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EC number: 606-744-8 | CAS number: 213464-77-8
- 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:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.3200 (Repeated Dose Dermal Toxicity -21/28 Days)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.9 (Repeated Dose (28 Days) Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF 12 NohSan No. 8147, Guideline 2-1-10
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Test material:
IR5878
Batch number: G 009/02
Purity: 98.56 ± 0.19 %
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Test animals:
Species and Strain: Male and Female Crl:CD (SD)IGS BR rats
Age: 62 to 69 days
Body weight: 321 ÷ 367 g (males) and 213 ÷ 238 g (females)
Housing: one animal per cage of polycarbonate body with a stainless mesh lid.
Feed: free access to a standard rodent diet (Rat and Mouse No. 1 Maintenance Diet from Special Diets Services Ltd., Witham, Essex, England), except overnight before routine blood sampling. Potable water was freely available.
Environmental conditions:
Temperature and humidity measured during the study were 19 ÷ 23°C and 40 ÷ 70%, respectively.
Light: 12 hours of continuous light and 12 hours of continuous dark.
Administration / exposure
- Type of coverage:
- semiocclusive
- Details on exposure:
- One group of 10 male and 10 female Crl:CD (SD)IGS BR rats received IR5878 topically, by means of a 6-hour period of semi-occluded application, at a dosage of 1000 mg/kg/day for 4 consecutive weeks.
At the end of the daily treatment period the dressing was carefully removed and the exposed area was cleansed with saline and dabbed- dry with a disposable towel to avoid the oral ingestion during grooming.
The application site remained non-occluded until the next administration.
A similarly constituted control group received the vehicle (purified water) obtained by reverse osmosis, at the same volume-dosage (2 mL/kg bw) and at the same period of occlusion. - Duration of treatment / exposure:
- One group of 10 male and 10 female Crl:CD (SD)IGS BR rats received IR5878 topically, by means of a 6-hour period of semi-occluded application, at a dosage of 1000 mg/kg/day for 4 consecutive weeks. At the end of the daily treatment period the dressing was carefully removed and the exposed area was cleansed with saline and dabbed- dry with a disposable towel to avoid the oral ingestion during grooming. The application site remained non-occluded until the next administration. A similarly constituted control group received the vehicle (purified water) obtained by reverse osmosis, at the same volume-dosage (2 mL/kg bw) and at the same period of occlusion.
- Frequency of treatment:
- One group of 10 male and 10 female Crl:CD (SD)IGS BR rats received IR5878 topically, by means of a 6-hour period of semi-occluded application, at a dosage of 1000 mg/kg/day for 4 consecutive weeks.
Doses / concentrations
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- One group of 10 male and 10 female Crl:CD (SD)IGS BR rats received IR5878 topically, by means of a 6-hour period of semi-occluded application, at a dosage of 1000 mg/kg/day for 4 consecutive weeks
- Control animals:
- yes
- Details on study design:
- . A similarly constituted control group received the vehicle (purified water) obtained by reverse osmosis, at the same volume-dosage (2 mL/kg bw) and at the same period of occlusion.
Examinations
- Observations and examinations performed and frequency:
- Clinical condition and dermal responses particularly in the application site were performed daily; bodyweight and food consumption were recoreded at day 0, weekly during the treatment and before necrospsy; ophthalmic examination was carried out before treatment commenced anf during week 4; haematology, blood chemistry, organ weight, macroscopic and microscopic pathology investigations were carried out according to the guideline indications.
- Sacrifice and pathology:
- Organ weights
Bodyweight-relative spleen weights were slightly increased for treated males. Females were not affected.
Macroscopic pathology
Macroscopic examination revealed an increased incidence of pale areas on the livers in treated males.
Microscopic pathology
There were no microscopic findings that were attributable to the administration of IR5878.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were no treatment-related systemic signs associated with dosing and no animals died prematurely. Changes at the dermal application site (slight to well-defined erythema, eschar-formation and exfoliation) occurred on occasion in a few treated animals, but it was not clearly attributable to treatment.
- Dermal irritation:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were no treatment-related systemic signs associated with dosing and no animals died prematurely. Changes at the dermal application site (slight to well-defined erythema, eschar-formation and exfoliation) occurred on occasion in a few treated animals, but it was not clearly attributable to treatment.
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Overall bodyweight gain was slightly increased for treated females, when compared to that of the control. Males were unaffected.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- effects observed, treatment-related
- Description (incidence and severity):
- Overall food conversion efficiency was slightly increased for treated females, when compared to that of the controls. This is attributed to the increased bodyweight gain in these animals. Males were unaffected.
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Organ weights
Bodyweight-relative spleen weights were slightly increased for treated males. Females were not affected. - Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Macroscopic examination revealed an increased incidence of pale areas on the livers in treated males.
- Histopathological findings: non-neoplastic:
- no effects observed
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- dermal irritation
- food consumption and compound intake
- food efficiency
- haematology
- mortality
- ophthalmological examination
- organ weights and organ / body weight ratios
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- A daily 6-hour semi-occluded dermal application of IR5878 to CD rats for 4 weeks was well-tolerated, producing no toxicologically significant change or any clear response at the dermal application site.
The NOAEL (No Observed Adverse Effect Level) in this study was considered to be 1000 mg/kg/day. - Executive summary:
In order to assess the systemic toxic potential of IR5878 following dermal application (semi-occlusive 6 hours/day) to rats for four weeks, one group of 10 male and 10 female Crl:CD (SD)IGS BR rats received IR5878 topically, by means of a 6-hour period of semi-occluded application, at a dosage of 1000 mg/kg/day for 4 consecutive weeks. A similarly constituted control group received the vehicle (purified water) obtained by reverse osmosis, at the same volume-dosage (2 mL/kg bw) and at the same period of occlusion.
IR5878 was well-tolerated, producing no toxicologically significant change or any clear response at the dermal application site. The NOAEL in this study was considered to be 1000 mg/kg/day.
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.
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