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Administrative data

Description of key information

The acute toxicity of Fatty acids, C18-unsatd., dimers, polymers with oleic acid and triethylenetetramine is low. The oral LD50 of the substance was determined to be > 2000 mg/kg bw in rats in an acute oral toxicity study (OECD Guideline 423) whereas the dermal LD50 of the substance was determined to be > 2000 mg/kg bw in rats in an acute dermal toxicity study (OECD Guideline 402). A waiver is proposed in accordance with Column 2 of Annex VIII of the REACH Regulation for acute inhalation toxicity on the basis that acute toxicity data are available for the oral and dermal routes. Inhalation is not predicted to be a significant route of exposure based on the physicochemical properties of the substance.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
Klimisch score = 1. Study compliant with current test guidelines and GLP.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
Klimisch score = 1. Study compliant with current test guidelines and GLP.

Additional information

Acute oral toxicity

The acute oral toxicity of Fatty acids, C18-unsatd., dimers, polymers with oleic acid and triethylenetetramine is low. The oral LD50of the substance was determined to be > 2000 mg/kg bw in an acute oral toxicity study conducted in rats according to OECD Test Guideline 423 and EU Method B.1 tris (Williams, 2012). 

In the study, two groups of three female rats were administered the test article dispersed in corn oil at a dose level of 2000 mg/kg bw and a maximum dose volume of 10 mL/kg bw. The rats were observed for 14 days during which, clinical signs, body weight changes and mortality were noted. Rats were euthanised on day 15 and subjected to a macroscopic examination. There were no deaths among rats dosed at 2000 mg/kg bw. There were no clinical signs and all rats achieved body weight gains during the first and second weeks of the study, with the exception of one animal which lost weight during the second week of the observation period. Macroscopic examination of these animals revealed no abnormalities. Under the conditions of this study, the acute median lethal oral dose level (LD50) of the test article, Fatty acids, C18-unsatd., dimers, polymers with oleic acid and triethylenetetramine , was found to exceed 2000 mg/kg bw.

Acute dermal toxicity

The acute dermal toxicity of Fatty acids, C18-unsatd., dimers, polymers with oleic acid and triethylenetetramine is low. The dermal LD50of the substance was determined to be > 2000 mg/kg bw in an acute dermal toxicity study conducted in rats according to OECD Test Guideline 402 and EU Method B.3 (Dreher, 2013a).

A preliminary study was conducted using one male and one female rat. Following the preliminary study an additional four rats per sex were treated. The test material was applied undiluted to the clipped dorsum of the rats at a dose of 2000 mg/kg bw. The test site was covered with a semi-occlusive dressing for 24 hours. Following dressing removal the animals were observed for dermal reactions at the test site, clinical signs of toxicity and mortality for 14 days. All animals were sacrificed at the end of the observation period and subject to full necropsy. There were no mortalities and no clinical signs of toxicity. Discolouration and scabbing of the test site was noted in treated animals, lasting up to Day 14. There were no treatment-related effects on body weight, and no abnormalities were noted at necropsy except for sore appearance of the test site in one female. Under the conditions of the study, the acute dermal LD50of the test material, Fatty acids, C18-unsatd., dimers, polymers with oleic acid and triethylenetetramine ,was found to exceed 2000 mg/kg bw in rats.

Acute inhalation toxicity

A waiver is proposed for acute inhalation toxicity studies in accordance with Column 2 of Annex VIII of the REACH Regulation on the basis that acute toxicity data are available for the oral and the dermal routes. Inhalation is not predicted to be a significant route of exposure based on the physicochemical properties of the substance. The substance is a non-volatile liquid and the use pattern indicates that significant inhalation exposure is unlikely. No additional testing is therefore warranted.

 


Justification for selection of acute toxicity – oral endpoint
Sole study; guideline and GLP compliant.

Justification for selection of acute toxicity – dermal endpoint
Sole study; guideline and GLP compliant.

Justification for classification or non-classification

Fatty acids, C18-unsatd., dimers, polymers with oleic acid and triethylenetetramine has low acute toxicity: the oral LD50and dermal LD50values in rats have both been determined to be > 2000 mg/kg bw/day. The substance does not therefore meet the criteria for classification for acute toxicity according to Regulation 1272/2008/EC or Directive 67/548/EEC.