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EC number: 274-828-8 | CAS number: 70729-65-6
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Stevens MA. Use of the Albino Guinea-pig to Detect the Skin-sensitizing Ability of Chemicals. British journal of industrial medicine 1967;24(3):189-202
- Principles of method if other than guideline:
- In a routine test for skin-sensitizing potential, the test substance was applied over three days to the ears of guinea-pigs, and the flanks have been challenged one week later with a range of concentrations of suspected sensitizing substance. The erythematous reaction produced 24 hours after challenge was rated and compared with that in unsensitized controls.
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP
- Type of study:
- other: ear/flank test
- Justification for non-LLNA method:
- Study available is over 12 years old.
Test material
- Reference substance name:
- Methyl N-[3-(acetylamino)-4-[(2,4-dinitrophenyl)azo]phenyl]-N-(3-methoxy-3-oxopropyl)-β-alaninate
- EC Number:
- 274-828-8
- EC Name:
- Methyl N-[3-(acetylamino)-4-[(2,4-dinitrophenyl)azo]phenyl]-N-(3-methoxy-3-oxopropyl)-β-alaninate
- Cas Number:
- 70729-65-6
- Molecular formula:
- C22H24N6O9
- IUPAC Name:
- methyl N-[3-(acetylamino)-4-[(2,4-dinitrophenyl)azo]phenyl]-N-(3-methoxy-3-oxopropyl)-β-alaninate
- Test material form:
- liquid
- Details on test material:
- Disperse Red 311
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: AlderleyPark strain albino guinea pigs
- Sex:
- not specified
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
5% w/v, 0.1% w/v and 0.01% 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 each ear 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 (5% w/v, 0.1% w/v and 0.01% 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
- Positive control results:
- Not specified.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5% 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:
- test chemical
- Dose level:
- 0.01% 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:
- 5% 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
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.01% 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
Induction was carried out using a 10.0% w/v solution of the test substance in dimethylformamide (DMF). The subsequent challenge was accomplished using 5.0, 0.1 and 0.01% w/v solutions in DMF.
None of the animals showed a visible erythemic response or any signs of oedema.
Applicant's summary and conclusion
- Interpretation of results:
- other: no skin sensitising effects noted
- 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 the ear/flank test method (Stevens).
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 (5% w/v, 0.1% w/v and 0.01% 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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