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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 268-516-0 | CAS number: 68110-27-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20.1. - 3.2.1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- OECD Guidelines for Testing of Chemicals, Paris, 1992
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,3-Benzenedisulfonic acid, 4-[[5-(aminocarbonyl)-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridinyl]azo]-6-[[4-[[3-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-sulfophenyl]amino]-6-chloro-1,3,5-triazin-2-yl]amino]-, trisodium salt
- EC Number:
- 268-516-0
- EC Name:
- 1,3-Benzenedisulfonic acid, 4-[[5-(aminocarbonyl)-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridinyl]azo]-6-[[4-[[3-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-sulfophenyl]amino]-6-chloro-1,3,5-triazin-2-yl]amino]-, trisodium salt
- Cas Number:
- 68110-27-0
- Molecular formula:
- C27H24Cl2N14O12S3.3Na
- IUPAC Name:
- 1,3-Benzenedisulfonic acid, 4-[[5-(aminocarbonyl)-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridinyl]azo]-6-[[4-[[3-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-sulfophenyl]amino]-6-chloro-1,3,5-triazin-2-yl]amino]-, trisodium salt
- Details on test material:
- Other name: Ostazinová žluť H8-GSOURCE OF TEST MATERIAL- Source and lot/batch No.of test material: 920/389 (sample supplied by the sponsor)- Expiration date of the lot/batch: unlistedSTABILITY AND STORAGE CONDITIONS OF TEST MATERIAL- Storage condition of test material: at laboratory conditions
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: Spolek chovatelů. Hradec Králové with veterinary health certificate; clinical examination confirmed the good state of health- Age at study initiation: not specified- Weight at study initiation: more than 2.5 kg- Housing: individually in metal cages (Velaz Praha)- Diet: ad libitum (standard granulated diet for rabbits TM-MAK1; Bergman)- Water: ad libitum (tap water acc. ČSN 757111)- Acclimation period: not specifiedENVIRONMENTAL CONDITIONS- Temperature (°C): 18±3- Humidity (%): 30 – 70%- Air changes (per hr): not specified- Photoperiod (hrs dark / hrs light): 12 /12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- only a bit moisturized with water before aplication
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 1, 24, 48, 72 hours
- Number of animals:
- 3 animals
- Details on study design:
- TEST SITE - Area of exposure: 6x6 cm - Type of wrap if used: A sample a bit moisturized with water was covered with gauze, Alu-foil and cellulose wadding as last layer and fixed by technical tape for contact of a substance with shaved skin. REMOVAL OF TEST SUBSTANCE - Washing (if done): not specified - Time after start of exposure: 4 hoursOBSERVATION TIME POINTS1, 24, 48, 72 hoursSCORING SYSTEM: see Any other information ...
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- animal: 20
- Time point:
- other: 1/24/48/72 h
- Score:
- 0
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Time point:
- other: 1/24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 1 h
- Score:
- 1
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 1 h
- Score:
- 1
- Irritation parameter:
- overall irritation score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The sample, Ostazinová žluť H8-G, is not irritating to the skin of the rabbit.
- Executive summary:
In the sample Ostazinová žluť H8-G, the skin irritation test was carried out on New Zealand white rabbit breeds.
Examination of skin irritation has shown that the sample is not irritating to the skin of the rabbit.
The skin irritation test was performed according to OECD methodology No. 404.
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.
