Registration Dossier
Registration Dossier
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EC number: 200-811-1 | CAS number: 74-79-3
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:
- 1 984
- 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
- Reference substance name:
- Arginine
- EC Number:
- 200-811-1
- EC Name:
- Arginine
- Cas Number:
- 74-79-3
- Molecular formula:
- C6H14N4O2
- IUPAC Name:
- arginine
Constituent 1
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
Resultsopen allclose all
- 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
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 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
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- 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.
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