Registration Dossier

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.
We sincerely apologise for any circumstances this may cause.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2022

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

Constituent 1
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

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