Arginine

Skin irritation / corrosion

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: Guideline Study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

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

Test material information

Constituent 1

Reference substance name:

Arginine

EC Number:

200-811-1

EC Name:

Arginine

Cas Number:

74-79-3

Molecular formula:

C6H14N4O2

IUPAC Name:

arginine

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

Remarks:

500 mg of test substance were moistened with 0.4 ml Aqua demin

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

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: Score was "0" for all animals at any of the 4 observation times

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: Score was "0" for all animals at any of the 4 observation times

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 7

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 72 h

Score:

0

Max. score:

8

Remarks on result:

other: 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.