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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

Developmental toxicity / teratogenicity

Currently viewing:

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:
2007
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

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:
See 7.8.1 Toxicity to reproduction: toxicity to reproduction. 001

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