Registration Dossier
Registration Dossier
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EC number: 805-440-4 | CAS number: 22972-51-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2019-03-01 to 2019-03-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2015
- GLP compliance:
- yes
Test material
- Reference substance name:
- (1S,4R)-1-methyl-4-(prop-1-en-2-yl)cyclohex-2-en-1-ol
- Cas Number:
- 22972-51-6
- Molecular formula:
- C10H16O
- IUPAC Name:
- (1S,4R)-1-methyl-4-(prop-1-en-2-yl)cyclohex-2-en-1-ol
- Test material form:
- liquid
- Details on test material:
- Test item: (1S,4R)-1-Methyl-4-(prop-1-en-2-yl)cyclohex-2-enol
CAS number: 22972-51-6
Physical state: Liquid
Storage: Room temperature
Constituent 1
- Specific details on test material used for the study:
- Test item: (1S,4R)-1-methyl-4-(prop-1-en-2-yl)cyclohex-2-en-1-ol (PMDOL)
CAS number: 22972-51-6
Physical state: Liquid
Storage: room temperature
Batch No. 118000-182001
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Wei Xin Hang, Banqiao, Taiwan
-female
- Age at study initiation: not reported
- Weight at study initiation: 3.0-4.0 kg
- Housing: single housing.
- Diet : ad libitum
-- Acclimation period: 3 days
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 22+/-3°C
- Humidity: 50+/- 20%
- Air changes (per hr): no data (air conditionned)
- Lighting: 12 hours (06:00 on, 18:00 off)
Test system
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 ml of test article
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Skin reactions were observed 1, 24, 48, and 72 hours post-rinsed. Additional examination up to 14 days if irritant reaction occurred.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm on the dorsal skin
REMOVAL OF TEST SUBSTANCE
- Washing : yes, rinse with distilled water
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
1, 24, 48, and 72 hours after patch removal. Additional daily examination up to 14 days
Grading System for Skin Reaction (OECD 404):
Erythema and Eschar Formation:
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beef redness) to slight eschar formation (injuries in depth) 4
Oedema formation:
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well defined by definite raising) 2
Moderate oedema (raised approximately 1mm) 3
Severe oedema (raised more than 1mm and extending beyond area of exposure) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 3 - <= 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 2 - <= 4
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 2 - <= 4
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 2 - <= 4
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 1 - <= 2
- Max. score:
- 2
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Skin irr. Category 2 (H315: Causes skin irritation) according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) as mean erythema and oedema value were >= 4 in at least two out of three animals.
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