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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
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

Constituent 1
Chemical structure
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

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.