3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-indenyl propionate

Skin irritation / corrosion

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

Test material information

1

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:

Reaction mass of 3a,4,5,6,7,7a-hexahydro-1H-4,7-methanoinden-5-yl propionate and 3a,4,5,6,7,7a-hexahydro-1H-4,7-methanoinden-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

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: Animal 6

Results 2

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

Results 3

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

Results 4

Irritation parameter:

edema score

Basis:

animal: 6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: Animal 6

Results 5

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

Results 6

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

Results 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	7	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.