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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984-04-04 to 1984-04-18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guidline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(OECD Guideline for Testing of Chemicals, 1981)
GLP compliance:
no
Remarks:
Study performed prior to implementation of GLP

Test material

Constituent 1
Chemical structure
Reference substance name:
Arginine
EC Number:
200-811-1
EC Name:
Arginine
Cas Number:
74-79-3
Molecular formula:
C6H14N4O2
IUPAC Name:
arginine
Test material form:
not specified

Test animals

Species:
rabbit
Strain:
other: White russian (Albino)
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Asta-Werke AG, Bielefeld, Germany
- Age at study initiation: 4 months
- Weight at study initiation: 2.0 - 2.1 kg
- Housing: Stainless steel cages, model Asta
- Diet (e.g. ad libitum): standardised test animal diet Altromin
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 day

ENVIRONMENTAL CONDITIONS
- according to guideline

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
yes, concurrent no treatment
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): 0.4 ml
- Purity: demineralised water
Duration of treatment / exposure:
4 hours
Observation period:
Observation times: 1 h, 24 h, 48 h and 72 h after removal of the patches. Total observation period:
3 days
Number of animals:
3
Details on study design:
TEST SITE
- % coverage: 100 %
- Type of wrap: The site of application was covered with a linen patch (ca. 6.25 cm²) sticking on a
synthetic adhesive film.
A bandage was wrapped around the trunk (Acrylastic, Nr. 2408, width 8 cm, supplied by P.
Beiersdorf and Co. AG, Hamburg).

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 h

SCORING SYSTEM:
Irritation index (Draize Grade) for
- erythema and eschar
- edema
Primary irritation index

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Remarks:
Score was "0" for all animals at any of the 4 observation times
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Remarks:
Score was "0" for all animals at any of the 4 observation times
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
8
Remarks on result:
no indication of irritation
Remarks:
Score was "0" for all animals at any of the 4 observation times

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
L-Arginine did not show any skin irritating or skin corrosive effects. Systemic toxic effects could not be detected.