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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 235-557-0 | CAS number: 12286-65-6
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: meets basic principles of the guideline, substance was not moistened befor application, age of test animals is not described
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Calcium bis[3-nitro-4-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]benzenesulphonate]
- EC Number:
- 235-557-0
- EC Name:
- Calcium bis[3-nitro-4-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]benzenesulphonate]
- Cas Number:
- 12286-65-6
- Molecular formula:
- C16H14N4O7S.1/2Ca
- IUPAC Name:
- calcium bis(3-nitro-4-{[2-oxo-1-(phenylcarbamoyl)propyl]diazenyl}benzenesulfonate)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Breeding farm VELAZ S.f.O., Kolec u Kladna, Czech Republic, RCH CZ 21760152
- Weight at study initiation: males 258 g, females 189 g
- Housing: singly
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30 - 70
- Air changes (per hr): /
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back
- % coverage: 10
- Type of wrap if used: semiocclusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): water
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution):
- Constant volume or concentration used: unchanged substance, constant dose level, volume individual
- For solids, paste formed: no
VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity: - Duration of exposure:
- 24h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighing before application, 8th and 15th day of study, observation daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs - Statistics:
- not applicable
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- no
- Clinical signs:
- other: no
- Gross pathology:
- no abnormalities
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Conclusions:
- According to the results of study, the value of LD50 (dermal) of the test substance is higher than 2000 mg/kg bw for rats of both sexes.
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.
