Tall oil, potassium salt

Toxicological Summary

Workers - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

4.9 mg/m³

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Oral

DNEL related information

DNEL derivation method:

other: ECETOC Technical Report No. 110

Overall assessment factor (AF):

18

Modified dose descriptor starting point:

NOAEC

Value:

88.15 mg/m³

Explanation for the modification of the dose descriptor starting point:

Convert oral NOAEL to Inhaltion NOAEC: 100 mg/kg/day x [1/0.38 x rat oral absorption (50%) / human inhalation absorption (100%) x (6.7/10)] = 88.15 mg/m3

AF for dose response relationship:

1

Justification:

Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment.

AF for differences in duration of exposure:

6

Justification:

Extrapolation from subacute study to chronic exposure value in line with Table R.8-5 of Chapter R.8 of Guidance on information requirements and chemical safety assessment and in ECETOC Technical Report 110.

AF for interspecies differences (allometric scaling):

1

Justification:

Differences in species addressed in calculation of dose descriptor starting point.

AF for other interspecies differences:

1

Justification:

All interspecies differences accounted for by allometric scaling. Default value in ECETOC Technical Report No. 110.

AF for intraspecies differences:

3

Justification:

Default value in ECETOC Technical Report No. 110.

AF for the quality of the whole database:

1

Justification:

Information taken from one 2 year chronic study on KCl and one 422 study on crude tall oil. Both were K1 studies that were only given K2 values due to read across.

AF for remaining uncertainties:

1

Justification:

Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment and ECETOC Guidance No. 110.

Acute/short term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

14.7 mg/m³

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Oral

DNEL related information

DNEL derivation method:

other: ECHA guidance states that a multiplying factor of between 1 and 5 may be used to derive an acute DNEL from a long-term DNEL. The median value of 3 is used here.

DNEL extrapolated from long term DNEL

Explanation for the modification of the dose descriptor starting point:

Convert oral NOAEL to Inhaltion NOAEC: 100 mg/kg/day x [1/0.38 x rat oral absorption (50%) / human inhalation abs

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:

1.39 mg/kg bw/day

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Oral

DNEL related information

DNEL derivation method:

other: ECETOC Guidance No. 110

Overall assessment factor (AF):

72

Modified dose descriptor starting point:

NOAEL

Value:

100 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

Assumed dermal absorption is equal to oral absorption as a precautionary measure.

AF for dose response relationship:

1

Justification:

Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment.

AF for differences in duration of exposure:

6

Justification:

Extrapolation from subacute study to chronic exposure value in line with Table R.8-5 of Chapter R.8 of Guidance on information requirements and chemical safety assessment and ECETOC Guidance No. 110.

AF for interspecies differences (allometric scaling):

4

Justification:

Default value in line with Table R.8-3 and Appendix R. 8-2, part 2, example B5 of Chapter R.8 of Guidance on information requirements and chemical safety assessment and ECETOC Guidance No. 110.

AF for other interspecies differences:

1

Justification:

All species differences accounted for in allometric scaling according to ECETOC Guidance 110.

AF for intraspecies differences:

3

Justification:

Default value in ECETOC Technical Report No. 110.

AF for the quality of the whole database:

1

Justification:

Information taken from one 2 year chronic study on KCl and one 422 study on crude tall oil. Both were K1 studies that were only given K2 values due to read across.

AF for remaining uncertainties:

1

Justification:

Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment and ECETOC Guidance No. 110.

Acute/short term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

4.17 mg/kg bw/day

Most sensitive endpoint:

repeated dose toxicity

DNEL related information

DNEL derivation method:

other: ECHA guidance states that a multiplying factor of between 1 and 5 may be used to derive an acute DNEL from a long-term DNEL. The median value of 3 is used here.

DNEL extrapolated from long term DNEL

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

All data for this substance is read across data from the two components, Tall Oil and various potassium salts. However, none of the read across data suggest the need for a classification for this substance. The NOAEL of 100 mg/kg bw/day is based on a 422 study on Tall Oil (CAS # 8002-26-4). The effects seen at 500 mg/kg bw/day only included minor increases in alkaline phosphatase levels and decreased adrenal gland, ovary, and kidney weights in females. There were no reproductive or developmental effects in this study. In a two year chronic study on potassium chloride, the NOAEL was set at >1820 mg/kg bw/day, based on no adverse effects occurring more frequently than in the control group.

Neither tall oil nor potassium chloride were toxic by oral administration. Tall oil and potassium nitrate were non-toxic by dermal administration. While dermal absorption is unlikely, dermal absorption was considered equal to oral absorption in the DNEL calculations as a precautionary measure.

Neither tall oil nor potassium chloride showed evidence of skin sensitization or skin/eye irritation. Therefore, DNELs for local effects are not considered necessary as tall oil, potassium salt is not likely to cause local effects.

Finally, neither tall oil nor potassium salts are considered genotoxic based on multiple in vitro assays.

All assessment factors were the default values taken from ECETOC Technical Report No. 110, Guidance on Assessment Factors to Derive a DNEL. To prepare this publication, ECETOC conducted an extensive and documented review of the scientific literature. Therefore, the AF supplied in the ECETOC document are considered valid and scientifically justifiable.

Tall Oil Summary

Repeated Dose - 422

A combined repeated dose toxicity study with reproduction/developmental toxicity screening test was carried out in order to assess the test material in accordance with the standardized guideline OECD 422 under GLP conditions.

Four groups of 10 male and 10 female Sprague-Dawley rats received the test material via the diet at concentrations of 0, 1000, 5000 and 20 000 ppm. The males were dosed for at least 4 weeks, starting 2 weeks prior to mating. The females were dosed from 2 weeks prior to mating until at least day 6 of lactation.

The animals were monitored for clinical signs, bodyweight, food consumption, mating and litter performance. Haematology and clinical chemistry parameters were investigated; additionally, all animals were subjected to necropsy and histopathology investigations were carried out on animals in the control and 20 000 ppm dose groups.

 At 20 000 ppm, in-life observations included decreased weight gain and food consumption in both sexes. Increased male liver weight following covariance analysis, and increases in bilirubin and alkaline phosphatase were noted in both sexes. In addition, small decreases were noted in adrenal gland weight in both sexes, and in albumin, white blood cell count and ovary weight in females; spleen weight and cholesterol were slightly increased in males.

At 5000 ppm, alkaline phosphatase was increased in both sexes and female adrenal gland weight was reduced. Under the conditions of this study, toxicity was exhibited at levels of 5000 and 20 000 ppm, but there were no clear effects of toxicity at 1000 ppm. There were no reproductive or developmental toxicity seen at any dose level. Therefore the parental repeated dose NOEL was considered to be 1000 ppm, which corresponds to 100 mg/kg bw/day.

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

Exposure to the general population is not expected based on the substance use pattern. Tall oil, potassium salt is intended for use within industrial and professional use sectors only and no uses by the general population are anticipated. As such it is considered justified not to derive a DNEL for this type of exposure.