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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
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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
2015
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Version / remarks:
August 1998
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
May 2008
Deviations:
no
Qualifier:
according to
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

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals 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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
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
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
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
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
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.