Fatty acids, C18-unsatd., dimers, polymers with 2-ethylhexanol and neopentyl glycol

Endpoint summary

Description of key information

Acute oral toxicity (OECD 423, GLP): LD50 > 2000 mg/kg bw (female, rat) (RA CAS 147256-33-5 and CAS 68440-06-2)

Acute inhalation toxicity (OECD 436, GLP): LC50 > 5.3 mg/L air (male/female, rat) (RA CAS 68334-05-4)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The available information comprises adequate, reliable studies from a reference substance with similar structure. Read-across is justified based on common functional groups and structural similarities (please refer to analogue justification). Taken together, the information from these independent sources is consistent and provides sufficient weight of evidence for hazard assessment leading to an endpoint conclusion in accordance with Annex XI, 1.2, of Regulation (EC) No 1907/2006. Therefore, the available information as a whole is sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The available information comprises an adequate and reliable study from a reference substance with similar structure. Read-across is justified based on common functional group(s) and structural similarities (refer to analogue justification). The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VIII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Justification for read-across

There are no available data assessing the acute oral, inhalation and dermal toxicity potential of Fatty acids, C18-unsatd., dimers, polymers with 2-ethylhexanol and neopentyl glycol (CAS 68552-19-2). The assessment of acute toxicity was therefore based on studies conducted with the source substances Fatty acids, C18-unsatd., dimers, mixed esters with oleic acid and trimethylolpropane (CAS 147256-33-5), Fatty acids, C18-unsatd., dimers, hydrogenated, 2-ethylhexyl esters (CAS 68440-06-2) and Fatty acids, C18-unsatd., dimers, 2-ethylhexyl esters (CAS 68334-05-4) as part of a read across approach, which is in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5. in order to fulfil the standard data requirements defined in Regulation (EC) No 1907/2006, Annex VII, 8.5. Structural similarities and comparable toxicokinetic properties of the source and target substance are the basis of read-across. A detailed justification for the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13).

Acute oral toxicity

CAS 147256-33-5

A reliable acute oral toxicity study with Fatty acids, C18-unsatd., dimers, mixed esters with oleic acid and trimethylolpropane (CAS 147256-33-5) is available and was performed according to OECD TG 423 and in compliance with GLP (Harlan Laboratories, 2012). In this study, following the acute toxic class method, three female fasted Wistar rats were administered a single dose of 2000 mg/kg bw of the test substance (CAS 147256-33-5) in a stepwise procedure via oral gavage. The animals were observed for 14 days after administration. No mortalities were observed during the study and no signs of systemic toxicity were noted during the observation period in any animal. All animals showed the expected gains in body weight and no abnormalities were observed at necropsy. The experimental acute oral LD50 value for females was considered to be greater than 2000 mg/kg bw. Thus, according to OECD TG 423, an oral LD50 cut-off value >5000 mg/kg bw was derived.

CAS 68440-06-2

A WoE acute oral toxicity study with Fatty acids, C18-unsatd., dimers, hydrogenated, 2-ethylhexyl esters (CAS 68440-06-2) is available and was performed according to OECD TG 423 and in compliance with GLP (Harlan Laboratories, 2015). In this study, following the acute toxic class method, three female fasted Wistar rats were administered a single dose of 300 mg/kg bw of the test substance (CAS 68440-06-2) whereas another six females received one dose of 2000 mg/kg bw of the test substance in a stepwise procedure via oral gavage. The animals were observed for 14 days after administration. The acute oral LD50 value for females was estimated to be 5000 mg/kg bw according to the flowchart in Annex 2c of OECD TG 423. No mortalities were observed during the study and no signs of systemic toxicity were noted during the observation period in animals treated at a dose level of 300 mg/kg bw. Hunched posture was noted during the day of dosing in all animals treated at a dose level of 2000 mg/kg bw. All animals treated at a dose level of 2000 mg/kg bw appeared normal 1 day after dosing. No abnormalities were noted at necropsy.

Based on the study results and according to EU classification criteria, the test substance is not to be classified.

Acute inhalation toxicity

CAS 68334-05-4

A reliable acute inhalation study was performed with Fatty acids, C18-unsaturated, dimers, 2-ethylhexyl esters (CAS 68334-05-4) according to OECD TG 436 and in compliance with GLP (Notox B.V., 2010). In this study, following the acute toxic class method, three Crl:WI(Han) rats of each sex were exposed to an aerosol with an analytical concentration of 5.3 mg/L of the test substance for 4 hours in an nose-only inhalation exposure chamber. No mortalities or any abnormal clinical signs were reported during the exposure or within the 14 days observation period. Additionally body weight gain in males and females was within the range expected for rats of this strain and age used in this type of study and no abnormalities were found at macroscopic post mortem examination of the animals. The acute inhalation LC50 value was calculated to be greater than 5.3 mg/L.

Based on the above study results and according to EU classification criteria, the test substance is not to be classified.

Justification for classification or non-classification

Based on the analogue read-across approach, the available data on acute toxicity do not meet the classification criteria according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification