Octahydro-4,7-methano-1H-inden-5-yl acetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion, other

Remarks:

The in vivo skin irritation test is performed before the REACH regulation came into force requesting in vitro studies

Type of information:

experimental study

Adequacy of study:

key study

Study period:

02-11-1976 - 13-12-1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test was conducted similar to OECD Test Guideline No. 404, but not under GLP Standards.

Justification for type of information:

Information used to read across to Cyclacet Dihydro.

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Reference

Endpoint:

skin irritation / corrosion, other

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The information is derived from read across.

Justification for type of information:

The information for Cyclacet Dihydro is derived from Cyclacet. The information is based on the analogue Cyclacet. The justification is presented in the Endpoint summary and includes also eye irritation. The accompanying file is also attached there.

Reason / purpose for cross-reference:

read-across source

Other effects / acceptance of results:

In vivo information is available before the Reach Regulation came into force requesting in vitro studies.

Irritation parameter:

other: mean irritation ranking

Basis:

mean

Time point:

24/48/72 h

Score:

3.1

Max. score:

12

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Overall Irritation Score: 23900
Mean Score per Site: 23.90
Mean Score per Site per Day: 5.97
Mean irritation ranking: 3.1
The maximum score is a very estimated score.

Interpretation of results:

other: not irritating

Remarks:

according to the EU CLP Regulation 1272/2008 and its amendments

Conclusions:

The substance is not a skin irritant.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

10 animals used; different scoring system; observation < 14 days (Reversibility check); positve and negative control substances used.

GLP compliance:

no

Test material

Test material information

1

Reference substance name:

Reaction mass of 3a,4,5,6,7,7a-hexahydro-4,7-methanoinden-5-yl acetate and 3a,4,5,6,7,7a-hexahydro-4,7-methanoinden-6-yl acetate

EC Number:

911-369-0

Molecular formula:

C12H16O2

IUPAC Name:

Reaction mass of 3a,4,5,6,7,7a-hexahydro-4,7-methanoinden-5-yl acetate and 3a,4,5,6,7,7a-hexahydro-4,7-methanoinden-6-yl acetate

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: 9-12 weeks
- Weight at study initiation: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS: no data

IN-LIFE DATES: no data

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): 100%

Controls:
Positve control: Cyclamen Aldehyde
Negative control: Diethyl Phthalate

Duration of treatment / exposure:

4 hours

Observation period:

at 4, 24, 48 and 72 hours

Number of animals:

10

Details on study design:

TEST SITE
- Area of exposure: dorsal
- % coverage: no data
- Type of wrap if used: Patches are prepared by heat-sealing 1" x 1" 24 ply gauze pads on to 1 1/4" x 1 1/4" squares of polythene sheeting which is then attached to 3 1/2" x 1" strips of adhesive tape. Test solutions are applied to a dry patch. The patches are firmly attached to ensure good contact between the skin and test substance.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped clean
- Time after start of exposure:4 hours

SCORING SYSTEM: The sites are 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). At the end of the test the reaction grades are converted to corresponding numerical scores which are used to calculate the total irritation score per animal, an overall score per treatment group, a mean irritation score per site, and a mean irritation score per site per day for each treatment group. A mean irritation ranking for each treatment group is also given.
Reaction Grades and Scores of erythema, oedema, cracking and scaling:
a marginal/very slight = 1
b slight = 2
c fairly distinct =3
d quite distinct = 4
e becoming well developed = 6
f well developed = 8
g becoming severe = 10
h severe = 12

STATISTICS:
The Wilcoxon Matched-Pairs Signed Ranks Test, which considers the size and direction of differences between reactions is used to test the significance of differences between pairs of treatment groups.

Results and discussion

In vivo

Results

Irritation parameter:

other: mean irritation ranking

Basis:

mean

Time point:

24/48/72 h

Score:

3.1

Max. score:

12

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Overall Irritation Score: 23900
Mean Score per Site: 23.90
Mean Score per Site per Day: 5.97
Mean irritation ranking: 3.1
The maximum score is a very estimated value, except for the last value: the mean score per site per day.

Other effects:

no data

Any other information on results incl. tables

Under the conditions of this test Jasmacyclene (crude) produced slight to moderate irritation consisting of marginal to slight erythema and oedema with variable cracking and scaling ranging from slight to distinct. The test substance was significantly more irritant than the negative control, diethyl phthalate, which produced only a marginal response. The test ingredient was significantly less irritant than the positive control, cyclamen aldehyde, which produced well-developed erythema fairly distinct cracking and slight scaling.

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Remarks:

according to the EU CLP Regulation 1272/2008 and its amendments

Conclusions:

In a Rabbit Covered Patch Skin Irritation Test, single 4-hour-exposure of Jasmacyclene (crude), under semi-occlusive conditions, caused slight to moderate irritation, consisting of marginal to slight erythema and oedema with variable cracking and scaling ranging from slight to distinct. No classification and labelling is required based on these results.

Executive summary:

The skin irritation/corrosion potential of Cyclacet was investigated in a study similar to OECD Test Guideline 404 (Acute Dermal Irritation / Corrosion). In this Rabbit Covered Patch Skin Irritation Test, single 4 -hour-exposure of Cyclacet under semi-occlusive conditions caused slight to moderate irritation, consisting of marginal to slight erythema and oedema with variable cracking and scaling ranging from slight to distinct. This does not result in the substance being a skin irritant.