Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 2014-12-09 to 2014-12-13
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: GB/T 21604-2008 Chemicals-Test method of acute dermal irritation/corrosion
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
no
Remarks:
authorized by CNAS

Test material

Constituent 1
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
- Purity: 100.0%
- Lot No.: KNC110310

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Tianqin biotechnology Ltd., Changsha
- Weight at study initiation: 1.9 - 2.2 kg
- Housing: housed in common environment
- Diet: AII of the feeds were supplied by Tianqin Biotechnology Ltd., Changsha
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-22
- Humidity (%): 54-65

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
other: methylcellulose
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration (if solution): 1 g/mL

VEHICLE
- Concentration (if solution): 1 % methylcellulose solution

NEGATIVE CONTROL
Adjacent areas of untreated skins of each rabbit served as control for the test.
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
2 males and 2 females
Details on study design:
TEST SITE
- Preparation of test area: Approximately 24 h before the test, about 3 cm x3 cm areas of fur was removed from both left and right sides of the animals dorsal. Only the animals with healthy intact skins was used.
- Exposure: A volume of 0.5 mL of the test substance was applied uniformly to a small area of skins on the left sides of the animals. The test substance was covered with a gauze patch with two layers, which was fixed with nonirritating tapes throughout the 4-h exposure period.

REMOVAL OF TEST SUBSTANCE
At the end of the exposure period, the residual test substance was removed with water.

OBSERVATION TIME POINTS
The signs of skin irritation at application site were observed at 24, 48 and 72 h after patch removal.

SCORING SYSTEM:
- Method of calculation: Draize

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:
other: for all animals tested
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: for all animals tested
Irritant / corrosive response data:
No sign of erythema and edema was observed at the skin of the four rabbits during 24h to 72 h.
Other effects:
Individual body weights were rising after exposing.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Not irritant
Conclusions:
The results of the acute dermal irritation/corrosion test showed that the highest average of score was 0 ( 24 - 72 h), and dermal irritation intensity of test item was no irritation.
Executive summary:

The irritation/corrosion effect of the test substance on the skin of mammals were determined using rabbit in accordance with GB/T 21604-2008 Chemicals-Test method of acute dermal irritation/corrosion.

 

No sign of erythema and edema was observed at the skin of the four rabbits during 24h to 72 h. Individual body weights were rising after exposing.

 

Thus the highest average of score was 0 ( 24 - 72 h), no irritation to the animals skin was concluded.