Registration Dossier
Registration Dossier
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EC number: 614-295-4 | CAS number: 68131-40-8
Toxicity to reproduction
Administrative data
- Endpoint:
- reproductive toxicity, other
- Type of information:
- other: Review of the toxicology profile similarity between softanol 30 and the alcohol ethoxylates described in several publications and assessment of data from available studies with softanol 30 and other alcohol ethoxylates to waive the execution of an EOGRTS
- Adequacy of study:
- weight of evidence
- Reliability:
- other: Review of data extracted from publications
Data source
Referenceopen allclose all
- Reference Type:
- review article or handbook
- Title:
- Human & Environmental Risk Assessment on ingredients of European household cleaning products. Alcohol Ethoxylates. Version 2.0
- Author:
- Human & Environmental Risk Assessment
- Year:
- 2 009
- Bibliographic source:
- http://www.heraproject.com/files/34-f-09%20hera%20ae%20report%20version%202%20-%203%20sept%2009.pdf
- Report date:
- 2009
- Reference Type:
- review article or handbook
- Title:
- Environmental and Human Safety of Major Surfactants: Alcohol Ethoxylates and Alkylphenol Ethoxylates.
- Author:
- Talmage S.S.
- Year:
- 1 994
- Bibliographic source:
- CRC Press,Technology & Engineering
- Report date:
- 1994
Materials and methods
- Principles of method if other than guideline:
- This document is a review of the similarity of the toxicology profile between softanol 30 and the alcohol ethoxylates described in several publications. the aim is to assess the data from available studies with softanol 30 and other alcohol ethoxylates in order to waive the execution of an EOGRTS.The notifier has performed a rat 90 day repeated dose toxicity study (OECD 408) and a developmental toxicity study (OECD 414) with softanol. Two-generation reproductive toxicity studies are available with other alcohol ethoxylates.
Test material
- Reference substance name:
- Alcohols, secondary C11-15, ethoxylated
- EC Number:
- 614-295-4
- Cas Number:
- 68131-40-8
- Molecular formula:
- C(11-15) H(23-31) O (C2H4O)xH where n= approximately 3
- IUPAC Name:
- Alcohols, secondary C11-15, ethoxylated
Constituent 1
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
- Remarks on result:
- other: Weight of evidence document including two generation and repeated dose studies
- Remarks:
- No compound related differences were seen between control and treated rats in any of the endpoints measured in the two generation and repeated dose studies available with ethoxylated alcohols
Results: P1 (second parental generation)
Effect levels (P1)
- Remarks on result:
- other: Weight of evidence document including two generation and repeated dose studies
- Remarks:
- No compound related differences were seen between control and treated rats in any of the endpoints measured in the two generation and repeated dose studies available with ethoxylated alcohols
Results: F1 generation
Effect levels (F1)
- Remarks on result:
- other: Weight of evidence document including two generation and repeated dose studies
- Remarks:
- No compound related differences were seen between control and treated rats in any of the endpoints measured in the two generation and repeated dose studies available with ethoxylated alcohols
Results: F2 generation
Effect levels (F2)
- Remarks on result:
- other: Weight of evidence document including two generation and repeated dose studies
- Remarks:
- No compound related differences were seen between control and treated rats in any of the endpoints measured in the two generation and repeated dose studies available with ethoxylated alcohols
Overall reproductive toxicity
- Reproductive effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Based on the data described above, enough information is available on the behaviour of softanol 30 and alcohol ethoxylates on reproduction and development of rats to justify waiving the performance of a new EOGRTS with softanol 30.
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