Fatty acids, palm-oil, hydrogenated

Toxicological Summary

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

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

3 125 mg/kg bw/day

Most sensitive endpoint:

repeated dose toxicity

DNEL related information

Overall assessment factor (AF):

24

Modified dose descriptor starting point:

NOAEL

Acute/short term exposure

DNEL related information

Additional information - workers

‘Fatty acids, palm-oil, hydrogenated’ is used in a variety of industrial, professional and consumer settings for a number of applications, including as a source material for energy production and as a raw material or feedstock for the production of other substances such as soaps and surfactants, candles, etc. In addition, it also acts as a processing aid in many industrial processes, such as the polymerization process in the production of resins and rubbers and the flotation processes (e.g. de-inking and mineral recovery). In these applications, ‘Fatty acids, palm-oil, hydrogenated’ can be used as such or in preparations and articles.

The main type of exposure at the workplace and for the consumer will be via the dermal route. Given the fact that ‘fatty acids, palm-oil, hydrogenated’does not volatilize and is not handled in powder or aerosol form, respiratory exposure is not relevant.

Given the above facts, and as recommended in Chapter R.8 of the REACH Technical Guidance Documents, long-term DNELs were derived for workers potentially exposed through the dermal route only.

As specified , the substance is acomplex combination of fatty acids, glycerides (comprising mono-, di- and triglycerides) and minor components that make up less than 3 % of the total substance.The composition of this substance varies depending on the vegetable oil feedstock type and the process efficiency.Based on this composition, a DNEL was calculated using fatty acid / glycerides data.

DNEL long-term, workers, dermal based on fatty acid / glyceride data

Fatty acids and glycerides of chain lengths ranging from C16-18, including C18-unsatd. show a comparable toxicity profile, with low acute and repeated-dose toxicity to animals and humans. They are not mutagenic, not carcinogenic and do not induce reproductive toxicity. Overall, the most appropriate NOAEL identified from a subchronic (24 week) repeated dose oral toxicity study in the rat was equivalent to15 % in diet, i.e. ca. 7,500 mg/kg bw/day fed as oleic acid. This value was used as a starting point for deriving a DNEL_{long-term, dermal}.

In a first step, the starting point oral value should be corrected for route-to-route extrapolation. In accordance with REACH guidance document R.8 (‘Characterization of dose (concentration)-response for human health’), in the absence of data, no default factor (i.e. factor of 1) should be introduced for oral-to-dermal extrapolation, basedon the assumption that dermal absorption will in general not be higher than oral absorption.However, for highly lipophilic substances (log Kow > 4), according to Section R.7.12.2.1 of REACH guidance document R7.C (May 2008), a 10% default dermal absorption percentage value is recommended (in the absence of test data) for the purpose of risk assessment. The next steps consist in applying assessment factors (AF) for interspecies difference, intraspecies variation, exposure duration, dose-response and quality of the database, as presented in Section R.8.4.3 of REACH guidance document R.8 and the ECETOC Technical Report 110, 2010 . The overall AF in this case corresponds to 24 (see Table).

The resulting DNEL_{long-term, workers, dermal} is equivalent to 3,125 mg/kg bw/day.

Table. Derivation of DNEL_{long-term, workers, dermal}for ‘fatty acids, palm-oil, hydrogenated’ based onfatty acids of chain lengths C18 as represented by oleic acid (C18:1).

	Value	Comment
Starting point	7,500 mg/kg bw/day	Oral NOAEL fromrepeated dose toxicity test in rat
Starting point corrected for route to route extrapolation factor (oral-to-dermal extrapolation)	75,000 mg/kg bw/day	Correction for difference in absorption between routes
Assessment factor	4	Interspecies difference - allometric (metabolic rate) scaling (rat-to-human)
	3	Combined inter and intraspecies difference - remaining non-metabolic differences (workers)
	2	Exposure duration (subchronic study)
	1	Dose-response (starting point is a NOAEL)
	1	Quality of whole database
DNELlong-term,workers, dermal	3,125 mg/kg bw/day	-

