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EC number: 273-321-9 | CAS number: 68956-82-1
- 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:
- 2006-04-27 to 2006-05-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Minor deviations without an effect on the study: -According to the guideline, after recording the observations at 24 hours, the eyes may be further examined with the aid of fluorescein. In the study evaluation with the aid of fluorescein was performed at 24 hours and no after the recording of the observations at 24 hours. - According to the guideline a rationale for in vivo testing should be stated in the study report. This is missing in this study report. - According to the guideline, the individual body weight at start and conclusion of the the test should be stated. In this study, the individual body weight of the animals at the start and at the conclusion of the study were not stated. - In the Draize scoring system referes conjunctival redness to palpebral and bulbar conjunctivae and excludes cornea and iris. In this study cornea and iris are included in the scoring system.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2002-04-24
- Deviations:
- yes
- Remarks:
- Minor deviations with no effect on the study (see rationale for reliability)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Resin acids and Rosin acids, cobalt salts
- EC Number:
- 273-321-9
- EC Name:
- Resin acids and Rosin acids, cobalt salts
- Cas Number:
- 68956-82-1
- IUPAC Name:
- λ²-cobalt(2+) bis((1R,4aR,4bR,10aR)-1,4a-dimethyl-7-(propan-2-yl)-1,2,3,4,4a,4b,5,6,10,10a-decahydrophenanthrene-1-carboxylate)
- Details on test material:
- - Name of test material (as cited in study report): Produit Y
- Name of test material (as cited in the EC inventory): Resin acids and Rosin acids, cobalt salts
- Physical state: Purple powder
- Storage condition of test material: At room temperature, protected from light and humidity and under argon gas
- The pH of the test item was not measurable (test item not soluble in water).
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Grimaud frères selection S.A.S., La Corbière, Roussay, France
- Age at study initiation: On the day of treatment, the animals were 2 to 4 months old
- Weight at study initiation: On the day of treatment, the animals had a mean body weight +/- standard deviation of 3.0 +/- 0.1 kg.
- Housing: The animals were housed individually in Pajon cages (50 cm X 57 cm X 75 cm) equipped with a food container and a water bottle.
- Diet: During the study, the animal had free access to 110C pelleted diet (SAFE, Villemoisson, Epinay-sur-Orge, France).
- Water (ad libitum): Drinking water
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 18 +/- 3 °C
- Relative humidity: 30 to 70 %
- Ventilation: approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12/12
No further information on the test animals was stated.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg of the test item in its original form
No further information on amount/concentration applied was stated. - Duration of treatment / exposure:
- not stated
- Observation period (in vivo):
- The eyes were examined approximately 1 hour, 24, 48 and 72 hours after administration of the test item.
- Number of animals or in vitro replicates:
- 3 rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
The eyes were not rinsed after administration of the test item.
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: Conjucntival reactions, iritis and corneal opacification were evaluated daily for each animal. For evaluation of corneal opacification (presence or absence, affected area), the eyes were examined under a UV lamp after instillation of one or two drops of 0.5 % sodium fluorescein solution (a clear fluorscence is visible in the area of opacification). This evaluation was performed on day 2 and repeated thereafter whenever necessary.
No further information in details on study design was stated.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal # 2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal # 2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- Slight or moderate chemosis (grade 1 or 2), slight or moderate redness of the conjunctiva n(grade 1 or 2) and clear discharge were observed in all the animals on day 1; some of these reactions persisted until day 2 (one animal) or 3 (two animals).
A slight corneal opacity (grade 1 ) was recorded in 2/3 animals on day 2.
No other ocular reactions were noted during the study.
Any other information on results incl. tables
Raw data of individual ocular examinations and mean values of the scores recorded for each animal (24, 48 and 72 hours)
Rabbit No. |
Region of eye |
Eye irritation |
1 hour Day 1 |
24 hours Day 2 |
48 hours Day 3 |
72 hours Day 4 |
Mean irritation score (24, 48 and 72 hours) |
1 |
Conjunctivae |
Chemosis |
2 |
1 |
1 |
0 |
0.7 |
Redness |
2 |
1 |
1 |
0 |
0.7 |
||
Discharge |
1 |
0 |
0 |
0 |
0.0 |
||
Iris |
|
0 |
0 |
0 |
0 |
0.0 |
|
Corneal opacity |
Intensity |
0 |
1 |
0 |
0 |
0.3 |
|
Area |
0 |
1 |
0 |
0 |
0.3 |
||
Other |
|
Residual test item |
|
|
|
|
|
Fluorescein |
|
Fluorescein not used |
Fluorescein used |
Fluorescein used |
Fluorescein used |
|
|
2 |
Conjunctivae |
Chemosis |
2 |
1 |
0 |
0 |
0.3 |
Redness |
2 |
1 |
1 |
0 |
0.7 |
||
Discharge |
1 |
0 |
0 |
0 |
0.0 |
||
Iris |
|
0 |
0 |
0 |
0 |
0.0 |
|
Corneal opacity |
Intensity |
0 |
0 |
0 |
0 |
0.0 |
|
Area |
0 |
0 |
0 |
0 |
0.0 |
||
Other |
|
Residual test item |
|
|
|
|
|
Fluorescein |
|
Fluorescein not used |
Fluorescein used |
Fluorescein not used |
Fluorescein not used |
|
|
3 |
Conjunctivae |
Chemosis |
1 |
1 |
0 |
0 |
0.3 |
Redness |
2 |
1 |
0 |
0 |
0.3 |
||
Discharge |
1 |
0 |
0 |
0 |
0.0 |
||
Iris |
|
0 |
0 |
0 |
0 |
0.0 |
|
Corneal opacity |
Intensity |
0 |
1 |
0 |
0 |
0.3 |
|
Area |
0 |
1 |
0 |
0 |
0.3 |
||
Other |
|
Residual test item |
|
|
|
|
|
Fluorescein |
|
Fluorescein not used |
Fluorescein used |
Fluorescein used |
Fluorescein not used |
|
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions, the test item Produit Y was slightly irritant when administered by ocualr route to rabbits.
Also, the test item should not be classified as skin irritant according to Regulation (EC) No.: 1272/2008.
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