL derivation method:

other: ECHA REACH Guidance and ECETOC Technical Report No. 110

Overall assessment factor (AF):

180

Modified dose descriptor starting point:

NOAEL

Value:

1 000 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

There are no relevant experimental data on repeated exposure by dermal absorption. Based on the physiochemical properties it is assumed that the test item's absorption corresponds to 10 % of the oral uptake.

AF for dose response relationship:

1

Justification:

The dose response relationship is considered unremarkable, therefore no additional factor is used.

AF for differences in duration of exposure:

6

Justification:

The default extrapolation factor for exposure duration is used: subacute (starting point) to chronic (end point).

AF for interspecies differences (allometric scaling):

4

Justification:

The default allometric scaling factor for the differences between rats and humans is used.

AF for other interspecies differences:

2.5

Justification:

Default factor according to ECHA guidance document.

AF for intraspecies differences:

3

Justification:

An intraspecies difference factor of 3 for workers is considered to be sufficient (ECETOC Technical Report No. 110).

AF for the quality of the whole database:

1

Justification:

The quality of the whole data base is considered to be sufficient and uncritical.

AF for remaining uncertainties:

1

Justification:

The approach used for DNEL derivation is conservative. No further aassessment factors are required.

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:

high hazard (no threshold derived)

Additional information - workers

General

DNEL derivation is performed under consideration of the recommendations of ECHA REACH Guidance (2010) and ECETOC (2010). In view of the data used for evaluation, the "quality of whole database factors" and "dose-response factors" are considered to be a value of 1.  

Long term exposure- systemic effect

Inhalation exposure

A subchronic repeated dose toxicity test with the reaction product of oleyl alcohol with polyphosphoric acid is not available. Consequently, a subacute repeated dose toxicity test with the test item was used to derive the worker DNEL (long-term inhalation exposure).

The 28 -day study revealed a NOAEL of > 1000 mg/kg bw/day.

Correction of the dose descriptor:

Oral NOAEL: > 1000 mg/kg bw/day

sRV(rat): 0.38 m3/ kg bw (8 hours) [standard respiratory volume of the rat]

ABS oral (rat)/ ABS inhalation (human): 0.5 [ratio of oral absorption in the rat to inhalative absorption in the human] sRV (human)/ wRV (human): 6.7 m3/ 10 m3= 0.67 m3 [ratio of human standard respiratory volume to worker respiratory volume]

The oral NOAEL > 1000 mg/kg bw/ day is converted in an inhalation NOAEC > 882 mg/ m3.  

Calculation of the worker DNEL:

Corrected inhalatory NOAEC for worker: > 882 mg/ m3

Assessment factor for exposure duration (subacute to chronic): 6

Assessment factor for intraspecies differences (worker): 3 

Assessment factor for other interspecies differences: 2.5

Worker DNEL (inhalation exposure) = 882 mg/m3/ (1 x 6 x 1 x 3 x 2.5 x 1 x 1) = 882 / 45 = 19.6 mg/ m3  

Dermal exposure

A subchronic repeated dose toxicity test with the reaction product of oleyl alcohol with polyphosphoric acid is not available. Consequently, a subacute repeated dose toxicity test with the test item was used to derive the worker DNEL (long-term inhalation exposure). A 28-day repeated dose oral toxicity study revealed a NOAEL of > 1000 mg/kg bw/day.

Considering the appropriate assessment factors, the worker DNEL (long-term dermal exposure) is calculated as follows:  

Correction of the dose descriptor:

Dose descriptor of relevant study: > 10 000 mg/kg bw/day (NOAEL x 10; assuming 10 % dermal absorption)

Assessment factor for exposure duration (subacute to chronic): 6

Allometric scaling factor (rat to human): 4

Assessment factor for other interspecies differences: 2.5

Assessment factor for intraspecies differences (worker): 3 

Taking the above mentioned assessment factors into account, the following worker DNEL is:

Worker DNEL (dermal exposure) = 10 000 mg/kg bw/day / (1 x 6 x 4 x 2.5 x 3 x 1 x 1) = 10 000 / 180 = 55.6 mg/kg bw/day  

Acute/ short term exposure- systemic effect

Inhalation

There is no indication for acute systemic toxicity of the reaction product of oleyl alcohol with polyphosphoric acid. The substance is not classified for inhalation toxicity. The vapour pressure of the high viscous liquid is negligible. Taken together, its physicochemical properties exclude inhalative exposure. Also no peak exposure is expected. Therefore no DNEL is required.

Dermal

In an acute dermal toxicity study with the reaction product of oleyl alcohol with polyphosphoric acid according EU method B.3 and OECD 402, a LD50 value of > 2000 mg/kg bw was obtained. Thus, the test material is not classified and labelled for acute dermal toxicity, according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP). Therefore no DNEL was derived.

Acute and long term exposure- local effect

Respiratory irritation

There is no indication for adverse local effects from acute/subacute oral and acute dermal toxicity tests and tests on skin irritation/corrosion. Therefore, the substance is neither classified for acute toxicity nor for skin irritation/corrosion according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP). However, the substance is classified as eye irritant cat. 1 according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP). The vapour pressure of the high viscous liquid is negligible. Taken together, its physicochemical properties exclude respiratory exposure. Therefore no DNEL is required.

Skin irritation

The test item is not classified for skin irritation/corrosion and skin sensitization according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP). Therefore no DNEL was derived.

Eye Irritation

The reaction product of oleyl alcohol with polyphosphoric acid is classified as eye irritant category 1 according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP).

References

- ECHA (2010). Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health. Version 2. ECHA-2010 -G-19–N.

- ECETOC (2010). Technical Report 110.Guidance on assessment factors to derive a DNEL. according to Annex VI of Regulation EC 1272/2008 (CLP).

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

General population is not intended to be exposed to the reaction product of oleyl alcohol with polyphosphoric acid via inhalation, dermal or oral route. Therefore, no DNEL (systemic or local, long-term or short-term) is derived for general population. The test item is classified for eye irritation category 1 according to Regulation (EC) No 1272/2008 (CLP) and Directive 67/548/EEC (DSD). However, general population is not intended to have eyes contact to the test material. Therefore, due to exposure based reasons no hazard for the general population is identified.