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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Additional information

No repeated dose toxicity data are available for 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.

Diethylene glycol (DEG) was tested in a 225-day oral feeding study (Gaunt et al., 1975). Male and female rats were given concentrations of 0.85, 0.17, 0.4 and 2.0% (= 64, 128, 300, and 1500 mg/kg bw/day). The elevated levels of oxalic acid in urine in this study were considered to be a biomarker and do not indicate toxicity. Mild defects of renal function at 0.4% DEG were considered to define the NOAEL as 128 mg/kg bw/day.

Another oral repeated-dose study (BASF 1988, acc. to OECD guideline 407) is available for DEG (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). At the highest dose (40 000 mg/kg diet), a significant concentration and amount of oxalic acid was found in the urea of both sexes, and oxalic acid stones in males after 28 days. However, these effects were reversible within 30 days, as demonstrated by means of arecovery group. The NOAEL was 10 000 mg/kg diet corresponding to 936 mg/kg bw/day.

A number of oral repeated dose studies are available for adipic acid (ADS) (http://apps.echa.europa.eu/registered/data/dossiers/DISS-9ebef55e-5c54-185f-e044-00144f67d031/DISS-9ebef55e-5c54-185f-e044-00144f67d031_DISS-9ebef55e-5c54-185f-e044-00144f67d031.html).

The most reliable one was considered to be a chronic feed study (Horn et al., 1957), which was, however, not conducted according

to modern standards. The NOAEL was 1% for male rats (approx. 750 mg/kg bw/day) and higher doses (3 and 5%) caused body

weight retardation with no indication of specific target organ toxicity. The NOAEL for female rats was 1% (approx. 750 mg/kg bw/day), the highest dose tested in females. Evaluation of further oral repeated dose data, including human data, gave no evidence of classifiable specific target organ toxicity.

DEG accounts for the main molar fraction of Polyesterol 90212 (see below) and, of the polyesterol’s hydrolysis products DEG and ADS, showed the more critical NOAEL upon chronic oral feeding. Therefore, the DEG NOAEL of 128 mg/kg bw/day was used to estimate a NOAEL for Polyesterol 90212.

Polyesterol 90212 is composed of the following constituents(see chapter 1.2 of the IUCLID):

32 %: 2,2'-Oxybis(ethanol) (DEG);

35 %: HO((CH2CH2-O-CH2CH2-O-C(=O)-(CH2)4-C(=O)-O)n)-CH2CH2-O-CH2CH2-OH; n = 1;

32 %: HO((CH2CH2-O-CH2CH2-O-C(=O)-(CH2)4-C(=O)-O)n)-CH2CH2-O-CH2CH2-OH; n = 2;

Taking into account the characterization above, DEG in total constitutes 74.6% of the polyesterol. Conversion of the NOAEL identified for DEG (128 mg/kg based on renal effects; Gaunt et al., 1975) results in a NOAEL of 172 mg/kg for Polyesterol 90212[=(100*128)/74.6].

Justification for classification or non-classification

Based on the information available for its hydrolysis products, diethylene glycol and adipic acid, classification of the test substance according to Regulation (EC) No. 1272/2008 and Directive 65/548/EEC is not warranted.