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EC number: 800-426-4 | CAS number: 1373883-45-4
Oral: LD50 (rat, m/f) > 5000 mg/kg bw (OECD 401, GLP, read-across from structurally similar substances)Dermal: LD50 (rat, m/f) > 2000 mg/kg bw (OECD 402, GLP)
Table 1. Individual dermal reactions
Effects noted after initiation of exposure (Days)
0 = No reactions
1 = Very slight erythema
Ss = Small superficial scattered scabs
x = Due to technician error observation not performed
Justification for grouping of substances and read-across
There are no data available on the acute oral toxicity of Fatty acids, C18-unsaturated, trimers, hydrogenated. In order to fulfil the standard information requirements set out in Annex VII, Section 8.5.1, in accordance with Annex XI, Section 1.5 of Regulation (EC) No 1907/2006, read-across from structurally similar substances is conducted.
In accordance with Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.” In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across).
Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No 1907/2006, whereby physicochemical, toxicological and ecotoxicological properties may be predicted from data for reference substance(s) by interpolation to other substances on the basis of structural similarity, Fatty acids, C18-unsatd., dimers (CAS 61788-89-4) and Fatty acids, C18-unsatd., dimers, hydrogenated (CAS 68783-41-5) are selected as reference substances for assessment of the acute oral toxicity.
The read-across is based on structural similarity as a result of common origin and production process line. Shortly, the source and target substances are derived from catalytically di- and trimerised long-chain fatty acids; dimers and trimers are separated by distillation and unsaturated alkyl chains are hydrogenated as specifically required. A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).
Overview of acute toxicity
Target substance (a)
Source substance 1 (b)
Source substance 2
Fatty acids, C18-unsaturated, trimers, hydrogenated
Fatty acids, C18-unsatd., dimers
Fatty acids, C18-unsatd., dimers, hydrogenated
Acute toxicity: oral
RA: CAS 61788-89-4
RA: CAS 68783-41-5
LD50 (rat, m/f) > 5000 mg/kg bw
Acute toxicity: inhalation
Acute toxicity: dermal
LD50 (rat, m/f) > 2000 mg/kg bw
(a) The substance subject to the REACh Phase-in registration deadline of 31 May 2013 is indicated in bold font. Only for this substance a full set of experimental results and/or read-across is given.
(b) Reference (read-across) substances are indicated in normal font. Lack of data for a given endpoint is indicated by “--“.
Acute toxicity: oral
CAS 61788-89-4, CAS 68783-41-5
Fatty acids, C18-unsatd., dimers and Fatty acids, C18-unsatd., dimers, hydrogenated were tested for acute oral toxicity in rats in GLP-compliant studies conducted according to OECD guideline 401 and EU Method B.1, respectively (Thouin, 1986; Reijnders, 1988). In each study, one group of 5 male and 5 female rats was given a single oral dose of the respective test material at 5000 mg/kg bw by gavage. In both studies, no mortalities occurred and no signs of systemic toxicity were observed up to the end of the observation period (14 days). Likewise, no effects on body weight (change) and no test substance-related gross abnormalities were seen at macroscopic examination.
Based on the results of these studies, the oral LD50 of both Fatty acids, C18-unsatd., dimers and Fatty acids, C18-unsatd., dimers, hydrogenated in male and female rats was greater than 5000 mg/kg bw.
Acute toxicity: dermal
The acute dermal toxicity of Fatty acids, C18-unsaturated, trimers, hydrogenated was assessed in rats in a GLP-compliant study carried out according to OECD guideline 402 (Bradshaw, 2013). Initially, two animals (one per sex) were given a single, 24-hour, semi-occluded dermal application of the test item to the intact skin at a dose level of 2000 mg/kg bw. Based on the results of the initial test, a further group of 8 rats (4 per sex) was similarly treated.
No mortality occurred and no signs of systemic toxicity were observed up to the end of the 14-day observation period. Animals showed expected body weight gain, except for one female which showed bodyweight loss during the first week (ca. -7%) but expected gain in bodyweight during the second week. No abnormalities were observed at necropsy.
There were no signs of dermal irritation in 2 animals (males). Skin reactions were limited to very slight erythema (Draize score 1) at the test sites of 8 animals, without any signs of edema. Very slight erythema was seen in 2 males only on Day 2 and in another male on Days 2-5. In females, very slight erythema was noted in 4 animals on Days 2 and 3 and in one animal on Days 2-8. Small superficial scattered scabs were also noted at the test sites of 3 females (in two animals on Days 2-3 and in one animal on Days 3-10).
The maximum mean erythema scores from 3 consecutive readings was 1 in 2/10 animals, 0.7 in in 4/10 animals, 0.3 in 2/10 animals and 0 in 2/10 animals. Therefore, the substance can be considered to be not irritating to the skin.
Based on the study results the dermal LD50 in male and female rats is > 2000 mg/kg bw and the substance is thus considered to be not acutely toxic by the dermal route.
No relevant information available.
In accordance with Column 2 of Annex VIII, Section 8.5.2 of Regulation (EC) No 1907/2006, testing by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols , particles or droplets of inhalable size.
The substance is a viscous liquid with low vapour pressure and it is not intended for use in spraying/brushing processes. Therefore, human exposure to vapours, aerosols, particles or droplets of inhalable size is unlikely and testing by the inhalation route is not appropriate.
Conclusions for acute toxicity
The substance Fatty acids, C18-unsaturated, trimers, hydrogenated has been tested for acute dermal toxicity resulting in a dermal LD50 > 2000 mg/kg bw and no toxicologically relevant signs of systemic or local (dermal) effects.
There is no information available on acute oral toxicity. Therefore, in order to fulfil the standard information requirements set out in Annex VII, Section 8.5.1, in accordance with Annex XI, Section 1.5 of Regulation (EC) No 1907/2006, read-across from structurally similar substances is conducted.
Acute oral toxicity studies with Fatty acids, C18-unsatd., dimers (CAS 61788-89-4) and Fatty acids, C18-unsatd., dimers, hydrogenated (CAS 68783-41-5) resulted in oral LD50 values > 5000 mg/kg bw/day and no toxicologically relevant effects.
Based on the available data, the substance Fatty acids, C18-unsaturated, trimers, hydrogenated is considered to be not toxic by the oral and dermal routes.
Human exposure to vapours, aerosols, particles or droplets of inhalable size is unlikely as anticipated from the physicochemical properties (viscous liquid with low vapour pressure) and identified uses of the substance (no uses involving spraying/brushing processes).
Based on substance specific data and read-across from structurally similar substances following an analogue approach, the available data on the acute oral and dermal toxicity of the substance do not meet the classification criteria according to Regulation (EC) No 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.
Data on acute toxicity by inhalation are lacking.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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