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EC number: 421-450-8 | CAS number: 154702-15-5
- 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:
- June 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The guinea pig maximisation test is a standard test method that has been well validated. The study presented here was performed in 1995, well before guidelines preferring LLNA methods were introduced. As this existing study is sufficient to establish the skin sensitization potential of the test substance, further use of vertebrate animals to perform skin sensitization in unwarranted.
Test material
- Reference substance name:
- -
- EC Number:
- 421-450-8
- EC Name:
- -
- Cas Number:
- 154702-15-5
- Molecular formula:
- C44H59N7O5
- IUPAC Name:
- 2-ethylhexyl 4-[(4-{[4-(tert-butylcarbamoyl)phenyl]amino}-6-[(4-{[(2-ethylhexyl)oxy]carbonyl}phenyl)amino]-1,3,5-triazin-2-yl)amino]benzoate
- Details on test material:
- - Name of test material (as cited in study report): RA 3643
- Physical state: white powder
- Lot/batch No.: 51/95
- Storage condition of test material: ambient and in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: SPF-bred albino
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga, Sulzfeld, Germany
- Age at study initiation: 2-3 weeks (ordered)
- Housing: in a mobile battery containing 4 cages; one cage per group of at most 10 animals
- Diet (e.g. ad libitum): pelleted, natural ingredient diet ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 3
- Humidity (%): 58-85%
- Air changes (per hr): about 10 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 h light/12 h dark cycle
IN-LIFE DATES: From: May 31, 1995 To: June 8, 1995
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- petrolatum
- Concentration / amount:
- 0.1 ml for the intradermal injection
Challengeopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- petrolatum
- Concentration / amount:
- 0.1 ml for the intradermal injection
- No. of animals per dose:
- Preliminary testr: two sets of 3 animals
Main study: test group of 5 males and 5 females; control group of 3males and 3 females - Positive control substance(s):
- yes
Results and discussion
- Positive control results:
- A positive control study was performed to verify the lab could correctly identity dermal sensitizers. The positive control study used 5 animals as a negative control, and 10 animals (5 male and 5 female) as the test group. The positive control substance was DNCB.
The negative control animals were exposed to FCA and saline (1:1), maize oil, and maize oil and FCA (1:1) by injection at 6 sites per animal, and a topical application of vaseline in the induction phase.
For the test animals, they were exposed to FCA and saline (1:1), 0.1% test substance in maize oil, 0.1% test substance in maize oil and FCA (1:1) by injection, and a topical application of 0.1% test substance in vaseline.
For the challenge phase, all animals were exposed to a dermal application of 0.05% test substance in vaseline.
In the control group, only one animal showed signs of irritation after the challenge phase (score of 1), while all animals in the test group showed signs of irritation (scores of 1-3).
The results show the lab can successfully identify skin sensitizing substances.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.05% DNCB in vaseline
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- One animal was killed due to poor condition. All other animals in the positive control group showed skin irritation with scores of 0-3.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30% RA 3646 in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of skin irritation were seen.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Vaseline only
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- No signs of skin irritation were seen.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.05% DNCB
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- One animal in the positive control group showed poor condition and was killed. All other animals showed skin reaction of 1-3 during the challenge phase. Two animals had small scratches and another two animals showed scaliness.
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30% dilution of test item
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no dermal reaction
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- the test substance RA 3643 is considered not to be a sensitizer
- Executive summary:
The test substance RA 3643 was examined for possible sensitizing properties by a maximization test in guinea pigs using 10 test animals and 6 controls.
The test comprised:
TEST ANIMALS
- induction treatment by intradermal injections of Freund's Complete Adjuvant (FCA) 1:1 diluted with isotonic saline, a 3% dilution of RA 3643 in maize oil, and a 3% dilution of RA 3643 in vaseline (test site pretreated with sodium lauryl sulfate),
- challenge treatment, 14 days after the last induction, by topical application of a 30% dilution of RA 3643 in vaseline and of vaseline alone,
CONTROLS
- induction treatment by intradermal injections of FCA 1:1 diluted with isotonic saline, maize oil, and FCA/saline 1:1 diluited with maize oil, followed one week later by topical application of patches loaded with vaseline (test sites pretreated with sodium lauryl sulfate), and
- challenge treatment, 14 days after the last induction, by topical application of a 30% dilution of RA 3643 in vaseline and of vaseline alone,
None of the test animals reacted positively. Therefore, the test substance RA 3643 is considered not to be a sensitizer. Since clear and unequivocal results were obtained in this study, no need for further examination in an additional batch of test and control animals is required.
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