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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 Decenber 29, 2015 to February 18, 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
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

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
- Source: Kitayama Labes Co., Ltd. (Japan)
- Age at study initiation: approximately 5 to 6 months
- Weight at study initiation: 2891 to 3910 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

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 0.3 mL water for injection
Duration of treatment / exposure:
4-4.5 hours
Observation period:
1, 24, 48, 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

Results
Irritation parameter:
primary dermal irritation index (PDII)
Score:
0.22
Reversibility:
fully reversible within: 72 hours
Remarks on result:
probability of mild 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

2891

2931

40

Normal

2

3910

3929

19

Normal

3

3031

3049

18

Normal

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

Animal ID

1

2

3

Score on each observation point (hour)

1

24

48

72

1

24

48

72

1

24

48

72

Control site

Erythema

0

0

0

0

0

0

0

0

0

0

0

0

Edema

0

0

0

0

0

0

0

0

0

0

0

0

Total irritation score for vehicle*

0

0

0

Test site

Erythema

1

1

1

0

0

0

0

0

0

0

0

0

Edema

0

0

0

0

0

0

0

0

0

0

0

0

Total irritation score for vehicle*

2

0

0

PII**

0.22

* The sum of scores at 24, 48 and 72 hours.

** (Total irritation score for test article-Total irritation score for vehicle)/9

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 result does not meet the CLP criteria. Therefore, CJ302 is not classified.
Executive summary:

This test using the procedures outlined in the QPS Taiwan Study Plan for T65315014-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. Erythema with score 1 was observed in one animal during 48 hours after patch removal. The Primary Irritation Index for CJ302 was calculated to be 0.22. On the basis of the test results given above and according to Draize Dermal Classification System, the response of CJ302 was not classified.