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EC number: 448-020-2 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
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- Particle size distribution (Granulometry)
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- Endpoint summary
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 2000-01-25 into 2000-02-04
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 2 000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: B5 Acute toxicity, Eye irritation OECD 405 Order of Ministry of the Health of Czech Republik No. 251/1998 Coll, B.5 Acute toxicity, Eye irrition
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- Nature of substance: The sample was applied in the form of undiluted liquid.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Spolek chovatelú Hradec králové
- Age at study initiation:
- Weight at study initiation: over 2.5 kg
- Housing: individual cage, climatization ,
- Diet (e.g. ad libitum): ad libidum
- Water (e.g. ad libitum):ad libidum
- Acclimation period:
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: right eye is control
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- exposure 24 hours
- Observation period (in vivo):
- The clinical eye examination was carried out in the periods
in 1, 24, 48 and 72 hours after application of the sample.
In 1 hour after application the eye reactions were
considered without the flush of the eye with water. In 24
hours the assessment was carried out after wary flush of the
eye with water. The examination of the cornea mesh defect
was carried out after decolouration with fluorescein. The
reaction after 72 hours after application was assessed by
using of fluorescein. - Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- issue
- Basis:
- animal: 19, 16, 17
- Time point:
- other: 1 h
- Score:
- >= 0 - <= 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: Max. duration: 1 h; Max. value at end of observation period: (related to all animals)
- Irritation parameter:
- chemosis score
- Remarks:
- chemosis
- Basis:
- animal: 19, 16, 17
- Time point:
- other: 1
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: Max. duration: 0 h; Max. value at end of observation period: (related to all animals)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 19, 16, 17
- Time point:
- other: 1
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: Max. duration: 0 h; Max. value at end of observation period: (related to all animals)
- Irritation parameter:
- iris score
- Basis:
- animal: 19, 16, 17
- Time point:
- other: 1
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: Max. duration: 0 h; Max. value at end of observation period: (related to all animals)
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 1 day.
- Other effects:
- The clinical eye examination was carried out in the periods in 1, 24, 48 and 72 hours after application of the sample. In 1 hour after application the eye reactions were considered without the flush of the eye with water. In 24 hours the assessment was carried out after wary flush of the eye with water. The examination of the cornea mesh defect was carried out after decolouration with fluorescein. The reaction after 72 hours after application was assessed by using of fluorescein. Results: In 1 hour after exposure a slight redness was observed at the first and third animals and slight ophthalmorrhoea was was observed at first animal. No observable changes was noted during the observation period - in 24, 48 and 72 hours after application of the sample among all animals.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information not classified Criteria used for interpretation of results: EU
- Conclusions:
- Average Eye Irritation Index : 2
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