Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 256-783-6 | CAS number: 50814-31-8 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 40215.
- 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:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Source study has reliability 2. Details on the read across are attached in section 13.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GMBH; Chemisch-pharmazeutische Fabrik D-7950 Biberach/Riss
- Weight at study initiation: 2230 to 2620 g
- Housing: individually
- Diet: ad libitum standard rabbit pellet
- Water: fresh water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3°C
- Humidity: 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12 hours light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml (32 mg) of test substance were applied into the conjunctival sac of the left eye of each animal.
- The right eye remained untreated and served as control - Duration of treatment / exposure:
- After instillation the lids were held together for about one second to prevent loss of test article.
- Observation period (in vivo):
- Ocular reactions were evaluated after 1, 24, 48 and 72 hours after instillation
Reaction was observed after 7, 10 and 14 days of instillation - Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM:
Cornea
A. Opacity-degree of density
0 No opacitiy
1 Scaterred or difussed area, details of iris clearly visible
2 Easily discernible translucent areas, details of iris slightly obscured
3 Opalescent areas, no details of iris visible
4 Opaque, iris invisible
B. Area of cornea involved
1 One quarter (or less) but not zero
2 Greater than one quarter, but less than half
3 Greater than half, but less than three quarters
4 Greater than three quarters, up to whole area
A×B×5 Total maximum = 80
Iris
A. Values
0 Normal
1 Folds above normal, congestion, swelling, circumcorneal injection
2 No reaction to light, hemorrhage, gross destruction
A×5 Total maximum=10
Conjuctivae
A. Redness
0 Vessels normal
1 Vessels definitely injected above normal
2 More diffuse, deeper crimson red, individual vessels not easily discernible
3 Diffuse beefy red
B. Chemosis
0 No swelling
1 Any swelling above normal
2 Obvious swelling with partial eversion of lids
3 Swelling with lids about half closed
4 Swelling with lids about half closed to completely closed
C. Discharge
0 No discharge
1 Any amount different from normal
2 Discharge with moistening of the lids and hairs just adjacent to lids
3 Discharge with moistening of the lids and hairs, and considerable area around the eye
(A+B+C)×2 Total maximum=20
TOOL USED TO ASSESS SCORE: slit-lamp was used to facilitate the evaluation
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- 658/F
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- 658/F
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Remarks:
- 658/F
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- 658/F
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- 110/F
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- 110/F
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Remarks:
- 110/F
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- 110/F
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- 098/F
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- 098/F
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Remarks:
- 098/F
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- 098/F
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
Any other information on results incl. tables
Results tabulated
3 animals or less | mean score animal (1 / 2 / 3) | maximum value | maximum duration of any effect | maximum value at the end of the observation period | ||
conjunctiva/redness | 1 | 2 | 1 | 2 | 10 days | 0 |
conjunctiva/chemosis | 0.33 | 0.33 | 0 | 1 | 24 hours | 0 |
cornea | 0.33 | 0.67 | 0.33 | 1 | 48 hours | 0 |
iris | 0 | 0.33 | 0 | 1 | 24 hours | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified, according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- The substance was tested according to the guidelines OECD 405.
Based on scores at 24 to 72 hours after instillation of the substance, the substance resulted as not irritant to rabbit eye. Changes were fully reversible within 14 days. - Executive summary:
Method
Eye irritation potential was assessed following OECD guideline 405. Test substance was applied to one eye of 3 rabbits; the other eye served as control. No indication of eye rinse was reported. Observations were done at 1, 24, 48 and 72 h and 7d, 10 d and 14 after application. Effects on cornea, iris and conjunctivae were noted.
Results
Test material induced reactions of cornea, iris and conjunctiva when instilled into the conjunctival sac of rabbits eyes.
The following mean scores over the period from 24 to 72 h were calculated:
animal no. 658 110 98 conj. redness 1 2 1 conj. chemosis 0.33 0.33 0 cornea 0.33 0.67 0.33 iris 0 0.33 0 Effects were fully reversible within the 14 days observation period.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.