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Registration Dossier
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EC number: 201-100-9 | CAS number: 78-27-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997 - 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study conducted in accordance with GLP. However, in case of the test substance the date of storage stability was crossed as the study was performed.
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 404 (Acute Dermal 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system 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: 3.74 kg (female); Animal 2: 3.41 kg (male); Animal 3: 3.66 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 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: Fully air-conditioned rooms
- Photoperiod: 12 hrs dark / 12 hrs light (6 .00 a .m . - 6 .00 p .m ./6 .00 p .m . - 6 .00 a .m . )
IN-LIFE DATES: From: 1997-01-20 To: 1997-02-03
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated skin sites of the same animal.
- Amount / concentration applied:
- undiluted
TEST MATERIAL
- Amount(s) applied: 0.5 mL (undiluted) - Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 15 days
- Number of animals:
- 3 rabbits
- Details on study design:
- TEST SITE: Third of the back or flanks
- Area of exposure: 6.25 cm²
- % coverage: 0.42
- Type of wrap if used: Adhesive fleece
REMOVAL OF TEST SUBSTANCE
- Washing: Lutrol(R) and Lutrol(R)/water (1 :1); Lutrol: Polyethylenglycol
- Time after start of exposure: at the end of the exposure period
SCORING SYSTEM: Draize scale of scoring
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 1, 24, 48, 72 h and 8, 15 d
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 1, 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 days
- Remarks on result:
- other: Erythema extending beyond the area of exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 48, 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 days
- Remarks on result:
- other: Erythema extending beyond the area of exposure
- Irritation parameter:
- erythema score
- Basis:
- animal: #2, #3
- Time point:
- other: 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 days
- Remarks on result:
- other: Erythema extending beyond the area of exposure
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #3
- Time point:
- other: 8, 15 d
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 d
- Remarks on result:
- other: Scaling, erythema extending beyond the area of exposure, scaling extending beyond the area of exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 8, 15 d
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h (mean)
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h (mean)
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h (mean)
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 days
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 24, 48, 72 h (mean)
- Score:
- 0
- Max. score:
- 4
Any other information on results incl. tables
Erythema remained over 15 days in two animals and extended beyond the application site; scaling was also still visible after 15 days and also extending beyond the application site.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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