Registration Dossier
Registration Dossier
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EC number: 939-292-8 | CAS number: -
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:
- March 2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No GLP compliant, the subsatance is salified with ammonium salt instead than sodium
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: REAL DECRETO 363/1995, 10 march
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- similar substance 3
- IUPAC Name:
- similar substance 3
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source:authorized supplier.
- Weight at study initiation:2341-2454g
- Housing:Housing: Stainless steel single cage
- Diet : daily dose of 150 g experimental diet for rabbits, provided by an authorized vendor
- Water :filtered tap water (5 µm) , ad libitum
- Acclimation period:7 days
- Health check: during observation period
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21± 2°C
- Humidity (%):55 ± 25%
- Air changes (per hr):15 air change per hour with filtered air (with 5 µm filter)
- Photoperiod : 12 hour cycle dark/light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied : 0.1 g - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 1,24,48,72 hours and 7,14,21 days
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- SCORING SYSTEM:cornea, iris, conjunctiva, (edema) Chemosis
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- ca. 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- ca. 0.775
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- ca. 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The tested substance is classified not irritant for eyes
- Executive summary:
Direct Brown 44 ammonium salt has been tested for eye irritation with 3 New Zealand white rabbits according to Royal decree 363/1995 . After 72 hours of observation no rabbits show any signs of damage. The substance is classified as non-irritating to the eyes.
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