Registration Dossier
Registration Dossier
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EC number: 201-100-9 | CAS number: 78-27-3
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997 - 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study conducted in accordance with GLP.
Data source
Reference
- Reference Type:
- publication
- 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)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1-ethynylcyclohexanol
- EC Number:
- 201-100-9
- EC Name:
- 1-ethynylcyclohexanol
- Cas Number:
- 78-27-3
- Molecular formula:
- C8H12O
- IUPAC Name:
- 1-ethynylcyclohexanol
- Test material form:
- other: solid
- Details on test material:
- Please refer to the section "confidential details on test material" below.
Constituent 1
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, Germany
- Age at study initiation: Young adult animals
- Weight at study initiation: Animal 1: 3.99 kg (female); Animal 2: 3.81 kg (male); Animal 3: 3.85 kg (male)
- Housing: Single housing; stainless steel wire mesh cages with grating, Floor area: 3000 cm², no bedding in the cages, sawdust in the waste trays
- Diet: Kliba-Labordiät, Klingentalmühle AG Kaiseraugst, Switzerland (about 130 g per animal per day
- Water: about 250 mL tap water per animal per day
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24 °C
- Humidity: 30 - 70 %
- Air changes (per hr): Fully-air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12 h/12 h (6.00 a.m. - 6.00 p.m./6.00 p.m. - 6.00 a.m.)
IN-LIFE DATES: From: 1997-01-20/27 To: 1997-02-03/10
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 mL - Duration of treatment / exposure:
- 24 hour(s)
- Observation period (in vivo):
- 15 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- PREPARATION:
- Both eyes of the animal(s) were examined before application of the test material for signs of pre-existing irritation, reaction or abnormality which would prevent it from being used in the study.
REMOVAL OF TEST SUBSTANCE
- Washing: rinsed with tap water
- Time after start of exposure: about 24 h after application (before 24 h reading)
SCORING SYSTEM: Draize scale of scoring
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein - no data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, 2, 3
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h (mean)
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h (mean)
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Remarks on result:
- other: 8 days observation - loss of corneal tissue
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 1 h
- Score:
- >= 2 - <= 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 or 15 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h (mean)
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h (mean)
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 1 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h (mean)
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h (mean)
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h (mean)
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h (mean)
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h (mean)
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- other: eye discharge
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 1 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- other: eye discharge
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- other: eye discharge
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h (mean)
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- other: eye discharge
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h (mean)
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritant / corrosive response data:
- All animals: discharge of blood was observed after 1, 24, 48 and 72 hours
Animal #2 and #3: suppuration was observed also after 48 and 72 hours
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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