Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The skin sensitizing potential of Hexanedioic acid, polymer with 2,2'-oxybis[ethanol] was evaluated in a weight-of-evidence approach,

by means of QSAR (quantitative structure-activity relationship) calculation and read across to the hydrolysis products of the test

substance, adipic acid and diethylene glycol. Read across to the hydrolysis products is considered appropriate in accordance with

section 1.5 of REACH Annex XI.

The skin sensitization potential of the test substance was predicted by means of TIMES-SS, a validated quantitative structure-activity

relationship (QSAR) system. The QSAR program calculated a negative sensitization potential of the test substance.

The substance was within the total domain, structural and parametric domain of the system.

Adipic acid was tested for skin sensitization in a non-guideline guinea pig maximization test (Haskell 1974). Groups of 10 guinea

pigs were given series of four sacral intradermal injections, one each week over a three-week period, which consisted of 0.1 ml of

a 1.0 % solution of adipic acid (99.99 %) in water. Following a two-week rest period, the test animals were challenged for sensitisation

by applying, and lightly rubbing in, approximately 0.05 ml of a 50 % and 25 % suspension of the test material in propylene glycol on

the shaved intact shoulder skin. A group of 10 previously unexposed animals received similar applications at the time of challenge to

provide direct comparison of the challenge reactions on the skin of similar age. The compound produced very mild to no skin irritation

to previously unexposed guinea pigs and did not cause sensitisation.

Further sensitization data for adipic acid (see REACH registration dossier 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), including a GPMT with a mixture and several human case studies also indicate that the test substance does not need to be

classified for skin sensitization according to Regulation (EU) 1272/2008 and Directive 65/548/EEC.

The skin sensitization potential of diethylene glycol was assessed in a study conducted according to EU Method B.6

(Skin Sensitization). For intradermal induction a 5% diethylene glycol (DEG) formulation in NaCl and for epidermal induction a

75% DEG formulation in water were used. A 50% DEG formulation in water was applied for challenge. No skin reactions could

be observed.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the results of a QSAR investigation, and taking into account in-vivo data from the hydrolysis products of the test substance, Hexanedioic acid, polymer with 2,2'-oxybis[ethanol] does not need to be classified for skin sensitization according to Regulation (EC) 1272/2008 and Directive 65/548/EEC.