Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
screening for reproductive / developmental toxicity
Remarks:
based on test type (migrated information)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Between 23 May 2007 and 27 November 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study (OECD TG421)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
β-alanine
EC Number:
203-536-5
EC Name:
β-alanine
Cas Number:
107-95-9
Molecular formula:
C3H7NO2
IUPAC Name:
β-alanine
Details on test material:
- Physical state: white crystalline solid
- Supplier: Yuki Gosei Kogyo Co. Ltd.
- Lot No.: 075008
- Purity: 99.8%
- Impurities (identity and concentrations): ammonia (%): <0.1, Chloride (%): <0.02, Sulfates (%): <0.05, Residue on ignition (%): 0.02

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: (P) x 8 wks
- Weight at study initiation: (P) Males: 283 - 361 g; Females: 169 - 219 g

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2 ℃
- Humidity (%): 55 ± 15 %
- Air changes (per hr): 15 air changes/hr
- Photoperiod (hrs dark / hrs light): 12 hrs dark /12 hrs light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on mating procedure:
- M/F ratio per cage: 1:1
- Length of cohabitation: 14 days (maximum)
- Proof of pregnancy: vaginal plug or sperm in vaginal smear referred to as day 0 of pregnancy
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
(P) Male: 42 days (from 14 days before mating to the day before sacrifice through the mating period)
(P) Female: 42 - 45 days (from 14 days before mating to 4 days after delivery through the mating and gestation periods)
Frequency of treatment:
once per day
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 40, 200, 1000 mg/kg/day
Basis:
actual ingested
No. of animals per sex per dose:
10 animals/sex/dose
Control animals:
yes, concurrent vehicle

Examinations

Parental animals: Observations and examinations:
CAGE SIDE OBSERVATIONS: Yes
DETAILED CLINICAL OBSERVATIONS: No
BODY WEIGHT: Yes
Oestrous cyclicity (parental animals):
No
Sperm parameters (parental animals):
Parameters examined in P male parental generations:
testis weight, epididymis weight
Litter observations:
STANDARDISATION OF LITTERS
- Performed on day 4 postpartum: No

PARAMETERS EXAMINED
The following parameters were examined in F1 offspring:
number of pups, sex ratio, live births index, viability index, clinical condition, body weights, surface righting reflex

GROSS EXAMINATION OF DEAD PUPS: Yes
Postmortem examinations (parental animals):
SACRIFICE
- Male animals: All surviving animals
- Maternal animals: All surviving animals

GROSS NECROPSY: Yes

HISTOPATHOLOGY: Yes (control and 1000 mg/kg/day groups)
- Histopathological examined organ:
Coagulating gland, Epididymides, Ovaries, Pituitary, Prostate, Seminal vesicles, Testes, Uterus/Cerivix, Vagina

ORGAN WEIGHTS: Yes (All groups of the male)
- Weighted organ:
Epididymides, Testes
Postmortem examinations (offspring):
SACRIFICE
- The F1 offspring were sacrificed on PND 5.
- These animals were subjected to macroscopic examination as follows:

GROSS NECROPSY: Yes
- Gross necropsy consisted of external and internal examinations.

HISTOPATHOLOGY / ORGAN WEIGTHS: No
Statistics:
Statistical analyses were conducted by Levene's test, one-way ANOVA, Dunnett’s test, Kruskal-Wallis ANOVA ,and Mann-Whitney U-test
Reproductive indices:
- Pre-coital interval (days)
- Mating index (%) = (Number of animals mated/number of animals paired) x 100
- Pregnancy index (%) = (Number of pregnant females/ Number of animals mated) x 100
- Gestation length
- Parturition index(%)= (Number of females delivering live offspring/ number of pregnant females) x 100
- % pre-implantation loss = (Number of corpora lutea - number of implantation sites/ number of corpora lutea) x 100
- % post - implantation loss = (Number of implantation sites - total number of offspring born/number of implantation sites) x 100
- Live birth index(%) = (Number of offspring alive on day 1/number of offspring born) x 100
- Sex ratio = (Number of male offspring/number of offspring of determined sex) x 100
Offspring viability indices:
Viability index (%) = (Number of offspring alive on day 4/number of offspring alive on day 1) x 100

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:
no effects observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Organ weight findings including organ / body weight ratios:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed

Reproductive function / performance (P0)

Reproductive function: oestrous cycle:
not examined
Reproductive function: sperm measures:
not examined
Reproductive performance:
no effects observed

Effect levels (P0)

Dose descriptor:
NOEL
Effect level:
1 000 mg/kg bw/day
Sex:
male/female
Basis for effect level:
other: The oral administration of beta-alanine to rats for a period of up to forty-five days at dose levels of up to 1000 mg/kg/day did not show any treatment-related effects at any dose level.

Results: F1 generation

General toxicity (F1)

Clinical signs:
no effects observed
Mortality / viability:
no mortality observed
Body weight and weight changes:
no effects observed
Sexual maturation:
not examined
Organ weight findings including organ / body weight ratios:
not examined
Gross pathological findings:
no effects observed
Histopathological findings:
not examined

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion