β-alanine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Between 14, July 1993 and 18, October 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP-Guideline study [the Good Laboratory Practice (GLP) standard (the Ministry of Health and Welfare of Japan, Yakuhatsu No. 313 enforced on March 31, 1982); the Guidelines for Toxicity Studies of Drugs (the Ministry of Health and Welfare of Japan, Yakuhin 1 No. 24 enforced on September 11, 1989)].

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: the Guidelines for Toxicity Studies of Drugs (Japan)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

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 crystal powder
Analytical purity: 99.9%
Impurities (identity and concentrations): No data
Composition of test material, percentage of components: No data
Isomers composition: No data
Manufacture, supplier, source of supply : Yuki Gosei Kogyo Co., Ltd.
Lot/batch No.: 404676

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: at 7 weeks of age
- Weight at study initiation: male: 212-224 g, female: 153-168 g

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-24 °C
- Humidity (%): 53-66 %
- Air changes (per hr): ventilated (all fresh air system) 10 times more per hour
- Photoperiod (hrs dark / hrs light): a 12-hour light-dark cycle (light on 7:00-19:00)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

-Manufacture, supplier, source of supply : Yuki Gosei Kogyo Co., Ltd.
- Lot/batch No.: 404676

Doses:

0, 5000 mg/kg

No. of animals per sex per dose:

6 animals/sex/dose

Control animals:

yes

Details on study design:

Duration of observation period following administration: 14 days

Frequency of observations and weighing:
Clinical observation : 0 to 30 minutes, 1, 3 and 6 hours after dosing. On day 2, all rats were observed twice daily. During Day 3 to Day 15, all rats were observed once daily.
Morbidity and mortality : 0, 30 minutes, 1, 3, 6 hours after dosing. During the Day 2 to Day 15, the mortality was observed twice daily.
Bodyweight : Day 1 (before dosing), Day 8 and Day 15.

Necropsy of survivors performed: yes

Other examinations performed: no

Statistics:

Body weigth : Scheffe's multiple comparison procedure, Clinical sign : Fischer's exact test

Results and discussion

Preliminary study:

In the preliminary test, no mortality was occurred at 5000 mg/kg, which was the maximum dose level could be administered. Therefore, 5000 mg/kg was determined as the dosage level.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No male or female rats in any groups died throughout the observation period.

Clinical signs:

No male or female rats with abnormal findings were observed in the control group throughout the observation period.
In the 5000 mg/kg group, decrease in voluntary movement was observed in 4 male and 6 female rats for the first 0 to 30 minutes after dosing, and the incidences of the finding in male and female rats of the 5000 mg/kg group were significantly higher than those in the control group. In the 5000 mg/kg group, diarrhea was observed in male rat for the first 0 to 30 minutes after dosing, 2 male rats at 3 hours and 3 male and 3 female rats at 6 hours after dosing.

Body weight:

The body weights in male and female rats of the 5000 mg/kg group were not siginificantly different from those in the control group throughout the observation period.

Gross pathology:

No abnormal gross findings were observed in any male or female rats of the control and 5000 mg/kg group.

Other findings:

Organ weights: No data
Histopathology: No data
Potential target organs: No data
Other observations: No data

Any other information on results incl. tables

Table 1. Clinical signs (5,000 mg/kg group)

		0 to 30 min	3 hr	6 hr
male	decrease in voluntary movement	4/6	0	0
	diarrhea	1/6	2/6	3/6
female	decrease in voluntary movement	6/6	0	0
	diarrhea	0	0	3/6

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information