Registration Dossier
Registration Dossier
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EC number: 200-773-6 | CAS number: 72-18-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005-05-10 to 2005-06-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP 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-valine
- EC Number:
- 200-773-6
- EC Name:
- L-valine
- Cas Number:
- 72-18-4
- Molecular formula:
- C5H11NO2
- IUPAC Name:
- L-valine
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Centro Lagro, France
- Age at study initiation: young adults
- Weight at study initiation: 1855 g, 1870 g, 1990 g
- Housing: individually in stainless steel cages with perforated floor
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- acclimatisation period: 12 days
ENVIRONMENTAL CONDITIONS
according to guideline
IN-LIFE DATES: From: 2005-05-23 To: no data
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: electric clipper
- Vehicle:
- water
- Controls:
- no
- 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): 0.5 ml - Duration of treatment / exposure:
- 4 h
- Observation period:
- 5 h, 24 h, 48 h, 72 h after treatment
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: ca. 19.6 cm² (moistened test substance beneath a plastic cup of 2.5 cm diameter)
- % coverage: entire area of exposure
- Type of wrap if used: 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
- Washing (if done): yes
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- All individual animals showed score "0".
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- All individual animals showed score "0".
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- All individual animals showed score "0".
- Time point:
- other: 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- All individual animals showed score "0".
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- All individual animals showed score "0".
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- All individual animals showed score "0".
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- All individual animals showed score "0".
- Time point:
- other: 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- All individual animals showed score "0".
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 4
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The dermal irritant potential of L-valine was assessed by application of the moistened product to the skin of three rabbits in accordance with OECD guideline 404. No signs of irritation were seen at any point after application, thus the product is classified as not-irritating to human skin.
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