Registration Dossier
Registration Dossier
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EC number: 807-821-0 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 September to 10 October 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed in accordance with OECD test guidelines in compliance with GLP and reported with a valid certificate
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS- Source: S&K LAP Kft, Hungary- Age at study initiation: 14 weeks old- Weight at study initiation: 3598-3864g- Housing: Individual- Diet (e.g. ad libitum): ad libitum- Water (e.g. ad libitum): ad libitum- Acclimation period: 31 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 17.5-20.8- Humidity (%): 29-78- Air changes (per hr): 15-20- Photoperiod (hrs dark / hrs light): 12 hours
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1g of test substance.
- Duration of treatment / exposure:
- 1 hour
- Observation period (in vivo):
- 1, 24, 48 and 72 hoursnd 1 week after application
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Discharge
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: Due to staining, clear scoring was not possible so estimated scores were estimated scores are listed
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- < 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Discharge
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: Due to staining, clear scoring was not possible so estimated scores were estimated scores are listed
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Discharge
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: Due to staining, clear scoring was not possible so estimated scores were estimated scores are listed
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- < 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Scoring was not posisble in all animals after 24 hours due to staning of the eyes ad fur around the eyes.
Any other information on results incl. tables
The test item is a dye-like substance. There was no permanent staining, but due to the intene colour, without washing, it was not possible to score redness, opacity or iris effects at the early time points in some animals. However, since the colour cleared sufficiently to make a score at 48 and 72 hours and there were no observed effects of opacity or iris effects there was assumed to have been no iris effects and no effects exceeding an opacity of 2 at any time. Where redness scording was not posisble, it was estimated that the score was a maximum of 3 at 24 hours after exposure based on scientific opinion and experience of the laboratory staff.
Applicant's summary and conclusion
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- The substance caused significant staining, affecting scoring at some of the early time points, but significant or persistent conjunctival or corneal irritant effects. All effects were fully reversible within 1 week. The effects of the substance are considered to classify the substance as a Cat 2 irritant.
- Executive summary:
The primary eye irritation has been assessed by instalation of 0.1g of test substance. to the eyes of three male rabbits in accordance with the OECD 405 test guideline in compliance with GLP.
The test item is a dye-like substance. There was no permanent staining, but due to the intene colour, without washing, affecting scoring at some of the early time points, but significant or persistent conjunctival or corneal irritant effects. All effects were fully reversible within 1 week. The effects of the substance are considered to classify the substance as a Cat 2 irritant.
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