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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 06, 2017 to May 18, 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)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
- Source: the animal health research institute, council of agriculture, executive yuan
- Age at study initiation: approximately 4 to 5 months
- Weight at study initiation: 2924 to 3276 g
- Housing: individually in a stainless steel wire mesh cage
- Water: ad libitum
- Acclimation period: at least 5 days
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 50 ± 20%
- Photoperiod: 12hrs dark / 12hrs light

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Remarks:
Water for injection (WFI)
Controls:
yes, concurrent vehicle
Amount / concentration applied:
- Amount(s) applied (volume or weight with unit): 0.5 g test article was moistened with 0.4 mL water for injection
Duration of treatment / exposure:
4-4.5 hours
Observation period:
1, 24, 48 and 72 hours
Number of animals:
three
Details on study design:
- Area of exposure: left dorsal area
- Washing (if done): with lukewarm water

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
primary dermal irritation index (PDII)
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation

Any other information on results incl. tables

Table 1. Individual Body Weights and Clinical Observations

Animal ID

Body weight (g)

Body weight change (g)

Clinical observation

D1

D4

D4-D1

1

2956

2955

-1

Normal

2

2924

3057

133

Normal

3

3276

3354

78

Normal

Table 2. Individual Scores and Total Scores for Skin Irritation During 72 hours

Animal ID

Observation point

Erythema

Edema

Control Site

1

1 h

0

0

24 h

0

0

48 h

0

0

72 h

0

0

2

1 h

0

0

24 h

0

0

48 h

0

0

72 h

0

0

3

1 h

0

0

24 h

0

0

48 h

0

0

72 h

0

0

Test Site

1

1 h

0

0

24 h

0

0

48 h

0

0

72 h

0

0

2

1 h

0

0

24 h

0

0

48 h

0

0

72 h

0

0

3

1 h

0

0

24 h

0

0

48 h

0

0

72 h

0

0

Total irritation score = 0

PII = 0

Total irritation score = The sum of irritation score got from test site at 24, 48 and 72h minus the sum of irritation score got from control site at the same time points.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to OECD 404 test method and Draize Dermal Classification System, the PII for CR SB32N2 in intact skin was 0 and CR SB32N2 was categorized as non-irritant. CR SB32N2 was not met classification on GHS criteria.
Executive summary:

This test using the procedures outlined in the QPS Taiwan Study Plan for T65316009-IR which is based on the SOP for the OECD 404 (CTPS-TE00440) 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. Neither erythema nor edema was observed within 72 hours. The Primary Irritation Index for CR SB32N2 was calculated to be 0. On the basis of the test results given above and according to Draize Dermal Classification System, the response of CR SB32N2 was categorized as non-irritant.