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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:
2019

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

Constituent 1
Chemical structure
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
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.