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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02 Feb 1988 to 05 Feb 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 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- May 1981
- GLP compliance:
- 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:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- KFM-NZW
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approx. 12 – 14 weeks old.
- Weight at study initiation: 2250 - 2510 g.
- Housing: Rabbits were individually housed in metal wire rabbit cages.
- Diet: standard rabbit pellet, ad libitum
- Water: fresh water, ad libitum. The quality of the drinking water was according to the specifications of the "Schweizerisches Lebensmittelbuch".
- Acclimation period: At least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g of the test substance - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- STUDY DESIGN
- The test was performed on 3 female rabbits, checked for normal skin conditions.
- The animals were checked daily for systemic symptoms and mortality.
- The body weight was recorded at start and on day 3 of the test.
TEST SITE
- Area of exposure: An area of at least 36 cm2 was shaved on both flanks of the animals approximately 24 hours before treatment.
- Type of wrap: A gauze patch (20 cm2) was applied to the flank. A control gauze patch was applied to the contralateral flank. Both gauze patches were moistened before application with distilled water containing 0.5 % carboxymethylcellulose and 0.1 % polysorbate 80. The patches were loosely covered with an aluminium foil (36 cm2) and held in place by an adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
Approximately 1, 24, 48 and 72 hours after the end of exposure
SCORING SYSTEM:
- Method of calculation: following the OECD TG 404 system. For criteria, see 'Any other information on materials and methods incl. tables'.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Two animals exhibited slight erythema reactions (score 1) one hour after treatment with test substance. Scores of erythema and oedema for the recordings 24 to 72 hours in all 3 animals were zero (considered to be non-irritating).
- Other effects:
- BODY WEIGHT
The body weights of all rabbits were considered to be within the normal range of variability.
DURATION OF THE IN-LIFE PHASE
Because no reactions were observed at 24 hours to 72 hours after removing the bandages, the test was ended after the 72 hours evaluation.
Any other information on results incl. tables
Table 2 Individual skin reaction score
E R Y T H E M A |
|
E D E M A |
|||||
animal |
#1 |
#2 |
#3 |
|
#1 |
#2 |
#3 |
CF/TF |
CF/TF |
CF/TF |
|
CF/TF |
CF/TF |
CF/TF |
|
after 1 hr |
0/0 |
0/1 |
0/1 |
|
0/0 |
0/0 |
0/0 |
after 24 hrs |
0/0 |
0/0 |
0/0 |
|
0/0 |
0/0 |
0/0 |
after 48 hrs |
0/0 |
0/0 |
0/0 |
|
0/0 |
0/0 |
0/0 |
after 72 hrs |
0/0 |
0/0 |
0/0 |
|
0/0 |
0/0 |
0/0 |
mean 24-72 hrs. |
0/0 |
0/0 |
0/0 |
|
0/0 |
0/0 |
0/0 |
CF = control flank TF = test flank
M = male F = female
Table 3 Body Weights
Animal |
#1 |
#2 |
#3 |
At start of test |
2250 |
2510 |
2480 |
After 3 days (end) |
2310 |
2570 |
2490 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Because the mean values of the recordings 24 to 72 hours after application were scored zero, the test substance can be classified as non-irritant.
- Executive summary:
The primary skin irritation potential of the test substance was investigated according to the GLP compliant OECD TG 404. An amount of 0.5 g unchanged test material was applied under occlusive conditions for 4 hours to the clipped backs of 3 females albino New Zealand White rabbits (KFM-NZW), using a gauze patch of 20 cm2. A control gauze patch was applied to the contralateral flank. Both gauze patches were moistened before application with distilled water containing 0.5 % carboxymethylcellulose and 0.1 % polysorbate 80. The patches were loosely covered with an aluminium foil (36 cm2) and held in place for 4 hours by an adhesive tape. Scoring was performed at 1, 4, 24, 48 and 72 hours and after 3 days of application following OECD TG 404.
Two animals exhibited slight erythema reactions (score 1) one hour after treatment with test substance. Since no reactions were observed at 24 hours to 72 hours after removing the bandages, the test was terminated after the 72 hours evaluation. Scores of erythema and oedema for the recordings 24 to 72 hours in all 3 animals were zero. Under the conditions of this study, the test substance was considered not to be irritating to the skin of rabbits.
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