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EC number: 632-619-2 | CAS number: 881685-58-1
- 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:
- 29 Jan 2014 to 05 Feb 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2012
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- 1998
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 2008
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 632-619-2
- EC Number:
- 632-619-2
- Cas Number:
- 881685-58-1
- Molecular formula:
- C20 H23 F2 N3 O
- IUPAC Name:
- 632-619-2
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Sex: Male
- Age at study initiation: 12-13 weeks
- Weight at study initiation: 3146 – 3169 g
- Housing: Rabbits were individually housed in AAALAC approved metal wire rabbit cages. Cages were of an open wire structure and cages were placed together to allow some social interaction with rabbit(s) in adjoining cages.
- Diet: UNI diet for rabbits. Ad libitum
- Water: Tap water. Ad libitum
- Acclimatisation period: at least 14 days
ENVIRONMENTAL CONDITIONS
- Temperature: 17.3 – 21.7 °C
- Humidity: 24 – 58 %
- Air changes: 15-20 air exchanges/hour
- Photoperiod: 12 hours daily from 6.00 a.m. to 6.00 p.m.
IN-LIFE DATES: From: 29 Jan 2014 To: 05 Feb 2014
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g of the test material - Duration of treatment / exposure:
- 1 hour
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- PRE-STUDY EXAMINATION
- The pH of the test material was measured as pH 4.0, permitting the test material to be used in the animal studies.
- The test was performed on 3 male rabbits. Before the start of the test, both eyes of the provisionally selected test rabbits were examined for evidence of ocular irritation or defect.
- Sixty minutes prior to test material application, a systemic opiate analgesic was administered by subcutaneous injection under direct Veterinary supervision. Repeat injections were given on the first day as appropriate to maintain an adequate level of analgesia. Five minutes prior to test material application, a topical ocular anaesthetic was applied to each eye (including the control eye) to ensure direct comparison of any ocular observations. Eight hours after test material application, a systemic opiate analgesic and a nonsteroidal anti-inflammatory drug (NSAID) were administered by subcutaneous injection under direct Veterinary supervision. The systemic opiate analgesic was again injected ~12 hours after the post-treatment analgesic and then every 12 hours, and NSAID injected every 24 hours, until eye scores were zero.
APPLICATION
The test material was placed in the conjunctival sac of the left eye of animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for at least one second in order to prevent loss of the material.
REMOVAL OF TEST SUBSTANCE
- Washing: The treated eye was rinsed with physiological saline solution at the first observation time point at 1 hour after the application of test item on the all animals as the irritation scores were greater than 1.
- Time after start of exposure: 1 hour
OBSERVATION TIME POINTS
Approximately 1, 24, 48 72 hours after the end of exposure. Observations with fluorescein staining were made approximately 24 hours before treatment and then 24, 48, 72 hours after treatment in all animals. All rabbits were examined for distress at least twice daily, with observations at least 6 hours apart.
SCORING SYSTEM:
The eye irritation scores were evaluated according to the scoring system by Draize (1977) and OECD 405 (02 October 2012). For criteria, see 'Any other information on materials and methods incl. tables'.
TOOL USED TO ASSESS SCORE: fluorescein
OTHER OBSERVATIONS
- Individual body weight was recorded on the day of treatment and before euthanasia.
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
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal: #1, #2, #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
- Reversibility:
- fully reversible within: 24 hours
- Irritant / corrosive response data:
- - Initial Pain Reaction/ Pain Reaction (IPR/PR) was not observed.
- Conjunctival redness (score 2), chemosis (score 1) and discharge (score 1 or 2) were seen in all rabbits at 1 hour after treatment. Conjunctival redness (score 1) was seen in all rabbits at 24 hours after treatment.
- All symptoms had fully reversed in all animals after 48 hours.
- Fluorescein staining was negative in all animals at 24, 48 and 72 hours after instillation.
- The control eyes were symptom-free during the study. - Other effects:
- OTHER EFFECTS
- The body weights of all rabbits were considered to be within the normal range of variability.
- No clinical signs of systemic toxicity were observed in any animals in this study.
- No mortality occurred in this study.
Any other information on results incl. tables
Table 1. Individual Draize Scores and Individual Total Scores* for Ocular Irritation.
Rabbit Number |
#1 |
#2 |
#3 |
|||||||||
IPR |
0 |
0 |
0 |
|||||||||
PR |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Time after treatment (hour) |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
Cornea |
|
|
|
|
|
|
|
|
|
|
|
|
Degree of Opacity (E) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Area involved (F) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
*Score (E x F) x 5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Iris (D) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
*Score (D x 5) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctivae |
|
|
|
|
|
|
|
|
|
|
|
|
Redness (A) |
2 |
1 |
0 |
0 |
2 |
1 |
0 |
0 |
2 |
1 |
0 |
0 |
Chemosis (B) |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
Discharge (C) |
1 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
*Score (A+B+C) x 2 |
8 |
2 |
0 |
0 |
10 |
2 |
0 |
0 |
8 |
2 |
0 |
0 |
*Total Score |
8 |
2 |
0 |
0 |
10 |
2 |
0 |
0 |
8 |
2 |
0 |
0 |
* Kay J H and Calandra J C (1962)
Table 2. Individual body weights and body weight changes.
Rabbit Number |
Body weight before treatment (g) |
Body weight after treatment (g) |
Body weight change (g) |
#1 |
3169 |
3197 |
28 |
#2 |
3161 |
3209 |
48 |
#3 |
3146 |
3210 |
64 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The application of the test material did not result in signs of eye irritation.
- Executive summary:
The test material was administered as an installation of a single dose of 0.1 g into the conjunctival sac of the left eye of 3 adult male New Zealand White rabbits in a study according to OECD TG 405 and GLP principles. The untreated right eye served as the control. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test material installation in all animals. Observations with fluorescein staining were made approximately 24 hours before treatment and then 24, 48 and 72 hours after the treatment in all animals. Results obtained from these three animals were used to classify the test item for irritation potential.
Initial Pain Reaction/Pain reaction (IPR/PR) was not observed. The average cornea opacity, iritis and chemosis score of all three animals over 24, 48 and 72 hours was 0. The average conjunctivae score of all three animals over 24, 48 and 72 hours was 0.33. All symptoms had fully reversed in all animals after 48 hours. Fluorescein staining was negative in all animals at 24, 48 and 72 hours after instillation. The control eye of animals was symptom-free during the study. No mortality occurred during the study. The body weights of all rabbits were considered to be within the normal range of variability.
The application of the test material did not result in signs of eye irritation.
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