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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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP
- Type of study:
- not specified
- Justification for non-LLNA method:
- Study available is over 12 years old.
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
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Ten young female Hartley-Dunkin albino guinea pigs obtained from Redfern Animal Breeders, Jasons Farm, Old Hay, Brenchley, Kent were used for this study. They were conditioned to the laboratory environment for not less than 6 days and on the day before initial treatment they were weighed. At this time the body weights of the guinea pigs were within the range 300 - 430 g. Three animals were marginally over the body weight range required by the protocol.
Diet
The animals were allowed free access to amins water and food (Guinea pig Diet-Standard supplemented with Vit. C., BP Nutrition (U.K.) Ltd., Stepfield, Witham, Essex).
Environment
All animals were housed in a single air-conditioned room maintained at a temperature of 22 + 3°C, relative humidity 50 + 10% and exposed to natural lighting conditions. They were caged in groups of 2 in grid floor polypropylene boxes.
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, open
- Vehicle:
- N,N-dimethylformamide
- Concentration / amount:
- 0.1 ml of a 10% w/v solution
- Day(s)/duration:
- 3 days
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- N,N-dimethylformamide
- Concentration / amount:
- 0.2 ml
10% w/v, 1% w/v and 0.1% w/v - Day(s)/duration:
- 1 day
- No. of animals per dose:
- 6 animals
- Details on study design:
- The test article (0.1 ml of a 10% w/v solution in dimethylformamjde) was applied daily by means of a glass syringe to the outer surface of the ears of 6 guinea pigs (animal numbers 1 - 6) for three days
(days 1, 2 and 3). On Day 8, 0.2 ml of the challenge solutions (10% w/v, 1% w/v and 0.1% w/v in dimethylformamide) was applied topically to 1 cm diameter circular areas on the clipped flanks of each of the same 6 animals. Solutions of test article were also applied in the same way on Day 8 to the clipped flanks of control animals (animal numbers 7 - 10) which had no previous treatment on the ears. The-applications were made on both flanks of all 10 guinea pigs, with each concentration being applied to each flank. The highest concentration was applied closest to the posterior end of the animal while the lowest concentration was applied nearest the anterior end.
The erythema produced on each site was assessed 24 hours later (Day 9) and graded on a 6 point scale. - Challenge controls:
- The highest concentration was applied closest to the posterior end of the animal while the lowest concentration was applied nearest the anterior end.
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- None specified
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- None specified
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- None specified
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- None specified
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1.0% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- None specified
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.1% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- None specified
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Skin reactions at challenge phase
Test article: Disperse Brown 19
Vehicle: dimethylformamide
Concentration: 10% w/v, 1% w/v and 0.1% w/v
Animal number and sex |
Weight (g) |
Skin reactions assessed at 24 hours after application |
||
10% w/v |
1% w/v |
0.1% w/v |
||
1 2 3 4 5 6 7 control 8 control 9 control 10 control |
410 410 430 321 308 318 340 355 344 351 |
0 0 0 0 0 0 0 0 0 0 |
0 0 0 0 0 0 0 0 0 0 |
0 0 0 0 0 0 0 0 0 0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No erythema was noted in any of the test or control animals. The test article was not considered to be a strong sensitiser.
- Executive summary:
A study was carried out to determine the skin-sensitising potential of test article in the albino guinea pig. The study was performed in accordance with Standard Operating Procedures.
Ten young female Hartley-Dunkin albino guinea pigs were used for this study. They were conditioned to the laboratory environment for not less than 6 days and on the day before initial treatment they were weighed. At this time the body weights of the guinea pigs were within the range 300 - 430 g. Three animals were marginally over the body weight range required by the protocol.
The test article (0.1 ml of a 10% w/v solution in dimethylformamjde) was applied daily by means of a glass syringe to the outer surface of the ears of 6 guinea pigs (animal numbers 1 - 6) for three days (days 1, 2 and 3).
On Day 8, 0.2 ml of the challenge solutions (10% w/v, 1% w/v and 0.1% w/v in dimethylformamide) was applied topically to 1 cm diameter circular areas on the clipped flanks of each of the same 6 animals. Solutions of test article were also applied in the same way on Day 8 to the clipped flanks of control animals (animal numbers 7 - 10) which had no previous treatment on the ears. The applications were made on both flanks of all 10 guinea pigs, with each concentration being applied to each flank.
The highest concentration was applied closest to the posterior end of the animal while the lowest concentration was applied nearest the anterior end.
The erythema produced on each site was assessed 24 hours later (Day 9).
Results
No erythema was noted in any of the test or control animals. The test article was not considered to be a strong sensitiser.
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