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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
EC number: 274-434-6 | CAS number: 70210-37-6
- 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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Well-documented study report which meets basic scientific principles, but low purity of the substance in the tested mixture.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Repeated Insult Patch Test was performed on 200 human volunteers to determine if the test material is capable of irritating the skin of humans under controlled test conditions. The test material was applied under occlusion for a series of effective contact periods of two days' duration. If no reactions occurred, the test material was re-applied immediately for another forty-eight-hour period. This cycle was repeated for three more weeks, so that a series of eight forty-eight-hour applications were completed. in addition, Sites were re-examined twenty-four and forty-eight hours later for delayed reactions.
- GLP compliance:
- no
- Remarks:
- pre-GLP
Test material
- Reference substance name:
- Disodium 5-(benzoylamino)-4-hydroxy-3-[[2-(2-methylphenoxy)phenyl]azo]naphthalene-2,7-disulphonate
- EC Number:
- 274-434-6
- EC Name:
- Disodium 5-(benzoylamino)-4-hydroxy-3-[[2-(2-methylphenoxy)phenyl]azo]naphthalene-2,7-disulphonate
- Cas Number:
- 70210-37-6
- Molecular formula:
- C30H21N3O9S2.2Na
- IUPAC Name:
- disodium (E)-5-benzamido-4-hydroxy-3-((2-(otolyloxy)phenyl)diazenyl)naphthalene-2,7-disulfonate
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- confirmed, but no further information available
- Subjects:
- Number of subjects exposed: 200
The criteria for qualifying were:
- General well-being.
- Absence of any skin disease which might be confused with skin reactions from the test material.
- Willingness to cooperate.
- Dependability and intelligence in following directions. - Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST USED: Repeated insult patch test
ADMINISTRATION
- Type of application: occlusive
- Description of patch: size 3 cm x 3 cm
- Removal of test substance: after two days
- Tested as: composite 4 %
PROCEDURE
On Monday, the test material was applied. The participants were instructed to contact the laboratory and inform the investigator immediately if any discomfort was felt at the patch site. On Wednesdays, the patches were removed, the contact sites examined, and the reactions, if any, were graded and recorded. If no reactions occurred, the test material was re-applied immediately for another forty-eight-hour period. The participants were instructed to call the laboratory on Thursday if any discomfort was felt. On Friday, the covers were removed and the contact sites were again examined and graded. The contact sites were then rested until the following Monday. This cycle was repeated for three more weeks, so that a series of eight forty-eight-hour applications were completed.
On the second Monday following the removal of the last series of applications, the test material was applied to the same contact site. The covers were removed on Wednesday, thereby effecting a challenge contact period of forty-eight hours' duration. The contact sites were examined for visible changes which, if present, were graded and recorded. Sites were re-examined twenty-four and forty-eight hours later for delayed reactions.
EXAMINATIONS
- Grading/Scoring system:
0 = No reactions.
1+ = Slight erythema.
2+ = Marked erythema.
3+ = Marked erythema, edema, with or without a few vesicles.
4+ = Marked erythema, edema, with vesicles and oozing.
- Other: Sites were re-examined twenty-four and forty-eight hours later for delayed reactions.
Results and discussion
- Results of examinations:
- No. of person with/without reactions compared to study population:
- Number of subjects with positive reactions: 1
- Number of subjects with negative reactions: 199
- Skin Changes Accompanying Application No. 1:
No visible skin changes signifying reaction to injury were observed in any of the 200 subjects.
- Skin Changes Accompanying Application Nos. 2 through 8:
Visible skin changes signifying reaction to injury were observed in 1 out of 200 subjects.
- Skin Changes Accompanying Challenge Application:
No visible skin changes signifying reaction to injury were observed in any of the 200 subjects.
Reaction of the case reported: marked erythema during application number 2 and 3
Any other information on results incl. tables
Summary of reaction grades:
Number of reaction in grades indicated | ||||||
Number of application | 0 | 1+ | 2+ | 3+ | 4+ | NP |
1 | 200 | 0 | 0 | 0 | 0 | 0 |
2 | 199 | 0 | 1 | 0 | 0 | 0 |
3 | 199 | 0 | 1 | 0 | 0 | 0 |
4 | 200 | 0 | 0 | 0 | 0 | 0 |
5 | 200 | 0 | 0 | 0 | 0 | 0 |
6 | 200 | 0 | 0 | 0 | 0 | 0 |
7 | 200 | 0 | 0 | 0 | 0 | 0 |
8 | 200 | 0 | 0 | 0 | 0 | 0 |
Challenge | 200 | 0 | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Conclusions:
- The test substance did elicit visible skin changes consistent with a fatiguing agent in 1 out of 200 subjects.
- Executive summary:
Repeated Insult Patch Test was performed on 200 human volunteers.The test material was applied under occlusion for a series of effective contact periods of two days' duration.
The test substance was not capable of eliciting visible skin changes consistent with the criteria deemed characteristic of a primary irritant or sensitizer. It did elicit visible skin changes consistent with a fatiguing agent in 1 out of 200 subjects.
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.