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Diss Factsheets
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EC number: 237-222-4 | CAS number: 13701-59-2
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 12 December, 1978 - 4 January, 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The quantiy of test material instilled in the sac of the eyes is not known. The study should have been carried out beyond 7 days to show reversibility in the animal that showed corneal opacity. Conducted prior to GLP, and the availability of OECD guidelines. No information on the purity of the test sample, limited information on the animals and the conditions of the testing (such as no information on temperature, humidity, how the test substance is instilled etc...).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Eye irritation was tested in 3 rabbits. Test substance was instilled into the eyes of the rabbits. The eyes were then washed for 1 minute with lukewarm water 30 seconds after instillation of the test material. The rabbits were observed for 72 hours. Corneal opacity and area, iris, and conjunctivae redness, chemosis and discharge were scored at the 24 hour, 48 hour, 72 hour and 7 day time points.
- GLP compliance:
- no
Test material
- Reference substance name:
- BUSAN 11-M1
- IUPAC Name:
- BUSAN 11-M1
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): BUSAN 11-1M
- Substance type: No data
- Physical state: No data
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No.: 47601
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: No data
- Other: No data
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Lesser's Rabbitry, Union Grove, WI
- Age at study initiation: No data
- Weight at study initiation: Males 2610 - 3058 g, female 3618 g
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data
IN-LIFE DATES: From: 88/12/1979 To: 04/01/1979
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): No data - Duration of treatment / exposure:
- 30 seconds
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 (2 male and 1 female)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes were then washed for 1 minute with lukewarm water
- Time after start of exposure: 30 seconds
SCORING SYSTEM:
Draize, J.H. 1965, Appraisal of the safety of chemicals in foods, drugs and cosmetics, Associateion of the Food and Drug Officials of the US, Topeka, Kansas
TOOL USED TO ASSESS SCORE: No data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: mean of 24, 48, 72 timepoints
- Score:
- 0.55
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: A further timepoint may have established reversibility
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: mean of 24, 48, 72 timepoints
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: mean of 24, 48, 72 timepoints
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: mean of 24, 48, 72 timepoints
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- No further data
- Other effects:
- No further data
Any other information on results incl. tables
No further data
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material caused mild and transient irritation to the eyes which is expected to be fully reversible and therefore is not classified for eye irritation/corrosion.
- Executive summary:
In a study conducted in 1979, the potential of the test substance Busan 11-M1to cause irritation to the eyes was determined in rabbits. Three New Zealand White rabbits were administered a single ocular dose of the test substance unchanged. After 30 seconds, the eyes were washed for 1 minute with lukewarm water. The test animals were observed for 7 days after instillation. Following application, the treated eyes elicited corneal opacity and conjunctival irritations. However, the conjunctival irritations had resolved by 7 days after instillation and it is expected that the cornea opacity would be fully reversible also, had the further time point of 14 days been examined. Based on these results, the test substance does not warrant classification for eye irritation in accordance with Regulation EC No. 1272/2008.
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.
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