Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 701-196-7 | CAS number: -
Toxicity to reproduction
Administrative data
- Endpoint:
- extended one-generation reproductive toxicity - with F2 generation and developmental neurotoxicity (Cohorts 1A, 1B with extension, 2A and 2B)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- pending (please refer to attached justification)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- study ongoing
- Justification for type of information:
- In the Final Decision on a Testing Proposal dated 10 December 2018, ECHA requested to submit a Pre-natal developmental toxicity study (Annex IX, Section 8.7.2.; test method: OECD TG 414) in a first species (rat or rabbit) via oral route and an Extended one-generation reproductive toxicity study (Annex IX, Section 8.7.3.; test method: OECD TG 443) in rats via oral route with the registered substance by 17 June 2021. However, due to several reasons as lined out in the letter from the performing laboratory, the experimental phase of these studies has been delayed.
Please refer to the attached documents for further details regarding the request of the ECHA Final Decision.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 443, including DNT cohort
- GLP compliance:
- yes
- Justification for study design:
- SPECIFICATION OF STUDY DESIGN FOR EXTENDED ONE-GENERATION REPRODUCTION TOXICITY STUDY WITH JUSTIFICATIONS (further details to be added, please also refer to attached justification above):
- Premating exposure duration for parental (P0) animals: at least 2 wks premating according to ECHA FD
- Basis for dose level selection: available information from toxicity studies and a dose range finding study
- Inclusion of extension of Cohort 1B
- Termination time for F2: week 14 of age
- Inclusion of developmental neurotoxicity Cohorts 2A and 2B
- Exclusion of developmental immunotoxicity Cohort 3
- Route of administration: oral
- Other considerations, e.g. on choice of species, strain, vehicle and number of animals: Wistar Han rats, further details to be added, please also refer to attached justification above
Test material
- Reference substance name:
- Reaction products of pentaerythritol, propoxylated and 1-chloro-2,3-epoxypropane with hydrogen sulfide
- EC Number:
- 701-196-7
- Cas Number:
- 72244-98-5
- Molecular formula:
- not applicable
- IUPAC Name:
- Reaction products of pentaerythritol, propoxylated and 1-chloro-2,3-epoxypropane with hydrogen sulfide
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on species / strain selection:
- Details will be added as soon as available.
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: to be determined
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Details will be added as soon as available.
- Details on study schedule:
- Details will be added as soon as available.
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
- Dose descriptor:
- other: to be determined
- Remarks on result:
- other: to be determined
Results: P1 (second parental generation)
Effect levels (P1)
- Dose descriptor:
- other: to be determined
- Remarks on result:
- other: to be determined
Results: F1 generation
Effect levels (F1)
- Dose descriptor:
- other: to be determined
- Remarks on result:
- other: to be determined
Results: F2 generation
Effect levels (F2)
- Dose descriptor:
- other: to be determined
- Remarks on result:
- other: to be determined
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- to be determined
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
