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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 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 (HLE protocol no. 524/6)
- 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Six New .Zealand White rabbits obtained from Buxted Rabbit Co. Ltd., Great Totease Farm, Buxted, Nr. Uckfield, Sussex were used for the study. At commencement the animals were free from any eye irritation or defects.
Diet
The animals were allowed unlimited access to filtered 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.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- 72 hours (no washing following installation of test article)
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 6 animals
- Details on study design:
- The animals were identified by an indelible number marked on the inner surface of the pinna. The test article (100 mg) was placed in one eye of each animal by gently pulling the lower lid away from the eyeball to form a cup into which the test substance was dropped.
The lids were then gently held together for about one second. The other eye, remaining untreated, served as a control. The eyes were not washed following instillation of the test article.
The eyes were examined 1 hour, 24 hours, 48 hours and 72 hours after instillation and the degree of irritation was 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". Where a substance caused irritation within the first three days after administration the ocular reaction was also assessed on the seventh day. This value was not included in the calculation of the irritant score.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.28
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No further details specified in the study report.
Any other information on results incl. tables
Individual total eye irritation scores
|
Individual total scores |
||
Rabbit number |
24 hours (a) |
48 hours (b) |
72 hours (c) |
347 348 536 540 579 581 |
2 4 4 6 8 6 |
2 2 2 2 2 2 |
0 0 0 0 0 0 |
Total |
30 |
12 |
0 |
Grand total (a + b + c) = 42 |
Irritation score = a + b + c
--------------- = 2.3
18
Individual conjunctival, iridial, corneal irritation scores
Rabbit No. |
TEST ARTICLE Y0154/001 |
||||||||||
Time |
Conjunctivae |
Iris |
Cornea |
(A+B+C) x2 |
Dx5 |
(ExF) x5 |
Total |
||||
A |
B |
C |
D |
E |
F |
||||||
347 |
1 hr 24 hr 48 hr 72 hr 7 days |
2 1 1 0 - |
2 0 0 0 - |
2 0 0 0 - |
0 0 0 0 - |
0 0 0 0 - |
0 0 0 0 - |
12 2 2 0 - |
0 0 0 0 - |
0 0 0 0 - |
12 2 2 0 - |
348 |
1 hr 24 hr 48 hr 72 hr 7 days |
2 1 1 0 - |
2 1 0 0 - |
2 0 0 0 - |
0 0 0 0 - |
0 0 0 0 - |
0 0 0 0 - |
12 4 2 0 - |
0 0 0 0 - |
0 0 0 0 - |
12 4 2 0 - |
536 |
1 hr 24 hr 48 hr 72 hr 7 days |
2 1 1 0 - |
2 1 0 0 - |
2 0 0 0 - |
0 0 0 0 - |
0 0 0 0 - |
0 0 0 0 - |
12 4 2 0 - |
0 0 0 0 - |
0 0 0 0 - |
12 4 2 0 - |
540 |
1 hr 24 hr 48 hr 72 hr 7 days |
2 1 1 0 - |
1 1 0 0 - |
1 1 0 0 - |
0 0 0 0 - |
0 0 0 0 - |
0 0 0 0 - |
8 6 2 0 - |
0 0 0 0 - |
0 0 0 0 - |
8 6 2 0 - |
579 |
1 hr 24 hr 48 hr 72 hr 7 days |
2 1 1 0 - |
2 1 0 0 - |
2 2 0 0 - |
0 0 0 0 - |
0 0 0 0 - |
0 0 0 0 - |
12 8 2 0 - |
0 0 0 0 - |
0 0 0 0 - |
12 8 2 0 - |
581 |
1 hr 24 hr 48 hr 72 hr 7 days |
2 1 1 0 - |
2 1 0 0 - |
2 1 0 0 - |
0 0 0 0 - |
0 0 0 0 - |
0 0 0 0 - |
12 6 2 0 - |
0 0 0 0 - |
0 0 0 0 - |
12 6 2 0 - |
- = observations not made
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance did not cause any signs of irritation in rabbit eyes (cornea opacity, iris). Very weak signs of irritation (chemosis, conjunctivae) were fully reversible within 48 and 72 h, respectively. The substance is not classifiable according to CLP criteria.
- Executive summary:
A study was carried out to determine the eye irritation score of test article in the albino rabbit.
The study was performed in accordance with Standard Operating Procedures as applied to ETAD test method 14.10.76 from Code of Federal Regulations.
Six New Zealand White rabbits were used for the study. At commencement the animals were free from any eye irritation or defects.
The test article (100 mg) was placed in one eye of each animal by gently pulling the lower lid away from the eyeball to form a cup into which the test substance was dropped. The lids were then gently held together for about one second. The other eye, remaining untreated, served as a control. The eyes were not washed following instillation of the test article.
The eyes were examined 1 hour, 24 hours, 48 hours and 72 hours after instillation and the degree of irritation was scored.
Where a substance caused irritation within the first three days after administration the ocular reaction was also assessed on the seventh day.
This value was not included in the calculation of the irritant score.
Result
An eye irritation score of 2.3 was obtained. The test article is therefore regarded as a non irritant.
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