Registration Dossier
Registration Dossier
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EC number: 202-676-4 | CAS number: 98-52-2
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- 50 mg application amount, no irrigation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 2012
- Deviations:
- yes
- Remarks:
- no pretreatment with topical anesthetics and systemic analgesics; 6 animals; 50 mg application amount; no irrigation (no data, if substance was already removed by physiological mechanisms at the first observation time point)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted in May 1981
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- study performed prior to implementation of GLP
Test material
- Reference substance name:
- 4-tert-butylcyclohexanol
- EC Number:
- 202-676-4
- EC Name:
- 4-tert-butylcyclohexanol
- Cas Number:
- 98-52-2
- Molecular formula:
- C10H20O
- IUPAC Name:
- 4-tert-butylcyclohexan-1-ol
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: males / females 2.3-2.7 kg
- Housing: individually in stainless steel cages
- Diet: K4 Alleindiaet fuer Kaninchen (Ssniff Versuchstier-Diaeten GmbH, Soest, Germany); ad libitum
- Water: tap water; ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 21 Dec 1982 To: 29 Dec 1982
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 50 mg
- Concentration: undiluted - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 8 days
Reading time points: 1, 24, 48, and 72 hours, 6 and 8 days after treatment - Number of animals or in vitro replicates:
- 6 (3 males, 3 females)
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein (at the 1, 24, 48 and 72 hours, 6 days observation interval)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: score = 1 at 1 h-reading
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: score = 1 at 1 h-reading
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #4, #5 and #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: score = 1 at 1 h-reading
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- iris score
- Basis:
- animal: #3, #5 and #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1 and #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: score = 1 at 1 h-reading
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: score = 1 at 1 h-reading
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: score = 1 at 1 h-reading
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: score = 1 at 1 h-reading
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: score = 1 at 1 h-reading
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #4 and #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: score = 1 at 1 h-reading
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: score = 1 at 1 h-reading
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: score = 2 at 1 h-reading
- Irritant / corrosive response data:
- Conjunctival discharge of grade 1 (any amount different from normal) and grade 2 (discharge with moistening of the lids and hairs just adjacent to lids) was observed in all animals at the 1 h-reading time point. At the 72 h-reading time point discharge was no longer noted except one male rabbit.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of this eye irritation study in the rabbit, the test item caused mean scores following grading at 24, 48 and 72 h after test substance instillation of ≥ 1 for corneal opacity and of ≥ 2 for conjunctival redness in 4 out of 6 tested animals and is therefore considered as irritating to eyes (Category 2, H319) according to Regulation (EC) 1272/2008. The effects were fully reversible within 8 days, at the latest.
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