Registration Dossier
Registration Dossier
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EC number: 618-460-1 | CAS number: 9010-89-3
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Additional information
No data are available concerning the toxicity to reproduction of Hexanedioic acid, polymer with 2,2'-oxybis[ethanol].
As extensively discussed in section 7.1 of the IUCLID, read across to the hydrolysis products adipic acid and diethylene glycol was
conducted in accordance with section 1.5 of REACH Annex XI.
No specific studies on fertility have been conducted for adipic acid. In a two-years feeding study in rats (Horn 1957; see also
chapter 7.5.1 of the IUCLID) histopathological examination of testes, ovaries, and uterus revealed no evidence of an adverse effect
on the reproductive organs up to the highest doses tested (males approx. 3750 mg/kg bw/day, females approx. 750 mg/kg bw/day).
Based on the available data there is no reason to expect specific reproductive toxicity of adipic acid.
Research Triangle Institute (1984) reported a reproduction and fertility assessment for diethylene glycol. The substance was
administered via the drinking water to mice. The male and female mice were given concentrations of 0, 0.35, 1.75 and 3.5%
(= 0, 612, 3063 and 6125 mg/kg bw/day) 7 days before, during and 21 days after a 98-day cohabitation stage. In this experiment,
diethylene glycol did not produce changes in the male or female reproductive capability. The NOAEL for general toxicity in the
parental animals was found to be 3060 mg/kg bw/day.
Further repeated dose data available for diethylene glycol gave no indication of toxicity to reproduction (
http://apps.echa.europa.eu/registered/data/dossiers/DISS-9d913d37-b787-0c08-e044-00144f67d249/DISS-9d913d37-b787-0c08-e044-00144f67d249_DISS-9d913d37-b787-0c08-e044-00144f67d249.html
Effects on developmental toxicity
Additional information
No data are available concerning the developmental toxicity/teratogenicty of Hexanedioic acid, polymer with 2,2'-oxybis[ethanol].
As extensively discussed in section 7.1 of the IUCLID, read across to the hydrolysis products adipic acid and diethylene glycol was
conducted in accordance with section 1.5 of REACH Annex XI.
A multi-generation reproduction toxicity study is not available for adipic acid. In a teratologic evaluation, up to 250 mg/kg bw/day
of the compound were administered to pregnant rabbits via gavage for 13 consecutive days
and had no effect on nidation or on maternal or fetal survival. The number of abnormalities seen in either soft or skeletal tissue
of the test groups did not differ from the numbers occurring spontaneously in the sham-treated controls. No difference between treatment and control groups were found for corpora lutea, implantations, total no. of resorptions, total no. of fetuses, total no. of live litters and fetal weights. No maternal toxicity observed. The resultes were not evaluated statistically, but inspection of tables
shows no effects in the treated groups vs. control.
In conclusion, there was no evidence of a specific reproductive toxicity of adipic acid in a developmental toxicity studies.
In a pre-developmental toxicity study conducted according to OECD guideline 414 (BASF 1989), the oral administration of diethylene glycol to pregnant Himalayan rabbits by stomach tube on day 7 through day 19 p.i. in dosages of 100, 400 and 1,000 mg/kg body weight/day led to no adverse effects which can be causally related to the test substance administration in both the does and in the fetuses. The observable differences between the control group and the substance-treated groups appeared either without a clear dose-response relationship and/or were assessed as being without biological relevance, because the relevant values/findings are to be found in a similar range within the historical control data.
In summary, diethylene glycol did not cause any signs of embryo-/fetotoxicity under the conditions of this study, up to and including a dose of 1,000 mg/kg body weight/day; no teratogenic effects could be detected.
Based on the results available for its hydrolysis products, the test substance Hexanedioic acid, polymer with 2,2'-oxylbis[ethanol] can be considered to not be toxic to reproduction.
Justification for classification or non-classification
The data available for the hydrolysis products of the test substance Hexanedioic acid, polymer with 2,2'-oxylbis[ethanol], adipic acid and diethylene glycol give no indication of toxicity to reproduction. Therefore, classification is not required according to the EU classification criteria 67/548/EWG and regulation no. 1272/2008 (GHS).
Additional information
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.
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