Registration Dossier
Registration Dossier
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EC number: 265-807-4 | CAS number: 65520-46-9
Developmental toxicity / teratogenicity
Administrative data
- 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.
Data source
Materials and methods
Test material
- Reference substance name:
- Bis[2-[2-(2-butoxyethoxy)ethoxy]ethyl] adipate
- EC Number:
- 265-807-4
- EC Name:
- Bis[2-[2-(2-butoxyethoxy)ethoxy]ethyl] adipate
- Cas Number:
- 65520-46-9
- Molecular formula:
- C26H50O10
- IUPAC Name:
- 1,6-bis({2-[2-(2-butoxyethoxy)ethoxy]ethyl}) hexanedioate
- Test material form:
- other: liquid
Constituent 1
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:
- 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
Results (fetuses)
Effect levels (fetuses)
- 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
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
- Lowest effective dose / conc.:
- 170 mg/kg bw/day
- Treatment related:
- not specified
Applicant's summary and conclusion
- 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.
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