Registration Dossier

Administrative data

Description of key information

L-valine is not be considered to have irritating or corrosive properties to human skin or eye nor to the respiratory system.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
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)
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
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
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
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2005-05-10 to 2005-06-2
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Reason / purpose:
reference to same study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues 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
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.07 g
Duration of treatment / exposure:
1 h.
At one hour after treatment, slight amounts of the test substance were still present in the conjunctival cul-de-sac of the rabbits. These remnants were removed by manipulation of the eye-lids.
Observation period (in vivo):
1 h, 24 h, 48 h, 72 h
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No washing. Remvoval of remnants by manipulation of the eye-lids.
- Time after start of exposure: 1 h
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
All individual animals showed score "0".
Time point:
other: 1 h, 24 h, 48 h, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
All individual animals showed score "0".
Time point:
other: 1 h, 24 h, 48 h, 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
All individual animals showed score "1".
Time point:
other: 1 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 24 h
Score:
0.33
Max. score:
3
Reversibility:
not fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
All individual animals showed score "0".
Time point:
other: 48 h, 72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Remarks:
swelling
Basis:
mean
Remarks:
All individual animals showed score "0".
Time point:
other: 1 h, 24 h, 48 h, 72 h
Score:
0
Max. score:
4
Irritation parameter:
other: Discharge
Basis:
mean
Remarks:
All individual animals showed score "0".
Time point:
other: 1 h, 24 h,. 48 h, 72 h
Score:
0
Max. score:
3
Irritant / corrosive response data:
At 1 h after treatment, slight redness of the conjunctivae was observed in the three rabbits.
At 24 h after treatment, slight redness of the conjunctivae was observed in one of the three rabbits.
At 48 and 72 h after removal, no signs of irritation were observed in any of the three rabbits.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The eye irritant potential of L-valine was assessed by application of the dry product to the eyes of three rabbits in accordance with OECD guideline 405. The product is classified as not-irritating to human eye.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin

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.

  

 Eye

 The eye irritant potential of L-valine was assessed by application of the dry product to the eyes of three rabbits in accordance with OECD guideline 405. The product is classified as not-irritating to human eye.

An in vitro/ex vivo Non-GLP Chicken Enucleated Eye Test did not show significant signs of irritation.

 

 Respiratory System

There are no data available which indicate that L-valine is irritant to the respiratory system.

 

Justification for selection of skin irritation / corrosion endpoint:

Key study.

Justification for selection of eye irritation endpoint:

Key study.

Justification for classification or non-classification

Several studies with L-valine did not show irritating or corrosive properties both to skin and eye.