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Toxicological information

Eye irritation

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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 1981
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye 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 / 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

Resultsopen allclose all
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
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
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 48 h after application
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
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
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.

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