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

Skin irritation / corrosion

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 1981

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

adopted 1992

GLP compliance:

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:

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

Results

Results 1

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

Results 2

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.