Registration Dossier
Registration Dossier
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EC number: 461-290-6 | CAS number: 167374-38-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study performed under GLP regulations
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): X-E-OXIMETHER
- Analytical purity: 98.4%
- Batch No.: 26249/176
- Substance No.: 96/288
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, FRG
- Age at study initiation: Young adult animals
- Weight at study initiation: 3.23, 3.35 and 3.54 kg
- Housing: Single in stainless steel wire mesh cages with grating
- Diet: Kliba-Labordiaet 341, Klingentalmuehle AG, Kaiseraugst, Switzerland (about 130 g/animal/day)
- Water: Tap water, about 250 ml/animal/day
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated left eye
- Amount / concentration applied:
- 0.1 ml bulk volume (about 23 mg)
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 72 hours
- Details on study design:
- Following single application of the test substance to the conjunctival sac of the right eyelid, the substance was washed out with tap water about 24 h after application (before 24 h reading) and the eyes were examined for signs indicative of irritation after 1, 24, 48 and 72 hours.
The assessment and scoring of the findings was based on the OECD Guideline 405 (adopted Feb. 24, 1987) and EEC L 383A, B.5 (Dec. 29, 1992).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24-48-72 h
- Score:
- 0.4
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 1 and 3
- Time point:
- other: 24-48-72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- other: individual scores: 1 - 0 - 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24-48-72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: individual scores: 1 - 1 - 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24-48-72 h
- Score:
- 0.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1 and 3
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: individual scores: 0 - 0 - 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: individual scores: 1 - 1 - 0
Any other information on results incl. tables
The potential of X-E-Oximether to cause damage to the conjunctiva, iris or cornea was assessed in 3 New Zealand White rabbits, subjected to a single ocular application of 0.1 ml bulk volume (about 23 mg) of the test substance.
The average score (24 to 72 hours) for irritation was calculated to be 0.0 for corneal opacity and for iris, 0.4 for conjunctiva and 0.2 for chemosis. The findings were reversible in all animals within 72 hours after application.
Thus, under the test conditions chosen and considering findings X-E-Oximether did not give indication of an irritant property to the eye.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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