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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

screening for reproductive / developmental toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because a pre-natal developmental toxicity study is available
Justification for type of information:
In view of the asence of effects to reproductive organs in a 90 day study on this substance and in view of the absence of effects in development studies, further animal work cannot be justifed.
The data refers to the non-pposphated form of the substance that is conisdered to be a metabolite of the substance to be registered
Reason / purpose for cross-reference:
data waiving: supporting information
developmental toxicity
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
Administration on gestation days 5 - 19 (14 day period)
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Information taken from US EPA review of surrogate substance
Considered reliable by EPA, although primary source not known.
equivalent or similar to guideline
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Principles of method if other than guideline:
Administration by gavage on days 5 - 19 of gestation in rats
GLP compliance:
not specified
Limit test:
Specific details on test material used for the study:
The test material is a betaine formed by hydrolysis of the phosphate ester
A justification for read-across is attached.
Route of administration:
oral: gavage
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
Treatment from day 5 - day 19 of gestation
Frequency of treatment:
Dose / conc.:
0 mg/kg bw/day (nominal)
Dose / conc.:
95 mg/kg bw/day (nominal)
Dose / conc.:
286 mg/kg bw/day (nominal)
Dose / conc.:
950 mg/kg bw/day (nominal)
No. of animals per sex per dose:
21 females
Control animals:
yes, concurrent vehicle
Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
At top dose level, one animal died and others showed reduced body weights and damage to GI tract.
mortality observed, treatment-related
Description (incidence):
One death in top group; assumed treatment related
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
Reduced body weight top dose
Total litter losses by resorption:
effects observed, treatment-related
Description (incidence and severity):
Resoprtions seen at highest dose levels
Dose descriptor:
Effect level:
95 mg/kg bw/day (nominal)
Based on:
test mat.
Basis for effect level:
body weight and weight gain
clinical signs
Dose descriptor:
Effect level:
286 mg/kg bw/day (nominal)
Based on:
test mat.
Basis for effect level:
reduction in number of live offspring
Developmental effects observed:

The reduced litter sizes due to resorptions considered to be related to maternal toxicity effects

The betaine was tested at up to tolerated treatment levels with reduction in live pups directly related to maternal toxicity.
There were no developmental effects.
Although there is little detail in the reivew document, the EPA considered the data valid in their assessment that there is no apparent developmental toxicity.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion