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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 401-300-8 | CAS number: 86168-95-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Body responsible for the test
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 12.05.81
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- Body responsible for the test
- IUPAC Name:
- Body responsible for the test
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- New Zealand white rabbits (KFM-NZW), 3 males
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- other: distilled water
- Controls:
- not specified
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4h
- Observation period:
- no data
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: erythema/eschar
- Basis:
- animal #1
- Time point:
- other: calculated on the basis of the scores at 24, 48 and 72 hours for each animal
- Score:
- 0.66
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 d
- Remarks on result:
- other: Max. duration: 72 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- other: erythema/eschar
- Basis:
- animal #2
- Time point:
- other: calculated on the basis of the scores at 24, 48 and 72 hours for each animal
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 d
- Remarks on result:
- other: Max. duration: 72 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- other: erythema/eschar
- Basis:
- animal #3
- Time point:
- other: calculated on the basis of the scores at 24, 48 and 72 hours for each animal
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 d
- Remarks on result:
- other: Max. duration: 72 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: calculated on the basis of the scores at 24, 48 and 72 hours for each animal
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 d
- Remarks on result:
- other: Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: calculated on the basis of the scores at 24, 48 and 72 hours for each animal
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 d
- Remarks on result:
- other: Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: calculated on the basis of the scores at 24, 48 and 72 hours for each animal
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 d
- Remarks on result:
- other: Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- other: edema/eschar
- Basis:
- mean
- Time point:
- other: 24-72h
- Score:
- 0.11
- Max. score:
- 1
- Reversibility:
- fully reversible within: 3 d
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0.22
- Max. score:
- 1
- Reversibility:
- fully reversible within: 3 d
Any other information on results incl. tables
Comments: 4105 SKIN IRR
RESULT: Non-irritant. Maximum grading = 1.
Not classified as skin irritant
Changes fully reversible within 3 days
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The value of the scores for erythema and edema was 0 in all animals. The substance is not classified as irritating or corrosive to the skin.
The test substance can be classified as non-irritant according to the EEC directive No. 83/467/1983 in albino rabbits
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.
