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Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted similarly to OECD Guideline 404 with deviations: no data about purity and no certificate of analysis of the test substance; no details on test animals and environmental conditions; animals were not observed for 14 days to study the reversibility; systemic effects not followed; individual animal weights not reported
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
no data about purity and no certificate of analysis of the test substance; no details on test animals and environmental conditions; reversibility of irritation and systemic effects not followed; individual animal weights not reported
Principles of method if other than guideline:
Not applicable
GLP compliance:
no
Remarks:
pre-GLP

Test material

Constituent 1
Chemical structure
Reference substance name:
3-methyl-5-(2,2,3-trimethylcyclopent-3-en-1-yl)pentan-2-ol; 6-(2,2,3-trimethylcyclopent-3-en-1-yl)hexan-3-ol
EC Number:
939-525-3
Cas Number:
1471313-03-7
Molecular formula:
C14H26O
IUPAC Name:
3-methyl-5-(2,2,3-trimethylcyclopent-3-en-1-yl)pentan-2-ol; 6-(2,2,3-trimethylcyclopent-3-en-1-yl)hexan-3-ol
Details on test material:
- Name of test material (as cited in study report): Sandalore; 9027
- Source: PPL
- Physical state: Clear liquid
- Date received: 21-12-1976
- Batch: P 9845

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 9-12 weeks

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: cyclamen aldehyde and diethyl phthalate were used as standards for comparison
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (weight with unit): 0.5 mL
- Concentration (if solution): 100 %
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
8
Details on study design:
TEST SITE
- Area of exposure: Dorsum of rabbits
- Type of wrap if used: Occlusive patches were prepared by heat-sealing 1" x 1" 24 ply gauze pads on to 1.25" X 1.25" squares of polythene sheeting, which was then attached to 3.5" x 1" strips of adhesive tape.

REMOVAL OF TEST SUBSTANCE
- After removal of the patches, the treated site was wiped to remove the residual material.

SCORING SYSTEM:
- Treated sites were scored for erythema, oedema, cracking and scaling and any other feature using an 8-point anchored ordinate scale ranging from "a" (very slight) to "h" (severe). For better interpretation, an equivalence with OECD guideline 404 scoring system was made (see table 1)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
8 animals
Time point:
other: 24, 48 and 72 h
Score:
1.8
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
mean
Remarks:
8 animals
Time point:
other: 24, 48 and 72 h
Score:
1.7
Max. score:
4
Reversibility:
no data
Irritant / corrosive response data:
- The test item produced fairly distinct to distinct erythema and oedema with slight to distinct cracking and scaling.
- Overall level of response was similar to that produced by the control, cyclamen aldehyde although cyclamen aldehyde produced slightly more erythema and oedema and slightly less cracking and scaling.
- Response to the test item was greater than that produced by the control, diethyl phthalate which produced only marginal to slight erythema and oedema with marginal cracking and scaling.
Other effects:
None

Any other information on results incl. tables

Table 7.3.1/1: equivalence in scoring systems

Study scaling

OECD 404 scaling

a: marginal/very slight

b: slight

1

c: fairly distinct

d: quite distinct

2

e: becoming well developed

f: well developed

3

g: becoming severe

h: severe

4

Table 7.3.1/2: irritation scores

Animal number

4 h

24 h

48 h

72 h

 

E

O

E

O

E

O

E

O

010

a

 

d

b

c

a

b

c

008

c

c

d

c

d

d

c

c

027

b

a

d

d

c

c

b

b

044

c

c

b

b

b

a

b

b

036

d

c

c

c

c

b

c

b

035

c

b

c

d

d

c

c

c

2828

d

b

d

c

d

d

d

d

038

d

b

d

d

d

e

e

d

Table 7.3.1/3: equivalence in OECD 404 scaling

Animal number

4 h

24 h

48 h

72 h

Individual means

at 24-48-72 h

 

E

O

E

O

E

O

E

O

E

O

010

1

0

2

1

2

1

1

2

1,7

1,3

008

2

2

2

2

2

2

2

2

2

2

027

1

1

2

2

2

2

1

1

1,7

1,7

044

2

2

1

1

1

1

1

1

1

1

036

2

2

2

2

2

1

2

1

2

1,3

035

2

1

2

2

2

2

2

2

2

2

2828

2

1

2

2

2

2

2

2

2

2

038

2

1

2

2

2

3

3

2

2,3

2,3

 

 

 

 

 

Overall mean

1,8

1,7

E: erythema

O: oedema

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, the substance induced only moderate skin irritation in rabbits. As overall mean scores for erythema and oedema were lower than 2, the substance should not be classified according to Directive 67/548/EEC and CLP Regulation (EC) N° 1272/2008.
Executive summary:

In a primary dermal irritation study performed similarly to OECD Guideline 404, eight New Zealand White rabbits were dermally exposed to 0.5 mL of the substance (100 %) under a semi-occlusive dressing for 4 h. After removal of the residual test item, treated sites were scored for erythema, oedema, cracking and scaling and any other feature using an 8-point anchored ordinate scale ranging from very slight to severe at 24, 48 and 72 h after exposure. Cyclamen aldehyde and diethyl phthalate were used as standards for comparison.

The substance produced fairly distinct to distinct erythema and oedema with slight to distinct cracking and scaling. The overall level of response was similar to that produced by cyclamen aldehyde although cyclamen aldehyde produced slightly more erythema and oedema and slightly less cracking and scaling. Response to the substance was greater than that produced by diethyl phthalate which produced only marginal to slight erythema and oedema with marginal cracking and scaling. When using an equivalence between this scoring scale and the OECD 404 scoring system, the overall mean scores at 24, 48 and 72 h were 1.8 and 1.7 for erythema and oedema, respectively.

Under the test conditions, the substance induced only moderate skin irritation in rabbits. As overall mean scores for erythema and oedema were lower than 2, the substance should not be classified for skin irritation according to Directive 67/548/EEC and CLP Regulation (EC) N° 1272 /2008.