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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1993-10-26 to 1993-11-05
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 1981
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
adopted 1992
GLP compliance:
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:
rabbit
Strain:
other: White russian
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: male: 12 months; females: 16, 17 months
- Weight at study initiation: male: 2.42 kg; females: 2.99 kg, 3.19 kg
- Housing: singly; Stainless steel cages with grating floor, type ASTA, size: 48.5x40x36.5 cm (LxBxH)
- Diet (e.g. ad libitum): approx. 120 g/day; ssniff K, special diet for rabbits supplied by ssniff Spezialdiaten GmbH, D-59494 Soest
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least one day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.0-20.5
- Humidity (%): 52-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
other: test substance moistened with 0.5 mL demineralized water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g


VEHICLE
- Amount(s) applied (volume or weight with unit): moistened with 0.5 mL demineralized water
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6.25 cm²
- Type of wrap if used: a patch consisting of the following layers: 1. cellulose fabric coated with natural rubber 2. synthetic film glue. A bandage wrapped several times around the trunk (Acrylastic, No. 2408, width 8 cm; supplied by P. Beiersdorf and Co.AG, D-20245 Hamburg) provided a complete occlusion.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the end of the exposure time remaining test material was gently washed off as far as possible.
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 0, 24, 48, 72 hours

SCORING SYSTEM:
- Method of calculation: Scoring system by Draize et al.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no alterations detected
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no alterations detected
Remarks on result:
no indication of irritation
Other effects:
In animal No. 2641 a very slight erythema (grade 1) was recorded only one hour after the end of exposure.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In the present study according to OECD guideline 404 and GLP compliant 0.5 g N-glycyl-L-tyrosine dihydrate was applied to the intact dorsal skin of rabbits (White Russian Strain) for four hours under occlusive conditions. After the exposure time the test substance was gently washed of the skin as far as possible. A very slight erthema was reported for one animal one hour after exposure which was fully reversible within the first 24 hours after exposure. Thus, N-glycyl-L-tyrosine dihydrate is considered to be non-irritating.

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