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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:
From February 16, 2016 to November 08, 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Evercion SR61
- Substance type: Powder
- Composition of test material, percentage of components: 84.05 %
- Lot/batch No.: 4501
- Storage condition of test material: Ambient

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
- Source: WEI XIN HANG
- Weight at study initiation: 2.6952 to 3.0700 kg
- Housing: individually in a stainless steel cage
- Water: ad libitum
- Acclimation period: 7 days
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 55 ± 15%
- Photoperiod: 12hrs dark / 12hrs light

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
yes, concurrent vehicle
Amount / concentration applied:
- Amount(s) applied (volume or weight with unit): 0.5 g test article was moistened with 0.5 mL normal saline
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours
Number of animals:
three
Details on study design:
- Area of exposure: upper left and lower right dorsal area
- Washing (if done): with distilled water

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Score:
0
Remarks on result:
no indication of irritation

Any other information on results incl. tables

Table 1. Body weight of the rabbits

Animal ID

Sex

Body weight (kg)

Day 1

Day 4

16

Female

3.0700

3.1088

17

Female

2.6952

2.7374

23

Female

2.9372

2.9776

Table 2. Individual skin reactions

Animal I.D.

Observation time (hours)

Grading (erythema / edema)

Test area

Control area

16

1

0/0

0/0

0/0

0/0

24± 1

0/0

0/0

0/0

0/0

48 ± 1

0/0

0/0

0/0

0/0

72 ± 1

0/0

0/0

0/0

0/0

17

1

0/0

0/0

0/0

0/0

24 ± 1

0/0

0/0

0/0

0/0

48 ± 1

0/0

0/0

0/0

0/0

72 ± 1

0/0

0/0

0/0

0/0

23

1

0/0

0/0

0/0

0/0

24 ± 1

0/0

0/0

0/0

0/0

48 ± 1

0/0

0/0

0/0

0/0

72 ± 1

0/0

0/0

0/0

0/0

Table 3. Individual animal primary irritation scores

Animal I.D.

Scoresa

Primary Irritation Scores (PIS)b

Test area

Control area

16

0

0

0

17

0

0

0

23

0

0

0

Primary Irritation Index (PII)c= 0

a Sum of scores at all time intervals on backside skin in each rabbit and divided the sum by the total number of observation.

b PIS = (scores of test area) – (scores of control area).

c PII = Sum of PIS÷number of animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to OECD 404 test method and Evaluation table for single dermal irritation, the PII for Evercion SR61 was 0 and Evercion SR61 was categorized as non-irritant. Therefore, Evercion SR61 was not met a category based on GHS criteria.
Executive summary:

This test using the procedures outlined in the SuperLab Study Plan for M62-151100093001EN which is based on the SOP for the OECD 404 (SOPP-305) and OECD 404 (OECD, 2015). The sites were grades for erythema and edema at 1, 24, 48 and 72 hours after the patches removal. No clinical signs of toxicity were found. Body weight changes were within the normal range in all animals. All animals was no formation of erythema, eschar or edema on the test area within 72 hours after patch removal. The Primary Irritation Index for Evercion SR61 was calculated to be 0. On the basis of the test results given above and according to Evaluation table for single dermal irritation, the response of Evercion SR61 was categorized as non-irritant.