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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1994-02-01 to 1994-02-11

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 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted 1981

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye 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 / tissue source

Species:

rabbit

Strain:

other: White russian

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: male: 17 months; females: 16, 17 months
- Weight at study initiation: male: 2.45 kg; females: 2.63 kg and 2.73 kg
- Housing: singly in stainless steel cages with grating floor, type ASTA, size: 48.5x40x36.5 cm (LxBxH)
- Diet (e.g. ad libitum): approx. 120 g/day and animal, ssniff K, Special diet for rabbits supplied by ssniff Spezialdiaten GmbH, 59494 Soest, Germany
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least one day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5-20.0
- Humidity (%): 53-65
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

not specified

Controls:

other: yes, untreated contralateral eyes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (40.6-43.4 mg)

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the eye was not rinsed

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity 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:

iris score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: no alterations detected

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 48 h after application

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal: #1, #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: no alterations detected

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

iris score

Basis:

animal: #1, #2

Time point:

other: on application day

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 48h

Remarks on result:

positive indication of irritation

Remarks:

slight circumcorneal hyperemia

Results 6

Irritation parameter:

chemosis 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:

- Lesions and clinical observations: The iris of animals Nos. 2660 and 2668 reacted with slight circumcorneal hyperemia (grade 1) only at the application day. The conjunctiva of all three animals showed hyperemia (grade 1) one hour after application. The finding had completely disappeared 48 hours after application.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Cornea	Iris	Conjunctivae	Chemosis
	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4
24 h	0/0/0	1/1/0	1/1/1	0/0/0
48 h	0/0/0	0/0/0	0/1/0	0/0/0
72 h	0/0/0	0/0/0	0/0/0	0/0/0
Average 24h, 48h, 72h	0/0/0	0.33/0.33/0	0.33/0.67/0.33	0/0/0
Reversibility*)	c.	c.	c.	c.
Average time (hours) for reversion	0 h	24 h	48 h	0 h

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In the present GLP-guideline compliant study according to OECD guideline 405, the test substance was instilled into the conjunctival sac of the left eye in three rabbits. Both lids were briefly closed by gentle finger pressure. The other eye of each animal was not treated and acted as control. Application of 40.67 - 43.4 mg resulted in a transient circumcorneal and conjuctival hyperemia. These effects were fully reversible within 48 hours. Thus, the test item is not considered for classification and labeling.