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

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

1 875 mg/kg bw/day

Most sensitive endpoint:

repeated dose toxicity

DNEL related information

Overall assessment factor (AF):

40

Modified dose descriptor starting point:

NOAEL

Acute/short term exposure

DNEL related information

General Population - Hazard via oral route

Systemic effects

Acute/short term exposure

DNEL related information

Additional information - General Population

‘Fatty acids, palm-oil, hydrogenated’ is used in a variety of industrial, professional and consumer settings for a number of applications, including as a source material for energy production and as a raw material or feedstock for the production of other substances such as soaps and surfactants, candles, etc. In addition, it also acts as a processing aid in many industrial processes, such as the polymerization process in the production of resins and rubbers and the flotation processes (e.g. de-inking and mineral recovery). In these applications, ‘Fatty acids, palm-oil, hydrogenated’ can be used as such or in preparations and articles.

The main type of exposure at the work place and for the consumer will be via the dermal route. Given the fact that ‘fatty acids, palm-oil, hydrogenated’does not volatilize and is not handled in powder or aerosol form, respiratory exposure is not relevant.

Given the above facts, and as recommended in Chapter R.8 of the REACH Technical Guidance Documents, long-term DNELs were derived for consumers potentially exposed through the dermal route only.

As specified, the substance is acomplex combination of fatty acids, glycerides (comprising mono-, di- and triglycerides) and minor components that make up less than 3 % of the total substance.The composition of this substance varies depending on the vegetable oil feedstock type and the process efficiency. Based on this composition, a DNEL was calculated using fatty acid / glycerides data.

DNEL long-term, consumers, dermal based on fatty acid / glyceride data

Fatty acids and glycerides of chain lengths ranging from C16-18, including C18-unsatd. show a comparable toxicity profile, with low acute and repeated-dose toxicity to animals and humans. They are not mutagenic, not carcinogenic and do not induce reproductive toxicity. Overall, the most appropriate NOAEL identified from a subchronic (24 week) repeated dose oral toxicity study in the rat was equivalent to 15 % in diet, i.e. ca. 7,500 mg/kg bw/day fed as oleic acid. This value was used as a starting point for deriving a DNEL_{long-term, dermal}.

In a first step, the starting point oral value should be corrected for route-to-route extrapolation. In accordance with REACH guidance document R.8 (‘Characterization of dose (concentration)-response for human health’), in the absence of data, no default factor (i.e. factor of 1) should be introduced for oral-to-dermal extrapolation, based on the assumption that dermal absorption will in general not be higher than oral absorption.However, for highly lipophilic substances (log Kow > 4), according toSection R.7.12.2.1 of REACH guidance document R7.C (May 2008), a 10% default dermal absorption percentage value is recommended (in the absence of test data) for the purpose of risk assessment.The next steps consist in applying assessment factors (AF) for interspecies difference, intraspecies variation, exposure duration, dose-response and quality of the database, as presented in Section R.8.4.3 of REACH guidance document R.8 and the ECETOC Technical Report 110, 2010 . The overall AF in this case corresponds to 40 (see Table).

The resulting DNEL_{long-term, consumers, dermal} is equivalent to1,875 mg /kg bw/day.

Table. Derivation of DNEL_{long-term, consumers, dermal} for ‘fatty acids, palm-oil, hydrogenated’ based on fatty acids of chain lengths C18 as represented by oleic acid (C18:1).

	Value	Comment
Starting point	7,500 mg/kg bw/day	Oral NOAEL fromrepeated dose toxicity test in rat
Starting point corrected for route to route extrapolation factor (oral-to-dermal extrapolation)	75,000 mg/kg bw/day	Correction for difference in absorption between routes
Assessment factor	4	Interspecies difference - allometric (metabolic rate) scaling (rat-to-human)
	5	Combined inter and intraspecies difference - remaining non-metabolic differences (general population)
	2	Exposure duration (subchronic study)
	1	Dose-response (starting point is a NOAEL)
	1	Quality of whole database
DNELlong-term,workers, dermal	1,875 mg/kg bw/day	-