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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 303-161-8 | CAS number: 94158-87-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April/May 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
- Remarks:
- but parallel running acute oral study was conducted under GLP
Test material
- Reference substance name:
- 4-[[2-[[2,5-dimethoxy-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-1,3-dioxobutyl]amino]-5-methoxy-2-methylbenzenesulphonic acid, sodium salt
- EC Number:
- 303-161-8
- EC Name:
- 4-[[2-[[2,5-dimethoxy-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-1,3-dioxobutyl]amino]-5-methoxy-2-methylbenzenesulphonic acid, sodium salt
- Cas Number:
- 94158-87-9
- Molecular formula:
- C22H(27-x)N3NaxO14S3 x<=2 C22H27N3O14S3.xNa
- IUPAC Name:
- 4-[[2-[[2,5-dimethoxy-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-1,3-dioxobutyl]amino]-5-methoxy-2-methylbenzenesulphonic acid, sodium salt
- Test material form:
- solid: particulate/powder
- Details on test material:
- Reactive Yellow 160
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, Kastengrund, konventionelle Zucht
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 2 - 3 kg
- Housing: single
- Diet (e.g. ad libitum): Altromin 2013 Zuchtdiät - Kaninchen (Altromin GmbH, Lage/Lippe), ad libitum
- Water (e.g. ad libitum): Water: deionized (ad libitum)
- Acclimation period: NA
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2
- Humidity (%): 55 +/- 10
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 12 To: 15. April 1983
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- physiological saline
- Remarks:
- pasted with 0.35 mL
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours after removal of the adhesive dressing
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 25 cm²
- % coverage:
- Type of wrap if used: gauze and semi-occlusive wrap
REMOVAL OF TEST SUBSTANCE
- Washing (if done): -
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
30 to 60 min, 24, 48, 72 hours after removal of the adhesive dressing
SCORING SYSTEM: Draize
- Method of calculation: mean of 24, 48, 72 hour observations for each animal
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- There was sloght reddening in two animals 30 to 60 min after test substance removal
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the test substance was determined to be not irritating to rabbit skin.
- Executive summary:
A study was conducted to determine the in vivo skin irritation potential of the test substance according OECD Guideline 404 and EU Method B.4. Three rabbits (New-Zealand White) were exposed to 500 mg of the test substance for 4 h. The type of coverage was semi-occlusive, realised on shaved dorsal skin. The observation period was 72 h post-exposure. No erythema, edema or eschar formation was noted in any of the animals. Under the study conditions, the test substance was determined to be not irritating to rabbit skin.
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.
