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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 278-145-6 | CAS number: 75234-41-2
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: method not exactly as in standard, no GLP; short report with limited data
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- intact an abraded skin; 6 Animals; evaluation at 24 and 72 hours only
- GLP compliance:
- no
- Remarks:
- predates GLP regulation
Test material
- Reference substance name:
- Trisodium bis[2-[[2,4-dihydroxy-3-[(2-methyl-4-sulphophenyl)azo]phenyl]azo]benzoato(3-)]chromate(3-)
- EC Number:
- 278-145-6
- EC Name:
- Trisodium bis[2-[[2,4-dihydroxy-3-[(2-methyl-4-sulphophenyl)azo]phenyl]azo]benzoato(3-)]chromate(3-)
- Cas Number:
- 75234-41-2
- Molecular formula:
- C40H26CrN8O14S2.3Na
- IUPAC Name:
- trisodium bis[2-[[2,4-dihydroxy-3-[(2-methyl-4-sulphophenyl)azo]phenyl]azo]benzoato(3-)]chromate(3-)
- Test material form:
- not specified
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- No data
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 500 mg per patch
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 1 square inch per patch
- Type of wrap if used: the gauze patches were held in place by a rubberized cloth.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 24 hours
SCORING SYSTEM: according to US CFR title 16, section 1500.41; similar to Draize system.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- all animals showed identical reactions
- Time point:
- other: 24 h and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- all animals showed identical reactions
- Time point:
- other: 24 h and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24h and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- No irritation
- Other effects:
- none
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material did not induce skin irritation.
- Executive summary:
After single occlusive exposure of intact as well as abraded clipped skin for 24 hours with 500 mg of moistened test material per site none of 6 animals showed irritation reactions. Neither erythema nor edema were observed at any treated site.
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.
