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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

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.

Data source

Materials and methods

Test material

Constituent 1
Chemical structure
Reference substance name:
Bis[2-[2-(2-butoxyethoxy)ethoxy]ethyl] adipate
EC Number:
EC Name:
Bis[2-[2-(2-butoxyethoxy)ethoxy]ethyl] adipate
Cas Number:
Molecular formula:
1,6-bis({2-[2-(2-butoxyethoxy)ethoxy]ethyl}) hexanedioate
Test material form:
other: liquid

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:no effects

Effect levels (maternal animals)

Key result
Dose descriptor:
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

Results (fetuses)

Effect levels (fetuses)

Key result
Dose descriptor:
Remarks on result:
not determinable due to adverse toxic effects at highest dose / concentration tested
no gross, skeletal or visceral abnormalities were observed

Fetal abnormalities

no effects observed

Overall developmental toxicity

Key result
Developmental effects observed:
Lowest effective dose / conc.:
170 mg/kg bw/day
Treatment related:
not specified

Applicant's summary and conclusion

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.