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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:
2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
2015
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: Liquid
Details on test material:
Name of test material (as cited in study report: MTDID 20422
- Substance type: Pure active substance
- Physical state: Liquid
- Analytical purity: 99.99%
- Purity test date: 02/16/2011
- Expiration date of the lot/batch: 02/16/2013
- Storage condition of test material: At room temperature in the dark.
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 3M Company, Lot 1
- Expiration date of the lot/batch: 05 June, 2019
- Purity test date: 05 June, 2017

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature
- Stability under test conditions: Stable

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: None, dosed neat

FORM AS APPLIED IN THE TEST: Neat

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: 21-22 weeks old
- Weight at study initiation: 3490-3727 grams
- Housing: On arrival and following assignment to the study, animals were housed individually in labeled cages with perforated floors (Ebeco, Germany, dimensions 67 x 62 x 55 cm) equipped with water bottles. The room(s) in which the animals were kept were documented in the study records. Each cage was clearly labeled.
- Diet (e.g. ad libitum): Pelleted diet for rabbits (Global Diet 2030 Teklad®, Mucedola, Milanese, Italy) was provided once daily throughout the study. In addition, hay (TecniLab-BMI BV, Someren, The Netherlands) was available during the study period. The feed was analyzed by the supplier for nutritional components and environmental contaminants. Results of the analysis were provided by the supplier and are on file at the Test Facility. It is considered that there were no known contaminants in the feed that would interfere with the objectives of the study.
- Water (e.g. ad libitum): Municipal tap-water was freely available to each animal via water bottles. Periodic analysis of the water was performed, and results of these analyses are on file at the Test Facility. It is considered that there were no known contaminants in the water that would interfere with the objectives of the study.
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 70-73
- Air changes (per hr): At least 10 an hour
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 10 October, 2017 To: 23 October, 2017

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other:
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

VEHICLE : None, dosed neat

NEGATIVE CONTROL : None

POSITIVE CONTROL : None
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: Flank
- % coverage: 2 x 3 cm
- Type of wrap if used: The test article was covered with a metalline patch mounted on micropore tape which was wrapped around the abdomen and secured with Coban elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with tap water
- Time after start of exposure: 4 hours after application.

OBSERVATION TIME POINTS
Skin reactions were assessed 1, 24, 48 and 72 hours after exposure.

SCORING SYSTEM:
- Method of calculation: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
Four hours exposure to 0.5 mL of the test article resulted in very slight edema in the treated areas of two of the three rabbits. The skin irritation resolved within 24 hours after exposure in these animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of the study (PII= 0.22), the test article is not a skin irritant.
Executive summary:

The acute dermal irritation potential of the test article was evaluated in three female rabbits. The study was conducted according to OECD 404 (2015) in compliance with OECD GLP principles. Three female rabbits were exposed to 0.5 mL of the test article by application onto clipped skin. The test article was covered with a metalline patch mounted on micropore tape which was wrapped around the abdomen and secured with Coban elastic bandage. Following a 4 hour exposure to the test article, the site was washed with tap water and skin reactions were assessed at 1, 24, 48 and 72 hours. Four hours exposure to 0.5 mL of the test article resulted in very slight edema in the treated areas of two of the three rabbits. The skin irritation resolved within 24 hours after exposure in these animals. Based on the results of the study (PII= 0.22), the test article is not a skin irritant.