Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2022 (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:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
GLP compliance:
yes

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 test animals or test system and environmental conditions:
Details will be added as soon as available.

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: to be determined
Details on exposure:
Details will be added as soon as available.
Analytical verification of doses or concentrations:
yes
Details on analytical verification of doses or concentrations:
Details will be added as soon as available.

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Dose descriptor:
other: to be determined
Remarks on result:
other: to be determined

Results (fetuses)

Effect levels (fetuses)

Dose descriptor:
other: to be determined
Remarks on result:
other: to be determined

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
to be determined