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EC number: 410-690-9 | CAS number: 103055-07-8 CGA 184699
- 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:
- 30 Jan 1989 to 27 Feb 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 82-2 (Repeated Dose Dermal Toxicity -21/28 Days)
- Version / remarks:
- Nov 1982
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.9 (Repeated Dose (28 Days) Toxicity (Dermal))
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- N-[2,5-dichloro-4-(1,1,2,3,3,3-hexafluoropropoxy)-phenyl-aminocarbonyl]-2,6-difluorobenzamide
- EC Number:
- 410-690-9
- EC Name:
- N-[2,5-dichloro-4-(1,1,2,3,3,3-hexafluoropropoxy)-phenyl-aminocarbonyl]-2,6-difluorobenzamide
- Cas Number:
- 103055-07-8
- Molecular formula:
- C17 H8 Cl2 F8 N2 O3
- IUPAC Name:
- 1-[2,5-dichloro-4-(1,1,2,3,3,3-hexafluoropropoxy)phenyl]-3-(2,6-difluorobenzoyl)urea
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Tif: RAIf (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approx. 8 weeks.
- Weight at study initiation: 237 - 281 g and 205 - 241 g in males and females, respectively.
- Housing: animals were housed individually in Macrolon cages type 3, with wire mesh tops and granulated soft wood bedding.
- Diet: Pelleted, certified standard diet (assayed for composition and contaminant levels).
- Water: Tap water, ad libitum. The drinking water quality fulfilled the critical parameters in the specifications of the "Schweizerisches Lebensmittelbuch".
- Acclimation period: 10 days prior to dosing
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 30 Jan1989 To: 27 Feb 1989
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5 % (w/v)
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- 5 day per week during 4 weeks
Doses / concentrationsopen allclose all
- Dose / conc.:
- 100 mg/kg bw/day
- Remarks:
- Group 2, low dose.
- Dose / conc.:
- 300 mg/kg bw/day
- Remarks:
- Group 3, mid-dose.
- Dose / conc.:
- 1 000 mg/kg bw/day
- Remarks:
- Group 4, high dose.
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
Results and discussion
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:
- not determinable due to absence of adverse toxic effects
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Any other information on results incl. tables
MORTALITY AND ANTEMORTEM FINDINGS
No symptoms or signs of systemic toxicity were seen that could be attributed to application of test substance throughout the study. No animal died or had to be killed during the study.
DERMAL IRRITATION
No signs of skin irritation were observed in any animal of the four dose groups throughout the study. All scores evaluated according to Draize et al (1944) were zero.
BODY WEIGHT
Mean body weight gain of treated animals was similar to that of the respective control animals.
FOOD CONSUMPTION
No treatment-related differences in mean food consumption were observed between control animals and those exposed to the test article.
HAEMATOLOGY
The haematological investigations revealed no changes attributable to the treatment
with test substance.
CLINICAL CHEMISTRY
No relevant differences between treated and control groups were observed.
ORGAN WEIGHTS AND RATIOS
There were only minor differences in mean absolute and relative organ weights between animals exposed to the test article and the respective control group, all of which are considered to be within the normal biological variation and not to be related to treatment with the test article.
GROSS PATHOLOGY AND HISTOPATHOLOGY
Macroscopical and microscopical examination of control and treated animals did not reveal any treatment related systemic effects or local pathological changes which could be attributed to the test article.
Applicant's summary and conclusion
- Conclusions:
- A dose level of 1000 mg/kg is recommended as the upper dose which needs not to be exceeded.
- Executive summary:
This OECD TG 410 study was conducted in order to determine the dermal toxicity of test substance upon repeated dermal application for 4 weeks (5 exposures per week) and to estimate a no-observable effect level of exposure according to GLP principles. In the present study a total of 40 albino Tif: RAIf (SPF) rats, distributed in 5 animals/sex/group. The test substance. was moistened and applied under occlusive dressing to the shaved back skin for a period of 4 weeks on a 5 day/week basis. The exposure period was 6 hours per day. The doses were 0, 100, 300 and 1000 mg/kg body weight per exposure (groups 1, 2, 3, and 4, respectively). The applied quantities of test article were adjusted weekly to individual animal body weight. The control animals (group 1) were treated with the vehicle only. The results of this study are summarised as follows:
No clinical symptoms or signs of systemic toxicity that could be attributed to treatment with test substance were observed. No signs of local irritation were seen in any animal throughout the study. No animal died or had to be killed during the study. Mean body weight gain in all treated groups did not differ from that of the respective control groups. No treatment-related differences in mean food consumption were observed between control animals and those exposed to the test article. No differences in food consumption relative to body weight that could be attributed to treatment with the test article were seen between control animals and those treated with the test article. The haematological investigations revealed no changes attributable to the treatment with the test article. No relevant differences between treated and control groups were observed. Analysis of the organ weights did not reveal any treatment-related differences between the animals of the control groups and those exposed to the test substance. Macroscopical and microscopical examination of control and treated animals did not reveal any treatment related systemic effects or local pathological changes which could be attributed to the test
substance.
It can be concluded from the above, that the no-observable effect level for test substance when applied dermally on a 5 day/week basis over a period of 4 weeks to rats is above 1000 mg/kg body weight. Since in OECD TG 410 and in EPA Guideline 82-2 a dose level of 1000 mg/kg is recommended as the upper dose which needs not to be exceeded, no further testing is envisaged. Hence, the NOAEL was set at > 1000 mg/kg bw/day.
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