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Toxicological information

Skin irritation / corrosion

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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
Study period:
1990-03-28 to 1990-04-10
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study, used for read-across

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: White russian (Albino)
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: ASTA Pharma AG, Bielefeld, Germany
- Age at study initiation: 9 - 10 months
- Weight at study initiation: 2.30 - 2.54 kg
- Caging: Stainless steel cages with grating floor, type ASTA
- Diet (e.g. ad libitum): ca,. 120 g /day per animal Standard Diet ssniff K, "Special diet for rabbits", supplied by ssniff Spezialfutter GmbH
- Water (e.g. ad libitum): ad libitum
- Acclimation period: one day acclimatisation period before study begin

ENVIRONMENTAL CONDITIONS
- according to guideline



Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Remarks:
0.5 g of the test substance were moistened with 1.6 ml of demineralized water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): 1.6 ml
- Purity: demineralized water
Duration of treatment / exposure:
4 h (occlusive patch)
Observation period:
3 d (p. appl.)
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: ca. 6.25 cm²
- % coverage: entire area of exposure
- Type of wrap (if used): The site of application was covered with a linen cloth which adhered to a synthetic film glue. A bandage (width 8 cm) wrapped several times around the trunk of the animal provided a complete occlusion.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Remaining Test material was gently washed off as far as posssible.
- Time after start of exposure: 4 h

SCORING SYSTEM:
Irritation index (Draize grade) for
- erythema and eschar
- edema
Primary irritation index modified according to Gilman et al, 1983

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
(All individual animals showed score "0".)
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
(All individual animals showed score "0".)
Time point:
other: 24 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
(All individual animals showed score "0".)
Time point:
other: 48 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
(All individual animals showed score "0".)
Time point:
other: 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
(All individual animals showed score "0".)
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
(All individual animals showed score "0".)
Time point:
other: 24 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
(All individual animals showed score "0".)
Time point:
other: 48 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
(All individual animals showed score "0".)
Time point:
other: 72 h
Score:
0
Max. score:
4
Irritation parameter:
primary dermal irritation index (PDII)
Remarks:
modified according to Gilman et al, 1983
Basis:
mean
Remarks:
(Mean value from 12 individual values of 3 animals at 4 observation times.)
Time point:
other: 1 - 72 h
Score:
0
Max. score:
8
Other effects:
Systemic toxic effects did not occur after dermal application of the test substance

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
L-Alanyl-L-glutamine was tested on rabbits for skin irritation / skin corrosion properties. The primary irritation index was 0.0. The substance was non-irritant to rabbit skin following a single four-hour application.