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EC number: 419-480-1 | CAS number: -
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 January 1995 to 24 January 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to recent EU and OECD test guidance. GLP is assumed, given the references and QA procedures, although is not specifically mentioned.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
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
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- GLP is assumed, given the references and QA procedures, although is not specifically mentioned.
Test material
- Reference substance name:
- -
- EC Number:
- 419-480-1
- EC Name:
- -
- IUPAC Name:
- Reaction mass of tetrasodium 2-((1-(3-(6-fluoro-(4-((N-(2-(2-sulfatoethanesulfonyl)ethyl)-N-phenyl)amino)-1,3,5-triazin-2-ylamino)-2-hydroxy-5-sulfonatophenylazo)-1-phenylmethyl)azo)-4-sulfonatobenzoate cuprate (4-) and trisodium 2-((1-(3-((4-(N-(2-ethenesulfonylethyl)-N-phenyl)amino)-6-fluoro-1,3,5-triazin-2-ylamino)-2-hydroxy-5-sulfonatophenylazo)-1-phenylmethyl)azo)-4-sulfonatobenzoate cuprate (4-)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Reactive Blue FC 75311
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Interfauna UK Ltd
- Age at study initiation: Adult
- Weight at study initiation: Average weight 3.8 kg
- Housing: Individually in stainless steel cages
- Diet (e.g. ad libitum): Standard diet, approx 100-120g per animal/day; once per day in the morning
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50 - 70
- Air changes (per hr): 12 -15 times per hour
- Photoperiod (hrs dark / hrs light): 12 hours, artifical illumination from 6am to 6pm
Test system
- Vehicle:
- not specified
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): approx 67mg (equivalent to 100 ul test substance) - Duration of treatment / exposure:
- 24 hours exposure
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- three
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Normal saline
- Time after start of exposure: 24 hoours
SCORING SYSTEM: DRAIZE
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: overall at 24, 48 72 hours
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: All animals showed mild effects up to 72 hours. No effects were noted at the end of the exposure period.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: overall at 24, 48 and 72 hours.
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72
- Remarks on result:
- other: All animals showed mild effects up to 72 hours. No effects were noted at the end of the exposure period.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: overall at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: overall at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritant / corrosive response data:
- Exposure of the test substance to the eye resulted in all three animals in transient slight conjunctival redness and discharge, and in one animal a very slight oedema was observed too (1 hour after the application). These signs of irritation had subsided in all animals by 72 hours. Cornea and iris showed no lesions or other signs of irritation. No ocular lesions and other signs of toxicity were not observed. This evidence indicates that the product may be considered as 'not irritating to the eye'.
- Other effects:
- Some discolouration occured in conjunctiva of all animals but not sufficient to affect the readings of reactions. Conjunctival swelling was noted in one animal and discharge from the eyes of all animals at the 1 hour reading. These were not noted in remaining assessments.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Substance is not irritating to the eye
- Executive summary:
Study conducted to recent EU test guidance 92/69/EEC B5 & OECD 405.
The substance was found not irritating to the eye.
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