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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09 Feb 1998 to 12 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 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Feb 1987
- 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- KFM-NZW
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 12 - 14 weeks
- Weight at study initiation: 2410 - 2640 g
- Housing: The animals were housed individually in metal cages.
- Diet: standard rabbit pellet, ad libitum (analysed for nutritive ingredients and contaminants)
- Water: Ad libitum.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 09 Feb 1998 To 12 Feb 1988
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- 0.1 mL (70 mg) - Duration of treatment / exposure:
- Single treatment
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- INSTILLATION
The test substance was placed into the conjunctival sac of the left eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test material. The right eye remained untreated and served as a control.
OCULAR SCORING
The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation of the test substance according to the OECD scoring system (see Table 1 at ‘Any other information on methods and materials incl. tables’). A slit-lamp was used to facilitate the evaluation.
The irritant/corrosive potency of test substance was classified according to the EC Commission Directive No. 83/467, 1983. Ocular lesions which occur within 72 hours after exposure and which persist for at least 24 hours and correspond to the following values determined on the rabbit according to the eye irritation method:
- The mean value of the scores for each type of lesion, calculated over all the animals tested, is one of the following:
(1) cornea opacity two or more
(2) iris lesion one or more
(3) redness of conjunctivae 2.5 or more
(4) oedema of conjunctivae
(5) (chemosis) two or more
- or, in the case where the Annex V test has been completed using three animals, either cornea opacity, iris lesion, redness of conjunctivae or oedema of conjunctivae (chemosis) equivalent to a mean value such as is quoted above, but calculated for each animal separately, has been observed in two or more animals.
In both cases all scores at each of the reading times (24, 48, and 72 hours) and for an effect should be used in calculating the respective means values.
CAGE SIDE OBERVATIONS
The animals were checked daily for systemic symptoms and mortality..
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity 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:
- iris score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal: #1, #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis 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:
- The test substance induced reactions in the cornea (score 1), iris (score 1) and conjunctiva (redness score 1 and/or chemosis score 1) in all 3 animals at the 1-hour reading. At the 24-hour reading, only 1 animal still exhibited redness of the conjunctiva (score 1). The eye reactions observed were reversible until the end of the observation period on day 3.
- Other effects:
- BODY WEIGHT
The body weights of all rabbits were considered to be within the normal range of variability.
Any other information on results incl. tables
Table 2 Scores of eye irritation after instillation of test substance
Cornea |
Iris |
Conjunctiva |
||
redness |
chemosis |
|||
score (3 animals investigated) |
0 -4 |
0 - 2 |
0 - 3 |
0 - 4 |
60 min |
1/1/1 |
1/1/1 |
1/1/1 |
1/0/1 |
24 hours |
0/0/0 |
0/0/0 |
0/0/1 |
0/0/0 |
48 hours |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
72 hours |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
average 24h, 48h, 72h |
0/0/0 |
0/0/0 |
0/0/0.33 |
0/0/0 |
Reversibility* |
c |
c |
c |
c |
time for reversion |
24 h |
24 h |
48 h |
24 h |
* c : completely reversible
Table 3 Body weight
Animal no. |
#1 |
#2 |
#3 |
At start of test |
2410 |
2630 |
2640 |
After 3 days (end) |
2460 |
2710 |
2670 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on this study, it was concluded that test substance was considered to be not irritating to the eyes of rabbits.
- Executive summary:
In a primary eye irritation study performed in accordance with OECD TG 405 following GLP principles. An amount of 0.1 mL (70 mg) of the undiluted test substance into the conjunctival sac of the left eye of each the 3 males albino New Zealand White rabbits (KFM-NZW), after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test material. The right eye remained untreated and served as a control. The animals were checked daily for systemic symptoms and mortality. The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation of test article. A slit-lamp was used to facilitate the evaluation. The animals were checked daily for systemic symptoms and mortality.
The test substance induced reactions in the cornea (score 1), iris (score 1) and conjunctiva (redness score 1 and/or chemosis score 1) in all 3 animals at the 1-hour reading. At the 24-hour reading, only 1 animal still exhibited redness of the conjunctiva (score 1). The eye reactions observed were reversible until the end of the observation period on day 3. The body weights of all rabbits were considered to be within the normal range of variability.
Under the conditions of this study, the test substance was considered to be not irritating to the eyes of rabbits.
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