Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Diss Factsheets
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.
Reaction mass of Cobaltate(2-), [2-[[[4-hydroxy-3-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]phenyl]sulfonyl]amino]benzoato(3-)][2-[[2-hydroxy-5-[(phenylamino)sulfonyl]phenyl]azo]-3-oxo-N-phenylbutanamidato(2-)]-, disodium and Cobaltate(3-), bis[2-[[[4-hydroxy-3-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]phenyl]sulfonyl]amino]benzoato(3-)]-, trisodium and sodium bis[2-[[2-hydroxy-5-[(phenylamino)sulphonyl]phenyl]azo]-3-oxo-N-phenylbutyramidato(2-)]cobaltate(1-)
EC number: 947-257-3 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Not skin sensitising
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Old test
- Species:
- guinea pig
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Housing: 5 animals were housed in each cage.
- Diet: a standard laboratory diet was provided, ad libitum. The batch of the diet used for the study was analysed for ctremical and microbiological contaminants.
- Acclimation period: all animals were acclimatized to the environment for a period of seven days prior to the start of the study.
- Indication of any skin lesions: 24 hours prior to the test, the skin of the back was clipped by means of an electric clipper and the skin was investigated for pre-existing injuries. This was repeated on days 7 and 22. The skin was cleaned with 10 % sodium laurylsulfate on day 7.
ENVIRONMENTAL CONDITIONS
- Temperature: 23 ± 1 °C
- Relative humidity: 50 ± 5 %
- Air changes: approx. 10-15 air changes per hour.
- Photoperiod: 12 hrs dark / 12 hrs Iight. - Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- 5 %
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 5 %
- No. of animals per dose:
- 20 animals per group
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal injection
- No. of exposures: test was started with three intradermal paired injections.
Epicutaneous
- Application: a patch (25 cm2) soaked with 3 mI was fixed on the clipped backs.
- Exposure period: 48 hours
- Control group: only water or adjuvant were used.
B. CHALLENGE EXPOSURE
- Day(s) after start: 21
- Exposure period: 24 hours
- Evaluation: after 24 and 48 hours respectively, the patches were removed and the resulting reactions were evaluated. - Positive control substance(s):
- yes
- Remarks:
- 1-chloro-2,4-dinitrobenzene
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 1 %
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 3 ml water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Interpretation of results:
- other: not classified, according to the CLP Regulation (EC) No 1272/2008
- Conclusions:
- Not skin sensitising
- Executive summary:
60 guinea pigs were divided in three groups, 20 animals each group: one group was treated with test item; another with 1-chloro-2,4-dinitrobenzene (DNCB) as a positive control and the third group served as negative controls, treated with water and Freuds Adjuvant alone.
Test substance was dissolved with water or Adjuvant respectively to 5 % solution, which was used for the paired injection on day 1 of the study. The test was started with three intradermal paired injections; on day 8, a patch (25 cm2) soaked with 3 ml was fixed for 48 hours on the clipped backs. 21 days after the start, the flanks of the animals were clipped and on the next day a patch was fixed for 24 hours, using test item 3 ml of the 5 % solution for the treated and negative control animals.
After 24 or 48 hours respectively, the patches were removed and the resulting reactions were evaluated.
The test item administered to guinea pigs, according to the maximization test, resulted in no reaction after 24, 48 and 72 hours respectively. In contrast, DNCB, a well known sensitizer, was positive after 24, 48 and 72 hours.
It can be concluded that test substance was not a sensitizer.
Conclusion
Less than ≥ 30 % of exposed population, showed positive reactions at intradermal induction dose higher than 1 %.
Reference
The test item administered to guinea pigs, according to the maximization test, resulted in no reaction after 24, 48 and 72 hours respectively. In contrast, DNCB, a well known sensitizer, was positive after 24, 48 and 72 hours.
It can be concluded that test substance was not a sensitizer.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
60 guinea pigs were divided in three groups, 20 animals each group: one group was treated with test item; another with 1-chloro-2,4-dinitrobenzene (DNCB) as a positive control and the third group served as negative controls, treated with water and Freuds Adjuvant alone. Test substance was dissolved with water or Adjuvant respectively to 5 % solution, which was used for the paired injection on day 1 of the study. The test was started with three intradermal paired injections; on day 8, a patch (25 cm2) soaked with 3 ml was fixed for 48 hours on the clipped backs. 21 days after the start, the flanks of the animals were clipped and on the next day a patch was fixed for 24 hours, using test item 3 ml of the 5 % solution for the treated and negative control animals.
After 24 or 48 hours respectively, the patches were removed and the resulting reactions were evaluated.
The test item administered to guinea pigs, according to the maximization test, resulted in no reaction after 24, 48 and 72 hours respectively. In contrast, DNCB, a well known sensitizer, was positive after 24, 48 and 72 hours. It can be concluded that test substance was not a sensitizer.
Since the Acid Yellow 235 lot tested in the key study was characterized by an appreciable non-hazardous impurity content, the available data on structural analogous Similar Substance 01 has been taken into account, in order to confirm the study outcomes. The read across approach can be considered as reliable and adequate for the purpose; details and explanations are detailed in the report attached to the IUCLID section 13.2.
The study was performed to detect the sensitisation potential of the Similar Substance 01 in the guinea pig maximisation test, by following the OECD Guideline No. 406. During induction phase on day 0 test substance was delivered by intradermal injections, with test item at 5 %. On day 8 of epidermal induction was performed with 50 % of test item in physiological saline, under occlusive conditions. During the challenge phase the test substance was administrated at 30 % in physiological saline.
No animal of the test group was sensitised by the substance under the experimental condition employed.
Justification for classification or non-classification
According to the CLP Regulation (EC) No 1272/2008, 3.4 Respiratory or skin sensitisation section, skin sensitizer means a substance that will lead to an allergic response following skin contact.
Based on the Guinea Pig Maximisation Test (GPMT) results, a substance is considered a skin sensitizer when: equal or more than 30 % to 60 % responding at intradermal induction dose > 0.1 % to ≤ 1 %; or equal or more than 30 % responding at intradermal induction dose higher than 1 %.
Less than ≥ 30 % of exposed population showed positive reactions at intradermal induction dose higher than 1 %.
In conclusion, Acid Yellow 235 does not meet the criteria to be classified as skin sensitizer, according to the CLP Regulation (EC) No 1272/2008.
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.