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Toxicological information

Acute Toxicity: oral

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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted 1987
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

Constituent 1
Chemical structure
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.