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Diss Factsheets

Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see remark
Remarks:
Work performed to OECD guidelines in 2009 and approved by the US Environmental Protection Agency Statement in report claiming the data covers range of alklyimines; specifically, "sodium and potassium salts of N-alkyl (C8-C18)-beta-iminodipropionic acid where the C8-C18 is linear and may be saturated and/or unsaturated, (CAS Reg. Nos. 110676-19-2, 3655-00-3, 61791-56-8, 14960-06-6, 26256-79-1, 90170-43-7, 91696-17-2, and 97862-48-1) [Ref 40 CFR Part 180, Federal Register Volume 76, number 24, 4 February 2011'

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developme ntal Toxicity Screening Test)
GLP compliance:
not specified
Remarks:
Claimed GLP but no detail
Limit test:
no

Test material

Constituent 1
Reference substance name:
Disodium N-(2-carboxyethyl)-N-dodecyl-β-alaninate
EC Number:
222-899-0
EC Name:
Disodium N-(2-carboxyethyl)-N-dodecyl-β-alaninate
Cas Number:
3655-00-3
IUPAC Name:
disodium N-(2-carboxyethyl)-N-dodecyl-beta-alaninate
Constituent 2
Reference substance name:
sodium and potassium salts of N-alkyl (C8-C18)-beta-iminodipropionic acid
IUPAC Name:
sodium and potassium salts of N-alkyl (C8-C18)-beta-iminodipropionic acid
Test material form:
semi-solid (amorphous): gel
Remarks:
migrated information: paste
Details on test material:
Batch number 184, state 87% purity
Dose levels were corrected for purity (ie reported figures are for nominal 100% purity)

Test animals

Species:
rat
Strain:
other: other: HanRcc:WIST (SPF)

Administration / exposure

Route of administration:
oral: gavage
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
Dosing began 14 days before mating and continued for 28 days for males and for day four of lactation for females
Frequency of treatment:
Daily
Duration of test:
28 days
Doses / concentrationsopen allclose all
Dose / conc.:
600 mg/kg bw/day (actual dose received)
Dose / conc.:
160 mg/kg bw/day (actual dose received)
Dose / conc.:
43 mg/kg bw/day (actual dose received)
Dose / conc.:
0 mg/kg bw/day (actual dose received)
No. of animals per sex per dose:
10 males and 10 females per group
Control animals:
yes, concurrent no treatment

Examinations

Maternal examinations:
Parental animals: Observations and examinations
Clinical signs daily (including maternal behaviour)
Functional observation battery (FOB)
Food consumption
Body weights
Blood sampling
Body temperature (during FOB)
Litter observations
Litter size and viabilty

Postmortem examinations (parental animals)
Yes
Fetal examinations:
Yes, macroscopic examinations for malformation

Results and discussion

Results: maternal animals

General toxicity (maternal animals)

Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
Taste aversion behaviour
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
Yes, intermediate and high dose
Food consumption and compound intake (if feeding study):
effects observed, treatment-related
Description (incidence and severity):
Yes, intermediate and high dose
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Description (incidence and severity):
Changes in liver in higher dose animals
Gross pathological findings:
effects observed, treatment-related
Description (incidence and severity):
Liver and kidney
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Description (incidence and severity):
Liver and kidney
Other effects:
effects observed, treatment-related
Description (incidence and severity):
Test substance intake: Decrease in top groups pre-mating

Effect levels (maternal animals)

open allclose all
Dose descriptor:
NOEL
Remarks:
male/female
Effect level:
> 43 mg/kg bw/day (nominal)
Based on:
act. ingr.
Basis for effect level:
other: Reduced weight gain, adaptive changes to liver and kidneys
Dose descriptor:
NOAEL
Remarks:
male/female
Effect level:
ca. 160 mg/kg bw/day (nominal)
Based on:
act. ingr.
Basis for effect level:
other: Reduced weight gain, adaptive changes to liver and kidneys
Dose descriptor:
LOAEL
Remarks:
male/female
Effect level:
ca. 600 mg/kg bw/day (nominal)
Based on:
act. ingr.
Basis for effect level:
other: see remark

Maternal abnormalities

Abnormalities:
no effects observed
Description (incidence and severity):
Reported effects were considered to be caused by systemic toxicity and did not affect reproductive performance

Results (fetuses)

Description (incidence and severity):
Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): no effects observed
Reduction in number of live offspring:
no effects observed
Changes in litter size and weights:
no effects observed
External malformations:
not specified
Skeletal malformations:
not specified
Visceral malformations:
not specified
Other effects:
no effects observed
Description (incidence and severity):
No clinical signs observed
Details on embryotoxic / teratogenic effects:
No adverse effects on litter size or viability. No abnormalities reported.

Effect levels (fetuses)

Dose descriptor:
NOAEL
Effect level:
> 600 mg/kg bw/day (nominal)
Based on:
act. ingr.
Sex:
male/female
Basis for effect level:
other: No adverse effects on litter size or viability. No malformations reported.

Fetal abnormalities

Abnormalities:
no effects observed

Overall developmental toxicity

Developmental effects observed:
no

Any other information on results incl. tables

No treatment-related effects on litter size or survival were observed. No treatment-related effects on body weight were observed in offspring. Body weight gain was slightly decreased in males and females at 160 and 600 mg/kg/day, but there was no dose response.

No findings were observed on macroscopic examination of the offspring. The reproductive/ developmental LOAEL for Sodium coco β-iminodipropionate in rats is not established.

The reproductive/developmental NOAEL is 600 mg/kg bw/day, the highest dose tested, in males and females.

Applicant's summary and conclusion

Conclusions:
No treatment-related effects on litter size or survival were observed. No treatment-related effects on body weight were observed in offspring. Body weight gain was slightly decreased in males and fem ales at 160 and 600 mg/kg/day, but there was no dose response.

No findings were observed on macroscopic examination of the offspring. The reproductive/developmental LOAEL for Sodium coco β-iminodipropionate in rats is not established.

The reproductive/developmental NOAEL is 600 mg/kg bw/day, the highest dose tested, in males and females.
Executive summary:

This EPA study is considered valid in terms of grouping of substances. Examination of data on various primary alkylamines show little difference in repeat toxicity effects, including reproduction, suggesting that there is minimal difference in terms of systemic toxicity between the different alklyamines, including

branched and linear.

The comparison of sub-acute toxicity between the tested substance and the result of this EPA study are consistent and read-across is considered valid; the EPA study shows slightly more adverse effects than the Key Study (on the registered substance) over 28 days and is therefore considered a suitable surrogate for the reporting of reproductive effects.