Hexanedioic acid, di-C16-18 (even numbered) alkyl esters

Endpoint summary

Description of key information

Oral (similar to OECD 401), rat: LD50 >15000 mg/kg bw
Inhalation (similar to OECD 403), rat: LC50 >3.2 mg/L

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 an adequate and reliable study from a reference substance with similar structure and intrinsic properties. Read-across is justified based on common functional group(s), common precursors/breakdown products, similarities in PC/ECO/TOX properties (refer to endpoint discussion for further details). The selected study is thus 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 and intrinsic properties. Read-across is justified based on common functional group(s), common precursors/breakdown products, similarities in PC/ECO/TOX properties (refer to endpoint discussion for further details). The selected study is thus 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 dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Justification for grouping of substances and read-across

There are no data available on the acute toxicity of Hexanedioic acid, di-C16-18 (even numbered)-alkyl esters (CAS 92969-90-9). In order to fulfil the standard information requirements set out in Annex VII and VIII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substances was 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 substances may be predicted as similar provided that their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity.

 

Acute oral toxicity

CAS 16958-92-2

An acute oral toxicity study was performed withBis(tridecyl) adipate (CAS 16958-92-2), following a protocolsimilar to OECD TG 401 (key, 1978).Groups of five Wistar rats per sex received the test substance via gavage at a limit dose of 15000 mg/kg bw. No mortalities were observed within the 14-day observation period. Diarrhoea was noted in all animals on the day of treatment and thereafter in 1/5 males and 1/5 females on day 1; in 2/5 males from day 2 until day 4; and in 1/5 male on day 13 and day 14, respectively. Other clinical signs during the 14-day observation period included lethargy, flaccidity, oily bodies, ptosis and chromorhinorrhoea. No body weights were recorded and gross necropsy was not performed. Based on the results of the study, the oral LD50 value was greater than 15000 mg/kg bw for male and female Wistar rats.

 

Acute inhalation toxicity

CAS 16958-92-2

The acute inhalation toxicity of Bis(tridecyl) adipate was investigated in a study performed similar to OECD guideline 403 (key, 1989). Groups of 10 Sprague Dawley rats per sex were exposed to analytical atmosphere concentrations of the test aerosol of 0.5 and 3.2 mg/L (highest achievable dose) for 4 h using a whole body exposure system. In addition, 10 control animals per sex were sham-exposed. An interim sacrifice of 5 males and 5 females of each group was performed 1 day after exposure to the test aerosol. No mortality and no clinical signs were observed in any of the animals during the 1- or 14-day observation period. Body and organ weights (liver, kidney and right middle lung lobe) were not affected by treatment and no abnormalities were noted at gross pathological examination. The histopathological examination did not reveal any substance-related changes in any of the organs examined (lungs, nasal turbinates, liver, kidney and tracheobronchial lymph node). Based on these results, the LC50 value for male and female Sprague Dawley rats was assumed to be greater than 3.2 mg/L air (analytical).

 

Conclusion for acute toxicity

The reliable data available for the analogue substance indicate a very low level of acute toxicity following the oral and inhalation route, as LD50 and LC50 values were greater than the currently applied limit values. In conclusion, as the available data did not identify any hazard for acute toxicity,Hexanedioic acid, di-C16-18 (even numbered)-alkyl esters (CAS 92969-90-9)is not considered to be hazardous following acute exposure via the oral and inhalation route.

Justification for classification or non-classification

According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint". Since the analogue concept is applied to Hexanedioic acid, di-C16-18 (even numbered)alkyl esters, data will be generated from information on reference source substance(s) to avoid unnecessary animal testing. Additionally, once the analogue read-across concept is applied, substances will be classified and labelled on this basis.

Therefore, 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.