Registration Dossier
Registration Dossier
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EC number: 200-798-2 | CAS number: 73-32-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- L-isoleucine
- EC Number:
- 200-798-2
- EC Name:
- L-isoleucine
- Cas Number:
- 73-32-5
- Molecular formula:
- C6H13NO2
- IUPAC Name:
- L-isoleucine
- Test material form:
- solid: crystalline
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Centre Lagro, France
- Age at study initiation: young adult
- Weight at study initiation:2015, 1965 and 1975g
- Housing: individually in stainless steel cages with perforated floor
- Diet: standard laboratory diet, ad libitum
- Water: tap water, ad libitum
- Quarantine/acclimation period: 12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3°C
- Humidity (%): 30-70%. Upper limit once up to 87.9% because of wet cleaning of the animal room
- Air changes (per hr): 10
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g
VEHICLE
- Amount(s) applied: 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 3 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
Three days prior to the start of the study, the hair was removed from the back and flanks of the animals using electric clippers in a way to avoid abrasions. The clipping was repeated if considered necessary. Just prior to application, a skin site suitable for application was selected on the clipped flank of the animal. A plastic cup with a diameter of ca. 2.5 cm was loaded with an amount of 0.5 g of the test substance and moistened with 0.5 mL of water. The loaded cup was fixed to the selected application site by means of semi-occlusive, adhesive tape (Leukopor, BDF, Germany). Subsequently, the entire trunk of the rabbit was wrapped with a self-adhesive-gauze (Fixomull, BDF, Germany) to maintain the cup in position and to retard evaporation of volatile substances. The gauze was additionally fastened with two strips of tape (Leukoflex, BDF, Germany).
REMOVAL OF TEST SUBSTANCE
After a 4-hour exposure period, the cup was removed and the test site was cleaned with a tissue moistened with water. One hour after treatment, the resulting skin reactions were evaluated by the method of Draize et al. Further skin readings were made at approximately 24, 48 and 72 h after treatment.
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: all 3 animals
- Time point:
- other: 1, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable: no effects observed
- Irritation parameter:
- edema score
- Basis:
- animal: all 3 animals
- Time point:
- other: 1, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable: no effects observed
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Conclusions:
- L-isoleucine did not cause any skin effects in rabbits.
- Executive summary:
A sample of L-isoleucine was tested for acute dermal irritating properties in an experiment with 3 albino rabbits, according to EEC Directive 92/69/EEC method B.4 and OECD Guideline 404.
L-isoleucine did not cause any skin effects in rabbits.
According to the EC standards, L-isoleucine is not irritating to (human) skin.
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