Registration Dossier
Registration Dossier
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EC number: 216-322-1 | CAS number: 1559-34-8
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Justification for type of information:
- For justification of read across see category justification attached to category object.
Data source
Materials and methods
Test material
- Reference substance name:
- 3,6,9,12-tetraoxahexadecan-1-ol
- EC Number:
- 216-322-1
- EC Name:
- 3,6,9,12-tetraoxahexadecan-1-ol
- Cas Number:
- 1559-34-8
- Molecular formula:
- C12H26O5
- IUPAC Name:
- 3,6,9,12-tetraoxahexadecan-1-ol
- Test material form:
- liquid
Constituent 1
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
- Dose descriptor:
- NOAEC
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Remarks:
- Current available data from category members suggests no adverse effects would be seen up to the limit dose which would be the maximum tested dose in a contemporary study.
Target system / organ toxicity (P0)
- Critical effects observed:
- no
Results: P1 (second parental generation)
Effect levels (P1)
- Dose descriptor:
- NOAEC
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Remarks:
- Current available data from category members suggests no adverse effects would be seen up to the limit dose which would be the maximum tested dose in a contemporary study.
Target system / organ toxicity (P1)
- Critical effects observed:
- no
Results: F1 generation
Effect levels (F1)
- Dose descriptor:
- NOAEC
- Generation:
- F1
- Effect level:
- > 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- other: Current available data from category members suggests no adverse effects would be seen up to the limit dose shown.
Target system / organ toxicity (F1)
- Critical effects observed:
- no
Results: F2 generation
Effect levels (F2)
- Remarks on result:
- not measured/tested
Overall reproductive toxicity
- Reproductive effects observed:
- no
Applicant's summary and conclusion
- Executive summary:
Current available data from category members suggests no adverse effects would be seen up to the limit dose which is 1000mg/kg in a contemporary guideline study. On this basis the conclusion is that this substance exhibits no evidence of reproductive toxicity.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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