Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-536-5 | CAS number: 107-95-9
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Between 23 May 2007 and 27 November 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test procedures in accordance with accepted standard methods, well documented, limitation for developmental effects
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
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:
- other: 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:
- See 7.8.1 Toxicity to reproduction: toxicity to reproduction. 001
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- See 7.8.1 Toxicity to reproduction: toxicity to reproduction. 001
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- yes
- Details on mating procedure:
- See 7.8.1 Toxicity to reproduction: toxicity to reproduction. 001
- Duration of treatment / exposure:
- See 7.8.1 Toxicity to reproduction: toxicity to reproduction. 001
- Frequency of treatment:
- See 7.8.1 Toxicity to reproduction: toxicity to reproduction. 001
- Duration of test:
- Adult male: 42 days
Adult female: maximum 45 days (non pregnant females: animals were sacrificed after day 26 or later after mating)
Pups: 4 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
See 7.8.1 Toxicity to reproduction: toxicity to reproduction. 001
Basis:
- No. of animals per sex per dose:
- See 7.8.1 Toxicity to reproduction: toxicity to reproduction. 001
- Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- See 7.8.1 Toxicity to reproduction: toxicity to reproduction. 001
- Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- Pups examination
- External examinations: Yes: all per litter
- Soft tissue examinations: No
- Skeletal examinations: No
- Head examinations: No - Statistics:
- See 7.8.1 Toxicity to reproduction: toxicity to reproduction. 001
- Indices:
- See 7.8.1 Toxicity to reproduction: toxicity to reproduction. 001
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Effect levels (maternal animals)
- Dose descriptor:
- NOEL
- Effect level:
- 1 000 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental 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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
