Registration Dossier
Registration Dossier
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EC number: 205-702-2 | CAS number: 147-85-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- 2009 - 2010
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Secondary literature
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) and EFSA Panel on Genetically Modified Organisms (GMO); Scientific opinion on the safety and efficacy of L-isoleucine for all animal species.
- Author:
- European Food Safety Authority (efsa)
- Year:
- 2 010
- Bibliographic source:
- EFSA Journal 2010; 8(1):1425. [19 pp.]. doi:10.2903/j.efsa.2010.1425. Available online: www.efsa.europa.eu
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- not specified
Test material
- Reference substance name:
- L-isoleucine
- EC Number:
- 200-798-2
- EC Name:
- L-isoleucine
- Cas Number:
- 73-32-5
- Molecular formula:
- C6H13NO2
- IUPAC Name:
- L-isoleucine
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
Test system
- Vehicle:
- not specified
- Controls:
- not required
- Observation period (in vivo):
- 48 h
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Results
- Irritation parameter:
- other: no details provided
- Irritant / corrosive response data:
- There were slight effects immediately after treatment which had resolved fully by 48 h.
Any other information on results incl. tables
There were slight effects immediately after treatment which had resolved fully by 48 h.
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-isoleucine was assessed by application of the product to the eyes of three rabbits in accord with OECD guideline 405. The product is classified as not-irritating to human eyes.
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