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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Effects on fertility

Description of key information

Treatment with the structurally similar 2,2’-ethylenedioxydiethyl bis (2-ethylhexanoate)(CAS No. 94 -28 -2) by dietary administration in male and female Wistar Han rats at dose levels of 1500, 5000 and 15000 ppm revealed parental toxicity at 15000 ppm. No reproduction and developmental toxicity was observed with treatment up to 15000 ppm. Based on these results, a parental No Observed Adverse Effect Level (NOAEL) of 5000 ppm was derived. The reproductive and developmental NOAEL was at least 15000 ppm. When corrected for mean test article intake the NOAEL of 5000 ppm corresponds to 314-576 mg/kg body weight/day and the NOAEL of 15000 ppm corresponds to 977-1563 mg/kg body weight/day.

Link to relevant study records
Reference
Endpoint:
screening for reproductive / developmental toxicity
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
Key result
Dose descriptor:
NOAEL
Effect level:
5 000 ppm
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: see Remark:
Key result
Dose descriptor:
NOAEL
Generation:
F1
Effect level:
15 000 ppm
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: no reproductive or developmental effects observed
Key result
Reproductive effects observed:
no
Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
977 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
The quality of the whole database was considered adequate.
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the lack of reproductive or developmental effects with a structurally similar material (CAS No. 94 -28 -2), the test substance would not be classified for reproductive or developmental toxicity according to the European Regulation (EC) No. 1272/2008 on classification and labelling of chemicals.

Additional information