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Diss Factsheets

Administrative data

Description of key information

Skin irritation (in vivo, OECD 404): not irritating

Eye irritation (in vivo, OECD 405): not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1992-12-01 to 1992-12-11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 12 May, 1981
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Comission Directive No. 84/449/EEC
Version / remarks:
adopted 25 April, 1984
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
other: White russian
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: ASTA Medica AG, Halle, Germany
- Age at study initiation: 8 - 12 months
- Weight at study initiation: 2.31 - 2.46 kg
- Housing:individually in stainless steel cages with grating floor
- Diet: standard diet: ssniff K, special diet for rabbits; approx. 120 g/day/animal
- Water: drinking water, ad libitum
- Acclimation period: 1 day under test conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 - 20.5
- Humidity (%): 55 - 70
- Photoperiod: 12/12
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
yes, concurrent vehicle
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g test item glycyl-L-glutamine monohydrate, equivalent to 0.46 g anhydrous glycyl-L-glutamine, moistened with 0.25 mL water

VEHICLE
- Amount(s) applied: 0.25 mL
Duration of treatment / exposure:
4 h
Observation period:
4 days
Reading time points: 1, 24, 48 and 72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: left site of the vertebral column (dorsal skin area between shoulder and sacrum), 6.25 cm2
- Type of wrap if used: The site of application was covered with a patch consisting of two layers: a cellulose fabric coated with natural rubber and a synthetic film glue. A bandage wrapped several times around the trunk provided a complete occlusion.

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

SCORING SYSTEM: Draize scoring system
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: reversibility not applicable
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: reversibility not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: reversibility not applicable
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: reversibility not applicable
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: reversibility not applicable
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: reversibility not applicable
Irritant / corrosive response data:
No local reactions indicative for skin irritation were observed at any time point in any animal.
Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the test, the test item is not irritating to the skin.
CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.


Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1992-12-08 to 1992-12-17
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 24 February, 1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Comission Directive No. 84/449/EEC
Version / remarks:
adopted 25 April, 1984
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
other: White russian (Albino)
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: ASTA Medica AG, Halle, Germany
- Age at study initiation: 8 - 9 months
- Weight at study initiation: 2.54 - 3.02 kg
- Housing: individually in stainless cages with grating floor, type ASTA, size 48.5 x 40 x 36.5 cm
- Diet: approx. 120 g/day / animal standard diet (ssniff K, special diet for rabbits)
- Water: drinking water, ad libitum
- Acclimation period: at least one day under test conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 - 20.5
- Humidity (%): 40 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 39.7 - 44.1 mg test item glycyl-L-glutamine monohydrate, equivalent to 36.5 - 40.6 anhydrous glycyl-L-glutamine (representing a volume of about 0.1 mL)
Duration of treatment / exposure:
Single exposure, no washing
Observation period (in vivo):
Reading time points: 1, 24, 48 and 72 h
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no washing
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: Cliptrix pencil light
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not applicable
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not applicable
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not applicable
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility not applicable
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility not applicable
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility not applicable
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritant / corrosive response data:
During the observation period the only eye lesion observed was a slight discharge (grade 1) detected in one animal at 48 h after application. The effect was fully reversible within 72 h.
Interpretation of results:
GHS criteria not met
Conclusions:
Glycyl-L-glutamine is not irritating to the eye.
CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation/corrosion

To assess the potential of the test material to cause skin irritation/corrosion an acute dermal irritation / corrosion study was performed in accordance with OECD guideline 404 and in compliance with GLP (92-0044-DNT). 0.5 g test item glycyl-L-glutamine monohydrate, equivalent to 0.46 g anhydrous glycyl-L-glutamine, was moistened in water and applied to the dorsal skin of 3 White Russian rabbits between shoulder and sacrum for 4 h under occlusive conditions. The adjacent area of the dorsal skin was treated in the same manner but without test substance (control site). Local skin reactions (erythema and edema) were evaluated according to the Draize scoring system, 1, 24, 48 and 72 h post-application.

There were no local skin reactions at any time point in any animal. The mean scores for the 3 animals over 24/48/72 h was 0 for erythema and oedema, respectively. Based on the results of the present study and under the experimental conditions mentioned, the test item is not considered to be irritating to the skin.

 

Eye irritation/corrosion

The eye irritating potential of the test item was evaluated in an acute eye irritation/corrosion in vivo study according to OECD guideline 405 and in compliance with GLP (92-0045-DNT). Three White Russian rabbits received a single test item dose of 39.7 - 44.1 mg test item glycyl-L-glutamine monohydrate, equivalent to 36.5 - 40.6 anhydrous glycyl-L-glutamine (corresponding to 0.1 mL) instilled into the conjunctival sack of the left or the right eye. The eye was not washed following installation. The other eye remained untreated and served as control.

The local irritation effects on the eyes were scored according to Draize criteria 1, 24, 48 and 72 h post instillation. 

During the observation period, the only eye lesion observed was a slight discharge (grade 1) which was detected in 1/3 rabbits 48 h after test substance instillation. The effect was fully reversible within 72 h. There were no other indication of eye irritation observed. The mean scores for the 3 animals over 24/48/72 h was 0 for all the irritation parameters measured (cornea, iris, conjunctivae and chemosis, respectively).

Based on these results and under the experimental conditions of the present study, the test item is not considered to be irritating to the eye.

Justification for classification or non-classification

The available data on skin and eye irritation do not meet the criteria for classification according to Regulation (EC) No. 1272/2008 (CLP) and are therefore conclusive but not sufficient for classification.

No classification for skin or eye irritation / corrosion is warranted according to the criteria of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations.