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Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
Administration on gestation days 5 - 19 (14 day period)
Reliability:
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.

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2010

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
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:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts
EC Number:
263-058-8
EC Name:
1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts
Cas Number:
61789-40-0
Molecular formula:
C19H38N2O3
IUPAC Name:
{[3-(Dodecanoylamino)propyl](dimethyl)ammonio}acetate
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.

Test animals

Species:
rat
Strain:
CD-1

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
Treatment from day 5 - day 19 of gestation
Frequency of treatment:
Daily
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day (nominal)
Remarks:
Control
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

Results and discussion

Results: maternal animals

General toxicity (maternal animals)

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:
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

Maternal developmental toxicity

Total litter losses by resorption:
effects observed, treatment-related
Description (incidence and severity):
Resoprtions seen at highest dose levels

Effect levels (maternal animals)

Dose descriptor:
NOAEL
Effect level:
95 mg/kg bw/day (nominal)
Based on:
test mat.
Basis for effect level:
body weight and weight gain
clinical signs

Results (fetuses)

Effect levels (fetuses)

Dose descriptor:
NOAEL
Effect level:
286 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
reduction in number of live offspring

Overall developmental toxicity

Developmental effects observed:
no

Any other information on results incl. tables

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

Applicant's summary and conclusion

Conclusions:
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.