Reaction mass of glycyl-L-glutamine and potassium chloride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study was conducted with a supporting substance, but according to the OECD guideline 404 and is fully GLP-compliant. As no study for the reaction mass of Glycyl-L-glutamine and potassium chloride is available, studies conducted with the two main components L-glycyl-L-glutamine and potassium chloride (such as this) were used for read-across in order to avoid unnecessary repitition of testing. As no synergistic or antagonistic effects from either of the main components are expected, the information derived from both main components is considered to be reliable for classification of the reation mass of Glycyl-L-glutamine and potassium chloride.

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

Test material information

Constituent 1

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

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

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: EU

Conclusions:

Glycyl-L-glutamine is not irritating to the skin.

Executive summary:

At none of the observation time points after treatment with Glycyl-L-glutamine either edema nor erythema were evident. Therefore Glycyl-L-glutamine is not classified regarding skin irritation.