Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study. K2 score due to read-across.

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:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals 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.