Reaction mass of glycyl-L-tyrosine hydrochloride and potassium chloride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1994-01-26 to 1994-04-05

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted 1987

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

adopted 1992

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-glycyl-L-tyrosine

EC Number:

211-525-1

EC Name:

N-glycyl-L-tyrosine

Cas Number:

658-79-7

Molecular formula:

C11H14N2O4

IUPAC Name:

glycyl-L-tyrosine

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Hsd/Win:WU

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: males: 8 weeks; females: 9 weeks
- Weight at study initiation: males: 182-208 g; females: 149-169 g
- Fasting period before study: approx. 16 hrs before treatment
- Housing: individually in Macrolon cages, type II
- Diet (e.g. ad libitum): ad libitum, ssniff R, Special diet for rats (ssniff Spezialdiäten GmbH, 59494 Soest, Germany)
- Water (e.g. ad libitum): ad libitum, in drinking water quality from the Stadtwerke Halle, using an automatic drinking water system with drinking nipplesor drinking bottles
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5-22.0
- Humidity (%): 43-67
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

0.5 % Tylose® (Tylopur® C 1000 P, batch E 084 4357 and E 114 30100

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 100 and 215 mg/mL
- Amount of vehicle (if gavage): 10.0 mL/kg bw
- Lot/batch no. (if required): batch E 084 4357 and E 114 30100

MAXIMUM DOSE VOLUME APPLIED: 10.0 mL/kg bw

DOSAGE PREPARATION (if unusual):The test substance was suspended in the vehicle immediately before dosing using a homogenizer (Ultraturrax, supplied by Janke & Kunkel, lKA-Werk, D-79219 Staufen) and an ultrasonic bath (Bandelin Sonorex RK 510 H, supplied by Bandelin Electronic, Berlin).

Doses:

1000 and 2150 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: on day 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, mortality

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

act. ingr.

Mortality:

not observed

Clinical signs:

not observed

Body weight:

no changes in body weight gain

Gross pathology:

At necropsy no macroscopical alterations were detected.

Any other information on results incl. tables

Table 2: Number of animals dead and with evident toxicity 

Dose (mg/kg bw)	Mortality (# dead/total)			Number with evident toxicity(#/total)
	Male	Female	Combined	Male	Female	Combined
1000	0/5	0/5	0/10	0/5	0/5	0/10
2150	0/5	0/5	0/10	0/5	0/5	0/10

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In this GLP study according to OECD guideline 401, N-glycyl-L-tyrosine dihydrate was administered by gavage to male and female Wistar rats at doses of 1000 and 2150 mg/kg bw. The animals were observed for 14 days after the single administration of the substance. No premature deaths occurred, no clinical signs of toxicity and at necropsy no macroscopical alterations were detected. Thus, the LD50 of N-glycyl-L-tyrosine dihydrate is considered to be > 2150 mg/kg bw corresponding to 2000 mg/kg bw N-glycyl-L-tyrosine.