Registration Dossier

Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
skin irritation in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1998-05-18 to 1998-05-25
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study following OECD guideline with several deviations: no details about test substance, no certificate of analysis, no individual body weights.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
no details about test substance, no certificate of analysis
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Name of test material : (2E)-ethyl-4-(2,2,3-trimethyl-3-cyclopenten-1-yl)-buten-1-ol / 2-ethyl-4-(2,2,3-trimethyl-3-cyclopenten-1-yl)-2-buten-1-ol
Molecular formula : C14H24O1
Smiles notation: OCC(=CCC(C(C(=C1)C)(C)C)C1)CC

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Jegard (Yffiniac, France)
- Weight at study initiation: average weight 2.4 kg
- Housing: individual housing on floor grid
- Diet (e.g. ad libitum): pelleted diet from ERGILAP Anco, COFNA (Tours, France), ad libitum
- Acclimation period: at least 5 days

IN-LIFE DATES: From: 1998-05-18 To: 1998-05-25

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: hair clipping
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL/rabbit



Duration of treatment / exposure:
4 h
Observation period:
14 days
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: 2.5 X 2.5 cm
- Type of wrap if used: 10 cm wide stretch tape (varicose vein tape)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test preparation removed with cotton wool moistened with distilled water
- Time after start of exposure: 4 h

SCORING SYSTEM: Erythema and eschar formation
-no erythema............................................................................................................................0
-very slight erythema ( barely perceptible ).........................................................................1
-Well defined erythema............................................................................................................2
-Moderate to severe erythema...............................................................................................3
-Severe erythema (beet 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 1 mm )...............................................................3
-Severe oedema ( raised more than 1 mm and extending beyond area of exposure )...4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean individual score
Time point:
other: 24, 48 and 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: day 7
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean individual score
Time point:
other: 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: day 6
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean individual score
Time point:
other: 24, 48 and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean individual scores
Time point:
other: 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: day 6
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean individual score
Time point:
other: 24, 48 and 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: day 5
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean individual score
Time point:
other: 24, 48 and 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: day 6
Irritant / corrosive response data:
Under experimental conditions, the application of test substance for 4 h to the skin of the rabbit produced, 1 hour after patch removal, slight to well defined erythema and oedema observed in all the animals. The reactions were decreased in less than 5 days (D6) for 2 animals and 6 days (D7) for the third rabbit.
Other effects:
There is a cutaneous dryness then rugosity from D3 to D14.

Any other information on results incl. tables

Individual values of skin reactions

Animal N°

SCORES

Mean scores

SCORES

D1 (1h)

24 h

48 h

72 h

Over 24-48-72 h

D5

D6

D7

Erythema

7307

2

2

1

1

1.3

1

1

0

7308

2

1

1

1

1.0

1

0

/

7309

1

1

0

0

0.3

0

0

/

Oedema

7307

1

1

1

1

1.0

1

0

0

7308

2

2

1

1

1.3

0

0

/

7309

2

2

1

1

1.3

1

0

/

/ : no reading

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the criteria of directive 67/548/EEC, the test item should not be classified as skin irritant.
Executive summary:

The dermal irritation study was conducted according to OECD guideline 404 in compliance with GLP. Three healthy adult New Zealand white rabbits were exposed to 0.5 mL/rabbit of the test item on clipped skin from the dorsal area for 4 hours in semi-occlusive conditions. Skin reactions were observed at 1, 24, 48 and 72 h after removal of the substance until the disappearance of the effects (day 7).1 hour after patch removal there was slight to well defined erythema and oedema in all animals. Mean individual scores were 1.3, 1.0 and 0.3 for erythma and 1.0, 1.3 and 1.3 for oedema. The reactions were reversible within 5 days (D6) for two animals and 6 days (D7) for the third rabbit.

Therefore, the test item should not be classified as irritating to the skin according to the criteria of directive n°67/548/EEC and CLP regulation (EC) n°1272/2008.