Fatty acids, C18-unsatd., dimers, di-Me esters, hydrogenated

Endpoint summary

Description of key information

Oral: LD50 (rat) > 2000 mg/kg bw (experimental value), ≥ 5000 mg/kg bw (LD50 cut-off) (OECD 423, GLP)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28 Jan – 17 Feb 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP – Guideline study.

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

The Department of Health of the Government of the United Kingdom, UK

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

other: Sprague-Dawley CD (Crl:CD® (SD) IGS BR)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Ltd, Margate, Kent, UK
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 193 – 216 g
- Fasting period before study: animals were fasted overnight prior to administration.
- Housing: animals were housed in groups of 3 per cage in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet: certified Rat and Mouse Diet (Code 5LF2; BCM IPS Limited, London, UK), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Example: 19-25
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

other: arachis oil BP

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: the test material did not dissolve/suspend in distilled water.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The author stated that using all available information on the toxicity of the test material, 2000 mg/kg bw was chosen as the starting dose.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 females (3 per testing step)

Control animals:

other: not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed 30 min, 1, 2 and 4 h after dosing and subsequently daily for 14 days and individual body weights were determined prior to dosing and 7 and 14 days after treatment.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical observations, body weight

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: experimental result

Sex:

female

Dose descriptor:

LD50

Effect level:

>= 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: LD50 cut-off according to OECD 423

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.

Gross pathology:

Necropsy revealed no substance-related findings.

Table 1. Individual body weights and body weight changes.

Dose Level mg/kg bw	Animal Number and Sex	Body weight (g) at Day			Body weight Gain (g) During Week
		0	7	14	1	2
2000	1-0 Female	201	247	263	46	16
	1-1 Female	210	268	306	58	38
	1-2 Female	216	253	272	37	19
	2-0 Female	206	258	276	52	18
	2-1 Female	200	240	260	40	20
	2-2 Female	193	243	259	50	16

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The available information comprises an adequate and reliable study (Klimisch score 1), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5.1, of Regulation (EC) No 1907/2006.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute toxicity: oral

The acute oral toxicity of Fatty acids, C18-unsatd., dimers, di-Me esters, hydrogenated was assessed in rats in a study conducted according to OECD guideline 423 and under GLP conditions (Sanders, 2004). Two groups of 3 female rats each were sequentially treated with the test material (diluted in arachis oil BP) at a dose level of 2000 mg/kg bw by oral gavage. No mortality occurred, no clinical signs of toxicity and no effects on body weight gain were observed up to the end of the 14-day observation period. No abnormalities were noted at necropsy.

Based on the study results, the experimentally determined oral LD50 in rats is greater than 2000 mg/kg bw.

Due to the lack of moribund or dead animals at both testing steps and according to Annex 2d of OECD guideline 423, the oral LD50 value can be considered to be equal or greater than 5000 mg/kg bw.

Acute toxicity: inhalation

This information is not available.

The substance Fatty acids, C18-unsatd., dimers, di-Me esters, hydrogenated is a viscous liquid with a very low vapour pressure. Due to its physiochemical properties, exposure of humans via inhalation is unlikely.

Acute toxicity: dermal

This information is not available.

The physicochemical properties of the substance (water solubility: < 0.1 mg/L; log Kow: > 6.5) and molecular weight (> 500 g/mol) are in a range which anticipate a low to very low dermal absorption. This assumption is supported by the available toxicological data involving dermal exposure: the substance is neither skin irritating nor skin sensitising, and no signs of systemic toxicity were observed in the corresponding studies. Thus, the physicochemical and toxicological properties of the substance do not suggest potential for a significant rate of absorption through the skin.

Furthermore, based on all the available data no human health hazard is identified resulting in classification and labelling of the substance. Thus, the substance is not toxic after acute oral exposure, not mutagenic or clastogenic in vitro and (based on read-across) not toxic after repeated oral exposure and not toxic to reproduction.

Taken together, there is sufficient weight of evidence available leading to the assumption/conclusion that the substance is not toxic after acute dermal exposure.

Conclusions for acute toxicity

The substance Fatty acids, C18-unsatd., dimers, di-Me esters, hydrogenated has been tested for acute oral toxicity in rats. No mortality and no signs of systemic toxicity were observed. The experimentally determined oral LD50 was greater than 2000 mg/kg bw. According to the applied test method (OECD Guideline 423), the oral LD50 can be considered to be ≥ 5000 mg/kg bw.

Based on the available data, the substance is considered to be not toxic by the oral route.

There are no studies available on the acute toxicity by the dermal and inhalation routes. The high molecular weight and physicochemical properties of the substance (viscous liquid of very low vapour pressure, low water solubility and high lipophilicity) indicate that human exposure by inhalation is unlikely and do not suggest potential for a significant rate of absorption through the skin.

Justification for selection of acute toxicity – oral endpoint
There is only one study available.

Justification for classification or non-classification

The available data on the acute oral toxicity of Fatty acids, C18-unsatd., dimers, di-Me esters, hydrogenated do not meet the classification criteria according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.

Data are lacking for acute toxicity by the inhalation and dermal routes.