Registration Dossier
Registration Dossier
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EC number: 292-053-3 | CAS number: 90530-15-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Sept 19 1983 - Oct 31 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was carried out according to OECD 405.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- same as guideline
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Hardener V 217
- IUPAC Name:
- Hardener V 217
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Hardener V 217
- Physical state: liquid
- Analytical purity: 100%
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: small white Russian, CHBB-SPF
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr Karl Thomae Gmbh, Biberach
- Female: 2 animals
- Weight at study initiation: 2.3 - 2.4kg
- Housing: individual housing in stainless steel cages
- Diet: ad libitum - K4 complete feed for rabbits, Ssniff Versuchstier-Diäten Gmbh, 4770 Soest
- Water: ad libitum - tap water
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/- 1°C
- Humidity (%): 60 +/- 5%
- Air changes (per hr): 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12-hour light/dark rhythm
IN-LIFE DATES: From: Oct 4 1983 To: Oct 7 1983
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1ml
- Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- after 1 hour, 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- no washing
- Time after start of exposure:
SCORING SYSTEM: Draize appraisal method (see attached)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 3.33
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 3.33
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 2.66
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 2.66
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritant / corrosive response data:
- Hardener V 217 has an irritation index of 91.75
- Other effects:
- 1 animal made complaining noises
Any other information on results incl. tables
see result tables
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Hardener V 217 showed an extremaly irritant or corrosive effect, the irritation index being 91.75/110, on eye and the muicosa of female rabbits.
- Executive summary:
In order to test the acute irritant effect on eyes and mucosa, hardener V 217 was administered undiluted to the eyes or eyelid sacs of female rabbits.
Result: Hardener V 217 showed an extremaly irritant or corrosive effect, the irritation index being 91.75/110, on eye and the muicosa of female rabbits.
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