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EC number: 203-536-5 | CAS number: 107-95-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Toxicity to reproduction
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:
- 2 007
- 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
- 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
Constituent 1
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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