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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:
2014-11-25~2014-11-28
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2014
Report Date:
2014

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):Everdirect SH05(DR224)
- Substance type:Powder
- Composition of test material, percentage of components:68.89%
- Lot/batch No.:4501
- Expiration date of the lot/batch:2016-10-31
- Storage condition of test material:Refrigeration (5 ± 3℃)

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Duration of treatment / exposure:
Test article in a dose of 0.5 g were applied topically on backside skin of test animals for 4 hrs.
Observation period:
1, 24, 48 and 72 hrs after patch removal
Number of animals:
Three female New Zealand white rabbits

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 70
Time point:
other: 1, 24, 48 and 72 hrs
Score:
0
Remarks on result:
other: no erythema
Irritation parameter:
edema score
Basis:
animal: 70
Time point:
other: 1, 24, 48 and 72 hrs
Score:
0
Remarks on result:
other: no edema
Irritation parameter:
erythema score
Basis:
animal: 71
Time point:
other: 1, 24, 48 and 72 hrs
Score:
0
Remarks on result:
other: no erythema
Irritation parameter:
edema score
Basis:
animal: 71
Time point:
other: 1, 24, 48 and 72 hrs
Score:
0
Remarks on result:
other: no edema
Irritation parameter:
erythema score
Basis:
animal: 72
Time point:
other: 1, 24, 48 and 72 hrs
Score:
0
Remarks on result:
other: no erythema
Irritation parameter:
edema score
Basis:
animal: 72
Time point:
other: 1, 24, 48 and 72 hrs
Score:
0
Remarks on result:
other: no edema
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: overall at 1, 24, 48 and 72 hrs
Score:
0
Remarks on result:
other: non-irritant

Any other information on results incl. tables

Table 1 : Body weight of the rabbits

Animal I.D.

Sex

Body weight (kg)

Day 1

Day 4

70

Female

2.0206

2.1040

71

Female

2.0326

2.0998

72

Female

2.0328

2.1106

Table 2 : Individual skin reaction

Animal I.D.

Observation time (hours)

Grading (erythema/edema)

Test area

Control area

70

1

0/0

0/0

0/0

0/0

24

0/0

0/0

0/0

0/0

48

0/0

0/0

0/0

0/0

72

0/0

0/0

0/0

0/0

71

1

0/0

0/0

0/0

0/0

24

0/0

0/0

0/0

0/0

48

0/0

0/0

0/0

0/0

72

0/0

0/0

0/0

0/0

72

1

0/0

0/0

0/0

0/0

24

0/0

0/0

0/0

0/0

48

0/0

0/0

0/0

0/0

72

0/0

0/0

0/0

0/0

Table 3 : Individual animal primary irritation scores

Animal I.D.

Scores

Primary Irritation Scores (PIS)

Test area

Control area

70

0

0

0

71

0

0

0

72

0

0

0

Primary Irritation index (PII) = 0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The dorsal part of three New Zealand white rabbits after single dermal application with the test article for 4 hours were observed by experienced veterinarian, and found that there was no irritation response within 72 hours after patch removal. The primary irritation index (PII) of the test article was zero.
Executive summary:

According to OECD Guideline 404 (Acute Dermal Irritation / Corrosion), the test article was considered as non-irritant on the skin of the New Zealand white rabbits. The test results are "non irritating", so that hazard category in CLP is not classified.