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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

According to the category approach, no effects on reproduction are expected for adipic acid diesters category members. However, the worst case NOAEL available among category memebrs is used for risk assessment purposes.

Link to relevant study records
Reference
Endpoint:
one-generation reproductive toxicity
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Justification for type of information:
Adipic acid diesters category. See attached report.
Key result
Dose descriptor:
NOAEL
Effect level:
170 mg/kg bw/day
Basis for effect level:
body weight and weight gain
Remarks on result:
other: worst case among category memebrs
Critical effects observed:
no
Remarks on result:
not measured/tested
Dose descriptor:
NOAEL
Generation:
F1
Effect level:
170 mg/kg bw/day
Basis for effect level:
body weight and weight gain
Remarks on result:
other: worst case among category memebrs
Remarks on result:
not measured/tested
Key result
Reproductive effects observed:
no
Lowest effective dose / conc.:
170 mg/kg bw/day
Treatment related:
not specified
Conclusions:
According to the category approach, no effects on reproduction are expected for adipic acid diesters category members. However, the worst case NOAEL available among category memebrs is used for risk assessment purposes.
Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
170 mg/kg bw/day
Study duration:
chronic
Species:
rat
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Basing on a QSAR approach, bis[2-[2-(2-butoxyethoxy)ethoxy]ethyl]adipate is not of concern for reproductive toxicity.


Effects on developmental toxicity

Description of key information

Data form the worst case category member was used for risk assessment purposes. Pregnant rats administered the test item in the diet throughout gestation showed reduced body weight at dietary equivalent doses of 1080 mg/kg/day. At 1080 mg/kg/day, implantation fetal loss was evident; however, no gross, skeletal or visceral abnormalities were observed. LOAEL was 1080 mg/kg/day and NOAEL was 170 mg/kg/day for developmental toxicity.

According to the category approach adopted, no developmental toxicity is expected for category members.

Link to relevant study records
Reference
Endpoint:
developmental toxicity
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Justification for type of information:
Adipic acid diesters category. See attached report.
Details on maternal toxic effects:
Maternal toxic effects:no effects
Key result
Dose descriptor:
NOAEL
Effect level:
170 mg/kg bw/day
Basis for effect level:
body weight and weight gain
pre and post implantation loss
Remarks on result:
other: worst case category member
Key result
Dose descriptor:
NOAEL
Remarks on result:
not determinable due to adverse toxic effects at highest dose / concentration tested
Remarks:
no gross, skeletal or visceral abnormalities were observed
Abnormalities:
no effects observed
Key result
Developmental effects observed:
no
Lowest effective dose / conc.:
170 mg/kg bw/day
Treatment related:
not specified
Conclusions:
Data form the worst case category member was used for risk assessment purposes. Pregnant rats administered the test item in the diet throughout gestation showed reduced body weight at dietary equivalent doses of 1080 mg/kg/day. At 1080 mg/kg/day, implantation fetal loss was evident; however, no gross, skeletal or visceral abnormalities were observed. LOAEL was 1080 mg/kg/day and NOAEL was 170 mg/kg/day for developmental toxicity.
According to the category approach adopted, no developmental toxicity is expected for category members.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
170 mg/kg bw/day
Study duration:
chronic
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

Basing on a read-across approach, bis[2-[2-(2-butoxyethoxy)ethoxy]ethyl]adipate is not of concern for developmental toxicity.

Justification for classification or non-classification

The whole dataset of reproductive and developmental data (comprising read-across and QSAR studies), lead to the conclusion that bis[2-[2-(2-butoxyethoxy)ethoxy]ethyl] adipate is not classified for reproductive toxicity according to Regulation (EC) n. 1272/2008.

Additional information