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EC number: 292-835-4 | CAS number: 91001-64-8
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was conducted according to internationally accepted technical guidelines and in compliance with GLP in a contract research organization. The study is scientifically valid and the report is fully adequate for assessment, despite some minor restrictions (e.g. due to limited reporting).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- of 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, Division of Pharmacology, FDA
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Tattooed New Zealands (albino rabbit)
- Details on test animals or tissues and environmental conditions:
- - Number: 6 animals,
- Bodyweight: 2.8 to 3.2 kg
- Housing: Individual housing in cages.
- Diet: Commercially available standard laboratory diet for rabbits ( Altromin, Lage, Germany).
Prior to dosing the animals were starved for 16 hours.
- Water: Ad libitum
ENVIRONMENTAL CONDITIONS
Room temperature kept constant at 18±2°C, the relative humidity at 50-60%. 12 hours illumination per day.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 ml of undiluted liquid test substance was administered into the conjunctival sac of one eye per rabbit. The contralateral eye remained untreated to serve as a control.
- Duration of treatment / exposure:
- There was no mentioning in the report that eyes were rinsed after treatment. Consequently the treatment/exposure period was equivalent to the entire observation period following administration, which was 7 days, or lasted until removal of the test material by physiological mechanisms, whichever happened sooner.
- Observation period (in vivo):
- 7 days (i.e. the final observation time point was 7 days post instillation)
- Number of animals or in vitro replicates:
- 6 adult rabbits
- Details on study design:
- Before and after the test the eyes were evaluated for occular lesions using ultraviolet light.
The numerical scoring system listed in Table 1 in the field below was adopted. Time points of evaluation were: Pretest (prior to treatment), 1, 2, 4, 8, 24, 48, 72 and 96 hours after administration and daily thereafter until 7 days after administration. Grades attained at 24, 48 and 72 hours after administration were included in the mean gradings of ocular lesions used for eye irritation/corrosion classification.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- over 6 animals and 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Corneal irritation or opacity was not evident during the study
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- over 6 animals and 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Iridal changes were not evident during the study
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Remarks:
- over 6 animals and 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #4
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #5
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #6
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- over 6 animals and 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 2.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- other: lacrimation score
- Basis:
- mean
- Remarks:
- over 6 animals and 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Irritant / corrosive response data:
- Corneal and iridic lesions were not evident throughout the study. Conjunctival redness, grade 2, was seen in all treated eyes until 72 hours post instillation, declining in severity thereafter and having completely disappeared in all animals by 5 to 6 days post instillation. Chemosis, grade 2 or 3, was seen in all treated eyes until 48 or 72 hours post instillation, declining in severity thereafter and having completely disappeared in all animals by 5 days post instillation. In addition, lacrimation, grade 1 or 2 was recorded in all treated eyes until 72 hours post instillation. As from 5 to 6 days post instillation, each treated eye was free from ocular findings.
- Other effects:
- There was no mentioning of any other effects in the report.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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.
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