Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
(2S)-5-amino-2-[(aminoacetyl)amino]-5-oxopentanoic acid
EC Number:
700-144-0
Cas Number:
13115-71-4
Molecular formula:
C7H13N3O4
IUPAC Name:
(2S)-5-amino-2-[(aminoacetyl)amino]-5-oxopentanoic acid

Test animals

Species:
rabbit
Strain:
other: White russian
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: ASTA Medica AG
- 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 hrs dark / 12 hrs light

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g moistened with 0.25 ml water

VEHICLE
- Amount(s) applied: 0.25 ml
Duration of treatment / exposure:
4 hours
Observation period:
3 days after application
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: dorsal skin between shoulder and sacrum

REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 4 hours

SCORING SYSTEM:
The evaluation of the cutaneous irritation effect at observation times 1, 24, 48 and 72 hours post application was expressed by an irritation index.
The arithmetical mean values of the individual grades obtained from the skin areas at observation times 1, 24, 48 and 72 hours were calculated - separately for erythema- /eschar and edema formation. The irritation index is represented by the sum of these two mean values.
A corresponding gradation was allocated to this index by the following scheme:

Index Ranges Gradation
0.0 - 0.5 non-irritant
0.6 - 3.0 slightly irritant
3.1 - 5.0 moderatly irritant
5.1 - 8.0 severely irritant

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: average of 24h, 48h, 72h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: average of 24h, 48h, 72h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: average of 24h, 48h, 72h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: average of 24h, 48h, 72h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: average of 24h, 48h, 72h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: average of 24h, 48h, 72h
Score:
0
Max. score:
4

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

Erythema

Edema

Max. score: 4

Max. score: 2

60 min

 

0/0/0

 

0/0/0

24 h

  

0/0/0

 

0/0/0

 

48 h

 

0/0/0

 

 

0/0/0

 

72 h

  

0/0/0

  

0/0/0

Average 24h, 48h, 72h

  

0/0/0

 

0/0/0

 

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Glycyl-L-glutamine is not irritating to the skin.