(octahydro-4,7-methano-1H-indenyl)methyl acrylate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01 August 2018 - 12 September 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

2015

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Version / remarks:

August 1998

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

May 2008

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Appendix to Director General Notification, No. 12-Nousan-8, JMAFF

Version / remarks:

November 2000, including the most recent revisions

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(octahydro-4,7-methano-1H-indenyl)methyl acrylate

EC Number:

300-723-4

EC Name:

(octahydro-4,7-methano-1H-indenyl)methyl acrylate

Cas Number:

127823-21-6

Molecular formula:

C14H20O2

IUPAC Name:

{tricyclo[5.2.1.0²,⁶]decan-8-yl}methyl prop-2-enoate

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: Charles River France, L’Arbresle, France
- Age at study initiation: approx. 12-16 weeks old
- Weight at study initiation: 2868 - 3365 g
- Housing: individually in cages with perforated floors
- Diet: pelleted diet for rabbits (Global Diet 2030 Teklad®, Mucedola, Milanese, Italy), once daily throughout the study ; in addition hay was available during the study period.
- Water: municipal tap-water, ad libitum
- Acclimation period: at least 5 days

It is considered that there were no known contaminants in the feed and the water that would interfere with the objectives of the study.
For psychological/environmental enrichment, animals were provided with shelters and wooden sticks.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Humidity (%): 48 - 90
- Air changes (per hr): >= 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 01 August 2018 To: 12 September 2018

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST ITEM:
- Amount applied: 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: 2x3 cm
- Type of wrap if used: the test item was applied using a metalline patch, mounted on Micropore tape which was wrapped with Coban elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing: with tap water
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
- Mortality: twice a day (morning and end of the working day)
- Clinical signs: 1, 24, 48 and 72 hours and 7 and 14 days after removal of the test item.
- Body weights: on day 1 (predose) and at the final day of the observation period

The study was performed in a stepwise manner and was started by treatment of a single rabbit (sentinel). The two other animals were treated in a similar manner 4 weeks later.

SCORING SYSTEM:
- Method of calculation: according to Draize system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.3

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2.3

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Irritant / corrosive response data:

Skin Irritation: The skin irritation was not fully reversible within 14 days after exposure in all animals. Slight oedema (score of 1 or 2) in all three animals, and slight erythema (score of 1) in one animal were observed at the end of the observation period. Reduced flexibility and scaliness of the skin was observed in all three animals during the observation period. One animal showed bald skin after 14 days.

Coloration/remnants: No staining of the treated skin by the test item was observed and no test item remnants were seen.
Toxicity/mortality: no signs of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Bodyweight: No abnormal change of bodyweight was recorded in the animals.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

Based on the persisting skin reactions until day 14 and the 24-72 hours mean oedema score = 2.3 for all animals: Tricyclodecanemonomethylol acrylate is considered as a skin irritant.

Executive summary:

An in vivo skin irritation study with Tricyclodecanemonomethylol acrylate was performed in rabbits according to OECD 404 and GLP principles.

The skin irritation was not fully reversible within 14 days after exposure in all 3 animals. Slight oedema (score of 1 or 2) in all three animals, and slight erythema (score of 1) in one animal were observed at the end of the observation period. Reduced flexibility and scaliness of the skin was observed in all three animals during the observation period. One animal showed bald skin after 14 days.

No staining of the treated skin by the test item was observed and no test item remnants were seen.

No signs of systemic toxicity were observed in the animals during the test period and no mortality occurred. No abnormal change of bodyweight was recorded in the animals.

Based on the persisting skin reactions until day 14 and the 24-72 hours mean oedema score = 2.3 for all animals: Tricyclodecanemonomethylol acrylate is classified as a skin irritant.