Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study performed according to a method similar to OECD 404, prior to GLP. Results are acceptable as basic data.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
no
Remarks:
pre GLP-test

Test material

1
Chemical structure
Reference substance name:
3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-indenyl propionate
EC Number:
272-805-7
EC Name:
3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-indenyl propionate
Cas Number:
68912-13-0
Molecular formula:
C13H18O2
IUPAC Name:
3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-6-yl propionate
Test material form:
liquid

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 old
- Animals in the telgen phase of hair growth were selected
- Dorsal surface was clipped 3-4 days before dosing

ENVIRONMENTAL CONDITIONS
no data

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: control substances were tested simultaneously
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): undiluted
Duration of treatment / exposure:
4 hours exposure
Observation period:
24, 48 and 72 hours after treatment
Number of animals:
8 animals
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm2 cotton gauze was used
- Type of wrap if used: A piece of flexible polythene (3 x 3 cm) was attached to a piece of zinc oxide plaster (9 x 2.5 cm). A 2.5 cm2 cotton gauze (8 ply folded in two) was laid on the polythene such that the edges of the pad are attached to the zinc oxide plaster.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After removal of the patches, the treated sites were wiped.
- Time after start of exposure: 4 hours

SCORING SYSTEM: Erythema, oedema, cracking and scaling were scored using an 8-point scale ranging from 'a' (very slight) to 'h' (severe)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: Animal 6
Irritation parameter:
erythema score
Basis:
animal: 1, 2, 5, and 7
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Animal 1, 2, 5, and 7
Irritation parameter:
erythema score
Basis:
animal: 3, 4, and 8
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Animal 3, 4, and 8
Irritation parameter:
edema score
Basis:
animal: 6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: Animal 6
Irritation parameter:
edema score
Basis:
animal: 2 and 5
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Animal 2 and 5
Irritation parameter:
edema score
Basis:
animal: 1, 3, 4, and 7
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Animal 1, 3, 4, and 7
Irritation parameter:
edema score
Basis:
animal: 8
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Animal 8
Irritant / corrosive response data:
Cyclaprop produced a mild reaction 72 hours after treatment. This reaction was greater than diethyl phthalate (which produced virtually no response) and less than that produced by cyclamen aldehyde and gerianiol (which produced severe reactions).

Any other information on results incl. tables

Skin reactions of florocyclene in each animal according to original scoring system:

Animal number

24h

48h

72h

Erythema

Oedema

Erythema

Oedema

Erythema

Oedema

1966

a

a

-

a

-

a

1969

a

a

a

b

-

-

1924

a

a

a

a

a

a

1944

a

b

b

a

a

b

1945

a

a

a

a

-

-

1974

-

-

-

-

-

-

1970

a

a

-

a

-

a

1920

b

c

b

b

a

a

Individual scores after conversion to OECD404 scoring system are summarized in the table below:

Animal number

24h

48h

72h

Erythema

Oedema

Erythema

Oedema

Erythema

Oedema

1966

1

1

0

1

0

1

1969

1

1

1

1

0

0

1924

1

1

1

1

1

1

1944

1

1

1

1

1

1

1945

1

1

1

1

0

0

1974

0

0

0

0

0

0

1970

1

1

0

1

0

1

1920

1

2

1

1

1

1

The difference in irritation score (original scoring system) between the test material (Cyclaprop) and the standards for comparison are all significant.

   Diethyl phthalate Cyclaprop (test material)  Geraniol  Cyclamen aldehyde 
 Overall irritation score 85  215  244 
 Mean score per site 0.88  10.63  26.88  30.5 
 Mean score per site per day 0.22  2.66  6.72  7.63 
 Mean irritation ranking 1.0  2.13  3.13  3.75 
         

Applicant's summary and conclusion

Interpretation of results:
other: Not a skin irritant
Remarks:
according to EU CLP (EC 1272/2008 and its amendments)
Conclusions:
In the in vivo rabbit skin irritation test according to OECD TG 404, the substance is not a skin irritant.
Executive summary:

8 New Zealand White rabbits were used to determine the skin irritation potential of test substance Cyclaprop. The whole dorsal surface of the animals was clipped and 0.5 ml of each substance was applied under semi-occlusion to the skin of the animals. After 4 hours, the patch was removed and exposure sites wiped clean. The skin sites were assessed immediately after treatment and 24, 48 and 72 hours after treatment. Cyclaprop produced a mild reaction 24 hours after treatment, which decreased at 48 and 72 hr. The mean erythema scores over the 24, 48 and 72 hour time period, were 0 (1 animal), 0.67 (4 animals) and 1 (3 animals). The mean edema scores over the 24, 48 and 72 hour time period, were 0 (1 animal), 0.67 (2 animals), 1 (4 animals), and 1.33 (1 animal). As all animals had scorings below 2.3, the test substance is not considered to be a skin irritant.