Registration Dossier
Registration Dossier
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EC number: 200-773-6 | CAS number: 72-18-4
Eye irritation
Administrative data
- 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
Cross-reference
- Reason / purpose for cross-reference:
- reference to same 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 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye 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 / 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.
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