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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 263-417-9 | CAS number: 62121-75-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- other: data sharing dispute
- Adequacy of study:
- key study
- Study period:
- 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: FDA Patch Test
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- p-[4,5-dihydro-4-[[2-methoxy-5-methyl-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonic acid, sodium salt
- EC Number:
- 263-417-9
- EC Name:
- p-[4,5-dihydro-4-[[2-methoxy-5-methyl-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonic acid, sodium salt
- Cas Number:
- 62121-75-9
- Molecular formula:
- C20H22N4O11S3.xNa C20H(22-x)N4NaxO11S3; x<=2
- IUPAC Name:
- sodium 4-[4-(2-{2-methoxy-5-methyl-4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)-3-methyl-5-oxo-4,5-dihydro-1H-pyrazol-1-yl]benzene-1-sulfonate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- - Test animal weight: 1.5 - 2.0 kg
- One cage per animal
- Feeding: standard food ERKA 8300, ad libitum
- Water: tap drinking water, ad libitum
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg powder - Duration of treatment / exposure:
- 1 treatment at 0 h
- Observation period:
- 72 h
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm²
- Type of wrap if used: gaze and PVC sheet (coverage)
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h
OBSERVATION TIME POINTS: 24 h, 48 h, 72 h
SCORING SYSTEM:
- Method of calculation: erythema (scoring 0-4) and oedema (scoring 0-4)
- The erythema and oedema scores were calculated for each individual animal after 25 and 72 h. The
sum of the scores for all rabbits was divided by 6 (number of test animals) and then by 4 (scoring).
The classification is: 0.0 - 0.5: non irritant, 0.6 - 3.0: slightly irritant, 3.1 - 5.0 (moderately irritant), 5.1 -
8.0: severely irritant
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: overall irritation score based on erythema and oedema score
- Basis:
- mean
- Time point:
- other: 24 and 72 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: not irritating
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not irritating
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not irritating
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No irritation observed.
- Other effects:
- - Other adverse local effects: none
- Other adverse systemic effects: none
Any other information on results incl. tables
Endpoint | 24 h | 48 h | 72 h | |
Scarified skin sum of 6 animals | Erythema | 0 | 0 | 0 |
Oedema | 0 | 0 | 0 | |
Intact skin sum of 6 animals | Erythema | 0 | 0 | 0 |
Oedema | 0 | 0 | 0 | |
Sum | 0 | 0 | 0 | |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No skin irritation (erythema and oedema scoring) was observed at 24h, 48h and 72h after a 24h
patch exposure with the pure substance on rabbits. Therefore, the substance is not considered to be
irritating to skin according to CLP criteria.
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.
