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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
Deviations:
not specified
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Reference substance name:
β-Alanine, N-(2-carboxyethyl)-, N-coco alkyl derivs., disodium salts
EC Number:
290-476-8
EC Name:
β-Alanine, N-(2-carboxyethyl)-, N-coco alkyl derivs., disodium salts
IUPAC Name:
290-476-8
Specific details on test material used for the study:
87 % pure. Dose levels were corrected for purity (ie reported figures are for nominal 100% purity).

Test animals

Species:
rat
Strain:
other: HanRcc WIST
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
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
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day (actual dose received)
Dose / conc.:
43 mg/kg bw/day (actual dose received)
Dose / conc.:
160 mg/kg bw/day (actual dose received)
Dose / conc.:
600 mg/kg bw/day (actual dose received)
No. of animals per sex per dose:
10 males and 10 females
Control animals:
not specified

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)

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
Reduced weight gain.
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Description (incidence and severity):
Adaptive changes to liver and kidneys.

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
43 mg/kg bw/day (actual dose received)
Based on:
act. ingr.
Sex:
male/female
Basis for effect level:
other: effects reported
Remarks on result:
other: 160 mg/kg bw/day used for calculation of DNELs as effects considered to be adaptive

Target system / organ toxicity (P0)

Critical effects observed:
not specified

Results: F1 generation

Details on results (F1)

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.

Effect levels (F1)

Dose descriptor:
NOAEL
Generation:
F1
Effect level:
600 mg/kg bw/day (nominal)
Based on:
act. ingr.
Remarks:
highest maternal dose
Sex:
male/female
Basis for effect level:
other: no adverse effects at highest maternal dose

Target system / organ toxicity (F1)

Critical effects observed:
no

Overall reproductive toxicity

Reproductive effects observed:
no

Applicant's summary and conclusion

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

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.