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EC number: 279-087-4 | CAS number: 79135-87-8
- 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:
- August from the 26th to the 30th, 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted on 12 May, 1981
- GLP compliance:
- no
Test material
- Reference substance name:
- Optical Brightener 380
- IUPAC Name:
- Optical Brightener 380
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoering, AG.
- Age at start of treatment: ca. 12 weeks.
- Body weight at start of treatment: 2.3 - 3 kg.
- Diet: pelleted standard Kliba 23/341/1 rabbit maintenance diet, ad libitum.
- Water: tap water, ad libitum.
- Accomodation: individually in stainless steel cage.
- Acclimation period: 4 days.
- Health check: before testing, both eyes of each animal were examined and any animal with eye defect was rejected.
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 55 ± 10 %
- Photoperiod: 12 hours light/dark.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 g/rabbit
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 1 male and 2 females
- Details on study design:
-
SCORING SYSTEM
The eye were examined and the grade of ocular reaction recorded at 1, 24, 48 and 72 hours after treatment.
Draize 1959; Appraisal of the Safety of Chemical in Foods, Drugs and Cosmetics, Association of Food and Drug Officials of the United States.
Corneal opacity
No ulceration or opacity 0
Scattered or diffuse areas, details of iris clearly vsible 1
Easily discernible translucent area, details of iris slightly obscured 2
Opalescent areas, no details of iris visible, size of pupil barely discernible 3
Opaque, iris not discernible through the opacity 4
Area of cornea affected
No ulceration or opacity 0
One quarter or less but not zero 1
Greater than one quarter, but less than half 2
Greater than half, but less than three quarters 3
Greater than three quarters, up to whole area 4
Iris
Normal 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia 1
No reaction to light, haemorrhage, gross destruction 2
Conjuctival redness
Vessels normal 0
Vessels definitely injected above normal 1
More diffuse, deeper crimson red, individual vessels not easily discernible 2
Diffuse beefy red 3
Conjunctival oedema (chemosis)
No swelling 0
Any swelling above normal 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids more than half closed 4
Discarge
No discharge 0
Any amount different from normal 1
Discharge with moistening of the lids and hairs 2
Discharge with moistening of the lids and hairs, in a considerable area 3
In addition the colouration of sclera/cornea was recorded in connection with the colour of the test compound.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 1
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 1
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2
- Reversibility:
- fully reversible within: 72 hrs in 2 out of 3 animals; no information about the 3rd animal because the test was stopped at 72 hrs
- Irritation parameter:
- chemosis score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2
- Reversibility:
- fully reversible within: 48 hrs
- Irritant / corrosive response data:
- Under the conditions of the test, the substance was found to cause no irritation when applied to rabbit eye mucosa.
No discolouration of the cornea and conjunctivae which could be related to compound effects was observed.
The primary irritaiton index was found to be 3.3
No corrosion effect was observed at each of the measuring intervals.
Any other information on results incl. tables
Individual reactions
Animal No | Reaction | 1 hr | 24 hrs | 48 hrs | 72 hrs | Mean 24/48/72 hrs |
374 M | Cornea opacity | 0 | 0 | 0 | 0 | 0.00 |
375 F | Cornea opacity | 0 | 0 | 0 | 0 | 0.00 |
376 F | Cornea opacity | 0 | 0 | 0 | 0 | 0.00 |
374 M | Iris | 0 | 0 | 0 | 0 | 0.00 |
375 F | Iris | 0 | 0 | 0 | 0 | 0.00 |
376 F | Iris | 0 | 0 | 0 | 0 | 0.00 |
374 M | Conjunctival redness | 2 | 1 | 1 | 1 | 1.00 |
375 F | Conjunctival redness | 1 | 0 | 0 | 0 | 0.00 |
376 F | Conjunctival redness | 2 | 1 | 1 | 0 | 0.67 |
374 M | Conjunctival chemosis | 1 | 1 | 0 | 0 | 0.33 |
375 F | Conjunctival chemosis | 1 | 0 | 0 | 0 | 0.00 |
376 F | Conjunctival chemosis | 1 | 0 | 0 | 0 | 0.00 |
374 M | Conjunctival discharge | 2 | 2 | 0 | 0 | - |
375 F | Conjunctival discharge | 1 | 0 | 0 | 0 | |
376 F | Conjunctival discharge | 1 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified, according to CLP Regulation (EC) No1272/2008
- Conclusions:
- Not eye irritating
- Executive summary:
The eye irritation potential of te test item was assessed in accordance with method and procedures outlined into the OECD guideline 405. 0.1 g of test substance were placed in the rabbit eyes, which were not rinsed. The eye were examined and the grade of ocular reaction recorded at 1, 24, 48 and 72 hours after treatment, according to the Draize system (1959) and in accordance with the Appraisal of the Safety of Chemical in Foods, Drugs and Cosmetics, Association of Food and Drug Officials of the United States criteria.
Under the conditions of the test, the substance was found to cause no irritation when applied to rabbit eye mucosa. No discolouration of the cornea and conjunctivae which could be related to compound effects was observed. The primary irritaiton index was found to be 3.3
No corrosion effect was observed at each of the measuring intervals.
Conclusion
The mean values from grading at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for irtitis, lower than 2 for both conjunctival redness and oedema, in all animals. No corrosion effect was observed at each of the measuring intervals. In one case the recovery of the redness cannot be judged because the test was stopped before; nevertheless, based on the severity of the effect observed and the decrease over the test period, the lacking of this information can be considered as not critical and not impacting the test outcomes conclusion.
Thus, the substance can be considered as non irritating to eye, according to the CLP Regulation (EC) No 1272/2008.
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