Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 11, 2016 to December 07, 2016. 24 hour exposure.
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 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
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): Everdirect SH12
- Substance type: Powder
- Composition of test material, percentage of components: 69.96 %
- Lot/batch No.: 3506
- Storage condition of test material: Ambient

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
- Source: BioLASCO Taiwan Co. Ltd.
- Age at study initiation: about 7 weeks old
- Housing: Male and female rats were fed, respectively. Two rats per cage in an autoclaved polyethylene cage.
- Acclimation period: 7 Days
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 15%
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Type of coverage:
occlusive
Vehicle:
olive oil
Duration of exposure:
24 hours
Doses:
2000 mg/kg B.W.
No. of animals per sex per dose:
For male: six
For female: six
Control animals:
yes, concurrent vehicle

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
no indication of skin irritation up to the relevant limit dose level

Any other information on results incl. tables

Table 1. Body weight of the rats in the study period

Group

Animal I.D.

Dosing volume (mL)

Body weight (g)

Weight chenges(g)

Day 1

Day 14

Control

01M

0.6

284.0

337.7

+53.7

02M

0.6

286.1

336.1

+50.0

03M

0.6

289.5

362.1

+72.6

04M

0.6

294.9

374.2

+79.3

05M

0.6

297.6

360.0

+62.4

06M

0.6

292.3

386.0

+93.7

Test

07M

0.6

284.8

340.0

+55.2

08M

0.6

286.3

345.0

+58.7

09M

0.6

291.7

340.0

+48.3

10M

0.6

295.1

350.0

+54.9

11M

0.6

295.5

340.0

+44.5

12M

0.6

295.2

360.0

+64.8

Control

13F

0.4

206.2

241.7

+35.5

14F

0.4

211.8

251.1

+39.3

15F

0.4

216.4

239.4

+23.0

16F

0.4

214.7

254.8

+40.1

17F

0.4

218.1

267.5

+49.4

18F

0.4

219.7

260.4

+40.7

Test

19F

0.4

211.0

246.3

+35.3

20F

0.4

213.1

252.6

+39.5

21F

0.4

214.6

241.1

+26.5

22F

0.4

214.6

258.7

+44.1

23F

0.4

219.2

265.1

+45.9

24F

0.4

221.3

256.2

+34.9

Table 2. Clinical observation of the rats

Animal I.D.

Clinical sign observation

30 mins

4 hours

D2

D3

D4

D5

D6

D7

D8

D9

D10

D11

D12

D13

D14

01M

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

02M

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

03M

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

04M

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

05M

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

06M

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

07M

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

08M

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

09M

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

10M

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

11M

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

12M

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

13F

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

14F

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

15F

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

16F

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

17F

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

18F

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

19F

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

20F

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

21F

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

22F

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

23F

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

24F

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

DX: Day X in the study period

N: Normal

 

Table 3. Results of gross necropsy examination

Animal I.D.

Dose

Gross lesion

01M

No significant lesion founded

02M

No significant lesion founded

03M

No significant lesion founded

04M

No significant lesion founded

05M

No significant lesion founded

06M

No significant lesion founded

07M

2000 mg/kg B.W.

No significant lesion founded

08M

No significant lesion founded

09M

No significant lesion founded

10M

No significant lesion founded

11M

No significant lesion founded

12M

No significant lesion founded

13F

No significant lesion founded

14F

No significant lesion founded

15F

No significant lesion founded

16F

No significant lesion founded

17F

No significant lesion founded

18F

No significant lesion founded

19F

2000 mg/kg B.W.

No significant lesion founded

20F

No significant lesion founded

21F

No significant lesion founded

22F

No significant lesion founded

23F

No significant lesion founded

24F

No significant lesion founded

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to OECD 402 test method, the LD50 of Everdirect SH12 was greater than 2000 mg/kg B.W.. Therefore, Everdirect SH12 was Category 5 based on GHS criteria.
Executive summary:

This test using the procedures outlined in the SuperLab for M62-151100081001EN which is based on the SOP (SOPP-342) for the OECD 402 and OECD 402 (OECD, 1987). Six male and six female Sprague-Dawley rats for each group were used in limit test. For Test group, 12Sprague-Dawley ratsweredermally dosed with 2000 mg/kg B.W. of Everdirect SH12. All animals tolerated the test article well with increasing body weights and no mortality or gross lesions findings reported. In absence of mortality or other significant clinical signs of toxicity, LD50 of Everdirect SH12 was greater than 2,000 mg/kg B.W..