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EC number: 269-304-0 | CAS number: 68214-62-0
- 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
- Remarks:
- source of read across
- Adequacy of study:
- key study
- 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:
- 1 984
- Report date:
- 1984
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- May 12, 1981
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Similar Substance 02
- IUPAC Name:
- Similar Substance 02
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 Madoerin AG, CH 4414 Fuellinsdorf / Switzerland.
- Age at study initiation: 14 - 15 weeks
- Weight at study initiation: 2.4 - 2.9 kg.
- Housing: individually in stainless steel cages equipped with a automatic cleaning and drinking system.
- Diet: pelleted standand KIiba 341, Batch 94/84 rabbit maintenance diet ("KIiba", Klingentalmuehle AG, Switzerland), ad libitum.
- Water: community tap water from Itigen, ad libitum.
- Acclimation period: four days under Iaboratory conditions, after veterinary examination.
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 55 ± 10 %
- Air changes: 15 air changes per hr.
- Photoperiod: 12 hrs dark / 12 hrs light.
- Other: at least 8 hours music/light period.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- A single dose was administrated to the left eye of each animal. The individual dose volume was 0.1 g per animal.
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 1 male and 2 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: eyes were not rinsed.
OBSERVATIONS
- Viability/mortality: daily.
- Body weight: pre-test, day 1 and at termination of test on Mettler PK 16 balance.
SCORING SYSTEM
The eyes of each animal were examined 1, 24, 48, 72 hours and 7 days after administration. The irritation was assessed according to the OECD guideline for testing of Chemicals, Section 4, number 405 "Acute Eye Irritation/Corrosion" adopted May 12, 1981.
The corrosive properties of the test article and the color of the treated eye were described and recorded.
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
- Reversibility:
- fully reversible within: 48 hrs
- 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: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2
- Reversibility:
- fully reversible within: 72 hrs
- Irritant / corrosive response data:
- Under the conditions of the experiment, the test item was found to cause a primary irritation score of 2.2 when applied to the rabbit eye mucosa.
In the area of application a bluish dicoloration of the conjunctivae was observed within 1 hour after treatment; this could be related to effects of the test article.
No corrosion was observed at each of the measuring intervals. - Other effects:
- TOXIC SYMPTOMS/MORTALITY
No acute toxic symptoms were observed in the animlas during the test period and no mortality occurred.
BODY WEIGHT
The body weight gain of all rabbits was similar.
Any other information on results incl. tables
Eye irritation score
Animal N. | Reaction | After | Mean 24/48/72 hrs | ||||
1 hr | 24 hrs | 48 hrs | 72 hrs | 7 days | |||
320 M | Cornea opacity | 1 | 1 | 0 | 0 | 0 | 0.33 |
321 F | Cornea opacity | 0 | 0 | 0 | 0 | 0 | 0.00 |
322 F | Cornea opacity | 0 | 0 | 0 | 0 | 0 | 0.00 |
320 M | Iris | 0 | 0 | 0 | 0 | 0 | 0.00 |
321 F | Iris | 0 | 0 | 0 | 0 | 0 | 0.00 |
322 F | Iris | 0 | 0 | 0 | 0 | 0 | 0.00 |
320 M | Conjuntivae redness | 1 | 2 | 2 | 1 | 0 | 1.67 |
321 F | Conjuntivae redness | 1 | 1 | 1 | 1 | 0 | 1.00 |
322 F | Conjuntivae redness | 1 | 1 | 1 | 1 | 0 | 1.00 |
320 M | Conjunctivae chemosis | 2 | 2 | 1 | 0 | 0 | 1.00 |
321 F | Conjunctivae chemosis | 2 | 1 | 0 | 0 | 0 | 0.33 |
322 F | Conjunctivae chemosis | 2 | 1 | 0 | 0 | 0 | 0.33 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified, according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Not irritating
- Executive summary:
Three rabbits were used to test the eye irritation potential of the substance, in accordance with OECD guideline 405. 0.1 g of the undiluted test material were placed into the conjunctival sac. The eyes of each animal were examined 1, 24, 48, 72 hours and 7 days after administration. Reading scores for ocular lesions were made according to the OECD guideline for testing of Chemicals, Section 4, number 405 "Acute Eye Irritation/Corrosion" adopted May 12, 1981.
Under the conditions of the experiment, the test item was found to cause a primary irritation score of 2.2 when applied to the rabbit eye mucosa. In the area of application a bluish dicoloration of the conjunctivae was observed within 1 hour after treatment; this could be related to effects of the test article. No corrosion was observed at each of the measuring intervals.
Conclusion
The mean values from gradings at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for iritis, lower than 2 for both conjunctival redness and chemosis, in all the tested animals. All the reactions were fully reversible.
Thus, the substance does not meet the criteria to be classified as eye irritating, according to the CLP Regulation (EC 1272/2008).
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