Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: - | CAS number: -
Skin irritation / corrosion
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:
- 2 015
- 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
- Test material form:
- solid: particulate/powder
Constituent 1
- 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
