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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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Oct-Dec 2022
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
- GLP compliance:
- yes
- Limit test:
- yes
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
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Details on exposure:
- From D0 to D27 , dose application: 4 layers of porous gauze were placed on a layer of non-irritating tape.
Finally, the patch was placed on the elastic bandage. For the treatment group and satellite group, the moistened test item was evenly put on the gauze, then be applied to the area where the hair was removed. Finally, the patch was applied to the area where the hair was removed.
Exposure time was 6 h a day, lasted for 28 days.
At the end of 6 hours (+ 10min) exposure period, the residual test item was removed by water. - Duration of treatment / exposure:
- Each rat in treatment group and satellite group was continuously repeatedly dosed at 1000mg/kg body weight per day for 28 days.
- Frequency of treatment:
- Exposure time was 6 h a day, lasted for 28 days.
Doses / concentrations
- Dose / conc.:
- 1 000 mg/kg bw/day
- No. of animals per sex per dose:
- 5 animals / sex / dose
- Control animals:
- yes
- Details on study design:
- The dose administration was calculated weekly on D0, D7, D14 and D21
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily from D- 1 to D27 in control group, satellite group and treatment group, while kept for a further 14 days for satellite group without dose administration
DETAILED CLINICAL OBSERVATIONS: No data
DERMAL IRRITATION (if dermal study): No
BODY WEIGHT: Yes
- Time schedule for examinations: weekly and before euthanasia
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: on D28 for animals in control group and treatment group, while operated on D42 for animals in satellite group in the recovery period
- Anaesthetic used for blood collection: Yes (5 0 mg/ kg Zoletil 50)
- Animals fasted: Yes
- How many animals: 30
- Parameters checked: Hematology Examination / Coagulation- related Examination / Biochemical Examination
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: on D28 for animals in control group and treatment group, while operated on D42 for animals in satellite group in the recovery period
- Animals fasted: Yes
- How many animals: 30
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes (the external surface of the body, all orifices, and the cranial, thoracic, abdominal cavities and their contents.)
HISTOPATHOLOGY: Yes (the normal and treated skin, liver and kidney after 2 8 days exposure period) - Statistics:
- Data of body weights and body weight changes, food consumption, organ weights and organ coefficients, and clinical examinations were analyzed by T-test in software Excel 20 1 3.
P- value of body weights and body weight changes, and food consumption from D0 to D2 8 were compared between indexes in control group and that in treatment and satellite group.
P- value of clinical examination, organ weights and organ coefficients on D28 were compared between indexes in control group and that in treatment group.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Dermal irritation:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, non-treatment-related
- Clinical biochemistry findings:
- effects observed, non-treatment-related
- Endocrine findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Coagulation-related Examination:
After 28 days exposure period, data showed that APTT of female rats decreased significantly and kept that level on D42. The change value of APTT was about 1 sec which is considered slightly and physiological caused by slightly increased PLT, rather than pathological.
After a further 14 days recovery period, PT and INR decreased significantly (P value<0.05) but did not show any significant change, so it was considered to be related to the age of animals.
The test item did not cause coagulation disorder.
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- other: no test item related functional and organic damages of visceral lesions were observed.
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Based on the results of the study, percutaneous repeated dose of 1000 mg/ kg Diethylhexyl Butamido Triazone for 28 days did not cause mortality and toxic effects and no test item related functional and organic damages of visceral lesions were observed.
- Executive summary:
No toxic effect of percutaneous repeated exposure to a dose of 1000 mg/kg bw of Diethylhexyl Butamido Triazone during 28 days has been observed.
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