Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

No data for reproductive toxicity towards 1,4-butanediol diglycidylether (BDDGE) are available, but considering the similarities in the read-across justification it appears justified to use the data for reproductive toxicity derived from application of 1,6-hexanediol diglycidylether (HDDGE) as read-across data for BDDGE.

The hexanediol derivative HDDGE was investigated in an OECD 422 screening study by gavage application to rats. Despite slight maternal effects observed, no fetal effects or fertility effects were seen at any of the doses applied (0, 50, 200, 500 mg/kg bw/d).

The study appears suitable for read-across to the butanediol-derivative BDDGE, considering the structural similarity, the similarity of phys-chem data, as well as the similarities in acute toxicity, corrosion/irritation data, sensitisation properties and most importantly the repeated dose toxicity data of both substances. However, as currently there is an EOGRTS study performed with HDDGE by oral application (see ECHA decision TPE-D-2114440646-47-01/F, August 31st, 2018), following approval by ECHA of a testing proposal submitted by the HDDGE registrants, it is proposed to adopt the findings of this study, once available (presumably in quarter 4, 2020), for read-across to BDDGE too. This appears justified in light of the similarities of both substances as described above and considering animal welfare aspects into this proposal. Thus, it is proposed to await the outcome of the EOGRTS study with HDDGE and accept the findings for read-across to BDDGE as is.

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
263 mg/kg bw/day
Study duration:
subacute
Species:
rat
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

No data for developmental toxicity towards 1,4-butanediol diglycidylether (BDDGE) are available, but considering the similarities in the read-across justification it appears justified to use the data for developmental toxicity derived from application of 1,6-hexanediol diglycidylether (HDDGE) as read-across data for BDDGE.

The hexanediol derivative HDDGE was investigated in an OECD 422 screening study by gavage application to rats. Despite slight maternal effects observed, no fetal effects or fertility effects were seen at any of the doses applied (0, 50, 200, 500 mg/kg bw/d).

Likewise, no developmental effects were observed in an OECD 414 developmental toxicity study performed with HDDGE using Sprague-Dawley rats with doses applied of0, 30, 100, 300 mg/kg bw/day, provided during gestation days 3 to 19.

Both studies appear suitable for read-across to the butanediol-derivative BDDGE, considering the structural similarity, the similarity of phys-chem data, as well as the similarities in acute toxicity, corrosion/irritation data, sensitisation properties and most importantly the repeated dose toxicity data of both substances.

The results from the OECD 414 study with HDDGE are used for read-across to BDDGE, showing no effects to rats in this developmental toxicity study.

As currently there is an EOGRTS study performed with HDDGE by oral application (see ECHA decision TPE-D-2114440646-47-01/F, August 31st, 2018), following approval by ECHA of a testing proposal submitted by the HDDGE registrants, it is furthermore proposed to adopt the findings of this study, once available (presumably in quarter 4, 2020), for read-across to BDDGE too. This appears justified in light of the similarities of both substances as described above and considering animal welfare aspects into this proposal. Thus, the outcome of this study is expected to support the findings for read-across to BDDGE as is.

Currently, there is no indication for developmental effects by 1,4-butanediol diglycidylether (BDDGE).

Justification for classification or non-classification

Based on currently available information regarding reproductive toxicity effects there is no need for classification of the test substance for reproduction endpoints according to CLP (Regulation EC No. 1272/2008).