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EC number: - | CAS number: -
- 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:
- 2007-05-30 to 2007-06-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted April 24, 2002
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- April 29, 2004
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction products of DL-methionine and C18 unsaturated fatty acid chloride and isopropanol
- Molecular formula:
- not applicable (UVCB)
- IUPAC Name:
- Reaction products of DL-methionine and C18 unsaturated fatty acid chloride and isopropanol
1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: 07SK021
- Description: Liquid, dark brownish
- Expiration date of the lot/batch: n.a.
- Purity test date: 94%
- Expiry date: March 2009
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature (range of 20 ± 5° C), light protected
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Netherlands BV, Kreuzelweg 53, NL-5961 NM Horst / The Netherlands
Postbus 6174, NL-5960 AD Horst / The Netherlands
- Age at study initiation: one male12 weeks; two females 13 weeks
- Weight at Day1 of treatment: females 2044 g and 2500 g, male 2373 g
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks and haysticks were provided for gnawing.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: yes
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 10-15
- Photoperiod: 12 hrs dark / 12 hrs light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 mL
- Observation period (in vivo):
- The eyes of each animal were examined approximately 1, 24, 48, 72 hours, as well as 7, 10, 14 and 21 days after administration.
- Number of animals or in vitro replicates:
- 3 (one male two females)
- Details on study design:
- On the day of treatment, 0.1 mL of DODICOR V 5654 was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of test item. The right eye remained untreated and served as the reference control.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: The eye reactions were assessed according to the numerical scoring system listed in the Commission Directive 2004/73/EC, April 29, 2004
TOOL USED TO ASSESS SCORE: hand-slit lamp (Cliptrix diagnostic-lamp)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21 day
- Remarks on result:
- probability of moderate irritation
- Remarks:
- At day 21 reading the score was still 1.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.19
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21 days
- Remarks:
- At 21 day reading in one animal conjunctiva reddining was still present.
- Remarks on result:
- probability of moderate irritation
- Remarks:
- The test item did not induce significant or irreversible damage to the rabbit eye.
Any other information on results incl. tables
TABLE 1: EYE IRRITATION SCORES - MEAN VALUES AFTER 24, 48 AND 72 HOURS
Animal Number |
Sex |
Corneal Opacity |
N |
Iris |
N |
Conjunctivae |
|||
Redness |
N |
Chemosis |
N |
||||||
4 |
M |
0.00 |
3 |
0.00 |
3 |
2.00 |
|
1.33 |
3 |
5 |
F |
1.00 |
3 |
0.00 |
3 |
2.00 |
|
1.33 |
3 |
6 |
F |
0.67 |
3 |
0.00 |
3 |
1.67 |
|
0.67 |
3 |
N = number of available data points
Applicant's summary and conclusion
- Interpretation of results:
- other: Cat 2 (irritating to eyes) based on CLP criteria
- Conclusions:
- Based on the results of a.m. study, Dodicor V 5654 is irritating to the eye.
- Executive summary:
The primary eye irritation potential of DODICOR V 5654 was investigated according toOECD test guideline no. 405. The test item was applied by instillation of 0.1 mL into the lefteye of each of three young adult New Zealand White rabbits. Scoring of irritation effects wasperformed approximately 1, 24, 48 and 72 hours, as well as 7, 10, 14 and 21 days after testitem instillation.The mean score was calculated across 3 scoring times (24, 48 and 72 hours afterinstillation) for each animal for corneal opacity, iris, redness and chemosis of theconjunctivae, separately. The individual mean scores for corneal opacity were 0.00, 1.00 and0.67, respectively and for iris 0.00 for each of all three animals. The individual mean scores for the conjunctivae were 2.00, 2.00 and 1.67 for reddening and 1.33, 1.33 and 0.67 forchemosis, respectively.
The instillation of DODICOR V 5654 into the eye resulted in mild to moderate, early-onsetocular changes, such as corneal opacity, reddening of the conjunctivae and sclerae,conjunctival swelling and discharge. The severity of the local reactions decreased throughthe 22 days of observation and the study was closed with a slight conjunctival redness in oneanimal.No abnormal findings were observed in the iris of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. No staining of the treated eyes by the test item was observed and no clinical signs were observed.
Thus, the test item did not induce significant or irreversible damage to the rabbit eye.
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