Registration Dossier
Registration Dossier
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EC number: 938-980-5 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 8th April 1998- 12th April 1998
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Glycine max. (L.) Merr. (Fabacee) aqueous alcoholic ext., concentrate by sequential extractions and filtration
- EC Number:
- 938-980-5
- IUPAC Name:
- Glycine max. (L.) Merr. (Fabacee) aqueous alcoholic ext., concentrate by sequential extractions and filtration
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Name: Soyselect
Batch No.: 26040/1
Physical State: powder
Colour: dark yellow
Storage Conditions: at room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Italia SpA, Calco (Como) Italy
- Age at study initiation: 8 to 10 weeks , nulliparous and non pregnant
- Weight at study initiation: about 1.8 kg
- Housing: in stainless cages suspended over trays and each tray held an absorbent material which was inspected daily and changed as necessary
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 to 21 °c
- Humidity (%): 45 to 65 %
- Photoperiod (hrs dark / hrs light): 24 hrs cycle of 12 hrs light/12 hrs dark
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 100 mg aliquot of the test item
- Observation period (in vivo):
- At 1, 24, 48 and 72 hrs after dosing the animals were observed under standard conditions and the treated eye examined macroscopically for damage or irritation to the cornea, iris an conjunctivae using the untrated eye as a comparator control.
- Number of animals or in vitro replicates:
- 6 animals
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance has little irritant effect in the eye. The response that was observed was readily reversibile and may have arisen from the mechanical action of a solid substance.
Therefore the test item was classified as moderate irritant.
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