Registration Dossier

Administrative data

Endpoint:
eye 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.
Cross-reference
Reason / purpose:
reference to same 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:
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)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

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

Test system

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

Results and discussion

In vivo

Resultsopen allclose all
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.

Applicant's summary and conclusion

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.