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EC number: 261-874-9 | CAS number: 59709-38-5
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: ETAD test method 14.10.76
- Version / remarks:
- Hazleton Manual of Standard Operating Procedures as applied to ETAD test method 14.10.76 from Code of Federal Regulations, Title 16, Section 1400.41
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP
Test material
- Reference substance name:
- Methyl N-[4-[(2-bromo-6-chloro-4-nitrophenyl)azo]phenyl]-N-(3-methoxy-3-oxopropyl)-β-alaninate
- EC Number:
- 261-874-9
- EC Name:
- Methyl N-[4-[(2-bromo-6-chloro-4-nitrophenyl)azo]phenyl]-N-(3-methoxy-3-oxopropyl)-β-alaninate
- Cas Number:
- 59709-38-5
- Molecular formula:
- C20H20BrClN4O6
- IUPAC Name:
- methyl N-[4-[(2-bromo-6-chloro-4-nitrophenyl)azo]phenyl]-N-(3-methoxy-3-oxopropyl)-β-alaninate
- Test material form:
- solid: granular
- Details on test material:
- Disperse Brown 19
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Six New Zealand White rabbits, free from any obvious skin lesions and weighing not less than 2.0 kg were used for the study. They were obtained from Buxted Rabbit Co. Ltd., Great Totease Farm, Buxted, Nr. Uckfield, Sussex.
Diet
The animals were allowed unlimited access to mains water and food (Standard Rabbit Diet - BP Nutrition (U.K.) Ltd., Stepfield, Witham, Essex) throughout the study.
Environment
The animals were housed individually in grid floor cages in a single room maintained under conditions of ambient humidity and temperature except that a lower temperature of 14°C is automatically imposed, and exposed to natural lighting conditions.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- 6 animals
- Details on study design:
- Procedure and observations
The animals were identified by a number stamped on a metal ear tag.
Twenty four hours prior to treatment, the back of each animal was shaved using electric clippers. One side of the shaven area on each animal was left intact. The other side of the shaven area was abraded using a sterile hypodermic needle to scratch a 5 x 5 lattice in an area measuring 2.5 cm x 2.5 cm such that only the stratum corneum was penetrated and bleeding did not occur. The test article (0.5 .g) was applied under gauze pads (2.5 cm x 2.5 cm) to the intact and abraded areas of each rabbit.
The patches were secured by adhesive strapping and the whole trunk further occluded with a stockinette bandage.
Twenty four hours after administration the patches were removed and the skin reactions on both the intact and abraded areas of each rabbit were scored according to Draize, J.H. (1959), Assoc. of Food and Drug Officials of the U.S., Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics.". The evaluation was repeated 48 hours later (72 hours after administration) and finally 7 days after administration if any irritation was apparent at the 72 hour reading.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- fully reversible
- 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:
- fully reversible
- 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:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The primary irritation index of test article Y0154/001 was 0.0. The test article was therefore classified as a non irritant.
- Other effects:
- Red/brown staining of the test area and surrounding skin made the irritation assessment difficult.
Any other information on results incl. tables
Skin irritation reactions
Test article/concentration: Y0154/001, as supplied |
|||||
Rabbit number |
Time (hours) |
Erythema |
Oedema |
||
A |
I |
A |
I |
||
688 |
24 |
0 |
0 |
0 |
0 |
72 |
0 |
0 |
0 |
0 |
|
689 |
24 |
0 |
0 |
0 |
0 |
72 |
0 |
0 |
0 |
0 |
|
691 |
24 |
0 |
0 |
0 |
0 |
72 |
0 |
0 |
0 |
0 |
|
692 |
24 |
0 |
0 |
0 |
0 |
72 |
0 |
0 |
0 |
0 |
|
693 |
24 |
0 |
0 |
0 |
0 |
72 |
0 |
0 |
0 |
0 |
|
694 |
24 |
0 |
0 |
0 |
0 |
72 |
0 |
0 |
0 |
0 |
|
|
Sub total |
0 |
0 |
0 |
0 |
Total |
0 |
0 |
|||
Sex Male |
Primary irritation index |
0/24 = 0.0 |
A = abraded skinI = intact skin
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance did not show any signs of irritation (erythema and edema score: 0.0). The substance is not classifiable according to CLP criteria.
- Executive summary:
The study was carried out to determine the primary irritation index of test article in the albino rabbit. The study was performed in accordance with the Standard Operating Procedures as applied to the ETAD test method 14.10.76 from Code of Federal Regulations, Title 16, Section 140041.
Six New Zealand White rabbits, free from any obvious skin lesions and weighing not less than 2.0 kg were used for the study.
Twenty four hours prior to treatment, the back of each animal was shaved using electric clippers. One side of the shaven area on each animal was left intact. The other side of the shaven area was abraded using a sterile hypodermic needle. The test article (0.5 .g) was applied under gauze pads to the intact and abraded areas of each rabbit. The patches were secured by adhesive strapping and the whole trunk further occluded with a stockinette bandage.
Twenty four hours after administration the patches were removed and the skin reactions on both the intact and abraded areas of each rabbit were scored. The evaluation was repeated 48 hours later (72 hours after administration) and finally 7 days after administration if any irritation was apparent at the 72 hour reading.
Results
The primary irritation index of test article was 0.0. The test article was therefore classified as a non irritant.
Red/brown staining of the test area and surrounding skin made the irritation assessment difficult.
Conclusion
A primary skin irritation study was performed in the albino rabbit on the test article.
A primary irritation index of 0.0 was obtained. The test article is therefore classified as a non-irritant.
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