Octahydro-4,7-methano-1H-indene-5-methanol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

Initiation: March 01, 1983 - Termination: March 08,1983.

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

No data about purity of the substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

May 12, 1981

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Octahydro-4,7-methano-1H-indene-5-methanol

EC Number:

260-789-4

EC Name:

Octahydro-4,7-methano-1H-indene-5-methanol

Cas Number:

57526-50-8

Molecular formula:

C11H18O

IUPAC Name:

{tricyclo[5.2.1.0²,⁶]decan-8-yl}methanol

Test material form:

liquid

Details on test material:

Hoechst 1983

Specific details on test material used for the study:

No information on purity. However, as it is stated in the section 13, the substance and its composition have remained essentially the same over the last decades.

Test animals

Species:

rabbit

Strain:

Himalayan

Remarks:

Albino Himalayan (SPF Wiga)

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HOECHST AG, Kastengrund, SPF-Zucht
- Weight at study initiation: 1.7 - 2.2 kg (3 animals)
- Housing: individual cages in fully air-conditioned rooms
- Diet (e.g. ad libitum): feed for breeding rabbits ERKA Z 6000, ad libitum
- Water (e.g. ad libitum): deionized chlorinated water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2 °C
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12 hours per day

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Remarks:

24 hours before test initiation

Vehicle:

unchanged (no vehicle)

Remarks:

0,5 mL

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted

Duration of treatment / exposure:

Exposure time of 4 hours. After the exposure the remaining substance was carefully removed from the skin.

Observation period:

First assessment 30-60 minutes after the treatment. Then after 24, 48 and 72 hours and after 7 days.

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: Dorsal / lateral part.
- Coverage / Type of wrap: substance placed on the cellulose part of a plaster (specially designed from Baiserdorf AG, Hamburg, 2.5 cm x 2.5 cm).

REMOVAL OF TEST SUBSTANCE
- After the exposure the remaining substance was carefully removed from the skin.

OBSERVATION TIME POINTS
30-60 minutes, 24 hours, 48 hours, 72 hours and 7 days after the removal of the plaster.

SCORING SYSTEM:
- Method of calculation: numerical assessment for the formation of erythema and oedema according to the OECD guideline (Draize) and with the labelling of the respective observations.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Remarks:

mean value of all animals and all time periods

Time point:

other: mean value from all time points between 30-60 minutes and 72 hours after exposure

Score:

2.8

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Remarks:

but decrease of effect and only grade 1 observed on Day 7

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2.3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 7

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The test item caused slight irritation under the conditions of this test.

Executive summary:

Based on an exposure of 4 hours of an undiluted solution of the test item, a PDII of 2.8 has been determined. It is calculated from the sum of the scoring for erytheme and oedeme observations (12 according to the grading of skin reactions of the OECD guideline) divided by a factor of 12 (number of animals and number of time points 3x4).

The test item caused well defined erythema and slight oedema in all rabbits within 24 hours after removal of the patch. The effect persisted until 72 hours (mean erythema scores for the individual animals after 24, 48 and 72 hours: 2.3, 2.0, 2.3;

mean edema scores for the individual animals after 24, 48 and 72 hours: 1.0, 1.0, 1.3 ) and subsided within 7 days except in one animal, which still showed slight erythema after 7 days (score 1).

Dry, chapped and squamos skin was found in 1 of 3 animals 72 hours after removal of the patch and in all animals after 7 days.