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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 256-457-3 | CAS number: 49744-26-5
- 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:
- 09 March to 02 April 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- Guideline 84/449
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Method was not available
Test material
- Reference substance name:
- 2-phenoxyethyl 4-((5-cyano-1,6-dihydro-2-hydroxy-1,4-dimethyl-6-oxo-3-pyridinyl)azo)benzoate
- EC Number:
- 414-260-1
- EC Name:
- 2-phenoxyethyl 4-((5-cyano-1,6-dihydro-2-hydroxy-1,4-dimethyl-6-oxo-3-pyridinyl)azo)benzoate
- Cas Number:
- 88938-37-8
- Molecular formula:
- C23H20N4O5
- IUPAC Name:
- 2-phenoxyethyl 4-[2-(5-cyano-2-hydroxy-1,4-dimethyl-6-oxo-1,6-dihydropyridin-3-yl)diazen-1-yl]benzoate
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH
- Females nulliparous and non-pregnant: [yes]
- Age at study initiation: 4 to 7 Weeks
- Weight at study initiation: Mean 317g (280 to 360g)
- Housing: 5 animals per cage
- Diet (e.g. ad libitum): Altromin 3020, ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 1.5
- Humidity (%): 40 - 70
- Air changes (per hr): 12 - 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Remarks:
- Cremophor EL (2% v/v) in sterile NaCl
- Concentration / amount:
- 5%
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Remarks:
- Cremophor EL (2% v/v) in sterile NaCl
- Concentration / amount:
- 10%
- Day(s)/duration:
- Day 8 / 48 h
- Adequacy of induction:
- highest technically applicable concentration used
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Remarks:
- Cremophor EL (2% v/v) in sterile NaCl
- Concentration / amount:
- 10%
- Day(s)/duration:
- Day 22 / 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Remarks:
- Cremophor EL (2% v/v) in sterile NaCl
- Concentration / amount:
- 6%
- Day(s)/duration:
- Day 22 / 24 h
- No. of animals per dose:
- One test substance group consisting of 20 experimental animals (No. 21 to 40) and two control groups consisting of 10 animals each (No. 1 to 10 and 11 to 20)
- Details on study design:
- Intradermal Induction
One day prior to application the skin on the dorsum and the flanks was shorn. Starting behind the nucha,three intradermal injections were administered on each side of and parallel to the spinal column.
The application volume per injection site was 0.1 ml, The animals of the three groups were treated as follows:
a) Test substance group
1. Injection site pair (cranial)
Freund's complete adjuvant (Difco Lab.) 1:1 diluted with physiological saline solution (sterile).
2. Injection site pair (medial)
5% test substance, formulated as a suspension in Cremophor EL (2% v/v) in sterile physiological NaCl
3. Injection site pair (caudal)
5% test substance, formulated as a suspension in Cremophor EL (2% v/v) in sterile physiological NaCl and Freund's complete adjuvant in equal proportions.
b) Control groups
The animals of the control groups were treated like the animals of the test substance group, the formulation for the injection site pairs 2 and 3, however, contained no test compound but a corresponding amount of Cremophor EL (2% v/v) in sterile physiological NaCl .
Topical Induction
One week after intradermal induction topical induction took place. On the eve, the areas to be treated were shorn, and a 10% preparation of sodium lauryl sulphate in parafin oil was spread on these areas. Hypoallergenic patches {2x4 cm) were applied between or on the injection sites; they were covered with aluminum foil and kept in place on the skin with Fermoflex adhesive tape (Transatlantic GmbH, Schwarzenbach).
The hypoallergenic patches were treated as follows:
a) Test substance group: 0.5 ml test substance 10%
b) Control group: 0.5 ml Cremophor EL (2% v/v) in sterile physiological NaCl
At the end of the 48-hour exposure period the substance residues were removed with physiological saline.
Topical Challenge of Sensitization
The topical challenge took place 3 weeks after intradermal induction. Meanwhile, the test compound concentration for challenge had been determined in a range-finding test on 5 guinea pigs treated like control animals during inductions.
One day prior to the treatment the animals were shorn on the dorsum and the flanks. For challenge a hypoallergenic patch saturated with 10% and 6% test compound formulation was placed on the left flank of the animals of the test substance group and the ist control group. The patch was fixed for 24 hours on the skin with Fermoflex adhesive tape. The patches were applied in both concentrations cranially or caudally - alternately from animal to animal. On the right flank two control patches were fixed, saturated with Cremophor EL (2% v/v) in sterile physiological NaCl.
The application volume was 0.5 ml in each case.
At the end of the exposure period, the skin of the animals was depilated in the region of the treated areas. Pilca cream (depilation cream for humans, containing salts of the thioglycolic acid; manufactured by Schwarzkopf GmbH, Hamburg) was used for that purpose. - Challenge controls:
- Control groups
The animals of the control groups were treated like the animals of the test substance group, the formulation for the injection site pairs 2 and 3, however, contained no test compound but a corresponding amount of sterile physiological saline solutiothe vehicle Cremophor EL (2% v/v) in sterile physiological NaCl. - Positive control substance(s):
- yes
Results and discussion
- Positive control results:
- positive controls are valid
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 6%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 6%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 6%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 6%
- No. with + reactions:
- 0
- Total no. in group:
- 10
Any other information on results incl. tables
The incidences of skin reddenings after challenge are summarized in the following table
|
Test substance Group (20 animals) |
1stControl group (10 animals) |
||||||||
Test substance patch |
Control patch |
Test substance patch |
Control patch |
|||||||
Hours |
48 |
72 |
Total |
48 |
72 |
48 |
72 |
Total |
48 |
72 |
Challenge 10% |
2 |
1 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Challenge 6% |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance was found to be non-sensitising in the maximisation test.
- Executive summary:
The test substance was tested for skin sensitizing properties on female guinea pigs in a maximisation test as described by MAGNUSSON and KLIGMAN. Intradermal induction was carried out with a 5% test compound formulation, topical induction with 10%, which was the highest doese which could be formulated. As this concentration had produced no primary skin irritant effects in the range-finding test, the areas to be treated were pre-irritated with sodium lauryl sulphate prior to topical induction.
After the challenge exposure one animal (5%) and two animals (10%) of the test substance group reacted with skin reddening to the 6% and 10% test compound formulation, respectively. In the control group no skin reactions were observed.
Thus, under the conditions of the maximisation test, the test compound has no skin sensitizing potential.
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.