3,6,9-trioxaundecamethylene bis(2-ethylhexanoate)

Endpoint summary

Description of key information

There is no repeated dose toxicity information available for the test substance. The structurally related material, ethane-1,2-diylbis(oxyethane-2,1-diyl) bis(2-ethylhexanoate)(CAS No. 94 -28 -2) was adiminstered by gavage to male and female Wistar rats for at least 28 days at dose levels in the diet 1500, 5000 and 15000 ppm. These treatments revealed parental toxicity at 15000 ppm. Based on these results, a parental No Observed Adverse Effect Level (NOAEL) of 5000 ppm was derived. When corrected for mean test article intakethe NOAEL of 5000 ppm corresponds to 314-576 mg/kg body weight/day.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records

Reference

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

The subject material is a member of a US HPV Glycol Esters category.

Reason / purpose for cross-reference:

read-across source

Dose descriptor:

NOAEL

Effect level:

5 000 ppm

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: see Remark:

Critical effects observed:

not specified

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

314 mg/kg bw/day

Study duration:

subacute

Species:

rat

Quality of whole database:

Based on a weight of evidence analysis, the quality of the database is considered sufficient.

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The test substance is a member of a category of aliphatic esters submitted by The American Chemistry Council's (ACC) Aliphatic Esters Panel (Panel) under the High Production Volume (HPV) Chemical Challenge Program (ACC, 2003). Information from a Screening Information Data Set (SIDS) developed in that program serves as supplementary or weight-of-evidence in the current dossier. Category ester compounds with similar structures and functionalities were of low toxicity following repeated oral dosing. The structurally related material, heptanoic acid, oxybis(2,1-ethanediyloxy-2,1-ethanediyl) ester (CAS 70729 -68 -9) was adiminstered by gavage to male and female Wistar rats for 28 days at a limit dose of 1000 mg/kg bw. This was followed by a 14 -day recovery period. There were no adverse, treatment related effects identified. The NOAEL was assigned as 1000 mg/kg bw/day. The test material 2,2'-ethylenedioxydiethyl bis(2 -ethylhexanoate) (CAS 94 -28 -0) showed no adverse effects with respect to food consumption, weight gain, behavior, hematology, clinical serum chemistry, liver or kidney weight, or gross or microscopic appearance of organs following dietary exposure for 12 days to 0.1% or 1.0% (approx. 80 or 800 mg/kg bw/day. The test material heptanoic acid, ester with 2,2,4 -trimethyl-1,3 -pentanediol (CAS 71839 -38 -8) was tested in rats in an OECD 407 guideline study. The no-observed-adverse-effect-level was assigned as 180 mg/kg bw.day based on the formation of the male-rat specific hyaline droplet formation. Doses of CAS 71839 -38 -8 up to 1000 mg/kg bw/day were otherwise well tolerated in animals with no mortality or clinical signs of toxiciyt. After 28 days of repeated dose exposure to up to 1000 mg/kg/day, there was no indication that the test material adversely affected the reproductive organs in male and female rats. No histopathological or gross abnormalities were reported for testes, epididymides and ovaries

Justification for classification or non-classification

Based on the results of repeated-dose oral toxicity testing in rats of structurally similar substances, the test substance would not be classified for repeated-dose toxicity according to the European Regulation (EC) No. 1272/2008 on classification and labelling of chemicals.