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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 255-217-5 | CAS number: 41098-56-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test procedures cannot be subsumed under testing guideline, nevertheless are well documented and scientifically acceptable.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-(diethylamino)-1,3,5-triazine-4,2-diyl]imino]]bis(benzene-1,4-disulphonate)
- EC Number:
- 255-217-5
- EC Name:
- Hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-(diethylamino)-1,3,5-triazine-4,2-diyl]imino]]bis(benzene-1,4-disulphonate)
- Cas Number:
- 41098-56-0
- Molecular formula:
- C40H44N12O18S6.6Na
- IUPAC Name:
- hexasodium 2,2'-(ethene-1,2-diylbis{(3-sulfonato-4,1-phenylene)imino[6-(diethylamino)-1,3,5-triazine-4,2-diyl]imino})dibenzene-1,4-disulfonate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf.
- Age at study initiation: approx. 12 -14 weeks.
- Weight at study initiation: 2220 g - 2770 g.
- Housing: individually.
- Diet: ad libitum.
- Water: ad libitum.
- Acclimation period: at least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 30-70 %
- Photoperiod: 12/12 hrs dark / hrs light
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, 72 hours.
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 12 - 16 square cm
- Type of wrap if used: aluminium foil.
SCORING SYSTEM: OECD Scoring System.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Slighly erythema was robserved in one rabbit. The effect is reverseble within 72 hours.
Any other information on results incl. tables
| Animal/sex | Reaction | 1 hr | 24 hrs | 48 hrs | 72 hrs | Mean 24, 48 and 72 hrs |
| 1 | Erythema | 0 | 0 | 0 | 0 | 0.00 |
| 2 | Erythema | 2 | 1 | 0 | 0 | 0.33 |
| 3 | Erythema | 1 | 0 | 0 | 0 | 0.00 |
| 1 | Oedema | 0 | 0 | 0 | 0 | 0.00 |
| 2 | Oedema | 0 | 0 | 0 | 0 | 0.00 |
| 3 | Oedema | 0 | 0 | 0 | 0 | 0.00 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified as skin irritant according to the CLP Regulation
- Conclusions:
- Non irritating.
- Executive summary:
Method
The skin irritation potential was tested in New Zealand White rabbits. The procedure used are similar to those described in the OECD Guidelines 404.
Results
Slight erythema was observed in one rabbit. The effect is reversible within 72 hours.
Conclusion
Mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema/eschar and oedema reactions (in both intact and abraded skin).
In conclusion, the test item can be classified as NON irritating, according to the CLP (EC 1272/2008) Regulation.
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.
