Registration Dossier
Registration Dossier
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EC number: 279-408-8 | CAS number: 80157-00-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From December 21, 1993 to February 02 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Remarks:
- The test was conducted by means of Read Across approach. The reliability of the source study report is 2. Further information was attached at section 13
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Similar Substance 01 - RY145
- IUPAC Name:
- Similar Substance 01 - RY145
- Test material form:
- solid
- Details on test material:
- - Similar substance 01: Reactive Red 195
- EC: 278-674-2
- CAS77365-64-1
- Internal batch: 761/93 (Sample about 750 g)
Content of dye: 67,5 %
Content of sodium sulphate: 32,0%
Rest: < 0,5%
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Supplier: Velaz Praha
- Weight: 205-200 g (prior the application)
- Helth status: quality certification, checked frormparasite and patogen microrganisms, viruses and fungi
- Housing: plastic cages in polypropilene T3( Velaz Praha), ventilated and bedding with pure light wood shavings
- Selection: 6 animals pro cage by gender
- Identification: by number on cages and on tail
- Diet: Altromin 1320 (Velaz Praha), daily dose of 20 g
- Water: ad libitum, according to SN 757111
- Cleaning: disinfection of cages
- Acclimatization: quarantine
- Acclimatization period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature : 22 ± 3 °C
- Humidity: 50 ± 15 %
- Photoperiod (hrs dark / hrs light): 12/12
Controlling of temperature and humidity automatic
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 0.1 g
- Observation period (in vivo):
- 1 hour, 24, 48, 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- DOSAGE PREPARATION
By Mettler AE 200
TEST SITE
Conjuntival sac
APPLICATION
Upper and lower eyelids, held for several seconds to prevent the loss of the substance
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Non irritating to the eye
- Executive summary:
Method
The substance was tested for irritation to the eye in rabbit, White New Zealand strain, according to OECD 405.
0.1 grams of the substance were applied to one eye and reactions (louding of the cornea surface, iris, conjunctival hyperemia, swelling) were observed for 72 hours.
Clinical signs were also observed and primary irritation score and the degree of ocular irritation were evaluated.
Conclusion
After 72 hours of observation the registering substance was considered non irritant to the eye.
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