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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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 Feb 1988 to 01 Mar 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- Feb 1987
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
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: RAI f (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Young adult of 7 to 8 weeks
- Weight at study initiation: 224 to 250 g
- Housing: Group of 5 (by sex); Macrolon cages, Type 3 with standardised soft wood bedding
- Diet: Rat diet, ad libitum.
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 16 Feb 1988 To: 01 Mar 1988
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- arachis oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: an area on the back of the rat
- Pre-treatment: Approximately 24 hours before treatment an area on the back of the rat of at least 10% of the body surface was shaved with an electric clipper.
- % coverage: 10 % of the total body surface
- Type of wrap if used: The treated area was covered with a gauze-lined semi occlusive dressing fastened around the trunk with an adhesive elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing: After 24 hours, the dressings were removed and treated area was the skin was cleaned with lukewarm water. Thereafter, the skin reaction was appraised repeatedly.
TEST MATERIAL
- Amount applied: 4 mL/kg
- Concentration: 2000 mg/kg bw test substance suspended in Oleum arachidis
- Constant volume or concentration used: yes - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent no treatment
- Remarks:
- A control gauze patch was applied to the contralateral flank.
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Frequency of weighing: Individual body weights of the animals were recorded on Days 1, 7 and 14.
- Frequency of observations: Animals were observed daily; a.m. and p.m. on working days, a.m. on weekend days
- Necropsy of survivors performed: yes, on Day 15 and were subjected to gross necropsy at the end of the observation period.
- Clinical signs: Clinical signs were recorded daily. Ruffled fur, dyspnoea, abnormal body positions, and spontaneous activity were monitored. - Statistics:
- From the body weights, the group means and their standard deviations were calculated.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: Not treatment-related observations: ruffled fur, dyspnea, abnormal body positions, and reduced spontaneous activity were seen, being common symptoms in acute tests. The animals recovered within 5 days.
- Gross pathology:
- No deviations from normal morphology were found at autopsy.
Any other information on results incl. tables
Table 1 Rate of deaths
Dose mg/kg |
Totals |
Hours aft. Treatment |
Day of post exposure period |
||||||||||||||||||
|
in grp |
Deaths |
1 |
2 |
3 |
5 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
>13 |
|
|
no |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2000 mg/kg, males |
5 |
0 |
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2000 mg/kg, females |
5 |
0 |
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Table 2 Mean body weight and standard deviation
Males |
Females |
|||||
dose mg/kg |
day 1 |
day 7 |
day 14 |
day 1 |
day 7 |
day 14 |
2000 |
244/ 6.3 |
281/23.6 |
328/21.4 |
233/ 6.6 |
243/ 6.5 |
259/10.9 |
Table 3 Signs and symptons
Observations |
Exposure day: hours |
Day of post-exposure period |
||||||||||||||||
1 |
2 |
3 |
5 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
>13 |
|
2000 mg/kg, males |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ruffled fur |
x |
x |
x |
x |
x |
x |
x |
x |
|
|
|
|
|
|
|
|
|
|
dyspnoea |
x |
x |
x |
x |
x |
x |
x |
|
|
|
|
|
|
|
|
|
|
|
hunched post. |
|
|
|
|
x |
x |
|
|
|
|
|
|
|
|
|
|
|
|
ventr.recumb |
x |
x |
x |
x |
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
red.spont.act |
x |
x |
x |
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2000 mg/kg, females |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ruffled fur |
x |
x |
x |
x |
x |
x |
x |
x |
|
|
|
|
|
|
|
|
|
|
dyspnoea |
x |
x |
x |
x |
x |
x |
x |
|
|
|
|
|
|
|
|
|
|
|
hunched post. |
|
|
|
|
x |
x |
|
|
|
|
|
|
|
|
|
|
|
|
ventr.recumb |
x |
x |
x |
x |
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
red.spont.act |
x |
x |
x |
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x = slight xx = moderate XXX = marked
hunched post. = hunched posture ventr.recumb. = ventral recumbency
red.spont.act = reduced spontaneous activity
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute median lethal percutaneous dose (LD50) to rats of test substance was found to be greater than 2000 mg/kg bw.
- Executive summary:
An acute dermal study was performed in accordance with OECD TG 402 following GLP principles. The test was conducted with Tif: RAI f (SPF) rats to determine the potential for the test substance to produce toxicity from a single topical application. Approximately 24 hours before treatment, an area of at least 10 % of the body surface of the back of one group of 10 rats (5/sex) was shaved with an electric clipper. Test article was evenly dispersed on the skin at a dosage of 2000 mg/kg bw in Oleum arachidis in a dose volume of 4 mL/kg bw and covered with a semi-occlusive dressing. After an exposure period of 24 hours, the dressing was removed and the skin was cleaned with lukewarm water. Thereafter, the skin reaction was appraised repeatedly. Mortality, signs and symptoms were recorded daily, body weight at start and on days 7 and 14 of the study, and the animals were subjected to gross necropsy at the end of the 14-day observation period.
No mortality occurred; ruffled fur, dyspnoea, abnormal body positions, and reduced spontaneous activity were seen, being common symptoms in acute tests. The animals recovered within 5 days. Body weight growth was observed and no deviations from normal morphology were found at autopsy. Upon an acute dermal application and a 14-day post-treatment observation period, the LD50 for the test substance in rats was greater than 2000 mg/kg bw in both sexes.
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